Ha, Richard From: Sent: To: Cc: Subject: Sandoval, Camilo J. Tuesday, March 06, 2018 7:13 PM O'Rourke, Peter M. Hayes-Byrd, Jacquelyn FW: [EXTERNAL] Fwd: EMR FYI…    From: Sandoval, Camilo J. Sent: Tuesday, March 06, 2018 7:12 PM To: Blackburn, Scott R. Subject: RE: [EXTERNAL] Fwd: EMR Is Bruce’s email one of the questions you think we’ve already answered in the past?     Can I offer a suggestion? Could we possibly create a tracker on all the incoming questions/answers? I believe this might  clarify the question and help get a quicker reply and keep everyone on the same page. Example below based on what  Bruce requested today.    Thoughts?      Question/Topic  Follow‐Up Questions  Response/Comments  1. Cloud   Are we getting the cloud   Document reference ?  correctly   Strategy?   POC?    2. CIO   Candidate Pool?      Key Qualifications?   Separation of roles?  3. Physician Input   Patient Centric?      Physician Usability Scope?     4.         5. Apple Project      Who is POC?   Project update?   Mental Health Strategy and  Portable EMR Solution that  works with DOD & VA &  Community?    6.         7.             From: Blackburn, Scott R. Sent: Tuesday, March 06, 2018 5:05 PM 1 0287 To: Sandoval, Camilo J. Subject: FW: [EXTERNAL] Fwd: EMR Sent with Good (www.good.com) From: David Shulkin Sent: Tuesday, March 06, 2018 7:09:43 AM To: Blackburn, Scott R. Subject: [EXTERNAL] Fwd: EMR Can we begin to address and then ill respond back? Sent from my iPhone Begin forwarded message: (b) (6) From: Bruce Moskowitz @mac.com> Date: March 5, 2018 at 6:49:58 AM EST (b) (6) (b) (6) To: @gmail.com, @reagan.com (b) (6) (b) (b) (6) Cc: @gmail.com, IP <(6) @frenchangel59.com>, Subject: EMR @gmail.com I would like to underscore the importance of getting the “Cloud”correctly and the other four issues with the new CIO’s. Also the composition of the physician input has to change immediately so that the EMR is patient centric and usable from the physician perspective. Second this is going to take years to implement and especially in mental health we need a portable EMR solution that works with the DOD, the VA and the private sector. No one at the VA got back to me on what the Apple project can and can not do in terms of solving this problem. Sent from my iPad Bruce Moskowitz M.D. 2 0288 Ha, Richard From: Sent: To: Cc: Subject: Hayes-Byrd, Jacquelyn Tuesday, March 13, 2018 4:40 PM Kuy, SreyRam (HOU) (b) (6) FW: Medical Device Registry Call - Wed 3/14/2018 at 7:30 am Good afternoon,    Thank you I can be there. I am including (b) (6)   Jacquie  Jacquelyn Hayes‐Byrd, Deputy Chief of Staff  US Department of Veterans Affairs  Jacquelyn.Hayes‐Byrd@va.gov  Cell:  202‐817‐5873         on this email to ensure that the time/date is on my schedule.  From: Kuy, SreyRam (HOU) Sent: Tuesday, March 13, 2018 4:36 PM To: Hayes-Byrd, Jacquelyn; (b) (6) Cc: O'Rourke, Peter M. Subject: Medical Device Registry Call - Wed 3/14/2018 at 7:30 am   Hi Jacquie!  Great seeing you again today (briefly)!  I spoke with Peter today about an effort around developing a Medical Device  Registry, in collaboration with Bruce Moskowitz and his colleagues.  We have a weekly call with the workgroup on  Wednesdays at 7:30 am, and Peter suggested we hold tomorrow’s call at 7:30 am in his office, and if you have time,  perhaps you could join?  I’ll forward the invite to you.  Let me know if you have any questions at all!      Thank you!  ‐Srey   (713‐503‐4274)      SreyRam Kuy, MD    Special Advisor to the Secretary  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  Washington, DC 20420  1 0289 Mobile: 713-503-4274 Office: 202-461-4875 0290 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, March 13, 2018 6:08 PM (b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; (b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: Attachments: Medical Device Registry Summit - Planning Meeting, Wednesday March 14, 2018 at 7:30 am Eastern, Conference call line: 800-767-(b) (5) Code (b) (5) Medical Device Registry Summit - 1 pager.pdf; Summit Planning Meeting - Minutes.docx Dear Colleagues,      For our planning meeting on Medical Device Registry tomorrow morning, attached is a 1 pager (double sided), which can  be used for discussion with outside stakeholders.  Also, I’ve attached meeting minutes from both prior conference  calls.  The minutes are displayed chronologically, with the most recent at the end.  I’ve also invited a few other  colleagues to join the call, depending on their availability.  And many apologies to our west coast colleagues for the very  early time    Conference call line:  800‐767‐(b) (5)  Code (b) (5)   Wednesday March 14, 2018 at 7:30 am Eastern    Thank you so much for all your enthusiasm and support for this effort!    Warmly,  SreyRam          SreyRam Kuy, MD    Special Advisor to the Secretary  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      1 0291 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners:      Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts:  SreyRam Kuy, MD SreyRam.Kuy@va.gov  @va.gov (b) (6) 0292 Medical Device Registry Summit Month, Day, 2018 Draft Agenda Meeting Objective: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts 1. Welcome and introductions of participants and organization 2. Moderated Roundtable Discussion with Key Agency Leadership      Panel Moderator – facilitates with questions Secretary of the VA FDA Commissioner (TBD) CMS leadership (TBD) HHS Leadership (TBD) 3. Topic Focused Presentations  Why Registries Matter – Data about how it helps lower costs, improve outcomes – Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management – Speaker  Other Key Topics 4. Closing Remarks, Thanks to Participants, Outline Key Next Steps  Speaker TBD 0293 SreyRam Kuy, MD (b) (6) Draft, Pre-Decisional, Only for Internal VA use Medical Device Registry Summit February 21, 2018 Meeting Minutes Meeting Objective: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts 1. Welcome and introductions of participants and organization Last Name Moskowitz Organization Role Bruce Bruce Danica McIntosh Moskowitz Marinac-Dabic Veterans Affairs NCPS SreyRam Thomas Kuy Concannon Veterans Affairs Special Advisor to the Secretary First Name Aaron (b) (6) (b) (6) 2. Discuss current state of VA/UDI Current state of VA • Product recall office in the VA takes 0-10 days to initiate a recall, with an estimated 99% recall rate • Bruce is conducting a stop-gap analysis focusing on implants, both biologic and non-biologic (mostly biological tissue in the VA population) • Suggestion from Danica: expand stop-gap analysis to close calls UDI • CFR requires UDI manufacturers • Getting information on the implanted devices, see if you can make that fast and easily go into patient medical records Track what gets implanted • • However, UDI has some push back from manufacturers, including: o Too expensive, small manufacturers who cannot afford it o Might not work for all devices because of packaging o Should be acquired by anyone purchasing a device o GUDID database  Need to bring in all these data sources and get an API to bring into your system 3. Discuss purpose and goals for the “Medical Device Registry” ; 0294 SreyRam Kuy, MD (b) (6) Draft, Pre-Decisional, Only for Internal VA use Registry’s Importance for Patients • Patients do not know the manufacturer of devices or type of device o This becomes an issue if they do not know why their device needs to get a revision • Need to capture this importation and develop a national registry to easily do recall • Need tracking system and registry 4. Discuss purpose and goals for the “Medical Device Registry” Summit Narrow the Focus to Make It Specifically about the Problem • What people are interested in: o Cost benefit analysis • 400% price reduction for manufacturers • Implant registry improves cost and quality with a good system o Not just in case of error; the registry can act as an early detection system o Really hopes for longer standing registries where you get outcome reports from them, pull something from the market if quality or safety is lower (i.e. if the device is not doing its job) o The registry will be a valuable resource and tool • Patient groups would love to use information to fund the study for feedback with people with devices o Many research opportunities (b) (6) can give input to incorporate outcomes • • Can locate a device in an organization (RSLD) such as an IV pump, and can find a device in an organization • Can help in the long term improve their product, become safer, and of better quality than the competitor 5. Determine Format of the “Medical Device Registry” Summit Part 1 • Discuss the rational for the Medical Device Registry, including use cases, purpose, etc. • Hear from each stakeholder, perspective, what is in it for them, barriers, SWAT analysis (better, faster, cheaper) Part 2 • How to structure data capture; discuss stop gap analysis from NCPS and, potentially, the Mercy Hospital Study 6. Determine Panel of Speakers/Attendants Summit invitees should include: o Medtronic o Johnson and Johnson o Recommend smaller companies, like Titan o Invite a portfolio of patient groups (Danica going to send to us) (b) (6) group, nice demonstration of organic collection of data to large roundtable • • Need to invite an additional voice, preferable a front-line provider • Need to invite provider groups 7. Ideas for Medical Device Registry ; 0295 SreyRam Kuy, MD (b) (6) Draft, Pre-Decisional, Only for Internal VA use Idea: Have a Patient Safety Device Score People need to report o Train and educate people, do a root cause analysis, consider reporting structures • Learn from users’ experiences and use their issues (learning from the field, field is seeing this) • Open database through NIH, can match with registries for global device 8. Next Steps Forward • 1. Create agenda template: Danica o Draft agenda: SreyRam/(b) (6) 2. Initiate contact with key stakeholders: Danica/Aaron/(b) (6) 3. Reach out for speakers and attendance (e.g. patient advocacy groups, manufacturers, provider groups, Cerner, major medical journals, etc.): Danica/Aaron/(b) (6) 4. Look for summit venues: Aaron ((b) (6) can help as well) 5. Create one-pager of summit or project, and modify for external audience: SreyRam 6. Pick a date, based on FDA’s calendar: (b) (6) February 28, 2018 Meeting Minutes First Name Aaron Last Name Moskowitz (b) (6) Bruce McIntosh (b) (6) SreyRam Kuy Role Organization Biomedical Research and Education Foundation Global Healthy Living Foundation NCPS Veterans Affairs Veterans Affairs Global Healthy Living Foundation Special Advisor to the Veterans Affairs Secretary 1. Discuss symposium speakers - For the symposium, it may be beneficial to have an unbiased third party speaker, such as an academic or consultant - A speaker who can talk about what already exists in terms of medical registries - Have a speaker on the UDI 2. Discuss outreach - Participants on this call, such as (b) (6) and Aaron, are going to reach out to patient advocacy groups, provider groups, medical device groups, etc. - (b) (6) will have informal calls to reach out to people; he wants a common message or paragraph we want to send out to experts ; 0296 SreyRam Kuy, MD (b) (6) Draft, Pre-Decisional, Only for Internal VA use - SreyRam will reach out to Secretary Shulkin to reach out to counterparts 3. Discuss location - DJS recommended we use the VA auditorium 4. Discuss dates - Calendars- tell everyone to email potential conflicts - However, Bruce noted that as long as we get CMS and VA leadership, others will send someone of important, won’t want to be left out with major players of the audience 5. Action Items - One pager (vague without any promises for external use) with “common message” that can be used in informal phone calls: SreyRam - Send one pager to experts/industry leaders to invite them into the conversation: Aaron, (b) (6) and Danica ; 0297 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, March 20, 2018 4:06 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) Hayes-Byrd, Jacquelyn; (b) (6) Subject: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5) Attachments: Medical Device Registry Summit - 1 pager.pdf; Medical Device Registry Summit - 1 pager.docx Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday 3/21/2018  7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       We’ve made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more  detailed agenda, with locations, possible time and a slate of speakers.  Several fantastic subject matter experts on board  to participate!  This is a draft ‐ welcome all your input, ideas, revisions!  Feel to revise the editable word doc and share  with us all.        Again, many apologies to our west coast colleagues for the very early time.    Thank you so much for all your efforts!    Warmly,  SreyRam    Special Advisor to the Secretary  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875            1 0298 0299 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership      3. Panel Moderator – facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each)  “Why Registries Matter” – Data about how it helps lower costs, improve outcomes • Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management • Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA  “Enabling Patient Participation in Device Registries” – Title TBD • Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University  “Current Cardiac Device Monitoring in the VA” • Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  “Current VA Medical Device Registries in Place” - Maximo • (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  “Building Future-State Model for VHA Implant Tracking” • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety  “Title TBD” • Frederic Resnic, MD  Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners” • Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0300 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • @va.gov (b) (6) 0301 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership      3. Panel Moderator – facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each)  “Why Registries Matter” – Data about how it helps lower costs, improve outcomes  Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management  Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA  “Enabling Patient Participation in Device Registries” – Title TBD  Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University  “Current Cardiac Device Monitoring in the VA”  Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  “Current VA Medical Device Registries in Place” - Maximo  (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  “Building Future-State Model for VHA Implant Tracking”  Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety  “Title TBD”  Frederic Resnic, MD  Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners”  Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0302 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners:      Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts:  SreyRam Kuy, MD SreyRam.Kuy@va.gov  @va.gov (b) (6) 0303 Ha, Richard From: Sent: To: Subject: Hayes-Byrd, Jacquelyn Wednesday, March 21, 2018 9:44 AM (b) (6) ; Kuy, SreyRam (HOU); (b) (6) GHLF; Bruce Moskowitz; Aaron Moskowitz; (b) (6) Thomas Concannon; McIntosh, Bruce (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) RE: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting, Wednesday March 14, 2018 at 7:30 am Eastern, Conference call line: 800-767-(b) (5) Code (b) (5) Thank you!        Sent with Good (www.good.com)    From: (b) (6) Sent: Tuesday, March 20, 2018 1:33:48 PM To: Kuy, SreyRam (HOU); (b) (6) GHLF; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) '; (b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: RE: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting, Wednesday March 14, 2018 at 7:30   am Eastern, Conference call line: 800-767-(b) (5) Code (b) (5) Hello everyone: Apologies for the delay in sending the one‐pager with comments/suggestions back from last week’s  discussion. Please see attached  for minor suggestions and look forward to talking tomorrow morning!        (b) (6) , PhD, MPH   (b) (6)  Patient‐Centered Research  Global Healthy Living Foundation  515 N. Midland Ave ‐ Upper Nyack, NY 10960  Cell: +1 (646) 427 (b) (6)    Office: +1 (845) 348 (b) (6)    Fax: +1 (845) 348 (b) (6)   (b) (6) @ghlf.org  GHLF.org   CreakyJoints.org   ArthritisPower.org  Facebook.com/CreakyJoints   Twitter.com/CreakyJoints   Twitter.com/GHLForg    Improving the lives of people with chronic disease through better access to care, education, support, advocacy and patient-centered research.                                           1 0304 From: Kuy, SreyRam (HOU)    Sent: Wednesday, March 14, 2018 10:34 AM  To: (b) (6) @ghlf.org>; (b) (6)  GHLF (b) (6) @ghlf.org>; Bruce Moskowitz  (b) (6) (b) (6) < @mac.com>; Aaron Moskowitz < @me.com>; Thomas Concannon  (b) (6) @rand.org>; McIntosh, Bruce (NCPS) <(b) (6) @va.gov>; (b) (6) @atlasresearch.us>;  (b) (6)  (Atlas Research) (b) (6) @va.gov>; 'Marinac‐Dabic, Danica' <(b) (6) fda.hhs.gov>; '(b) (6) dc‐crd.com>; (b) (6) @dc‐crd.com>; (b) (6)   (b) (6)   @va.gov>; Hayes‐Byrd, Jacquelyn ;  (b) (6) va.gov>  Subject: RE: [EXTERNAL] RE: Medical Device Registry Summit ‐ Planning Meeting, Wednesday March 14, 2018 at 7:30 am  Eastern, Conference call line: 800‐767‐(b) (5)  Code (b) (5)      Thank you everyone for your great input and effort on this project!     (b) (6)  great question.  Here is the double‐sided one pager, as an editable word version (attached).  I made it as “track‐ changes” enabled, so changes can be seen.  I think it’s reasonable to share revisions and changes with the whole group.       Again, thanks for all your hard work and looking forward to a successful summit in June!     Warmly,  SreyRam     SreyRam Kuy, MD     Special Advisor to the Secretary  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center     810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875        From: (b) (6) [mailto:(b) (6) @ghlf.org] Sent: Wednesday, March 14, 2018 9:47 AM To: Kuy, SreyRam (HOU); (b) (6) GHLF; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) Atlas Research); 'Marinac-Dabic, Danica'; (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) Subject: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting, Wednesday March 14, 2018 at 7:30 am   Eastern, Conference call line: 800-767-(b) (5) Code (b) (5)    Hi Srey Ram: Thanks again for these conference calls with the group – exciting to see how wonderfully this is developing!  Shall we make comments/edits to the one‐pager you sent us in word version or are we waiting on another version from  you? And are we sending back the document with comments to everyone in the group or just you‐ I ask for version  control purposes.   ‐‐S  2 0305       (b) (6) , PhD, MPH   (b) (6) Global Healthy Living Foundation   Patient‐Centered Research  515 N. Midland Ave ‐ Upper Nyack, NY 10960  Cell: +1 (646) 427 (b) (6)    Office: +1 (845) 348 (b) (6)    Fax: +1 (845) 348 (b) (6)   (b) (6) @ghlf.org  GHLF.org   CreakyJoints.org   ArthritisPower.org  Facebook.com/CreakyJoints   Twitter.com/CreakyJoints   Twitter.com/GHLForg      Improving the lives of people with chronic disease through better access to care, education, support, advocacy and patient-centered research.                                   From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov]   Sent: Tuesday, March 13, 2018 18:08  To: (b) (6)  GHLF <(b) (6) @ghlf.org>; Bruce Moskowitz <(b) (6) @mac.com>; Aaron Moskowitz  (b) (6) < @me.com>; Thomas Concannon <(b) (6) @rand.org>; McIntosh, Bruce (NCPS)  (b) (6) @va.gov>; (b) (6) @atlasresearch.us>; (b) (6)  (Atlas Research)  <(b) (6) @va.gov>; 'Marinac‐Dabic, Danica' <(b) (6) fda.hhs.gov>; (b) (6)   (b) (6) @ghlf.org>; '(b) (6) dc‐crd.com>; '(b) (6) @dc‐crd.com>; (b) (6)   (b) (6) @va.gov>; Hayes‐Byrd, Jacquelyn ;    (b) (6) va.gov>; (b) (6) @va.gov>  Subject: Medical Device Registry Summit ‐ Planning Meeting, Wednesday March 14, 2018 at 7:30 am Eastern,  Conference call line: 800‐767‐(b) (5)  Code (b) (5)      Dear Colleagues,      For our planning meeting on Medical Device Registry tomorrow morning, attached is a 1 pager (double sided), which can  be used for discussion with outside stakeholders.  Also, I’ve attached meeting minutes from both prior conference  calls.  The minutes are displayed chronologically, with the most recent at the end.  I’ve also invited a few other  colleagues to join the call, depending on their availability.  And many apologies to our west coast colleagues for the very  early time     Conference call line:  800‐767‐(b) (5)  Code (b) (5)   Wednesday March 14, 2018 at 7:30 am Eastern     Thank you so much for all your enthusiasm and support for this effort!     Warmly,  SreyRam           3 0306    SreyRam Kuy, MD     Special Advisor to the Secretary  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center     810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875        4 0307 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership      3. Panel Moderator – facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each)  “Why Registries Matter” –Matter” – Data about how it helps lower costs, improve outcomes • Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management • Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA  “Enabling Patient Participation in Device Registries” – Title TBD • Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University  “Current Cardiac Device Monitoring in the VA” • Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  “Current VA Medical Device Registries in Place” - Maximo • (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  “Building Future-State Model for VHA Implant Tracking” • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety  “Title TBD” • Frederic Resnic, MD  Talks by other stakeholders (Amazon, Medtronic) TBD 4. Commented [S1]: If this is going to be a document we are circulating I was wondering if it may work better for this page to be page 2, and what is currently page 2, to be page 1- to provide more context and framing. Commented [S2]: Since this is an introductory session (I’m assuming), wondering if the “Why registries matter” topic could also include “Perspectives on registries (thereby including a multi-stakeholder perspective) and spanning things like a) surveillance, b) post-market observation, c) Best practices sessions or models of current registries, d) Hurdles and obstacles e) Some kind of data on integrating clinical and PROs? The idea being that each topic could relate to a different stakeholder. Just a thought. Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners” • Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0308 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Commented [S3]: Would be useful to add “Aims” as well to this- this will allow us to highlight the “multi-stakeholder” focus of the conference. It would also nicely lead into participating partners. Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov (b) (6) • @va.gov 0309 Ha, Richard From: Sent: To: Cc: Subject: Kuy, SreyRam (HOU) Tuesday, March 27, 2018 6:11 PM Hayes-Byrd, Jacquelyn (b) (6) RE: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) (b) (5) Jacquie,  Thank you!!!  ‐Srey        From: Hayes-Byrd, Jacquelyn Sent: Tuesday, March 27, 2018 5:30 PM To: Kuy, SreyRam (HOU) Cc: (b) (6) Subject: RE: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5)   Hello!    I have reserved the 2nd floor conference room in this bldg. for the Summit.  Let me know if I am off base.    Thanks,    Jacquie    From: Kuy, SreyRam (HOU) Sent: Tuesday, March 27, 2018 5:05 PM To: '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5)   Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday 3/28/2018  7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)     Thank you so much for all your efforts!    Warmly,  SreyRam        1 0310 Code SreyRam Kuy, MD, MHS, FACS    Special Advisor to the Secretary  Senior Advisor to the PDUSH  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      2 0311 Ha, Richard From: Sent: To: Subject: Hayes-Byrd, Jacquelyn Thursday, March 29, 2018 6:20 AM (b) (6) RE: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5) Thank you    From: (b) (6) Sent: Wednesday, March 28, 2018 6:46 AM To: Hayes-Byrd, Jacquelyn Subject: RE: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5)   Ok, this event is confirmed. I can reach out to Dr. SreyRam to identify the type of logistical support she will need (Power  Point, Microphone, Banner, etc)        Monday, June 04, 2018 7:00 AM - 5:00 PM Medical Supply Conference (Web Confirmed) VACO RM 230/330       (b) (6) retary 810 Vermont Ave, NW Washingt DC 20420 (b) (6) (b) (6) VA Core Values: @va.gov egrity, Commitment, Advocacy, Respect, and Excellence—I CARE   From: Hayes-Byrd, Jacquelyn Sent: Tuesday, March 27, 2018 5:29 PM To: (b) (6) Subject: FW: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5)   This Subject is the 2nd floor reservation title for June 4, 2018    From: Kuy, SreyRam (HOU) Sent: Tuesday, March 27, 2018 5:05 PM To: '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; (b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5)   Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    1 0312 Medical Device Registry Summit ‐ Planning Call  Wednesday 3/28/2018  7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)     Thank you so much for all your efforts!    Warmly,  SreyRam        SreyRam Kuy, MD, MHS, FACS    Special Advisor to the Secretary  Senior Advisor to the PDUSH  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      2 0313 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, April 03, 2018 4:57 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: Attachments: Medical Device Registry Summit - Planning Meeting Wednesday April 4 at 7:30 am: Conference call line 800-767-(b) (5) Code (b) (5) 3-28-2018 device registry meeting.docx Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday 3/28/2018  7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       Attached are the minutes from last week’s call.      Again, thank you so much for all your efforts!    Warmly,  SreyRam      SreyRam Kuy, MD, MHS, FACS    Senior Advisor to the PDUSH  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      1 0314 1 Medical Device Registry Symposium March 28, 2018 Meeting Minutes Meeting Objective: Bring together VA, FDA, and other federal agencies and key stakeholders for a national symposium about medical device registry efforts 1. Participants and organization First Name Aaron Last Name Moskowitz Bruce Bruce Danica McIntosh Moskowitz Marinac-Dabic (b) (6) (b) (6) SreyRam Thomas Kuy Concannon Organization BREF GHLF Veterans Affairs Food and Drug Administration DC-CRD DC-CRD Veterans Affairs GHLF Veterans Affairs RAND 2. Discuss updates Symposium Logistics • Auditorium Secured • SreyRam talking to DJS today to finalize date; DJS going to reach out to other leadership, such as HHS secretary and FDA commissioner (update: spoke with Chief of Staff, date finalized) Danica Speaker • Danica is going to reach out to Dr. (b) (6) and potentially add as speaker for return on investment for registries • Danica going to send one of his past presentations • Include a forum at the end; many “acronyms” we can invite to the forum , led pinnacle registry, and is part of the • Recommends that we consider (b) (6) American association for orthopedic surgeon coordinating a registry o Lots of recent developments, need to invite speakers who can move the needle DOD • Bruce having trouble finding someone significantly involved in implant registry at DOD Bruce Moskowitz • Wants to invite major manufacturers, big players, to be there in attendance • Bruce is going to invite the head of American Association of Surgeons to attend and relay info to their list serve Would there be controversy if J&J is asked to speak and metronics is not? Trying to avoid hot • water o Move the needle vs. politics discussion ; 0315 2 Shilpa • Our focus topics should reflect the speakers if such a way that our speakers will complement of all the topics 3. Action Item 4. Follow up with DOD- Bruce 5. Follow up with additional contacts she wants to include in this discussion- Danica 6. Reach out to orthopedics- (b) (6) 7. Finalize dates- SreyRam ; 0316 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, April 10, 2018 4:30 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: Attachments: Medical Device Registry Summit - Planning Meeting Wednesday April 11, 2018 at 7:30 am; Conference call line: 800-767-(b) (5) Code (b) (5) Medical Device Registry Summit - 1 pager.docx Dear colleagues,    Looking forward to catching up tomorrow for our weekly Wednesday morning call.    Here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday 4/11/2018  7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       I don’t think I’ve been emailed any revisions to the agenda yet (many apologies if you did send and I missed!).  So I’m  attaching the agenda ‐ welcome all your revisions!  I added the Pew Trust as a tentative participant.  Feel free to revise  the editable word doc (it’s track changes enabled) and share with us all.  Not too late to send in changes!      I owe Dr. Moskowitz a budget – Bruce and I are editing it.      Thank you so much for all your efforts!  Much appreciated!    Warmly,  SreyRam      SreyRam Kuy, MD, MHS, FACS    Senior Advisor to the PDUSH  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1022  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875    1 0317 0318 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD  CMS leadership (TBD)  HHS Leadership (TBD) 3. Topic Focused Presentations (15 minutes each)  “Why Registries Matter” – Data about how it helps lower costs, improve outcomes • Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management • Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA  “Enabling Patient Participation in Device Registries” – Title TBD • Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University  “Current Cardiac Device Monitoring in the VA” • Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  “Current VA Medical Device Registries in Place” - Maximo • (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  “Building Future-State Model for VHA Implant Tracking” • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety  “Title TBD” - Frederic Resnic, MD  “Title TBD” - Art Sedrakyan, MD  “Title TBD” – Pew Charitable Trust (tentative)  Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners” • Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0319 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • @va.gov (b) (6) 0320 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Thursday, April 05, 2018 4:59 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: Attachments: Medical Device Registry Summit - Planning Committee - Draft Agenda Medical Device Registry Summit - 1 pager.docx Hi Everyone!    Great conversation yesterday morning.  Attached is the draft agenda, “Track changes enabled”.  Please do revise and  add to it, and circulate your additions to the whole group.  All your efforts are greatly appreciated!    ‐SreyRam    SreyRam Kuy, MD, MHS, FACS    Senior Advisor to the PDUSH  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1022  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875        1 0321 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD  CMS leadership (TBD)  HHS Leadership (TBD) 3. Topic Focused Presentations (15 minutes each)  “Why Registries Matter” – Data about how it helps lower costs, improve outcomes • Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management • Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA  “Enabling Patient Participation in Device Registries” – Title TBD • Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University  “Current Cardiac Device Monitoring in the VA” • Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  “Current VA Medical Device Registries in Place” - Maximo • (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  “Building Future-State Model for VHA Implant Tracking” • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety  “Title TBD” - Frederic Resnic, MD  “Title TBD” - Art Sedrakyan, MD  Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners” • Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0322 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • @va.gov (b) (6) 0323 Ha, Richard From: Sent: To: McIntosh, Bruce (NCPS) Tuesday, April 10, 2018 10:30 PM Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) ; Hayes-Byrd, Jacquelyn;(b) (6) Subject: Attachments: RE: Medical Device Registry Summit - Planning Committee - Draft Agenda Medical Device Registry Summit - 1 pager_BMedits.docx I edited two names for spelling and added two VA physicians as potential speakers: Dr. Nicholas Giori has an innovative  approach to medical device registry outcome monitoring of orthopedic joint replacements, and Dr. Stephen Waldo who  leads VA CART‐CL (heart catheterizations‐ stents) where they have advanced to RTLS implant tracking and EHR  integration for stent and cardiac device implants in the EP labs.     Thanks,  Bruce     From: Kuy, SreyRam (HOU) Sent: Thursday, April 05, 2018 4:59 PM To: '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; (b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: Medical Device Registry Summit - Planning Committee - Draft Agenda   Hi Everyone!    Great conversation yesterday morning.  Attached is the draft agenda, “Track changes enabled”.  Please do revise and  add to it, and circulate your additions to the whole group.  All your efforts are greatly appreciated!    ‐SreyRam    SreyRam Kuy, MD, MHS, FACS    Senior Advisor to the PDUSH  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1022  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      1 0324 0325 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD  CMS leadership (TBD)  HHS Leadership (TBD) 3. Topic Focused Presentations (15 minutes each)  “Why Registries Matter” – Data about how it helps lower costs, improve outcomes • Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management • Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA  “Enabling Patient Participation in Device Registries” – Title TBD • Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University  “Current Cardiac Device Monitoring in the VA” • Merritt H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  “Current VA Medical Device Registries in Place” - Maximo • (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  “Building Future-State Model for VHA Implant Tracking” • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety  “Title TBD” - Frederic Resnic, MD  “Title TBD” - Art Sedrakyan, MD  “Title TBD” – Stephen Waldo, MD  “Title TBD” – Nicholas Giori, MD  Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners” • Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0326 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • @va.gov (b) (6) 0327 Ha, Richard From: Sent: To: Subject: Attachments: (Atlas Research) Tuesday, April 17, 2018 5:35 PM Marinac-Dabic, Danica; Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; (b) (6) Thomas Concannon; McIntosh, Bruce (NCPS); '(b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) ' Hayes-Byrd, Jacquelyn; Medical Device Registry Summit - Action Items Medical Device Registry Summit - Agenda - Dr. SreyRam Kuy.docx (b) (6) Hi team,    In preparation for our weekly call tomorrow, here are a few reminders from last week’s action items.    1.  Fill in the 3rd page of the agenda (agenda attached) with list of attendees/groups invited to the symposium— Everyone 2. Contact speakers for the title, topic, and content of their presentation (needed to ensure appropriate topics and  no redundancy)—Everyone  3. Send us contact information for the speakers so we can coordinate a call with them all prior to the event‐‐  Everyone  4. Create a draft to operationalize the “formal and structured interaction between attendees”—(b) (6)   a. Add this to the agenda draft—(b) (6)   5. Create a draft to operationalize the “smaller discussion groups between or after the topic focused  presentations”—Danica  a. Add this to the agenda draft—(b) (6)   6. Edit agenda with track changes—Everyone     Thanks again everyone for all your hard work! Looking forward to our call tomorrow. Let us know if you have any  questions.    All the best,    SreyRam and (b) (6)     1 0328 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD  CMS leadership (TBD)  HHS Leadership (TBD) 3. Topic Focused Presentations (15 minutes each)  “Why Registries Matter” – Data about how it helps lower costs, improve outcomes • Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management • Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA  “Enabling Patient Participation in Device Registries” – Title TBD • Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University  “Current Cardiac Device Monitoring in the VA” • Merritt H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  “Current VA Medical Device Registries in Place” - Maximo • (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  “Building Future-State Model for VHA Implant Tracking” • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety  “Title TBD” - Frederic Resnic, MD  “Title TBD” - Art Sedrakyan, MD  “Title TBD” – Stephen Waldo, MD  “Title TBD” – Nicholas Giori, MD  “Title TBD” – Pew Charitable Trust (tentative)  Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners” • Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0329 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • va.gov (b) (6) 0330 List of Symposium Attendees/Groups: Name Af?liation Title {?u-gam- n1 ?rst Diffusion of Duffuslrg BEBE Flames .?cmstA' US, Department, Ha, Richard From: Sent: To: Concannon, Thomas <(b) (6) rand.org> Tuesday, April 17, 2018 5:51 PM (b) (6) (Atlas Research); Marinac-Dabic, Danica; Kuy, SreyRam (HOU); '(b) (6) Bruce Moskowitz; Aaron Moskowitz; McIntosh, Bruce (NCPS); (b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) GHLF'; (b) (6) Subject: [EXTERNAL] Re: Medical Device Registry Summit - Action Items For item 4 in the agenda, following is a draft plan for involving attendees actively in the summit. This plan follows from  the meeting aims (stated in my own words):   Aim1 is to unveil, learn about and discuss the VA national device registry plan   Aim 2 is to leverage the VA experience in the development and spread of other device registries     To accomplish both of these aims, we’ll need a systematic approach for identifying key stakeholder communities and  finding a way to meaningfully involve them in the meeting..     Identifying the stakeholder communities who can advance meeting aims. If we want to keep the list of stakeholder  communities contained for now, we could focus on the bolded groups that have already been mentioned during our  planning calls. If this is the right list of stakeholder communities, the next step is to extend invitations to flesh each  community out    1. The actors – the developers of device registries in other settings. These include AAOS, ECRI, DCRI, and others  2. Other stakeholders – those whose decision‐making depends on registries, including:  ∙ Policymakers who use registry data in regulatory decisions  ∙ Payers who use registry data in coverage determinations  ∙ ∙ ∙ ∙ ∙ Patient communities (GHLF, PPRNs, others) who use registries with patient‐centered data to report and  track health data and use it to plan care  Industry associations or representatives (Advamed, J&J, DePuy, others) who will increasingly use registries  with RWD in device development  Clinicians who use registry‐based evidence in clinical decision making  Researchers who use registries to produce new evidence  (and others)     Involving actors and stakeholders meaningfully. We need a quick plan that will not cost a lot of time and resources to  organize. The most effective approach will be to structure stakeholder listening sessions that are aligned with the  meeting agenda.      1. Danica is redrafting the agenda to group speaker sessions in some way. Presumably, this will give some shape to  the two aims. I proposed to organize stakeholder listening sessions around aim 2 and related topics: how we  leverage the VA experience in the development of device registries nationally.   2. The listening sessions should form a major part of any report and action plan that comes out of the summit. This  is what will make the summit reflective of multi‐stakeholder views and not just of the organizing committee.  3. We should allow for pre‐meeting feedback from stakeholder representatives on the draft of the agenda,  listening sessions, and proposed reporting and action plan.    (b) (6)       1 0332 (b) (6) (b) (6) From: " (Atlas Research)" < va.gov> Date: Tuesday, April 17, 2018 at 5:36 PM (b) (6) To: Danica Marinac-Dabic < fda.hhs.gov>, "Kuy, SreyRam (HOU)" (b) (6) (b) (6) , GHLF < ghlf.org>, Bruce Moskowitz (b) (6) (b) (6) < mac.com>, Aaron Moskowitz < me.com>, "Concannon, Thomas" (b) (6) (b) (6) (b) (6) < rand.org>, Bruce McIntosh < va.gov>, (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < atlasresearch.us>, ' < ghlf.org>, ' < dc-crd.com>, (b) (6) (b) (6) (b) (6) (b) (6) ' < dc-crd.com>, " < va.gov>, "Hayes(b) (6) (b) (6) Byrd, Jacquelyn" , " < va.gov>, (b) (6) (b) (6) " < va.gov> Subject: Medical Device Registry Summit - Action Items Hi team,   In preparation for our weekly call tomorrow, here are a few reminders from last week’s action items.   1.  Fill in the 3rd page of the agenda (agenda attached) with list of attendees/groups invited to the symposium— Everyone 2. Contact speakers for the title, topic, and content of their presentation (needed to ensure appropriate topics and  no redundancy)—Everyone 3. Send us contact information for the speakers so we can coordinate a call with them all prior to the event‐‐  Everyone 4. Create a draft to operationalize the “formal and structured interaction between attendees”—(b) (6) a. Add this to the agenda draft—(b) (6) 5. Create a draft to operationalize the “smaller discussion groups between or after the topic focused  presentations”—Danica a. Add this to the agenda draft—(b) (6) 6. Edit agenda with track changes—Everyone    Thanks again everyone for all your hard work! Looking forward to our call tomorrow. Let us know if you have any  questions.   All the best,   SreyRam and (b) (6)     __________________________________________________________________________  This email message is for the sole use of the intended recipient(s) and  may contain information that is sensitive, proprietary, and/or privileged.  Any unauthorized review, use, disclosure or distribution is prohibited. If  you are not the intended recipient, please contact the sender by reply  email and destroy all copies of the original message.  2 0333 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, April 17, 2018 5:58 PM (b) (6) (Atlas Research); Marinac-Dabic, Danica; '(b) (6) GHLF'; Bruce Moskowitz; Aaron (b) (6) Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Attachments: FW: Medical Device Registry Summit - 1 pager (005)DMD.docx Medical Device Registry Summit - 1 pager (005)DMD.docx (b) (6)  thanks for sharing!   great job with keeping us on track!  Danica, thanks for sending suggestions!    Sharing with everyone Danica’s great suggestions, attached.    Looking forward to hearing everyone’s great input tomorrow! ‐SreyRam  (b) (6)     From: Marinac-Dabic, Danica [mailto:(b) (6) fda.hhs.gov] Sent: Tuesday, April 17, 2018 5:03 PM To: Kuy, SreyRam (HOU) Subject: [EXTERNAL] Medical Device Registry Summit - 1 pager (005)DMD.docx   Dear SreyRam,   For your consideration I’ve attached my suggested revisions to the June 4th  Medical Device Registry Summit  Program. I  look forward to tomorrow’s discussion.  Best,   Danica     Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE    Director, Division of Epidemiology  Center for Devices and Radiological/OSB  White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6)   Silver Spring MD 20993; (301)796‐(b) (6)        (b) (6) fda.hhs.gov;    Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;      1 0334 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 Welcome and Introductions of Participants and Organizations- SreyRam Kuy Session 1: Keynote Address: Leveraging the Medical Device Ecosystem Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Roundtable Discussion with Key Agency Leadership Moderator: SreyRam Kuy, MD, PhD  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD  CMS leadership (TBD)  NIH Leadership (TBD) - Mike Lauer, MD  CDC  AHRQ  HHS Session 2. VA Landscape Moderator: TBD  Current Cardiac Device Monitoring in the VA • Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  Current VA Medical Device Registries in Place - Maximo • (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: 0335 Session 3. Value of Registries for Partners/Stakeholders Moderator: (b) (6) Titan Spine  Enabling Patient Participation in Device Registries”, Harlan Krumholtz, MD, Yale  Professional societies perspective – ACC/AAOS  Hospital/system perspective - Kaiser  Industry perspective – AdvaMed/MDMA  Payer perspective- Blue Cross/CMS Panel Discussion: Session 4. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health  UDI implementation – Terrie Reed, FDA  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic  Straegically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell  Methodology innovations – (b) (6) PhD – Medtronic  Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH  ONC- led efforts -TBD Panel Discussion: Session 5. Partnership Efforts/Sustainability Considerations Moderator: Bruce Moscowitz , MD, BREF  Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH  PCORTF harmonization efforts - (b) (6) PhD, OS/ASPE  Leveraging existing national informatics/standards efforts - (b) (6) Panel Discussion: Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners” • Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0336 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • va.gov (b) (6) 0337 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, April 24, 2018 4:07 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) Subject: (b) (6) (b) (6) Medical Device Registry Summit - Planning Meeting 4/25/2018; Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday 4/25/2018  7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)     Danica, Bruce, (b) (6)  and I are having a call this afternoon to try to finalize the speaker schedule, and as soon as that’s  done, will forward on to you all.      Thank you so much for all your efforts!    Warmly,  SreyRam    Senior Advisor  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      SreyRam Kuy, MD, MHS, FACS    Senior Advisor to the PDUSH  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  1 0338 Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1022  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      2 0339 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Wednesday, April 25, 2018 8:39 AM '(b) (6) GHLF'; 'Bruce Moskowitz'; 'Aaron Moskowitz'; 'Thomas Concannon'; McIntosh, Bruce (b) (6) (b) (6) (NCPS); ' (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) Subject: Attachments: (b) (6) (b) (6) (b) (6) Medical Device Registry Summit Medical Implant Registry Summit Program 4-25-2018.docx; Medical Implant Registry Summit - List of Invitees.docx Dear Colleagues,  Wonderful discussion this morning!  Thank you for everyone’s input & support, whether by phone or email or  otherwise.  I appreciate all your efforts!    Next steps and deliverables:  Danica – could you add the final closing panel (VA/FDA/Others) to the agenda  (b) (6) (b) (6) Bruce McIntosh/Danica (and anyone else) – could you add a patient perspective/speaker to the agenda  Everyone – could you please send a list of attendees to invite (see attached prelim, draft list)    Could I ask you to send to me this by end of tomorrow, Thursday 4/25/2018?  Would like to get things the list of  attendees vetted by our leadership, the agenda sent to communications, and the final list of speakers to invite for a  planning conference call.      Thank you so very much!!!    ‐SreyRam    SreyRam Kuy, MD, MHS, FACS        From: Kuy, SreyRam (HOU)   Sent: Tuesday, April 24, 2018 4:07 PM  To: '(b) (6)  GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz <(b) (6) mac.com>; Aaron Moskowitz  (b) (6) < me.com>; Thomas Concannon <(b) (6) rand.org>; McIntosh, Bruce (NCPS)  <(b) (6) va.gov>; (b) (6)  <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research)  <(b) (6) va.gov>; 'Marinac‐Dabic, Danica' <(b) (6) fda.hhs.gov>; '(b) (6)   <(b) (6) ghlf.org>; '(b) (6)  <(b) (6) dc‐crd.com>; '(b) (6)  <(b) (6) dc‐crd.com>; (b) (6)   <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6) (b) (6) < va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Subject: Medical Device Registry Summit ‐ Planning Meeting 4/25/2018; Conference call line: 800‐767‐(b) (5)  Code  (b) (5)     Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday 4/25/2018  7:30 am – 8:00 am Eastern  1 0340   Conference call line:  800‐767‐(b) (5)  Code (b) (5)     Danica, Bruce, (b) (6)  and I are having a call this afternoon to try to finalize the speaker schedule, and as soon as that’s  done, will forward on to you all.      Thank you so much for all your efforts!    Warmly,  SreyRam    Senior Advisor  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      SreyRam Kuy, MD, MHS, FACS    Senior Advisor to the PDUSH  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1022  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      2 0341 Medical Implant Registry Summit DRAFT list of invitees Date: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use Invitees Societies AAMI AORN ECRI American Academy of Orthopaedic Surgeons Orthopedic Network News Society for Vascular Surgery The American Association for Vascular Surgery American College of Surgeons The American Society of General Surgeons American Dental Association VA Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar Office of Dentistry: Dr. (b) (6) (b) (6) of Reproductive Health in Women’s Health: Dr. (b) (6) (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) Ophthalmology: Dr. (b) (6) and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) Prosthetic and Sensory Aids Service: Ms. (b) (6) and Mr. (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. (b) (6) Mr. (b) (6) Mr. (b) (6) NCPS: Ms. (b) (6) and Ms. (b) (6) Salt Lake City VAMC: Mr. (b) (6) Medical Device Companies Abbot Laboratories Academy Medical LLC AMO Sales and Services 0342 AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA Nuvasive Smith & Nephew St. Jude Medical Zimmer 0343 Medical Implant Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 – 4:00 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD 8:45 – 10:00 Session 1: Value for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs TBA – VA patient Leveraging the Medical Device Ecosystem Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Value Roundtable Discussion Moderator: SreyRam Kuy, MD, PhD  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS leadership (TBD)  Professional societies perspective – AMA – Kathy Blake  Hospital/system perspective - Kaiser  Industry perspective – AdvaMed/MDMA 10:00 – 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future 0344 Moderator: TBD  Current Cardiac Device Monitoring in the VA • Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  Current VA Medical Device Registries - Maximo • TBD Office of Healthcare Technology Management, Veterans Health Affairs  “Title TBD” – Nicholas Giori, MD  “Title TBD” – Stephen Waldo, MD (or Paul Varosy, MD)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Lunch: 11:30 – 12:30 12:30 – 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  ONC Efforts - TBD  UDI implementation efforts – Terrie Reed, FDA  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell  Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH  Patient -enabled evidence generation - Harlan Krumholz, MD, Yale  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic Panel Discussion: 2:00 – 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz, MD, BREF 0345 Objective: Begin development of the framework for VA registry development Panel: Jack Cronenwett, MD, Art Sedrakyan, MD; PhD, Mike Lauer, MD, PhD, (b) (6)  Who should be at the table: What can we learn from VQI? – Jack Cronenwett, MD, Dartmouth, M2S  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH  Quality Management opportunities and compliance with standards– (b) (6)  Privacy/Ethics issues – TBD Panel Discussion: 3:15 –4:00 Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners” • VHA Leadership 0346 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • va.gov (b) (6) 0347 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, May 01, 2018 6:06 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) Subject: Attachments: (b) (6) (b) (6) (b) (6) (b) (6) Medical Device Registry Summit - Planning Call, 5/2/2018 Wednesday 7:30 am Eastern, 800-767-(b) (5) Code (b) (5) Medical Implant Registry Summit - List of Invitees.docx; VA Medical Implant Registry Summit Invitation and 1 Pager.docx; VA Medical Implant Registry Summit Program.docx Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday mornings 7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       Again, many apologies to our west coast colleagues for the very early time.    Attached is the program, a sample invitation letter with one pager, and a preliminary invitee list.  Please feel free to add  to the invitee list, edit the program and the invite letter, and share with us all.     Thank you so very much for ALL your hard work and efforts around this summit!          Warmly,  SreyRam    SreyRam Kuy, MD, MHS, FACS  Special Advisor   Office of the Secretary  Department of Veterans Affairs    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1022  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      1 0348 0349 Medical Implant Registry Summit DRAFT list of invitees Date: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use Invitees Societies AAMI AORN ECRI American Academy of Orthopaedic Surgeons Orthopedic Network News Society for Vascular Surgery The American Association for Vascular Surgery American College of Surgeons The American Society of General Surgeons American Dental Association AMA – Kathy Blake Agencies Department of Veterans Affairs Leadership Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health CMS Leadership DOD Leadership HHS Leadership Health Systems (b) (6) Kaiser VA COS Mr. Peter O’Rourke Deputy COS Ms. Jacquelyn Hayes-Byrd Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar (b) (6) Office of Dentistry: Dr. 0350 (b) (6) (b) (6) of Reproductive Health in Women’s Health: Dr. (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) (b) (6) Ophthalmology: Dr. and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) (b) (6) Prosthetic and Sensory Aids Service: Ms. and Mr. (b) (6) (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. Mr. (b) (6) Mr. (b) (6) (b) (6) NCPS: Ms. and Ms. (b) (6) Salt Lake City VAMC: Mr. VA Office of Healthcare Technology Management Merrit H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) MD, VA, Vanderbilt (b) (6) FDA Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Terrie Reed, FDA Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH Vahan Simonyan, PhD (FDA) Greg Pappas, MD, PhD FDA/CDRH Medical Device Companies Abbot Laboratories Academy Medical LLC AMO Sales and Services AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA 0351 Nuvasive Smith & Nephew St. Jude Medical Zimmer AdvaMed/MDMA Others: John Rumsfeld, MD (ACC) Art Sedrakyan, MD, PhD, Cornell/MDEpiNet Harlan Krumholz, MD, Yale Fred Resnic, MD, Lahey Clinic Jack Cronenwett, MD, Dartmouth, M2S (b) (6) Rob Portman Mike Lauer, MD (NIH) Elise Berliner (AHRQ) (b) (6) PhD (b) (6) (b) (6) (b) (6) (b) (6) Thomas Concannon EHR Vendor DOD Representative for Session 2 panel ONC Representative for Session 3 panel 0352 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 May 1, 2018 From: SreyRam Kuy, MD To: ---Subj: Medical Implant Registry Summit Dear Colleagues The Department of Veterans Affairs is convening leaders to host a national healthcare summit on “Medical Implants Registry”. VA is partnering with sister agencies to ensure patient safety and implement the largest health system medical implant tracking program in the country. We would like to respectfully invite you to participate in this national “Medical Implants Registry Summit”. The summit will be held on June 4, 2018 at in the VA auditorium. Medical Implant Registry Summit Date: Monday, June 4, 2018 Location: VA Auditorium, room 230 Leadership Panel: 8:30 am -4:30 pm Attached is a one pager briefing on medical implant registry systems, and a draft of the “Medical Implant Registry Summit” program. Warmly, SreyRam Kuy, MD Special Advisor Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Confidential - Working DRAFT, Informational Only, Pre-Decisional – VA Internal Use Only 0353 A VA Medical Implant Registry: Why it Matters The Vision  A nationwide Implant Registry that enables VA to monitor the safety of implants in our veterans, track quality metrics and ensure the best possible care for VA patients Current surveillance of medical implants is piecemeal  Adverse Event Reports: mandatory for manufacturers & hospitals, but incomplete clinical data  Insurance Claims data – lack clinical details  Clinical Registries - operated by various groups & societies but not linked to VA’s Electronic Medical Records Does VA need an Implant Registry?  Yes! • • • Needed to monitor patient safety Needed for recall of faulty medical implants Needed to measure quality & compare outcomes of implants Why is an Implant Registry important to the VA?  A medical implant registry will: • Allow us to notify patients about safety recalls • Allows us to identify the exact device when patient shows up in ER with complications • Allows us to track clinical follow-up What makes an Implant Registry effective for the VA?  An effective medical implant registry will: • Link with the VA’s Electronic Medical Record to facilitate rapid identification • Easily accessible for VA clinicians, and from any VA medical center the veteran presents at • UDI barcode input automated (manual entry raises risk of error & patient safety) • Tracks both medical devices and biological implants (pending legislation will require VA to track biological implants) • Monitors veterans from the pre-registry era (comprises the majority of implants needing surveillance) • Implementable in the short-term via VA’s CPRS and VistA, and able to interface with Cerner in the long term Collaboration  As VA develops the nations’ largest implant registry, we welcome opportunities to collaborate with our sister agencies & the medical community in novel partnerships that advance this vision. Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Confidential - Working DRAFT, Informational Only, Pre-Decisional – VA Internal Use Only 0354 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Implant Registry Summit Date: June 4, 2018 Location: VA Auditorium 8:30 – 4:30 pm 8:30 Welcome and Introductions of Participants and Organizations SreyRam Kuy, MD 8:45 – 10:00 Session 1: Value for Stakeholders Objective: To describe value of medical implant registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA – Patient perspectives Leveraging the Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) invited/available Value Roundtable Discussion Moderator: SreyRam Kuy, MD  Department of Veterans Affairs Leadership  Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS Leadership - TBD  DOD Leadership - TBD  HHS Leadership - TBD  Professional societies perspective – AMA – Kathy Blake  Hospital/system perspective - (b) (6) Kaiser  Industry perspective – AdvaMed/MDMA 0355 10:00 – 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: TBD  Current Cardiac Device Monitoring in the VA • Merrit H. Raitt, MD Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  Current VA Medical Device Registries - Maximo • Presenter TBD, VA Office of Healthcare Technology Management  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL • Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch Break: 11:30 – 12:30 12:30 – 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  ONC Efforts - TBD (10 min)  UDI implementation efforts – Terrie Reed, FDA (10 min) – invited/available  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) – invited/available  Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH (10 min) 0356  Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) – invited/available  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 – 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: TBD Objective: Begin development of the framework for VA registry development  Who should be at the table: What can we learn from VQI? – Jack Cronenwett, MD, Dartmouth, M2S (10 min)  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min)  Quality Management opportunities and compliance with standards– (b) (6) (10 min)  Privacy/Ethics issues –Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 –4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan – Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD - FDA Rachael Fleurence, PhD – NESTcc Patient (TBD) Closing Remarks • VA Leadership 0357 Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 0358 From: To: Kuy, SreyRam (HOU) "(b) (6) GHLF"; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (b) (6) (Atlas Research); "Marinac-Dabic, Danica"; "(b) (6) "(b) (6) (b) (6) (b) (6) (b) (6) "(b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Cc: Subject: Attachments: (b) (6) (b) (6) (b) (6) Medical Device Registry Summit - Planning Meeting VA Medical Implant Registry Summit Program 5-8-2018.docx Medical Implant Registry Summit - List of Invitees 5-8-2018.docx Dear colleagues, In preparation for our weekly Wednesday morning call, here’s the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/21/2018  7:30 am – 8:00 am Eastern Conference call line:  800-767-(b) (5) Code (b) (5)   We’ve made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda and a slate of speakers.  Several fantastic subject matter experts on board to participate!  Attached is a draft - welcome all your input, ideas, revisions!  Feel to revise the editable word doc and share with us all.    Again, many apologies to our west coast colleagues for the very early time. Thank you so much for all your efforts! Warmly, SreyRam Special Advisor Office of the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile:  713-503-4274 Office:  202-461-4875     0359 Medical Implant Registry Summit DRAFT list of invitees Date of Summit: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use *These are planned invitees – they have not yet confirmed attendance, and may send a representative in their place. Invitees* Agencies Department of Veterans Affairs Leadership Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health FDA Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health CMS Administrator Seema Verma (tentative) or representative HHS Secretary Alex Azar (tentative) or representative DoD Secretary James Mattis or representatiave (tentative) VA employees COS Mr. Peter O’Rourke Deputy COS Ms. Jacquelyn Hayes-Byrd Secretary Wilkie (tentative) or Deputy Secretary Bowman (tentative) Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar (b) (6) Office of Dentistry: Dr. (b) (6) (b) (6) of Reproductive Health in Women’s Health: Dr. (b) (6) (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) (b) (6) Ophthalmology: Dr. and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) (b) (6) Prosthetic and Sensory Aids Service: Ms. and Mr. (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. (b) (6) Mr. (b) (6) (b) (6) NCPS: Ms. and Ms. Mr. (b) (6) 0360 (b) (6) Salt Lake City VAMC: Mr. VA Office of Healthcare Technology Management Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) MD, VA, Vanderbilt FDA Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Terrie Reed, FDA Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH Vahan Simonyan, PhD (FDA) Greg Pappas, MD, PhD FDA/CDRH Others: John Rumsfeld, MD (ACC) Art Sedrakyan, MD, PhD, Cornell/MDEpiNet Harlan Krumholz, MD, Yale Fred Resnic, MD, Lahey Clinic Jack Cronenwett, MD, Dartmouth, M2S (b) (6) Rob Portman Mike Lauer, MD (NIH) AHRQ representative (b) (6) PhD (b) (6) (b) (6) (b) (6) (b) (6) Thomas Concannon PEW Trust EHR Vendor DOD Representative for Session 2 panel ONC Representative for Session 3 panel - Donald Rucker, MD Kristy Mitchel - Avalere Christine Stake - Ann & Robert H. Lurie Children's Hospital of Chicago (b) (6) 0361 Societies/Nonprofits Association for the Advancement of Medical Instrumentation (AAMI) leadership (b) (6) (b) (6) PhD (b) (6) FHIMSS (b) (6) PhD Association of peri-Operative Registered Nurses (AORN) (b) (6) MSHA, RN, CNOR, CSSM (b) (6) MHA, RN-BC, CNOR, CSSM (b) (6) MSN, RN, CNOR (b) (6) MSN, MBA, RN, ACNS-BC, CNS-CP, CNOR Emergency Care Research Institute (ECRI) (b) (6) MD, PhD (b) (6) MS American Academy of Orthopaedic Surgeons (AAOS) (b) (6) MD (b) (6) MD (b) (6) III MD American College of Cardiology (b) (6) MD, FACC (b) (6) MD, FACC (b) (6) Jr., MD, MBA, FACC (b) (6) MD, FACC American Association of Neurological Surgeons (b) (6) MD, PhD, FAANS, FACS (b) (6) MD, FAANS (b) (6) MD, MPH, FAANS, FACS (b) (6) MD, FAANS American Neurological Association (b) (6) PhD, MS (b) (6) MD Society for Vascular Surgery (b) (6) III, MD (b) (6) MD (b) (6) MD American College of Surgeons (b) (6) - 0362 (b) (6) (b) (6) (b) (6) American Dental Association (b) (6) DDS (b) (6) DDS AMA (b) (6) (b) (6) -Kathy Blake MD, MHA MD AcademyHealth (b) (6) -Dr. Association for Healthcare Resources and Materials Management (AHRMM) (b) (6) (b) (6) (b) (6) Senior Supply Chain ( aha.org) Cognitive Health - Julia Skapik, MD, PhD Pew Charitable Trust (b) (6) MD Henry J. Kaiser Family Foundation (b) (6) Medical Device Companies (Tentative – pending OGC and ethics approval, would send invite to their government affairs contact) Abbot Laboratories Academy Medical LLC AMO Sales and Services AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA 0363 Nuvasive Smith Nephew St. Jude Medical Zimmer I 1? A us. lhpartment Wu?! ?Wm-Wm {Jr?v?ctcram Affairs Di?uairg Ben Pratt :95 . 0364 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Device Registry Summit VA Auditorium Room 230 810 Vermont Avenue, NW Washington, DC 20420 June 4, 2018 8:30 a.m. – 4:30 p.m. 8:30 a.m. Welcome and Introductions of Participants and Organizations SreyRam Kuy, MD 8:45 a.m. – 10 a.m. Session 1: Value for Stakeholders Objective: To describe value of medical device registries to major stakeholders; identify the gaps; prioritize opportunities Patient Perspective (10 min) Christine Stake Leveraging the Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Value Roundtable Discussion Moderator: SreyRam Kuy, MD  VA Secretary or Deputy Secretary  FDA Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS Administrator Seema Verma (tentative)  HHS Secretary Alex Azar (tentative) or representative  DoD Secretary James Mattis or representative (tentative)  Professional societies perspective – AMA – Cathy Blake 10 a.m. – 11:30 a.m. Session 2: VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future 0365 Moderator: TBD  Current Cardiac Device Monitoring in the VA • Merritt H. Raitt, MD Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  Current VA Medical Device Registries - Maximo • Presenter TBD VA Office of Healthcare Technology Management  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL • Stephen Waldo, MD (or Paul Varosy, MD) Director, VA Clinical Assessment, Reporting and Tracking Program (CART)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) Panel Discussion: Speakers + MD (VA, Vanderbilt) and John Rumsfeld, MD (ACC) + EHR Vendor + DOD Representative 11:30 a.m. – 12:30 p.m. Lunch Break 12:30 p.m. – 2 p.m. Session 3: Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  ONC Efforts – Don Rucker (10 min)  UDI implementation efforts – Terrie Reed, FDA (10 min) – invited/available  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) – invited/available  Harmonization Efforts with National/International Registries Danica MarinacDabic, MD, PhD, MMSC, FISPE – FDA/CDRH (10 min)  Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) – invited/available  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic (10 min) - invited/available 0366 Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2 p.m. – 3:15 p.m. Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: TBD Objective: Begin development of the framework for VA registry development  Who should be at the table: What can we learn from VQI? – Jack Cronenwett, MD, Dartmouth, M2S (10 min)  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) (b) (6)  Quality Management opportunities and compliance with standards– (10 min)  Privacy/Ethics issues –Rob Portman, JD (10 min) Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ), Julia Skapik, Cognitive Health (invited and available), Kristy Mitchel (Avalere) 3:15 p.m. – 4:30 p.m. Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD Panel: Bruce McIntosh – VA (b) (6) Kaiser Permanente – NJRR Art Sedrakyan – Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD – FDA Rachael Fleurence, PhD – NESTcc Patient (TBD) Closing Remarks • VA Leadership Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 0367 Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) Tuesday, May 08, 2018 3:49 PM Kuy, SreyRam (HOU); '(b) (6) McIntosh, Bruce (NCPS); (b) (6) '(b) (6) '(b) (6) fda.hhs.gov> GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (Atlas Research); '(b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Attachments: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program05082018.docx The latest round of revisions.    1. 2. 3. 4. 5. (b) (6)  from Kaiser – has a last minute conflict and I removed her – but she definitely wants to  help with the effort in  the next phase.      Added Julia Skapik, MD,PhD to the Panel ( former ONC, currently with Cognitive Health )   Added Kristy Mitchel to the Panel  – formerly ACC now Avalere  Still waiting to hear from (b) (6)   Still waiting to hear from AHRQ    Several people requested the agenda. Are we finalizing tomorrow?       Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     ‐‐‐‐‐Original Appointment‐‐‐‐‐  From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov]   Sent: Tuesday, March 20, 2018 4:06 PM  To: Kuy, SreyRam (HOU); '(b) (6)  GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce  (b) (6) (b) (6) (NCPS);     (Atlas Research); Marinac‐Dabic, Danica; '(b) (6)  '(b) (6)   '(b) (6)  (b) (6)  Hayes‐Byrd, Jacquelyn; (b) (6)  (b) (6)   Subject: Medical Device Registry Summit ‐ Planning Meeting  When: Wednesday, May 09, 2018 7:30 AM‐8:00 AM (UTC‐05:00) Eastern Time (US & Canada).  Where: Conference call line: 800‐767‐(b) (5)  Code (b) (5)     1 0368 Dear colleagues,   In preparation for our weekly Wednesday morning call, here’s the call‐in information:   Medical Device Registry Summit ‐ Planning Call Wednesday 3/21/2018  7:30 am – 8:00 am Eastern Conference call line:  800‐767‐(b) (5)  Code (b) (5)   We’ve made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more  detailed agenda, with locations, possible time and a slate of speakers.  Several fantastic subject matter experts on board  to participate!  This is a draft ‐ welcome all your input, ideas, revisions!  Feel to revise the editable word doc and share  with us all.       Again, many apologies to our west coast colleagues for the very early time.   Thank you so much for all your efforts!   Warmly, SreyRam   Special Advisor to the Secretary Veterans Health Administration   Associate Chief of Staff  Quality, Safety & Value Michael E. DeBakey VA Medical Center   810 Vermont Avenue, NW, #1069 Washington, DC 20420   Mobile:  713‐503‐4274 Office:  202‐461‐4875                     << File: Medical Device Registry Summit ‐ 1 pager.docx >>  << File: Medical Device Registry Summit ‐ 1 pager.pdf >>    2 0369 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 – 4:30 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 – 10:00 Session 1: Value of Registries for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA – VA patient Leveraging Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NESTcc) - invited/available Value Roundtable Discussion (45min) Moderator: SreyRam Kuy, MD, PhD  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS leadership (TBD)  Professional societies perspective – AMA – Cathy Blake (invited and available)  Hospital/system perspective - (b) (6) Kaiser  Industry perspective – AdvaMed/MDMA (invited)  ONC – Don Rucker 10:00 – 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future 0370 Moderator: TBD  Current Cardiac Device Monitoring in the VA • Merritt H. Raitt, MD Director, VA National Cardiac Device Surveillance Program  Current VA Medical Device Registries - Maximo • Presenter TBD VA Office of Healthcare Technology Management  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL • Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) MD (VA, Vanderbilt) Lunch: 11:30 – 12:30 12:30 – 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  UDI implementation efforts – Terrie Reed, FDA (10 min) – invited/available  Harmonization Efforts with National/International Registries and Consortia- Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH (10 min) - invited/available  Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) – invited/available  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 0371 2:00 – 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF Objective: Begin development of the framework for VA registry development  Who should be at the table : What can we learn from VQI?– Jack Cronenwett, MD, Dartmouth, M2S (10 min) – invited/available  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) – invited/available  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) – invited/available  Quality Management opportunities and compliance with standards– (b) (6) (10 min) – invited/available  Privacy/Ethics issues –Rob Portman (10 min) JD Panel Discussion: Speakers + Julia Skapik, Cognitive Health (invited and available), Kristy Mitchel (Avalere) - invited and available 3:15 –4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD Panel: Bruce McIntosh - VA – invited/available Art Sedrakyan – Weill Cornell Medical College- invited /available Danica Marinac-Dabic, MD, PhD - FDA - invited/available Rachael Fleurence, PhD – NESTcc - invited available Bruce Moscowitz, MD – BREF – invited/available Patient representative 0372 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • va.gov (b) (6) 0373 US. Department nWetcransAffairs I 0374 . A Diffusion of 1 #2wa Di?usirg BESI Pratt :95 ?ats: . Ha, Richard From: Sent: To: GHLF <(b) (6) ghlf.org> Tuesday, May 08, 2018 12:50 PM Marinac-Dabic, Danica; Kuy, SreyRam (HOU); Bruce Moskowitz; Aaron Moskowitz; Thomas (b) (6) Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); (b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) (b) (6) Subject: Attachments: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program05022018-bn.docx Hi all,    I added the name of our patient speaker, Christine Stake, to the attached program. We are working with Chris on her  comments so we can share them in the coming week. Since she’s probably not known to everyone, here’s her bio:    Chris has been a patient, caregiver and researcher for hip replacement. She is passionate about making sure that  clinical decision making is a shared process between patients and health professionals and is particularly  interested in health decision making at all ages due to her experience as a young person requiring joint  replacement. She’s especially concerned about medical device safety and tracking, given that younger people  may need revision surgery due to the early age of initial joint replacement. It’s important to her that the factors  most important to patients, such as quality of life, are prioritized in both clinical care and research. Chris  is currently employed at Ann & Robert H. Lurie Children's Hospital of Chicago as the Research Operations  Manager for Neuroscientific Aspects of Pain. She also serves as a Patient Governor for the ArthritisPower patient  research registry and app (www.ArthritisPower.org).         (b) (6) (b) (6) PhD Patient-Centered Research  Global Healthy Living Foundation  515 N. Midland Ave - Upper Nyack, NY 10960  Cell: +1 (917) 455 (b) (6) Office: +1 (845) 348 (b) (6) Fax: +1 (845) 348 (b) (6) (b) (6) ghlf.org GHLF.org CreakyJoints.org ArthritisPower.org Facebook.com/CreakyJoints Twitter.com/CreakyJoints Twitter.com/GHLForg   Improving the lives of people with chronic disease through better access to care, education, support, advocacy and patient-centered research.                       From: Marinac‐Dabic, Danica [mailto:(b) (6) Sent: Monday, May 7, 2018 7:56 AM  fda.hhs.gov]   1 0375   To: 'Kuy, SreyRam (HOU)' ; (b) (6)  GHLF <(b) (6) ghlf.org>; Bruce Moskowitz  (b) (6) (b) (6) < mac.com>; Aaron Moskowitz < me.com>; Thomas Concannon  <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; (b) (6)  <(b) (6) atlasresearch.us>;  (b) (6) (b) (6) (b) (6) (b) (6)  (Atlas Research) < va.gov>;   < ghlf.org>; '(b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < dc‐crd.com>; '  < dc‐crd.com>;   < va.gov>;  Hayes‐Byrd, Jacquelyn ; (b) (6)  <(b) (6) va.gov>; (b) (6)   <(b) (6) va.gov>  Subject: RE: Medical Device Registry Summit ‐ Planning Meeting    Sending  updated Program  with the names of confirmed speakers THIS MORNING.  AHRQ is sending another speaker – as Eiise Berliner has a conflict. Stay tuned.     Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     ‐‐‐‐‐Original Appointment‐‐‐‐‐  From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov]   Sent: Tuesday, March 20, 2018 4:06 PM  To: Kuy, SreyRam (HOU); '(b) (6)  GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce  (b) (6) (b) (6) (NCPS);     (Atlas Research); Marinac‐Dabic, Danica; '(b) (6)  '(b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) '    Hayes‐Byrd, Jacquelyn;      Subject: Medical Device Registry Summit ‐ Planning Meeting  When: Wednesday, May 09, 2018 7:30 AM‐8:00 AM (UTC‐05:00) Eastern Time (US & Canada).  Where: Conference call line: 800‐767‐(b) (5)  Code (b) (5)     Dear colleagues,   In preparation for our weekly Wednesday morning call, here’s the call‐in information:   Medical Device Registry Summit ‐ Planning Call Wednesday 3/21/2018  7:30 am – 8:00 am Eastern Conference call line:  800‐767‐(b) (5)  Code (b) (5)   We’ve made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more  detailed agenda, with locations, possible time and a slate of speakers.  Several fantastic subject matter experts on board  to participate!  This is a draft ‐ welcome all your input, ideas, revisions!  Feel to revise the editable word doc and share  with us all.       Again, many apologies to our west coast colleagues for the very early time.   2 0376 Thank you so much for all your efforts!   Warmly, SreyRam   Special Advisor to the Secretary Veterans Health Administration   Associate Chief of Staff  Quality, Safety & Value Michael E. DeBakey VA Medical Center   810 Vermont Avenue, NW, #1069 Washington, DC 20420   Mobile:  713‐503‐4274 Office:  202‐461‐4875                     << File: Medical Device Registry Summit ‐ 1 pager.docx >>  << File: Medical Device Registry Summit ‐ 1 pager.pdf >>    3 0377 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 – 4:30 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 – 10:00 Session 1: Value of Registries for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) Christine Stake, PhD, MA, Hip Replacement Patient Global Healthy Living Foundation, ArthritisPower Patient Powered Research Network Leveraging Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NESTcc) - invited/available Value Roundtable Discussion (45min) Moderator: SreyRam Kuy, MD, PhD  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS leadership (TBD)  Professional societies perspective – AMA – Cathy Blake (invited and available)  Hospital/system perspective - (b) (6) Kaiser  Industry perspective – AdvaMed/MDMA (invited)  ONC – Don Rucker 10:00 – 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future 0378 Moderator: TBD  Current Cardiac Device Monitoring in the VA • Merritt H. Raitt, MD Director, VA National Cardiac Device Surveillance Program  Current VA Medical Device Registries - Maximo • Presenter TBD VA Office of Healthcare Technology Management  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL • Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch: 11:30 – 12:30 12:30 – 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  ONC Efforts - TBD (10 min) –  UDI implementation efforts – Terrie Reed, FDA (10 min) – invited/available  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) – invited/available  Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH (10 min) - invited/available  Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) – invited/available 0379  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 – 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF Objective: Begin development of the framework for VA registry development  Who should be at the table : What can we learn from VQI?– Jack Cronenwett, MD, Dartmouth, M2S (10 min) – invited/available  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) – invited/available  Quality Management opportunities and compliance with standards– (b) (6) (10 min) – invited/available  Privacy/Ethics issues –Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 –4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan – Weill Cornell Medical College- invited /available Danica Marinac-Dabic, MD, PhD - FDA - invited/available Rachael Fleurence, PhD – NESTcc Bruce Moscowitz, MD – BREF Patient 0380 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov 0381 Depa r1 ment. 0382 A I Diffusiunm? . EXCELLENCE: . uh \r 9 "t Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Wednesday, May 02, 2018 10:59 AM Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (b) (6) McIntosh, Bruce (NCPS); (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Cc: Subject: Attachments: (b) (6) (b) (6) [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program05022018.docx Cathy Blake – confirmed; Jack Cronenwett  ‐ confirmed; Elsie Berliner – sending another person from AHRQ; still waiting  for AdvaMed speaker and confirmation for (b) (6)  and ONC – speaker . I updated the agenda with the confirmed  speakers ( I called them invited/available).  Sending further updates as I receive them.         Danica        Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     ‐‐‐‐‐Original Appointment‐‐‐‐‐  From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov]   Sent: Tuesday, March 20, 2018 4:06 PM  To: Kuy, SreyRam (HOU); '(b) (6)  GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce  (NCPS); (b) (6)  (b) (6)  (Atlas Research); Marinac‐Dabic, Danica; '(b) (6)  '(b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) '    Hayes‐Byrd, Jacquelyn;        Cc: (b) (6)   Subject: Medical Device Registry Summit ‐ Planning Meeting  When: Wednesday, May 02, 2018 11:30 AM‐12:00 PM .  Where: Conference call line: 800‐767‐(b) (5)  Code (b) (5)     Dear colleagues,   In preparation for our weekly Wednesday morning call, here’s the call‐in information:   Medical Device Registry Summit ‐ Planning Call 1 0383 Wednesday mornings 7:30 am – 8:00 am Eastern Conference call line:  800‐767‐(b) (5)  Code (b) (5)   Again, many apologies to our west coast colleagues for the very early time.   Thank you so very much for ALL your hard work and efforts around this summit!         Warmly, SreyRam   SreyRam Kuy, MD, MHS, FACS Special Advisor  Office of the Secretary Department of Veterans Affairs   Associate Chief of Staff  Quality, Safety & Value Michael E. DeBakey VA Medical Center   810 Vermont Avenue, NW, #1022 Washington, DC 20420   Mobile:  713‐503‐4274 Office:  202‐461‐4875                         << File: VA Medical Implant Registry Summit Program.docx >>  << File: VA Medical Implant Registry Summit ‐ Invitation  and 1 Pager.docx >>  << File: Medical Implant Registry Summit ‐ List of Invitees.docx >>    2 0384 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 – 4:30 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 – 10:00 Session 1: Value of Registries for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA – VA patient Leveraging Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NESTcc) - invited/available Value Roundtable Discussion (45min) Moderator: SreyRam Kuy, MD, PhD  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS leadership (TBD)  Professional societies perspective – AMA – Cathy Blake (invited and available)  Hospital/system perspective - (b) (6) Kaiser  Industry perspective – AdvaMed/MDMA (invited)  ONC – Don Rucker 10:00 – 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future 0385 Moderator: TBD  Current Cardiac Device Monitoring in the VA • Merritt H. Raitt, MD Director, VA National Cardiac Device Surveillance Program  Current VA Medical Device Registries - Maximo • Presenter TBD VA Office of Healthcare Technology Management  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL • Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch: 11:30 – 12:30 12:30 – 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  ONC Efforts - TBD (10 min) –  UDI implementation efforts – Terrie Reed, FDA (10 min) – invited/available  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) – invited/available  Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH (10 min) - invited/available  Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) – invited/available 0386  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 – 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF Objective: Begin development of the framework for VA registry development  Who should be at the table : What can we learn from VQI?– Jack Cronenwett, MD, Dartmouth, M2S (10 min) – invited/available  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) – invited/available  Quality Management opportunities and compliance with standards– (b) (6) (10 min) – invited/available  Privacy/Ethics issues –Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 –4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan – Weill Cornell Medical College- invited /available Danica Marinac-Dabic, MD, PhD - FDA - invited/available Rachael Fleurence, PhD – NESTcc Bruce Moscowitz, MD – BREF Patient 0387 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov 0388 Depa r1 ment. 0389 A I Diffusiunm? . EXCELLENCE: . uh \r 9 "t Ha, Richard Subject: Location: Medical Device Registry Summit - Planning Meeting Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Wed 5/2/2018 7:30 AM Wed 5/2/2018 8:00 AM Tentative Weekly Recurrence: Recurrence Pattern:every Wednesday from 7:30 AM to 8:00 AM Meeting Status: Not yet responded Kuy, SreyRam (HOU) Organizer: Required Attendees:'(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) (b) (6) Optional Attendees: (b) (6)   1 0390 Ha, Richard Subject: Location: Medical Device Registry Summit - Planning Meeting Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Wed 5/2/2018 7:30 AM Wed 5/2/2018 8:00 AM Tentative Weekly Recurrence: Recurrence Pattern:every Wednesday from 7:30 AM to 8:00 AM Meeting Status: Not yet responded Kuy, SreyRam (HOU) Organizer: Required Attendees:'(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) (b) (6) Optional Attendees: (b) (6) Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday mornings 7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       Again, many apologies to our west coast colleagues for the very early time.    Thank you so very much for ALL your hard work and efforts around this summit!          Warmly,  SreyRam    SreyRam Kuy, MD, MHS, FACS  Special Advisor   Office of the Secretary  Department of Veterans Affairs    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1022  Washington, DC 20420  1 0391 Mobile: 713-503-4274 Office: 202-461-4875 0392 Medical Implant Registry Summit DRAFT list of invitees Date: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use Invitees Societies AAMI AORN ECRI American Academy of Orthopaedic Surgeons Orthopedic Network News Society for Vascular Surgery The American Association for Vascular Surgery American College of Surgeons The American Society of General Surgeons American Dental Association AMA – Kathy Blake Agencies Department of Veterans Affairs Leadership Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health CMS Leadership DOD Leadership HHS Leadership Health Systems (b) (6) Kaiser VA COS Mr. Peter O’Rourke Deputy COS Ms. Jacquelyn Hayes-Byrd Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar (b) (6) Office of Dentistry: Dr. 0393 (b) (6) (b) (6) of Reproductive Health in Women’s Health: Dr. (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) (b) (6) Ophthalmology: Dr. and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) (b) (6) Prosthetic and Sensory Aids Service: Ms. and Mr. (b) (6) (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. Mr. (b) (6) Mr. (b) (6) (b) (6) NCPS: Ms. and Ms. (b) (6) Salt Lake City VAMC: Mr. VA Office of Healthcare Technology Management Merrit H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) MD, VA, Vanderbilt (b) (6) FDA Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Terrie Reed, FDA Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH Vahan Simonyan, PhD (FDA) Greg Pappas, MD, PhD FDA/CDRH Medical Device Companies Abbot Laboratories Academy Medical LLC AMO Sales and Services AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA 0394 Nuvasive Smith & Nephew St. Jude Medical Zimmer AdvaMed/MDMA Others: John Rumsfeld, MD (ACC) Art Sedrakyan, MD, PhD, Cornell/MDEpiNet Harlan Krumholz, MD, Yale Fred Resnic, MD, Lahey Clinic Jack Cronenwett, MD, Dartmouth, M2S (b) (6) Rob Portman Mike Lauer, MD (NIH) Elise Berliner (AHRQ) (b) (6) PhD (b) (6) (b) (6) (b) (6) (b) (6) Thomas Concannon EHR Vendor DOD Representative for Session 2 panel ONC Representative for Session 3 panel 0395 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 May 1, 2018 From: SreyRam Kuy, MD To: ---Subj: Medical Implant Registry Summit Dear Colleagues The Department of Veterans Affairs is convening leaders to host a national healthcare summit on “Medical Implants Registry”. VA is partnering with sister agencies to ensure patient safety and implement the largest health system medical implant tracking program in the country. We would like to respectfully invite you to participate in this national “Medical Implants Registry Summit”. The summit will be held on June 4, 2018 at in the VA auditorium. Medical Implant Registry Summit Date: Monday, June 4, 2018 Location: VA Auditorium, room 230 Leadership Panel: 8:30 am -4:30 pm Attached is a one pager briefing on medical implant registry systems, and a draft of the “Medical Implant Registry Summit” program. Warmly, SreyRam Kuy, MD Special Advisor Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Confidential - Working DRAFT, Informational Only, Pre-Decisional – VA Internal Use Only 0396 A VA Medical Implant Registry: Why it Matters The Vision  A nationwide Implant Registry that enables VA to monitor the safety of implants in our veterans, track quality metrics and ensure the best possible care for VA patients Current surveillance of medical implants is piecemeal  Adverse Event Reports: mandatory for manufacturers & hospitals, but incomplete clinical data  Insurance Claims data – lack clinical details  Clinical Registries - operated by various groups & societies but not linked to VA’s Electronic Medical Records Does VA need an Implant Registry?  Yes! • • • Needed to monitor patient safety Needed for recall of faulty medical implants Needed to measure quality & compare outcomes of implants Why is an Implant Registry important to the VA?  A medical implant registry will: • Allow us to notify patients about safety recalls • Allows us to identify the exact device when patient shows up in ER with complications • Allows us to track clinical follow-up What makes an Implant Registry effective for the VA?  An effective medical implant registry will: • Link with the VA’s Electronic Medical Record to facilitate rapid identification • Easily accessible for VA clinicians, and from any VA medical center the veteran presents at • UDI barcode input automated (manual entry raises risk of error & patient safety) • Tracks both medical devices and biological implants (pending legislation will require VA to track biological implants) • Monitors veterans from the pre-registry era (comprises the majority of implants needing surveillance) • Implementable in the short-term via VA’s CPRS and VistA, and able to interface with Cerner in the long term Collaboration  As VA develops the nations’ largest implant registry, we welcome opportunities to collaborate with our sister agencies & the medical community in novel partnerships that advance this vision. Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Confidential - Working DRAFT, Informational Only, Pre-Decisional – VA Internal Use Only 0397 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Implant Registry Summit Date: June 4, 2018 Location: VA Auditorium 8:30 – 4:30 pm 8:30 Welcome and Introductions of Participants and Organizations SreyRam Kuy, MD 8:45 – 10:00 Session 1: Value for Stakeholders Objective: To describe value of medical implant registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA – Patient perspectives Leveraging the Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) invited/available Value Roundtable Discussion Moderator: SreyRam Kuy, MD  Department of Veterans Affairs Leadership  Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS Leadership - TBD  DOD Leadership - TBD  HHS Leadership - TBD  Professional societies perspective – AMA – Kathy Blake  Hospital/system perspective - (b) (6) Kaiser  Industry perspective – AdvaMed/MDMA 0398 10:00 – 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: TBD  Current Cardiac Device Monitoring in the VA • Merrit H. Raitt, MD Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  Current VA Medical Device Registries - Maximo • Presenter TBD, VA Office of Healthcare Technology Management  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL • Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch Break: 11:30 – 12:30 12:30 – 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  ONC Efforts - TBD (10 min)  UDI implementation efforts – Terrie Reed, FDA (10 min) – invited/available  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) – invited/available  Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH (10 min) 0399  Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) – invited/available  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 – 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: TBD Objective: Begin development of the framework for VA registry development  Who should be at the table: What can we learn from VQI? – Jack Cronenwett, MD, Dartmouth, M2S (10 min)  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min)  Quality Management opportunities and compliance with standards– (b) (6) (10 min)  Privacy/Ethics issues –Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 –4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan – Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD - FDA Rachael Fleurence, PhD – NESTcc Patient (TBD) Closing Remarks • VA Leadership 0400 Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 0401 Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Friday, April 27, 2018 11:37 AM McIntosh, Bruce (NCPS); Kuy, SreyRam (HOU); '(b) (6) GHLF'; 'Bruce Moskowitz'; 'Aaron (b) (6) (b) (6) Moskowitz'; 'Thomas Concannon'; ' (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) Subject: Attachments: (b) (6) [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program04262018_BM editDMDeditREV.docx Made the correction ‐ time is now consistent on the first page and in the last session – ending at 4:30.      Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE    Director, Division of Epidemiology  Center for Devices and Radiological/OSB  White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6)   Silver Spring MD 20993; (301)796‐(b) (6)        (b) (6) fda.hhs.gov;    Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;    From: Marinac‐Dabic, Danica   Sent: Thursday, April 26, 2018 11:29 PM  To: 'McIntosh, Bruce (NCPS)' <(b) (6) va.gov>; Kuy, SreyRam (HOU) ; '(b) (6)   (b) (6) (b) (6) GHLF' < ghlf.org>; Bruce Moskowitz < mac.com>; Aaron Moskowitz  <(b) (6) me.com>; Thomas Concannon <(b) (6) rand.org>; (b) (6)  <(b) (6) atlasresearch.us>;  (b) (6)  (Atlas Research) <(b) (6) va.gov>; '(b) (6)  <(b) (6) ghlf.org>; '(b) (6)   <(b) (6) dc‐crd.com>; '(b) (6)  <(b) (6) dc‐crd.com>; (b) (6)  <(b) (6) va.gov>;   <(b) (6) va.gov>; (b) (6)   Hayes‐Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>  Subject: RE: Medical Device Registry Summit ‐ Planning Meeting  Bruce and the Team,  Do you think we need to invite someone from DOD?     Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE    Director, Division of Epidemiology  Center for Devices and Radiological/OSB  White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6)   Silver Spring MD 20993; (301)796‐(b) (6)        (b) (6) fda.hhs.gov;    1 0402 Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;    From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov]   Sent: Thursday, April 26, 2018 9:28 PM  To: Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU) ; '(b) (6)   (b) (6)  GHLF' < ghlf.org>; Bruce Moskowitz <(b) (6) mac.com>; Aaron Moskowitz  <(b) (6) me.com>; Thomas Concannon <(b) (6) rand.org>; (b) (6)  <(b) (6) atlasresearch.us>;  (b) (6) (b) (6) (b) (6) (b) (6)  (Atlas Research) < va.gov>; '  < ghlf.org>; '(b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < dc‐crd.com>; '  < dc‐crd.com>;   < va.gov>;  Hayes‐Byrd, Jacquelyn ; (b) (6)  <(b) (6) va.gov>; (b) (6)   <(b) (6) va.gov>  Subject: RE: Medical Device Registry Summit ‐ Planning Meeting  Nice work Danica!    Attached are edits to Agenda for VA section. I am waiting to receive who will cover for (b) (5)  presentation (still  TBD). Don’t hold up locking this in though if we have to leave as TBD.     Regarding a VA patient to present, I think we may be making this too complicated. To find a VA patient who is  comfortable presenting with a story to tell effectively and with proper HIPAA release and clearance will likely be  complicated, especially without funding for travel. Perhaps we should use one of the previous non‐VA patients  presented earlier with a known story , or remove this.    Thanks,  Bruce       From: Marinac-Dabic, Danica [mailto:(b) (6) fda.hhs.gov] Sent: Thursday, April 26, 2018 9:14 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); '(b) (6) '(b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; Subject: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Colleagues,  The updated document is attached. Please note that I added additional names of potential speakers, panelists and  moderators for your consideration. In addition I marked the names of those speakers who have been already tentatively  invited/available  (pending the VA Senior leadership approval). Please review and revise as needed. Danica      Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   2 0403 Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     ‐‐‐‐‐Original Appointment‐‐‐‐‐  From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov]   Sent: Tuesday, March 20, 2018 4:06 PM  To: Kuy, SreyRam (HOU); '(b) (6)  GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce  (NCPS); (b) (6)  (b) (6)  (Atlas Research); Marinac‐Dabic, Danica; '(b) (6)  '(b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) '    Hayes‐Byrd, Jacquelyn;      Subject: Medical Device Registry Summit ‐ Planning Meeting  When: Wednesday, April 25, 2018 7:30 AM‐8:00 AM (UTC‐05:00) Eastern Time (US & Canada).  Where: Conference call line: 800‐767‐(b) (5)  Code (b) (5)     Dear colleagues,   In preparation for our weekly Wednesday morning call, here’s the call‐in information:   Medical Device Registry Summit ‐ Planning Call Wednesday 3/21/2018  7:30 am – 8:00 am Eastern Conference call line:  800‐767‐(b) (5)  Code (b) (5)   We’ve made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more  detailed agenda, with locations, possible time and a slate of speakers.  Several fantastic subject matter experts on board  to participate!  This is a draft ‐ welcome all your input, ideas, revisions!  Feel to revise the editable word doc and share  with us all.       Again, many apologies to our west coast colleagues for the very early time.   Thank you so much for all your efforts!   Warmly, SreyRam   Special Advisor to the Secretary Veterans Health Administration   Associate Chief of Staff  Quality, Safety & Value Michael E. DeBakey VA Medical Center   810 Vermont Avenue, NW, #1069 Washington, DC 20420   Mobile:  713‐503‐4274 Office:  202‐461‐4875           3 0404           << File: Medical Device Registry Summit ‐ 1 pager.docx >>  << File: Medical Device Registry Summit ‐ 1 pager.pdf >>    4 0405 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 – 4:30 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 – 10:00 Session 1: Value of Registries for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA – VA patient Leveraging Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NESTcc) - invited/available Value Roundtable Discussion (45min) Moderator: SreyRam Kuy, MD, PhD  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS leadership (TBD)  Professional societies perspective – AMA – Kathy Blake  Hospital/system perspective - (b) (6) Kaiser  Industry perspective – AdvaMed/MDMA 10:00 – 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: TBD 0406  Current Cardiac Device Monitoring in the VA • Merritt H. Raitt, MD Director, VA National Cardiac Device Surveillance Program  Current VA Medical Device Registries - Maximo • Presenter TBD VA Office of Healthcare Technology Management  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL • Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch: 11:30 – 12:30 12:30 – 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  ONC Efforts - TBD (10 min)  UDI implementation efforts – Terrie Reed, FDA (10 min) – invited/available  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) – invited/available  Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH (10 min)  Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) – invited/available  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic (10 min) - invited/available 0407 Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 – 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF Objective: Begin development of the framework for VA registry development  Who should be at the table : What can we learn from VQI?– Jack Cronenwett, MD, Dartmouth, M2S (10 min)  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min)  Quality Management opportunities and compliance with standards– (b) (6) (10 min)  Privacy/Ethics issues –Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 –4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan – Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD - FDA Rachael Fleurence, PhD – NESTcc Bruce Moscowitz, MD – BREF Patient 0408 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • (b) (6) 0409 - 0410 A Diffusion of . Bl?uslrg Hes: Praclceshucss'u'HA Ha, Richard From: Sent: To: Cc: Subject: Attachments: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Friday, April 27, 2018 10:30 AM 'Bruce Moskowitz' McIntosh, Bruce (NCPS); Kuy, SreyRam (HOU); (b) (6) GHLF; Aaron Moskowitz; Thomas (b) (6) (b) (6) Concannon; (b) (6) (Atlas Research); (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program04262018_BM editDMDedit.docx   Just added  a placeholder on the VA session Panel for DOD panelist Another option would be to have DOD speaker. I was  given (by a colleague )as a suggestion the name of Col. John Smith who works with FDA on another collaborative project;  not sure if you know him and if he is the right person.     Danica         Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE    Director, Division of Epidemiology  Center for Devices and Radiological/OSB  White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6)   Silver Spring MD 20993; (301)796‐(b) (6)        (b) (6) fda.hhs.gov;    Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;    From: Bruce Moskowitz [mailto:(b) (6) mac.com]   Sent: Friday, April 27, 2018 5:27 AM  To: Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>  Cc: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Kuy, SreyRam (HOU) ; (b) (6)  GHLF  <(b) (6) ghlf.org>; Aaron Moskowitz <(b) (6) me.com>; Thomas Concannon <(b) (6) rand.org>;  (b) (6)  <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research) <(b) (6) va.gov>; (b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) (b) (6)  < ghlf.org>;   < dc‐crd.com>;   < dc‐crd.com>;  (b) (6)  <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)    <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Subject: Re: Medical Device Registry Summit ‐ Planning Meeting  Yes very important Sent from my iPad Bruce Moskowitz M.D. (b) (6) On Apr 26, 2018, at 11:29 PM, Marinac-Dabic, Danica < fda.hhs.gov> wrote: Bruce and the Team, 1 0411 Do you think we need to invite someone from DOD?    Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)     (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer  service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;   From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov]   Sent: Thursday, April 26, 2018 9:28 PM  To: Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU)  (b) (6) (b) (6) ; '  GHLF' < ghlf.org>; Bruce Moskowitz  <(b) (6) mac.com>; Aaron Moskowitz <(b) (6) me.com>; Thomas Concannon  <(b) (6) rand.org>; (b) (6)  <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research)  (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; '  < ghlf.org>; '  <(b) (6) dc‐ (b) (6) (b) (6) (b) (6) crd.com>; '  < dc‐crd.com>;    (b) (6) < va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)    <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Subject: RE: Medical Device Registry Summit ‐ Planning Meeting Nice work Danica!   Attached are edits to Agenda for VA section. I am waiting to receive who will cover for (b) (5)   presentation (still TBD). Don’t hold up locking this in though if we have to leave as TBD.    Regarding a VA patient to present, I think we may be making this too complicated. To find a VA patient  who is comfortable presenting with a story to tell effectively and with proper HIPAA release and  clearance will likely be complicated, especially without funding for travel. Perhaps we should use one of  the previous non‐VA patients presented earlier with a known story , or remove this.   Thanks, Bruce      From: Marinac-Dabic, Danica [mailto:(b) (6) fda.hhs.gov] Sent: Thursday, April 26, 2018 9:14 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Colleagues,  The updated document is attached. Please note that I added additional names of potential speakers,  panelists and moderators for your consideration. In addition I marked the names of those speakers who  have been already tentatively invited/available  (pending the VA Senior leadership approval). Please review and revise as needed. Danica    2 0412   Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer  service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     ‐‐‐‐‐Original Appointment‐‐‐‐‐  From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov]   Sent: Tuesday, March 20, 2018 4:06 PM  To: Kuy, SreyRam (HOU); '(b) (6)  GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon;  McIntosh, Bruce (NCPS); (b) (6)  (b) (6)  (Atlas Research); Marinac‐Dabic, Danica;  (b) (6) (b) (6) (b) (6) '  '  '  (b) (6)  Hayes‐Byrd, Jacquelyn;  (b) (6)  (b) (6)   Subject: Medical Device Registry Summit ‐ Planning Meeting  When: Wednesday, April 25, 2018 7:30 AM‐8:00 AM (UTC‐05:00) Eastern Time (US & Canada).  Where: Conference call line: 800‐767‐(b) (5)  Code (b) (5)     Dear colleagues,   In preparation for our weekly Wednesday morning call, here’s the call‐in information:   Medical Device Registry Summit ‐ Planning Call Wednesday 3/21/2018  7:30 am – 8:00 am Eastern Conference call line:  800‐767‐(b) (5)  Code (b) (5)   We’ve made great headway with fleshing out the Medical Device Registry Summit details, and attached  is a much more detailed agenda, with locations, possible time and a slate of speakers.  Several fantastic  subject matter experts on board to participate!  This is a draft ‐ welcome all your input, ideas,  revisions!  Feel to revise the editable word doc and share with us all.       Again, many apologies to our west coast colleagues for the very early time.   Thank you so much for all your efforts!   Warmly, SreyRam   Special Advisor to the Secretary Veterans Health Administration   Associate Chief of Staff  Quality, Safety & Value Michael E. DeBakey VA Medical Center 3 0413   810 Vermont Avenue, NW, #1069 Washington, DC 20420   Mobile:  713‐503‐4274 Office:  202‐461‐4875                     << File: Medical Device Registry Summit ‐ 1 pager.docx >>  << File: Medical Device Registry Summit ‐ 1  pager.pdf >>    4 0414 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 – 4:00 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 – 10:00 Session 1: Value of Registries for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA – VA patient Leveraging Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NESTcc) - invited/available Value Roundtable Discussion (45min) Moderator: SreyRam Kuy, MD, PhD  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS leadership (TBD)  Professional societies perspective – AMA – Kathy Blake  Hospital/system perspective - (b) (6) Kaiser  Industry perspective – AdvaMed/MDMA 10:00 – 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: TBD 0415  Current Cardiac Device Monitoring in the VA • Merritt H. Raitt, MD Director, VA National Cardiac Device Surveillance Program  Current VA Medical Device Registries - Maximo • Presenter TBD VA Office of Healthcare Technology Management  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL • Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch: 11:30 – 12:30 12:30 – 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  ONC Efforts - TBD (10 min)  UDI implementation efforts – Terrie Reed, FDA (10 min) – invited/available  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) – invited/available  Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH (10 min)  Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) – invited/available  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic (10 min) - invited/available 0416 Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 – 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF Objective: Begin development of the framework for VA registry development  Who should be at the table : What can we learn from VQI?– Jack Cronenwett, MD, Dartmouth, M2S (10 min)  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min)  Quality Management opportunities and compliance with standards– (b) (6) (10 min)  Privacy/Ethics issues –Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 –4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan – Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD - FDA Rachael Fleurence, PhD – NESTcc Bruce Moscowitz, MD – BREF Patient 0417 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • (b) (6) 0418 - 0419 A Diffusion of . Bl?uslrg Hes: Praclceshucss'u'HA Ha, Richard From: Sent: To: Cc: Subject: GHLF <(b) (6) ghlf.org> Friday, April 27, 2018 10:20 AM Marinac-Dabic, Danica; 'Bruce Moskowitz' McIntosh, Bruce (NCPS); Kuy, SreyRam (HOU); Aaron Moskowitz; Thomas Concannon; (b) (6) (b) (6) (b) (6) (b) (6) (Atlas Research); (b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting (b) (6) Regarding Bruce McIntosh’s comment below, we have a non‐VA patient who could fill this role. She was part of our  PCORI‐funded arthroplasty engagement project (BeTTER SAID) where patients identified device selection/tracking as a  critical concern. I’ll check with her about her interest and availability. Then I’ll get back to everyone with more info about  the patient so we can collectively make a decision.      (b) (6) (b) (6) PhD Patient-Centered Research  Global Healthy Living Foundation  515 N. Midland Ave - Upper Nyack, NY 10960  Cell: +1 (917) 455 (b) (6) Office: +1 (845) 348 (b) (6) Fax: +1 (845) 348 (b) (6) (b) (6) ghlf.org GHLF.org CreakyJoints.org ArthritisPower.org Facebook.com/CreakyJoints Twitter.com/CreakyJoints Twitter.com/GHLForg     Improving the lives of people with chronic disease through better access to care, education, support, advocacy and patient-centered research.                       From: Marinac‐Dabic, Danica [mailto:(b) (6) @fda.hhs.gov]   Sent: Friday, April 27, 2018 8:09 AM  To: 'Bruce Moskowitz' <(b) (6) mac.com>  Cc: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Kuy, SreyRam (HOU) ; (b) (6)  GHLF  (b) (6) (b) (6) < ghlf.org>; Aaron Moskowitz < me.com>; Thomas Concannon <(b) (6) rand.org>;  (b) (6)  <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research) <(b) (6) va.gov>; (b) (6)    <(b) (6) ghlf.org>; (b) (6)  <(b) (6) dc‐crd.com>; (b) (6)  <(b) (6) dc‐crd.com>;  (b) (6) (b) (6)  < va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)    <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Subject: RE: Medical Device Registry Summit ‐ Planning Meeting  TY.     Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE    1 0420 Director, Division of Epidemiology  Center for Devices and Radiological/OSB  White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6)   Silver Spring MD 20993; (301)796‐(b) (6)        (b) (6) fda.hhs.gov;    Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;    From: Bruce Moskowitz [mailto:(b) (6) mac.com]   Sent: Friday, April 27, 2018 7:50 AM  To: Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>  Cc: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Kuy, SreyRam (HOU) ; (b) (6)  GHLF  (b) (6) (b) (6) (b) (6) < ghlf.org>; Aaron Moskowitz < me.com>; Thomas Concannon < rand.org>;  (b) (6)  <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research) <(b) (6) va.gov>; (b) (6)    <(b) (6) ghlf.org>; (b) (6)  <(b) (6) dc‐crd.com>; (b) (6)  <(b) (6) dc‐crd.com>;  (b) (6) (b) (6)  < va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)   (b) (6) (b) (6)  < va.gov>;   <(b) (6) va.gov>  Subject: Re: Medical Device Registry Summit ‐ Planning Meeting  Will ask Sent from my iPad Bruce Moskowitz M.D. (b) (6) On Apr 27, 2018, at 7:45 AM, Marinac-Dabic, Danica < fda.hhs.gov> wrote: Any suggestions?   Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)     (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer  service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;   From: Bruce Moskowitz [mailto:(b) (6) mac.com]   Sent: Friday, April 27, 2018 5:27 AM  To: Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>  Cc: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Kuy, SreyRam (HOU) ;  (b) (6)  GHLF <(b) (6) ghlf.org>; Aaron Moskowitz <(b) (6) me.com>; Thomas  Concannon <(b) (6) rand.org>; (b) (6)  <(b) (6) atlasresearch.us>; (b) (6)  (Atlas  Research) <(b) (6) va.gov>; (b) (6)  <(b) (6) ghlf.org>; (b) (6)   <(b) (6) dc‐crd.com>; (b) (6)  <(b) (6) dc‐crd.com>; (b) (6)   <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)   2 0421 (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Subject: Re: Medical Device Registry Summit ‐ Planning Meeting Yes very important Sent from my iPad Bruce Moskowitz M.D. (b) (6) On Apr 26, 2018, at 11:29 PM, Marinac-Dabic, Danica < wrote: fda.hhs.gov> Bruce and the Team, Do you think we need to invite someone from DOD?    Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)     (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback  regarding the customer service you have received.  https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;   From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov]   Sent: Thursday, April 26, 2018 9:28 PM  To: Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU)  ; '(b) (6)  GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz  <(b) (6) mac.com>; Aaron Moskowitz <(b) (6) me.com>;  (b) (6) (b) (6) (b) (6) Thomas Concannon < rand.org>;   < atlasresearch.us>;  (b) (6)  (Atlas Research) <(b) (6) va.gov>; '(b) (6)   <(b) (6) ghlf.org>; '(b) (6)  <(b) (6) dc‐crd.com>; '(b) (6)   <(b) (6) dc‐crd.com>; (b) (6)  <(b) (6) va.gov>; Hayes‐ Byrd, Jacquelyn ; (b) (6)   <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Subject: RE: Medical Device Registry Summit ‐ Planning Meeting Nice work Danica!   Attached are edits to Agenda for VA section. I am waiting to receive who will cover for  (b) (5)  presentation (still TBD). Don’t hold up locking this in though if we have to  leave as TBD.    Regarding a VA patient to present, I think we may be making this too complicated. To  find a VA patient who is comfortable presenting with a story to tell effectively and with  proper HIPAA release and clearance will likely be complicated, especially without  funding for travel. Perhaps we should use one of the previous non‐VA patients  presented earlier with a known story , or remove this.   Thanks, Bruce  3 0422     From: Marinac-Dabic, Danica [mailto:(b) (6) fda.hhs.gov] Sent: Thursday, April 26, 2018 9:14 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; (b) (6) Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas (b) (6) (b) (6) (b) (6) (b) (6) Research); ' ' ' (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) Subject: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Colleagues,  The updated document is attached. Please note that I added additional names of  potential speakers, panelists and moderators for your consideration. In addition I  marked the names of those speakers who have been already tentatively  invited/available  (pending the VA Senior leadership approval). Please review and revise as needed. Danica      Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback  regarding the customer service you have received.  https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     ‐‐‐‐‐Original Appointment‐‐‐‐‐  From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov]   Sent: Tuesday, March 20, 2018 4:06 PM  To: Kuy, SreyRam (HOU); '(b) (6)  GHLF'; Bruce Moskowitz; Aaron Moskowitz;  Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6)  (b) (6)  (Atlas  (b) (6) (b) (6) Research); Marinac‐Dabic, Danica; '  '  '(b) (6)   (b) (6) (b) (6) (b) (6)    Hayes‐Byrd, Jacquelyn;        Subject: Medical Device Registry Summit ‐ Planning Meeting  When: Wednesday, April 25, 2018 7:30 AM‐8:00 AM (UTC‐05:00) Eastern Time (US &  Canada).  Where: Conference call line: 800‐767‐(b) (5)  Code (b) (5)     Dear colleagues,   In preparation for our weekly Wednesday morning call, here’s the call‐in information:   Medical Device Registry Summit ‐ Planning Call Wednesday 3/21/2018  7:30 am – 8:00 am Eastern Conference call line:  800‐767‐(b) (5)  Code (b) (5) 4 0423   We’ve made great headway with fleshing out the Medical Device Registry Summit  details, and attached is a much more detailed agenda, with locations, possible time and  a slate of speakers.  Several fantastic subject matter experts on board to  participate!  This is a draft ‐ welcome all your input, ideas, revisions!  Feel to revise the  editable word doc and share with us all.       Again, many apologies to our west coast colleagues for the very early time.   Thank you so much for all your efforts!   Warmly, SreyRam   Special Advisor to the Secretary Veterans Health Administration   Associate Chief of Staff  Quality, Safety & Value Michael E. DeBakey VA Medical Center   810 Vermont Avenue, NW, #1069 Washington, DC 20420   Mobile:  713‐503‐4274 Office:  202‐461‐4875                     << File: Medical Device Registry Summit ‐ 1 pager.docx >>  << File: Medical Device  Registry Summit ‐ 1 pager.pdf >>    5 0424 Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Wednesday, April 25, 2018 6:05 AM Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (b) (6) McIntosh, Bruce (NCPS); (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Attachments: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program04242018.docx Further revisions  added to the version Bruce had sent las night.    Talk to you at 7:30.      Danica   Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     ‐‐‐‐‐Original Appointment‐‐‐‐‐  From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov]   Sent: Tuesday, March 20, 2018 4:06 PM  To: Kuy, SreyRam (HOU); '(b) (6)  GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce  (b) (6) (b) (6) (NCPS);     (Atlas Research); Marinac‐Dabic, Danica; '(b) (6)  '(b) (6)   '(b) (6)  (b) (6)  Hayes‐Byrd, Jacquelyn; (b) (6)  (b) (6)   Subject: Medical Device Registry Summit ‐ Planning Meeting  When: Wednesday, April 25, 2018 7:30 AM‐8:00 AM (UTC‐05:00) Eastern Time (US & Canada).  Where: Conference call line: 800‐767‐(b) (5)  Code (b) (5)     Dear colleagues,   In preparation for our weekly Wednesday morning call, here’s the call‐in information:   Medical Device Registry Summit ‐ Planning Call Wednesday 3/21/2018  7:30 am – 8:00 am Eastern Conference call line:  800‐767‐(b) (5)  Code (b) (5)   We’ve made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more  detailed agenda, with locations, possible time and a slate of speakers.  Several fantastic subject matter experts on board  1 0425 to participate!  This is a draft ‐ welcome all your input, ideas, revisions!  Feel to revise the editable word doc and share  with us all.       Again, many apologies to our west coast colleagues for the very early time.   Thank you so much for all your efforts!   Warmly, SreyRam   Special Advisor to the Secretary Veterans Health Administration   Associate Chief of Staff  Quality, Safety & Value Michael E. DeBakey VA Medical Center   810 Vermont Avenue, NW, #1069 Washington, DC 20420   Mobile:  713‐503‐4274 Office:  202‐461‐4875                     << File: Medical Device Registry Summit ‐ 1 pager.docx >>  << File: Medical Device Registry Summit ‐ 1 pager.pdf >>    2 0426 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 – 4:00 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 – 10:00 Session 1: Value for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritiez opportunities Patient Needs TBA – VA patient Leveraging the Medical Device Ecosystem Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Value Roundtable Discussion Moderator: SreyRam Kuy, MD, PhD  Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O’Rourke TBD)  Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS leadership (TBD)  Professional societies perspective – AMA – Kathy Blake  Hospital/system perspective - Kaiser  Industry perspective – AdvaMed/MDMA 10:00 – 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future 0427 Moderator: TBD  Current Cardiac Device Monitoring in the VA • Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  Current VA Medical Device Registries - Maximo • TBD Office of Healthcare Technology Management, Veterans Health Affairs  “Title TBD” – Nicholas Giori, MD  “Title TBD” – Stephen Waldo, MD (or Paul Varosy, MD)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Lunch: 11:30 – 12:30 12:30 – 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  ONC Efforts - TBD  UDI implementation efforts – Terrie Reed, FDA  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell  Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH  Patient -enabled evidence generation - Harlan Krumholtz, MD, Yale  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic Panel Discussion: 2:00 – 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF 0428 Objective: Begin development of the framework for VA registry development Panel: Jack Cronenwett, MD, Art Sedrakyan, MD; PhD, Mike Lauer, MD, PhD, (b) (6)  Who should be at the table : What can we learn from VQI?– Jack Cronenwett, MD, Dartmouth, M2S  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH  Quality Management opportunities and compliance with standards– (b) (6)  Privacy/Ethics issues – TBD Panel Discussion: 3:15 –4:00 Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners” • Carolyn Clancy, MD or USH or PDUSH for VHA 0429 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • va.gov (b) (6) 0430 Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Wednesday, April 11, 2018 7:41 AM Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (b) (6) McIntosh, Bruce (NCPS); (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting   Dialing in a few minutes. Sorry – had a phone issue.   Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     ‐‐‐‐‐Original Appointment‐‐‐‐‐  From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov]   Sent: Tuesday, March 20, 2018 4:06 PM  To: Kuy, SreyRam (HOU); '(b) (6)  GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce  (b) (6) (b) (6) (NCPS);     (Atlas Research); Marinac‐Dabic, Danica; '(b) (6)  '(b) (6)   '(b) (6)  (b) (6)  Hayes‐Byrd, Jacquelyn; (b) (6)  (b) (6)   Subject: Medical Device Registry Summit ‐ Planning Meeting  When: Wednesday, April 11, 2018 7:30 AM‐8:00 AM (UTC‐05:00) Eastern Time (US & Canada).  Where: Conference call line: 800‐767‐(b) (5)  Code (b) (5)     Dear colleagues,   In preparation for our weekly Wednesday morning call, here’s the call‐in information:   Medical Device Registry Summit ‐ Planning Call Wednesday 3/21/2018  7:30 am – 8:00 am Eastern Conference call line:  800‐767‐(b) (5)  Code (b) (5)   We’ve made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more  detailed agenda, with locations, possible time and a slate of speakers.  Several fantastic subject matter experts on board  to participate!  This is a draft ‐ welcome all your input, ideas, revisions!  Feel to revise the editable word doc and share  with us all.       1 0431 Again, many apologies to our west coast colleagues for the very early time.   Thank you so much for all your efforts!   Warmly, SreyRam   Special Advisor to the Secretary Veterans Health Administration   Associate Chief of Staff  Quality, Safety & Value Michael E. DeBakey VA Medical Center   810 Vermont Avenue, NW, #1069 Washington, DC 20420   Mobile:  713‐503‐4274 Office:  202‐461‐4875                     << File: Medical Device Registry Summit ‐ 1 pager.docx >>  << File: Medical Device Registry Summit ‐ 1 pager.pdf >>    2 0432 Ha, Richard Subject: Location: FW: Medical Device Registry Summit - Planning Meeting Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Wed 3/21/2018 7:30 AM Wed 3/21/2018 8:00 AM Tentative Weekly Recurrence: Recurrence Pattern:every Wednesday from 7:30 AM to 8:00 AM Organizer: Kuy, SreyRam (HOU) Can this be added to my schedule?        Sent with Good (www.good.com)    From: Kuy, SreyRam (HOU) Sent: Tuesday, March 20, 2018 1:05:15 PM To: '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) '(b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; Subject: Medical Device Registry Summit - Planning Meeting When: Occurs every Wednesday from 7:30 AM to 8:00 AM effective 3/21/2018 until 6/11/2018. (UTC-05:00) Eastern Time (US & Canada)   Where: Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues,     In preparation for our weekly Wednesday morning call, here’s the call‐in information:     Medical Device Registry Summit ‐ Planning Call  Wednesday 3/21/2018  7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)      We’ve made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more  detailed agenda, with locations, possible time and a slate of speakers.  Several fantastic subject matter experts on board  to participate!  This is a draft ‐ welcome all your input, ideas, revisions!  Feel to revise the editable word doc and share  with us all.         Again, many apologies to our west coast colleagues for the very early time.     Thank you so much for all your efforts!     Warmly,  SreyRam     1 0433 Special Advisor to the Secretary  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center     810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875                       2 0434 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership      3. Panel Moderator – facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each)  “Why Registries Matter” – Data about how it helps lower costs, improve outcomes • Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management • Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA  “Enabling Patient Participation in Device Registries” – Title TBD • Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University  “Current Cardiac Device Monitoring in the VA” • Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  “Current VA Medical Device Registries in Place” - Maximo • (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  “Building Future-State Model for VHA Implant Tracking” • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety  “Title TBD” • Frederic Resnic, MD  Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners” • Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0435 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • va.gov (b) (6) 0436 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership      3. Panel Moderator – facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each)  “Why Registries Matter” – Data about how it helps lower costs, improve outcomes  Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management  Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA  “Enabling Patient Participation in Device Registries” – Title TBD  Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University  “Current Cardiac Device Monitoring in the VA”  Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  “Current VA Medical Device Registries in Place” - Maximo  (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  “Building Future-State Model for VHA Implant Tracking”  Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety  “Title TBD”  Frederic Resnic, MD  Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners”  Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0437 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners:      Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts:  SreyRam Kuy, MD SreyRam.Kuy@va.gov  va.gov (b) (6) 0438 Ha, Richard Subject: Location: Medical Device Registry Summit - Planning Meeting Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Wed 3/21/2018 7:30 AM Wed 3/21/2018 8:00 AM Tentative Weekly Recurrence: Recurrence Pattern:every Wednesday from 7:30 AM to 8:00 AM Meeting Status: Not yet responded Kuy, SreyRam (HOU) Organizer: Required Attendees:'(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday 3/21/2018  7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       We’ve made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more  detailed agenda, with locations, possible time and a slate of speakers.  Several fantastic subject matter experts on board  to participate!  This is a draft ‐ welcome all your input, ideas, revisions!  Feel to revise the editable word doc and share  with us all.        Again, many apologies to our west coast colleagues for the very early time.    Thank you so much for all your efforts!    Warmly,  SreyRam    Special Advisor to the Secretary  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  Washington, DC 20420  1 0439 Mobile: 713-503-4274 Office: 202-461-4875 0440 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership      3. Panel Moderator – facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each)  “Why Registries Matter” – Data about how it helps lower costs, improve outcomes • Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management • Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA  “Enabling Patient Participation in Device Registries” – Title TBD • Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University  “Current Cardiac Device Monitoring in the VA” • Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  “Current VA Medical Device Registries in Place” - Maximo • (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  “Building Future-State Model for VHA Implant Tracking” • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety  “Title TBD” • Frederic Resnic, MD  Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners” • Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0441 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • va.gov (b) (6) 0442 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership      3. Panel Moderator – facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each)  “Why Registries Matter” – Data about how it helps lower costs, improve outcomes  Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management  Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA  “Enabling Patient Participation in Device Registries” – Title TBD  Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University  “Current Cardiac Device Monitoring in the VA”  Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  “Current VA Medical Device Registries in Place” - Maximo  (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs  “Building Future-State Model for VHA Implant Tracking”  Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety  “Title TBD”  Frederic Resnic, MD  Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps  “Pulling it All Together: Next Steps Working with Our Partners”  Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA 0443 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners:      Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts:  SreyRam Kuy, MD SreyRam.Kuy@va.gov  va.gov (b) (6) 0444 Ha, Richard Subject: Location: Medical Device Registry Summit - Planning Meeting Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Wed 3/14/2018 7:30 AM Wed 3/14/2018 8:00 AM Tentative Recurrence: (none) Meeting Status: Not yet responded Kuy, SreyRam (HOU) Organizer: Required Attendees:'(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) ' ' (b) (6) Optional Attendees: Hayes-Byrd, Jacquelyn Dear colleagues,      For our planning meeting on Medical Device Registry tomorrow morning, attached is a 1 pager (double sided), which can  be used for discussion with outside stakeholders.  Also, I’ve attached meeting minutes from both prior conference calls.   The minutes are displayed chronologically, with the most recent at the end.  I’ve also invited a few other colleagues to  join the call, depending on their availability.  And many apologies to our west coast colleagues for the very early time    Thank you so much for all your enthusiasm and support for this effort!    Warmly,  SreyRam            ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐  Hi Everyone,     We’ll have our next Medical Device Registry Summit planning meeting next week, Wednesday March 14 at 7:30 am  eastern.  I’ll send out a calendar invite.    Thank you for all your help on this effort!    SreyRam Kuy, MD  1 0445   Special Advisor to the Secretary  Department of Veterans Affairs    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    Mobile:  713‐503‐4274  Office:  202‐461‐4875      2 0446 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: • • • • • Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: • SreyRam Kuy, MD SreyRam.Kuy@va.gov • va.gov (b) (6) 0447 Medical Device Registry Summit Month, Day, 2018 Draft Agenda Meeting Objective: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts 1. Welcome and introductions of participants and organization 2. Moderated Roundtable Discussion with Key Agency Leadership      Panel Moderator – facilitates with questions Secretary of the VA FDA Commissioner (TBD) CMS leadership (TBD) HHS Leadership (TBD) 3. Topic Focused Presentations  Why Registries Matter – Data about how it helps lower costs, improve outcomes – Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management – Speaker  Other Key Topics 4. Closing Remarks, Thanks to Participants, Outline Key Next Steps  Speaker TBD 0448 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners:      Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts:  SreyRam Kuy, MD SreyRam.Kuy@va.gov  va.gov (b) (6) 0449 Medical Device Registry Summit Month, Day, 2018 Draft Agenda Meeting Objective: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts 1. Welcome and introductions of participants and organization 2. Moderated Roundtable Discussion with Key Agency Leadership      Panel Moderator – facilitates with questions Secretary of the VA FDA Commissioner (TBD) CMS leadership (TBD) HHS Leadership (TBD) 3. Topic Focused Presentations  Why Registries Matter – Data about how it helps lower costs, improve outcomes – Subject Matter Expert TBD  NEST – the next frontier in device surveillance and outcomes management – Speaker  Other Key Topics 4. Closing Remarks, Thanks to Participants, Outline Key Next Steps  Speaker TBD 0450 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, May 08, 2018 4:39 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) Subject: Attachments: (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Medical Device Registry Summit - Planning Call, Wednesday May 9, 2018 7:30 am – 8:00 am Eastern, Conference call line: 800-767-(b) (5) Code (b) (5) VA Medical Implant Registry Summit Program 5-8-2018.docx; Medical Implant Registry Summit - List of Invitees 5-8-2018.docx Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday May 9, 2018  7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       Attached is the latest version of the agenda and the invitee list.  Please use this version, dated 5/8/2018.  Please review  the invitee list, and add as appropriate.  If a name is not on this list, they will not be able to clear security to attend the  summit.    Thank you so much for all your efforts!  It’s phenomenal how much has been accomplished with your incredible work!  I  really appreciate it.  Looking forward to a fantastic summit!    Warmly,  SreyRam    SreyRam Kuy, MD, MHS, FACS  Special Advisor   Office of the Secretary  Veterans Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875    1 0451 Medical Implant Registry Summit DRAFT list of invitees Date of Summit: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use *These are planned invitees – they have not yet confirmed attendance, and may send a representative in their place. Invitees* Agencies Department of Veterans Affairs Leadership Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health FDA Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health CMS Administrator Seema Verma (tentative) or representative HHS Secretary Alex Azar (tentative) or representative DoD Secretary James Mattis or representatiave (tentative) VA employees COS Mr. Peter O’Rourke Deputy COS Ms. Jacquelyn Hayes-Byrd Secretary Wilkie (tentative) or Deputy Secretary Bowman (tentative) Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar (b) (6) Office of Dentistry: Dr. (b) (6) (b) (6) of Reproductive Health in Women’s Health: Dr. (b) (6) (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) (b) (6) Ophthalmology: Dr. and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) (b) (6) Prosthetic and Sensory Aids Service: Ms. and Mr. (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. (b) (6) Mr. (b) (6) (b) (6) NCPS: Ms. and Ms. Mr. (b) (6) 0452 (b) (6) Salt Lake City VAMC: Mr. VA Office of Healthcare Technology Management Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) MD, VA, Vanderbilt FDA Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Terrie Reed, FDA Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH Vahan Simonyan, PhD (FDA) Greg Pappas, MD, PhD FDA/CDRH Others: John Rumsfeld, MD (ACC) Art Sedrakyan, MD, PhD, Cornell/MDEpiNet Harlan Krumholz, MD, Yale Fred Resnic, MD, Lahey Clinic Jack Cronenwett, MD, Dartmouth, M2S (b) (6) Rob Portman Mike Lauer, MD (NIH) AHRQ representative (b) (6) PhD (b) (6) (b) (6) (b) (6) (b) (6) Thomas Concannon PEW Trust EHR Vendor DOD Representative for Session 2 panel ONC Representative for Session 3 panel - Donald Rucker, MD Kristy Mitchel - Avalere Christine Stake - Ann & Robert H. Lurie Children's Hospital of Chicago (b) (6) 0453 Societies/Nonprofits Association for the Advancement of Medical Instrumentation (AAMI) leadership (b) (6) (b) (6) PhD (b) (6) FHIMSS (b) (6) PhD Association of peri-Operative Registered Nurses (AORN) (b) (6) MSHA, RN, CNOR, CSSM (b) (6) MHA, RN-BC, CNOR, CSSM (b) (6) MSN, RN, CNOR (b) (6) MSN, MBA, RN, ACNS-BC, CNS-CP, CNOR Emergency Care Research Institute (ECRI) (b) (6) MD, PhD (b) (6) MS American Academy of Orthopaedic Surgeons (AAOS) (b) (6) MD (b) (6) MD (b) (6) III MD American College of Cardiology (b) (6) MD, FACC (b) (6) MD, FACC (b) (6) Jr., MD, MBA, FACC (b) (6) MD, FACC American Association of Neurological Surgeons (b) (6) MD, PhD, FAANS, FACS (b) (6) MD, FAANS (b) (6) MD, MPH, FAANS, FACS (b) (6) MD, FAANS American Neurological Association (b) (6) PhD, MS (b) (6) MD Society for Vascular Surgery (b) (6) III, MD (b) (6) MD (b) (6) MD American College of Surgeons (b) (6) - 0454 (b) (6) (b) (6) (b) (6) American Dental Association (b) (6) DDS (b) (6) DDS AMA (b) (6) (b) (6) -Kathy Blake MD, MHA MD AcademyHealth (b) (6) -Dr. Association for Healthcare Resources and Materials Management (AHRMM) (b) (6) (b) (6) (b) (6) Senior Supply Chain ( aha.org) Cognitive Health - Julia Skapik, MD, PhD Pew Charitable Trust (b) (6) MD Henry J. Kaiser Family Foundation (b) (6) Medical Device Companies (Tentative – pending OGC and ethics approval, would send invite to their government affairs contact) Abbot Laboratories Academy Medical LLC AMO Sales and Services AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA 0455 Nuvasive Smith Nephew St. Jude Medical Zimmer I 1? A us. lhpartment Wu?! ?Wm-Wm {Jr?v?ctcram Affairs Di?uairg Ben Pratt :95 . 0456 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Device Registry Summit VA Auditorium Room 230 810 Vermont Avenue, NW Washington, DC 20420 June 4, 2018 8:30 a.m. – 4:30 p.m. 8:30 a.m. Welcome and Introductions of Participants and Organizations SreyRam Kuy, MD 8:45 a.m. – 10 a.m. Session 1: Value for Stakeholders Objective: To describe value of medical device registries to major stakeholders; identify the gaps; prioritize opportunities Patient Perspective (10 min) Christine Stake Leveraging the Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Value Roundtable Discussion Moderator: SreyRam Kuy, MD  VA Secretary or Deputy Secretary  FDA Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS Administrator Seema Verma (tentative)  HHS Secretary Alex Azar (tentative) or representative  DoD Secretary James Mattis or representative (tentative)  Professional societies perspective – AMA – Cathy Blake 10 a.m. – 11:30 a.m. Session 2: VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future 0457 Moderator: TBD  Current Cardiac Device Monitoring in the VA • Merritt H. Raitt, MD Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  Current VA Medical Device Registries - Maximo • Presenter TBD VA Office of Healthcare Technology Management  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL • Stephen Waldo, MD (or Paul Varosy, MD) Director, VA Clinical Assessment, Reporting and Tracking Program (CART)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) Panel Discussion: Speakers + MD (VA, Vanderbilt) and John Rumsfeld, MD (ACC) + EHR Vendor + DOD Representative 11:30 a.m. – 12:30 p.m. Lunch Break 12:30 p.m. – 2 p.m. Session 3: Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  ONC Efforts – Don Rucker (10 min)  UDI implementation efforts – Terrie Reed, FDA (10 min) – invited/available  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) – invited/available  Harmonization Efforts with National/International Registries Danica MarinacDabic, MD, PhD, MMSC, FISPE – FDA/CDRH (10 min)  Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) – invited/available  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic (10 min) - invited/available 0458 Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2 p.m. – 3:15 p.m. Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: TBD Objective: Begin development of the framework for VA registry development  Who should be at the table: What can we learn from VQI? – Jack Cronenwett, MD, Dartmouth, M2S (10 min)  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) (b) (6)  Quality Management opportunities and compliance with standards– (10 min)  Privacy/Ethics issues –Rob Portman, JD (10 min) Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ), Julia Skapik, Cognitive Health (invited and available), Kristy Mitchel (Avalere) 3:15 p.m. – 4:30 p.m. Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD Panel: Bruce McIntosh – VA (b) (6) Kaiser Permanente – NJRR Art Sedrakyan – Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD – FDA Rachael Fleurence, PhD – NESTcc Patient (TBD) Closing Remarks • VA Leadership Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 0459 Ha, Richard Subject: Location: Medical Device Registry Summit - Weekly Planning Meeting - Wednesdays 7:30 am Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Wed 5/16/2018 7:30 AM Wed 5/16/2018 8:00 AM Tentative Weekly Recurrence: Recurrence Pattern:every Wednesday from 7:30 AM to 8:00 AM Meeting Status: Not yet responded Kuy, SreyRam (HOU) Organizer: Required Attendees:'(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Optional Attendees: (b) (6) Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday 7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       We’ve made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more  detailed agenda and a slate of speakers.  Several fantastic subject matter experts on board to participate!      Attached is a draft ‐ welcome all your input, ideas, revisions!  Feel to revise the editable word doc and share with us all.       Again, many apologies to our west coast colleagues for the very early time.    Thank you so much for all your efforts!    Warmly,  SreyRam    Special Advisor   Office of the Secretary  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  1 0460 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 0461 Medical Implant Registry Summit DRAFT list of invitees Date of Summit: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use *These are planned invitees – they have not yet confirmed attendance, and may send a representative in their place. Invitees* Agencies Department of Veterans Affairs Leadership Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health FDA Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health CMS Administrator Seema Verma (tentative) or representative HHS Secretary Alex Azar (tentative) or representative DoD Secretary James Mattis or representatiave (tentative) VA employees COS Mr. Peter O’Rourke Deputy COS Ms. Jacquelyn Hayes-Byrd Secretary Wilkie (tentative) or Deputy Secretary Bowman (tentative) Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar (b) (6) Office of Dentistry: Dr. (b) (6) (b) (6) of Reproductive Health in Women’s Health: Dr. (b) (6) (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) (b) (6) Ophthalmology: Dr. and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) (b) (6) Prosthetic and Sensory Aids Service: Ms. and Mr. (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. (b) (6) Mr. (b) (6) (b) (6) NCPS: Ms. and Ms. Mr. (b) (6) 0462 (b) (6) Salt Lake City VAMC: Mr. VA Office of Healthcare Technology Management Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) , MD, VA, Vanderbilt FDA Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Terrie Reed, FDA Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH Vahan Simonyan, PhD (FDA) Greg Pappas, MD, PhD FDA/CDRH Others: John Rumsfeld, MD (ACC) Art Sedrakyan, MD, PhD, Cornell/MDEpiNet Harlan Krumholz, MD, Yale Fred Resnic, MD, Lahey Clinic Jack Cronenwett, MD, Dartmouth, M2S (b) (6) Rob Portman Mike Lauer, MD (NIH) AHRQ representative (b) (6) PhD (b) (6) (b) (6) (b) (6) (b) (6) Thomas Concannon PEW Trust EHR Vendor DOD Representative for Session 2 panel ONC Representative for Session 3 panel - Donald Rucker, MD Kristy Mitchel - Avalere Christine Stake - Ann & Robert H. Lurie Children's Hospital of Chicago (b) (6) 0463 Societies/Nonprofits Association for the Advancement of Medical Instrumentation (AAMI) leadership (b) (6) (b) (6) PhD (b) (6) FHIMSS (b) (6) PhD Association of peri-Operative Registered Nurses (AORN) (b) (6) MSHA, RN, CNOR, CSSM (b) (6) MHA, RN-BC, CNOR, CSSM (b) (6) MSN, RN, CNOR (b) (6) MSN, MBA, RN, ACNS-BC, CNS-CP, CNOR Emergency Care Research Institute (ECRI) (b) (6) MD, PhD (b) (6) MS American Academy of Orthopaedic Surgeons (AAOS) (b) (6) MD (b) (6) MD (b) (6) III MD American College of Cardiology (b) (6) MD, FACC (b) (6) MD, FACC (b) (6) Jr., MD, MBA, FACC (b) (6) MD, FACC American Association of Neurological Surgeons (b) (6) MD, PhD, FAANS, FACS (b) (6) MD, FAANS (b) (6) MD, MPH, FAANS, FACS (b) (6) MD, FAANS American Neurological Association (b) (6) PhD, MS (b) (6) MD Society for Vascular Surgery (b) (6) III, MD (b) (6) MD (b) (6) MD American College of Surgeons (b) (6) - 0464 (b) (6) (b) (6) (b) (6) American Dental Association (b) (6) DDS (b) (6) DDS AMA (b) (6) (b) (6) -Kathy Blake MD, MHA MD AcademyHealth (b) (6) -Dr. Association for Healthcare Resources and Materials Management (AHRMM) (b) (6) (b) (6) (b) (6) Senior Supply Chain ( aha.org) Cognitive Health - Julia Skapik, MD, PhD Pew Charitable Trust (b) (6) MD Henry J. Kaiser Family Foundation (b) (6) Medical Device Companies (Tentative – pending OGC and ethics approval, would send invite to their government affairs contact) Abbot Laboratories Academy Medical LLC AMO Sales and Services AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA 0465 Nuvasive Smith Nephew St. Jude Medical Zimmer I 1? A us. lhpartment Wu?! ?Wm-Wm {Jr?v?ctcram Affairs Di?uairg Ben Pratt :95 . 0466 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Device Registry Summit VA Auditorium Room 230 810 Vermont Avenue, NW Washington, DC 20420 June 4, 2018 8:30 a.m. – 4:30 p.m. 8:30 a.m. Welcome and Introductions of Participants and Organizations SreyRam Kuy, MD 8:45 a.m. – 10 a.m. Session 1: Value for Stakeholders Objective: To describe value of medical device registries to major stakeholders; identify the gaps; prioritize opportunities Patient Perspective (10 min) Christine Stake Leveraging the Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Value Roundtable Discussion Moderator: SreyRam Kuy, MD  VA Secretary or Deputy Secretary  FDA Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health  CMS Administrator Seema Verma (tentative)  HHS Secretary Alex Azar (tentative) or representative  DoD Secretary James Mattis or representative (tentative)  Professional societies perspective – AMA – Cathy Blake 10 a.m. – 11:30 a.m. Session 2: VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future 0467 Moderator: TBD  Current Cardiac Device Monitoring in the VA • Merritt H. Raitt, MD Director, National Cardiac Device Surveillance Program, Veterans Health Affairs  Current VA Medical Device Registries - Maximo • Presenter TBD VA Office of Healthcare Technology Management  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL • Stephen Waldo, MD (or Paul Varosy, MD) Director, VA Clinical Assessment, Reporting and Tracking Program (CART)  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) Panel Discussion: Speakers + MD (VA, Vanderbilt) and John Rumsfeld, MD (ACC) + EHR Vendor + DOD Representative 11:30 a.m. – 12:30 p.m. Lunch Break 12:30 p.m. – 2 p.m. Session 3: Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities  ONC Efforts – Don Rucker (10 min)  UDI implementation efforts – Terrie Reed, FDA (10 min) – invited/available  Strategically Coordinated Registry Networks (CRNs) – Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) – invited/available  Harmonization Efforts with National/International Registries Danica MarinacDabic, MD, PhD, MMSC, FISPE – FDA/CDRH (10 min)  Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) – invited/available  Active Surveillance via DELTA in National Registries – Fred Resnic, MD, Lahey Clinic (10 min) - invited/available 0468 Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2 p.m. – 3:15 p.m. Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: TBD Objective: Begin development of the framework for VA registry development  Who should be at the table: What can we learn from VQI? – Jack Cronenwett, MD, Dartmouth, M2S (10 min)  How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) (b) (6)  Quality Management opportunities and compliance with standards– (10 min)  Privacy/Ethics issues –Rob Portman, JD (10 min) Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ), Julia Skapik, Cognitive Health (invited and available), Kristy Mitchel (Avalere) 3:15 p.m. – 4:30 p.m. Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD Panel: Bruce McIntosh – VA (b) (6) Kaiser Permanente – NJRR Art Sedrakyan – Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD – FDA Rachael Fleurence, PhD – NESTcc Patient (TBD) Closing Remarks • VA Leadership Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 0469 Ha, Richard From: Sent: To: Cc: Subject: Hutton, James Friday, May 11, 2018 10:29 AM Hayes-Byrd, Jacquelyn (b) (6) (b) (6) FW: Medical Device Registry Summit - June 4 Jacque,    This is an event that will likely attract media.  We intend to provide public affairs coverage including media escort.    Any objections? I was told you had some concerns.    James    James Hutton  Deputy Assistant Secretary  Office of Public and Intergovernmental Affairs  Department of Veterans Affairs  810 Vermont Ave, NW  Washington, D.C. 20420  Office: 202-461-7558  Email: james.hutton@va.gov  Twitter: @jehutton   VA on Facebook . Twitter . YouTube . Flickr . Blog       (b) (6) From: (b) (6) Sent: Thursday, May 10, 2018 4:16 PM To: Hutton, James (b) (6) Cc: (b) (6) Subject: RE: Medical Device Registry Summit - June 4   Hi James, just following up on our conversation about you sending an email to inform Ms. Hayes‐Byrd about OPIA’s  recommendation that media attend the event.        From: (b) (6) Sent: Thursday, May 03, 2018 11:52 AM (b) (6) To: (b) (6) (b) (6) (b) (6) Cc: Hutton, James; (b) (6) Subject: FW: Medical Device Registry Summit - Planning Call, 5/2/2018 Wednesday 7:30 am Eastern, 800-767-(b) (5) Code (b) (5)   (b) (6) Sharing all the information with you. Please follow up with background. 1 (b) (6) if you have questions and need more 0470 Very Respectfully, (b) (6) Office of Media Relations, U.S. Department of Veterans Affairs 810 Vermont Ave. NW, Room 913 Washington, D.C. 20420 (b) (6) va.gov (b) (6) 202-461(work) (b) (6) 202-590(cell) www.vets.gov VA on Facebook. Twitter. YouTube. Flickr. Blog From: (b) (6) Sent: Thursday, May 03, 2018 9:59 AM To: (b) (6) ; (b) (6) Subject: FW: Medical Device Registry Summit - Planning Call, 5/2/2018 Wednesday 7:30 am Eastern, 800-767-(b) (5) Code (b) (5)   Good morning (b) (6) ,    Please see below and let me know if you one of you should take the lead for providing  the following support: news  media invite and escort, press releases, and  web posting.    Thanks,    (b) (6)     From: Kuy, SreyRam (HOU) Sent: Tuesday, May 01, 2018 6:06 PM To: '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) '(b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Medical Device Registry Summit - Planning Call, 5/2/2018 Wednesday 7:30 am Eastern, 800-767-(b) (5) Code (b) (5)   Dear colleagues,    In preparation for our weekly Wednesday morning call, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesday mornings 7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       Again, many apologies to our west coast colleagues for the very early time.    Attached is the program, a sample invitation letter with one pager, and a preliminary invitee list.  Please feel free to add  to the invitee list, edit the program and the invite letter, and share with us all.     Thank you so very much for ALL your hard work and efforts around this summit!          Warmly,  2 0471 SreyRam    SreyRam Kuy, MD, MHS, FACS  Special Advisor   Office of the Secretary  Department of Veterans Affairs    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1022  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875                          3 0472 Ha, Richard From: Sent: To: Cc: Subject: Attachments: Kuy, SreyRam (HOU) Tuesday, May 15, 2018 9:47 AM (b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn (b) (6) RE: Summit Monday June 4, 2018 Medical Device Registry Briefing - SecVA - Dr. SreyRam Kuy - 5-14-2018.docx Jackie,     Thank you and great idea!  Prepared remarks by the SecVA would be fantastic.      Let me know if I can help in any way, including giving a short briefing if needed, or working with his speech writers.    Attached is a short double sided one‐pager briefing document on the summit.    Thanks!  ‐Srey      From: (b) (6)    Sent: Tuesday, May 15, 2018 9:09 AM  To: Kuy, SreyRam (HOU) ; (b) (6)  <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn    Cc: (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)   (b) (6) < va.gov>  Subject: RE: Summit Monday June 4, 2018    Will discuss this with SecVA ASAP.  Perhaps he’d be better suited to give brief welcoming remarks?    From: Kuy, SreyRam (HOU) Sent: Thursday, May 10, 2018 3:23 PM (b) (6) To: (b) (6) Hayes-Byrd, Jacquelyn (b) (6) (b) (6) (b) (6) Cc: Subject: Summit Monday June 4, 2018   Hi (b) (6)  and (b) (6)     I wanted to check if this was on the Secretary’s schedule.  Under COS Peter O’Rourke’s leadership, VA is hosting a  healthcare summit about Medical Device Registries.  There’ll be panel on Monday June 4, at 8:45 ‐ 10 am, that will  include leadership from the various agencies, and the plan was to have SecVA on the panel too.  I think the DepCoS  Jacquie Hayes‐Byrd had mentioned her staff would facilitate getting it on the SecVA’s calendar, but wanted to double  check if you needed anything else.    Attached is the summit program.  And please let us know who else we should keep in the loop.    Thank you!    SreyRam Kuy, MD, MHS, FACS  1 0473   Special Advisor  Office of the Secretary    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1022  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      2 0474 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 To: Acting Secretary Wilkie From: SreyRam Kuy, MD Subj: Medical Device Registry Summit Does VA Need a Medical Device Registry?  Yes! • Allows us to notify patients about safety recalls • Allows us to identify the exact device when patient shows up in ER with complications • Allows us to track & compare outcomes of implants Why Registries Matter to VHA:  Legislation: H.R. 28: Rep Roe, unanimous vote Jan 2017 (408-0) S. 23: Senator Cassidy, SVAC hearing 5/2017 “Biological Implant Tracking and Veteran Safety Act”  Focused on biological implants only  Adopt UDI for biologicals & a tracking system that enables recall notification  6 months for VA to implement  VHA doesn’t have a standardized system. Multiple databases capturing only about 60% of patients with implants. Past VA Efforts  Several VA funded initiatives over past 10 years, $5.5 million spent on trying to build our own product  VITAS (Veterans Implant Tracking and Alert System) and ITR (Implant Tracking Registry)  Now efforts focused on COTS based solution The Summit  VA convenes leaders on medical device tracking;  Partners with sister agencies FDA and CMS to ensure patient safety;  Highlights efforts of VA to implement largest health system device tracking program and FDA NEST Stakeholders Federal  Rep Roe & Senator Cassidy  FDA • Unique Device Identifiers (UDI) in 2007 to enable tracking 0475 • Registry efforts contracted out  $3 million to “Medical Device Innovation Consortium” in 2016  Establish post market surveillance system NEST (National Evaluation System for Health Technology) 1  CMS & HHS – 2017 MEDPAC recommendation to require device identifiers on claims forms 2,3  VA  DoD Private Interests  American Association of Tissue Banks • Focus on biological implants • Accredits organizations for a fee (125 tissue banks)  Bruce Moskowitz, MD • Founder of nonprofit “Biomedical Research and Education Foundation” (BREF) • Son (Aaron) serves as executive director of BREF 1 2 3 https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm http://medpac.gov/docs/default-source/reports/jun17_ch7.pdf?sfvrsn=0 https://blogs.fda.gov/fdavoice/index.php/tag/national-evaluation-system-for-medical-devices-nest/ 0476 Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Friday, May 25, 2018 12:47 PM Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (b) (6) McIntosh, Bruce (NCPS); (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) Cc: Subject: Attachments: (b) (6) (b) (6) (b) (6) (b) (6) [EXTERNAL] MOST RECENT AGENDA + BIOS - VA MEDICAL DEVICE REGISTRY SUMMIT VA Medical Device Summit Final.docx; 2018 VA Registry Summit Bios Final.docx Hello Colleagues,  Attached please find the CLOSE TO FINAL DRAFT of the AGENDA ( in a slightly changed format – we hope you’d like it))  and  the WORKING DRAFT OF THE SPEAKERS BIOS ( the ones we had on file).  Please send the outstanding bios to (b) (6)  (copied) today if possible or early next week.   Have a great weekend! Danica     Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)       (b) (6) fda.hhs.gov;     1 0477 Medical Device Registry Summit June 4, 2018 Brief Biographical Sketches for Moderators and Presenters Kathleen Blake, MD, MPH (b) (6) Kathleen Blake is Vice President, Healthcare Quality, at the American Medical Association where she works to ensure that physicians have the information and tools they need to successfully participate in new payment (b) (6) programs. (b) (6) Jack L. Cronenwett, M.D. (b) (6) Jack L. Cronenwett is Professor of Surgery and The Dartmouth Institute for Health Policy and Clinical Practice at Dartmouth-Hitchcock Medical Center, and Chief Medical Officer for Medstreaming/M2S, which provide (b) (6) Rachael L. Fleurence, PhD (b) (6) Dr. Rachael L. Fleurence is the Executive Director for the NEST Coordinating Center and (b) (6) 1 0478 (b) (6) Harlan Krumholz M.D (b) (6) Harlan Krumholz is a cardiologist, health care scientist, and health care improvement expert at Yale University where he is the Harold H. Hines, Jr. Professor of Medicine and the Director Emeritus of the National Clinician Scholars Program, formerly the Robert Wood Johnson Foundation Clinical Scholars Program, a postdoctoral training program that he co-directed from 1996-2017. He is the Director of the Center for Outcomes Research and Evaluation (CORE) at Yale-New Haven Hospital. He has led (b) (6) Danica Marinac-Dabic, MD, PhD, MMSc, FISPE (b) (6) Danica Marinac-Dabic is the Director of the Division of Epidemiology at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). She has over (b) (6) (b) (6) 2 0479 (b) (6) Gregory Pappas, MD, PhD Gregory Pappas is the Associate Director for National Devices Surveillance at the FDA’s Center for Devices (b) (6) and Radiological Health (CDRH). He previously served as the (b) (6) Terrie Reed, MSc (b) (6) Terrie Reed works as a Senior Advisor for UDI Adoption at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). Formerly, Terrie worked as a (b) (6) (b) (6) Art Sedrakyan, MD, PhD (b) (6) Art Sedrakyan is a Professor at Weill Cornell Medical College and leads the FDA Medical Device Epidemiology (MDEpiNet) Coordinating, Science and Infrastructure Center. At Cornell, he directs the (b) (6) (b) (6) 3 0480 Vahan Simonyan, Ph.D. (b) (6) Vahan Simonyan has solid scientific background in varied academic disciplines: MS in Physical Organic Chemistry, PhD in Quantum Physics and Mathematics, post-doctoral training in Nanotechnology and Quantum Statistical Thermodynamics. After 2001 he switched his expertise to (b) (6) Julia Skapik, M.D., M.P.H. (b) (6) Julia Skapik a board-certified Internist and Clinical Informaticist and Chief Health Information Officer at Cognitive Medical Systems. Currently, she is focused on (b) (6) 4 0481 Medical Device Registry Summit June 4, 2018 Brief Biographical Sketches for Moderators and Presenters Kathleen Blake, MD, MPH Kathleen Blake is Vice President, Healthcare Quality, at the American Medical Association where she works (b) (6) to ensure that physicians have the information and tools they need to successfully participate in new payment (b) (6) programs. (b) (6) Jack L. Cronenwett, M.D. (b) (6) Jack L. Cronenwett is Professor of Surgery and The Dartmouth Institute for Health Policy and Clinical Practice at Dartmouth-Hitchcock Medical Center, and Chief Medical Officer for Medstreaming/M2S, which provide (b) (6) Rachael L. Fleurence, PhD (b) (6) Dr. Rachael L. Fleurence is the Executive Director for the NEST Coordinating Center and (b) (6) 1 0482 (b) (6) t Harlan Krumholz M.D (b) (6) Harlan Krumholz is a cardiologist, health care scientist, and health care improvement expert at Yale University where he is the Harold H. Hines, Jr. Professor of Medicine and the Director Emeritus of the National Clinician Scholars Program, formerly the Robert Wood Johnson Foundation Clinical Scholars Program, a postdoctoral training program that he co-directed from 1996-2017. He is the Director of the Center for Outcomes Research and Evaluation (CORE) at Yale-New Haven Hospital. He has led (b) (6) Danica Marinac-Dabic, MD, PhD, MMSc, FISPE (b) (6) Danica Marinac-Dabic is the Director of the Division of Epidemiology at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). She has over (b) (6) (b) (6) 2 0483 garnered experience in obstetrics, gynecology, and epidemiology in the academic and hospital settings as well as teaching experience in academic environment. Gregory Pappas, MD, PhD Gregory Pappas is the Associate Director for National Devices Surveillance at the FDA’s Center for Devices (b) (6) and Radiological Health (CDRH). He previously served as the (b) (6) Terrie Reed, MSc (b) (6) Terrie Reed works as a Senior Advisor for UDI Adoption at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). Formerly, Terrie worked as a(b) (6) Art Sedrakyan, MD, PhD (b) (6) Art Sedrakyan is a Professor at Weill Cornell Medical College and leads the FDA Medical Device Epidemiology (MDEpiNet) Coordinating, Science and Infrastructure Center. At Cornell, he directs (b) (6) (b) (6) 3 0484 Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Friday, May 25, 2018 12:56 PM Kuy, SreyRam (HOU); '(b) (6) GHLF'; 'Bruce Moskowitz'; 'Aaron Moskowitz'; 'Thomas (b) (6) Concannon'; McIntosh, Bruce (NCPS); '(b) (6) (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) Cc: Subject: Attachments: (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) [EXTERNAL] MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit PROGRAM VA Medical Device Registry Summit FINAL DRAFT .docx Sorry – did not attach the AGENDA/PROGRAM – attaching it now. Made formatting changes and added the times for  each presentation/panel discussion.     Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     _____________________________________________  From: Marinac‐Dabic, Danica   Sent: Friday, May 25, 2018 12:47 PM  To: 'Kuy, SreyRam (HOU)' ; '(b) (6)  GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz  (b) (6) (b) (6) < mac.com>; Aaron Moskowitz < me.com>; Thomas Concannon  <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; (b) (6)  <(b) (6) atlasresearch.us>;  (b) (6)  (Atlas Research) <(b) (6) va.gov>; '(b) (6)  <(b) (6) ghlf.org>; (b) (6)      <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6) (b) (6) <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  (b) (6)  <(b) (6) va.gov>;  (b) (6) (b) (6) (b) (6) (b) (6)  < va.gov>;   < va.gov>; (b) (6)   <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Cc: (b) (6)  <(b) (6) fda.hhs.gov>  Subject: MOST RECENT AGENDA + BIOS ‐ VA MEDICAL DEVICE REGISTRY SUMMIT      Hello Colleagues,  Attached please find the CLOSE TO FINAL DRAFT of the AGENDA ( in a slightly changed format – we hope you’d like it))  and  the WORKING DRAFT OF THE SPEAKERS BIOS ( the ones we had on file).  Please send the outstanding bios to (b) (6)  (copied) today if possible or early next week.   << File: VA Medical Device Summit Final.docx >>   << File: 2018 VA Registry Summit Bios Final.docx >>  Have a great weekend! 1 0485 Danica     Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)     << OLE Object: Picture (Device Independent Bitmap) >>  (b) (6) fda.hhs.gov;     2 0486 DEPARTMENT OF VETERANS AFFAIRS Medical Device Registry Summit June 4, 2018 GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW Washington, DC 20420 Presenter/Affiliations Registration 8:30-8:45 Welcome and Introduction of Participants and Organizations 8:45-10:00 Session 1: Value for Stakeholders SreyRam Kuy, MD - VA Objective: To describe value of medical device registries to major stakeholders, identify the gaps and prioritize the opportunities Moderator: SreyRam Kuy, MD - VA 8:45-9:00 Patient Perspective 9:00-9:15 Leveraging the National Medical Device Ecosystem 9:15-10:00 Christine Stake, Patient Governor-The Arthritis Power Patient Research Registry Rachael Fleurence, PhD NESTcc Value Roundtable Discussion: • Veterans Affairs (VA) Chief of Staff Peter O’Rourke • Food and Drug Administration (FDA) • Scott Gottlieb, MD, FDA Commissioner • Jeff Shuren, MD, PhD, Director, Center for Devices and Radiological Health • Centers for Medicare and Medicaid Services Administrator Seema Verma (tentative) • Secretary of Health and Human Services Alex M. Azar (tentative) • Secretary of Defense James N. Mattis (tentative) • American Medical Association, Kathleen Blake, MD • National Coordinator for Health Information Technology - Donald Rucker, MD 10:00-11:30 Session 2: VA Landscape 0487 Objective: To share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA 10:00-10:10 Current Cardiac Device Monitoring in the VA Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Affairs (VHA) 10:10-10:20 Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System 10:20-10:30 Medical Device Tracking in Cardiology: The integration of Real Time Locations System into The Clinical Assessment, Reporting, and Tracking System (CART) for Cardiac Catheterization Laboratories Paul Varosy, MD Director, CART Program 10:30-10:50 Building Future-State Model for VHA Implant Tracking Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety 10:50-11:30 Panel Discussants: Speakers & Julia Skapik, MD, PhD Cognitive Medical Systems 11:30-12:30 Lunch 12:30-2PM Session 3: Infrastructure/Methodology Opportunities for Standing Up a Medical Device Registry – Short and Long-Term Objective: To identify key national and international efforts in the device space that can be leveraged for the development of a Medical Device Registry; present short- and long-term opportunities Moderator: Sharon-Lise Normand, PhD - Harvard Medical School/Harvard School of Public Health 12:30-12:40 Strategically Coordinated Registry Networks – Linking Registries with other data sources Art Sedrakyan, MD, PhD WCMC MDEpiNet 12:40-12:50 Unique Device Identifier implementation efforts Terrie Reed, FDA Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA 12:50-1:00 0488 1:00-1:10 Patient -enabled evidence generation Harlan Krumholz, MD - Yale University 1:10-1:20 Active Surveillance via DELTA in National Registries (b) (6) MD - Lahey Clinic 1:20-2:00 Panel Discussants: Speakers & Vahan Simonyan, PhD - FDA 2:00-3:15 Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Objective: How to begin development of the framework for a VA Medical Device Registry Moderator: Thomas Concannon, PhD – RAND 2:00-2:10 Device Evaluation in a Quality Improvement Registry: Lessons learned from VQI. 2:10-2:20 How to Build in the Sustainability: Return of Investment Multi-stakeholder Analysis Greg Pappas, MD, PhD - FDA 2:20-2:30 Privacy/Ethics Issues Robert M Portman, JD Powers, Pyles, Sutter and Verville PC 2:30-3:15 Panel Discussants: Speakers & Kristi Mitchell - Avalere Health 3:15-4:30 Jack Cronenwett, MD Dartmouth Panel: Pulling it All Together Objective: To summarize key points in the next steps toward building a VA Medical Device Registry Moderator: Harlan Krumholz, MD - Yale University Panel Discussants: Bruce McIntosh, PhD - VA Art Sedrakyan, MD, PhD - WCMC Danica Marinac-Dabic, MD, PhD - FDA Rachael Fleurence, PhD - NEST 5:00 Closing Remarks VA Leadership – Dr. Carolyn Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 0489 Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Saturday, May 26, 2018 12:16 AM McIntosh, Bruce (NCPS); Kuy, SreyRam (HOU); '(b) (6) GHLF'; 'Bruce Moskowitz'; 'Aaron (b) (6) (b) (6) Moskowitz'; 'Thomas Concannon'; ' (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) Cc: Subject: Attachments: (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) [EXTERNAL] LIST OF ATENDEES - VA Medical Device Registry Summit Medical Implant Registry Summit - List of Invitees 5-25-2018 .docx Dear Colleagues,   I have updated the list of attendees with couple of additional FDA, NIH staff/leadership and other experts from other  organizations (please see attached).  Please note that I used the version dated 5‐8 and made updates and save it as 5‐ 25.  Please advise if we need to merge some other versions to this one.   Danica  Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE    Director, Division of Epidemiology  Center for Devices and Radiological/OSB  White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6)   Silver Spring MD 20993; (301)796‐(b) (6)        (b) (6) fda.hhs.gov;    Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;    From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov]   Sent: Friday, May 25, 2018 2:53 PM  To: Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU) ; '(b) (6)   (b) (6)  GHLF' < ghlf.org>; 'Bruce Moskowitz' <(b) (6) mac.com>; 'Aaron Moskowitz'  (b) (6) (b) (6) (b) (6) < me.com>; 'Thomas Concannon' < rand.org>; '   <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research) <(b) (6) va.gov>; '(b) (6)   <(b) (6) ghlf.org>; (b) (6)  <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>;   < va.gov>;    <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  (b) (6) (b) (6) Cc:   < fda.hhs.gov>  Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit     Thanks Danica,      I like the new format. I also changed myself from PhD to PharmD for the last panel discussion and removed (b) (6) from Dr. (b) (6)  title. Regarding timing for the first session, I want each of the VA speakers to have at least 15 minutes,  that leaves 30 minutes for the panel discussion (I changed times for presentations for panel and this session).    Also, I think SreyRam mentioned Dr. (b) (6)  would be added to the last panel. SreyRam is in clinic today and will  review this later.   1 0490   Thanks and enjoy the holiday everyone.  Bruce     From: Marinac‐Dabic, Danica [mailto:(b) (6) fda.hhs.gov]   Sent: Friday, May 25, 2018 1:28 PM  To: Kuy, SreyRam (HOU) ; '(b) (6)  GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz'  (b) (6) (b) (6) < mac.com>; 'Aaron Moskowitz' < me.com>; 'Thomas Concannon'  <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; '(b) (6)   <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research) <(b) (6) va.gov>; '(b) (6)   (b) (6) (b) (6) (b) (6) < ghlf.org>;   < va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>;   < va.gov>;    (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>;   < va.gov>;   < va.gov>  Cc: (b) (6)  <(b) (6) fda.hhs.gov>  Subject: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit     Removed FDA Commissioner’s name ( in the attached) version as just confirmed  by Dr. Shuren’s office that he will  represent the FDA/CDRH.  Still working on Don Rucker’s confirmation.  Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     _____________________________________________  From: Marinac‐Dabic, Danica   Sent: Friday, May 25, 2018 12:56 PM  To: 'Kuy, SreyRam (HOU)' ; '(b) (6)  GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz'  <(b) (6) mac.com>; 'Aaron Moskowitz' <(b) (6) me.com>; 'Thomas Concannon'  <(b) (6) rand.org>; 'McIntosh, Bruce (NCPS)' <(b) (6) va.gov>; '(b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) < atlasresearch.us>; '  (Atlas Research)' < va.gov>; '   <(b) (6) ghlf.org>; '(b) (6)  <(b) (6) va.gov>; 'Hayes‐Byrd, Jacquelyn' ; '(b) (6)  <(b) (6) va.gov>; '(b) (6)  <(b) (6) va.gov>; '(b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6)  < va.gov>; '  < va.gov>; '   <(b) (6) va.gov>; '(b) (6)  <(b) (6) va.gov>; '(b) (6)  <(b) (6) va.gov>  Cc: (b) (6)  <(b) (6) fda.hhs.gov>  Subject: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit      Sorry – did not attach the AGENDA/PROGRAM – attaching it now. Made formatting changes and added the times for  each presentation/panel discussion.   << File: PROGRAM  VA Medical Device Registry Summit FINAL DRAFT .docx >>    Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   2 0491   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     _____________________________________________  From: Marinac‐Dabic, Danica   Sent: Friday, May 25, 2018 12:47 PM  To: 'Kuy, SreyRam (HOU)' ; '(b) (6)  GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz  (b) (6) (b) (6) < mac.com>; Aaron Moskowitz < me.com>; Thomas Concannon  <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; (b) (6)  <(b) (6) atlasresearch.us>;  (b) (6)  (Atlas Research) <(b) (6) va.gov>; '(b) (6)  <(b) (6) ghlf.org>; (b) (6)    <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)   (b) (6) <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  (b) (6)  <(b) (6) va.gov>;  (b) (6) (b) (6) (b) (6) (b) (6)  < va.gov>;   < va.gov>; (b) (6)   <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Cc: (b) (6)  <(b) (6) fda.hhs.gov>  Subject: MOST RECENT AGENDA + BIOS ‐ VA MEDICAL DEVICE REGISTRY SUMMIT      Hello Colleagues,  Attached please find the CLOSE TO FINAL DRAFT of the AGENDA ( in a slightly changed format – we hope you’d like it))  and  the WORKING DRAFT OF THE SPEAKERS BIOS ( the ones we had on file).  Please send the outstanding bios to (b) (6)  (copied) today if possible or early next week.   << File: VA Medical Device Summit Final.docx >>   << File: 2018 VA Registry Summit Bios Final.docx >>  Have a great weekend! Danica     Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)     << OLE Object: Picture (Device Independent Bitmap) >>  (b) (6) fda.hhs.gov;     3 0492 Medical Implant Registry Summit DRAFT list of invitees Date of Summit: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use *These are planned invitees – they have not yet confirmed attendance, and may send a representative in their place. Invitees* Agencies Department of Veterans Affairs Leadership Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health FDA Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health CMS Administrator Seema Verma (tentative) or representative HHS Secretary Alex Azar (tentative) or representative DoD Secretary James Mattis or representatiave (tentative) VA employees COS Mr. Peter O’Rourke Deputy COS Ms. Jacquelyn Hayes-Byrd Secretary Wilkie (tentative) or Deputy Secretary Bowman (tentative) Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar (b) (6) Office of Dentistry: Dr. (b) (6) (b) (6) of Reproductive Health in Women’s Health: Dr. (b) (6) (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) (b) (6) Ophthalmology: Dr. and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) (b) (6) Prosthetic and Sensory Aids Service: Ms. and Mr. (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. (b) (6) Mr. (b) (6) (b) (6) NCPS: Ms. and Ms. Mr. (b) (6) 0493 (b) (6) Salt Lake City VAMC: Mr. VA Office of Healthcare Technology Management Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) MD, VA, Vanderbilt FDA Terrie Reed, FDA/CDRH Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA/CDRH Vahan Simonyan, PhD - FDA/CBER Greg Pappas, MD, PhD FDA/CDRH (b) (6) MD, MPH, FDA/CDRH (b) (6) PhD – FDA/CDRH on detail to HHS National Evaluation System for health Technologies Coordinating Center /MDIC Rachael Fleurence, PhD, Executive Director Medical Device Epidemiology Network (MDEpiNet) Art Sedrakyan, MD, PhD, Weill Cornell Medical College, MDEpiNet Coordinating Science and Infrastructure Center Sharon-Lise Normand, PhD, Harvard medical School/Harvard School of Public Health/MDEpiNet Methodology Center Fred Resnic, MD, Leahy Clinic Leahy Clinic Jack Cronenwett, MD, Dartmouth Julia Skapik , MD, PhD – Cognitive Health (b) (6) – NIH/NLM Kristy Mitchell – Avalere (b) (6) John Rumsfeld, MD (ACC) Harlan Krumholz, MD, Yale (b) (6) Rob Portman Michael Lauer, MD (NIH) Elise Berliner - AHRQ (sending replacement) 0494 (b) (6) PhD (b) (6) (b) (6) (b) (6) (b) (6) Thomas Concannon PEW Trust EHR Vendor DOD Representative for Session 2 panel ONC Representative for Session 3 panel - Donald Rucker, MD Kristy Mitchel - Avalere Christine Stake - Ann & Robert H. Lurie Children's Hospital of Chicago (b) (6) Societies/Nonprofits Association for the Advancement of Medical Instrumentation (AAMI) leadership (b) (6) (b) (6) PhD (b) (6) FHIMSS (b) (6) PhD Association of peri-Operative Registered Nurses (AORN) (b) (6) MSHA, RN, CNOR, CSSM (b) (6) MHA, RN-BC, CNOR, CSSM (b) (6) MSN, RN, CNOR (b) (6) MSN, MBA, RN, ACNS-BC, CNS-CP, CNOR Emergency Care Research Institute (ECRI) (b) (6) MD, PhD (b) (6) MS American Academy of Orthopaedic Surgeons (AAOS) (b) (6) MD (b) (6) MD (b) (6) III MD American College of Cardiology (b) (6) MD, FACC (b) (6) MD, FACC (b) (6) Jr., MD, MBA, FACC (b) (6) MD, FACC American Association of Neurological Surgeons (b) (6) MD, PhD, FAANS, FACS (b) (6) MD, FAANS (b) (6) MD, MPH, FAANS, FACS 0495 - (b) (6) MD, FAANS American Neurological Association (b) (6) PhD, MS (b) (6) MD Society for Vascular Surgery (b) (6) III, MD (b) (6) MD (b) (6) MD American College of Surgeons (b) (6) (b) (6) (b) (6) (b) (6) American Dental Association (b) (6) DDS (b) (6) DDS AMA (b) (6) (b) (6) -Kathy Blake MD, MHA MD AcademyHealth (b) (6) -Dr. Association for Healthcare Resources and Materials Management (AHRMM) (b) (6) (b) (6) (b) (6) Senior Supply Chain ( aha.org) Cognitive Health - Julia Skapik, MD, PhD Pew Charitable Trust (b) (6) MD Henry J. Kaiser Family Foundation (b) (6) Medical Device Companies (Tentative – pending OGC and ethics approval, would send invite to their government affairs contact) Abbot Laboratories 0496 Academy Medical LLC AMO Sales and Services AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA Nuvasive Smith & Nephew St. Jude Medical Zimmer AdvaMed/MDMA 0497 Ha, Richard From: Sent: To: Hayes-Byrd, Jacquelyn Tuesday, May 29, 2018 6:53 PM Kuy, SreyRam (HOU); '(b) (6) McIntosh, Bruce (NCPS); (b) (6) (b) (6) '(b) (6) (b) (6) Cc: Subject: (b) (6) (b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; (b) (6) (b) (6) (b) (6) (b) (6) (b) (5) RE: Medical Device Registry Summit - Weekly Planning Meeting - Wednesdays 7:30 am; Conference call line: 800-767-(b) (5) Code (b) (5) Thank you for all of your hard work in making this event happen.    Jacquie         Sent with Good (www.good.com)    From: Kuy, SreyRam (HOU) Sent: Tuesday, May 29, 2018 1:54:17 PM To: '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (b) (6) (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) Hayes(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Byrd, Jacquelyn; Cc: (b) (5) Subject: Medical Device Registry Summit - Weekly Planning Meeting - Wednesdays 7:30 am; Conference call line: 800  767-(b) (5) Code (b) (5) Dear colleagues,     Nearing the finish line!  Thank you ALL for your phenomenal efforts pulling together this national summit on Medical  Device Registries!  We’ve got a fantastic line‐up of amazing speakers!  Thanks for making this possible.     For our weekly Wednesday morning calls, here’s the call‐in information:     Medical Device Registry Summit ‐ Planning Call  Wednesdays 7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       I’ve attached the latest version of the agenda, the speaker ready packet, and the RSVP list (as of 5/29/2018 at 2  pm).  Could you look over, and if the speakers you’ve been in contact with aren’t on the list, please have them RSVP as  soon as possible to the office of protocol at rsvpprotocol@va.gov. This is the list that will go to security, allowing them  to enter the building. Thank you!        Thank you so much for all your incredible efforts!  So proud of your work and this wonderful summit.     Warmly,  1 0498 SreyRam        SreyRam Kuy, MD, MHS, FACS     Special Advisor  Office of the Secretary    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center     810 Vermont Avenue, NW, #858  Washington, DC 20420     Mobile:  713‐503‐4274  Office:  202‐461‐4875        2 0499 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, May 22, 2018 4:53 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Attachments: (b) (6) (b) (6) (b) (6) (b) (6) (b) (5) Medical Device Registry Summit - Weekly Planning Meeting - Wednesdays 7:30 am; Conference call line: 800-767-(b) (5) Code (b) (5) News Release - Medical Device Registry Summit - Dr. SreyRam Kuy.docx; Medical Device Registry Summit Program June 4, 2018.docx Dear colleagues,    For our weekly Wednesday morning calls, here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Wednesdays 7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       Thank you so much for all your efforts!    Warmly,  SreyRam      SreyRam Kuy, MD, MHS, FACS    Special Advisor  Office of the Secretary    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #858  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875      1 0500 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Device Registry Summit GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW Washington, DC 20420 June 4, 2018 8:30 a.m. – 4:30 p.m. 8:30 a.m. Welcome and Introduction of Participants and Organizations SreyRam Kuy, MD 8:45 a.m. – 10 a.m. Session 1: Value for Stakeholders Objective: To describe value of medical device registries to major stakeholders; identify the gaps; prioritize opportunities Patient Perspective Christine Stake, Patient Governor, the ArthritisPower Patient Research Registry Leveraging the Medical Device Ecosystem Rachael Fleurence Ph.D., National Evaluation System for Health Technologies Value Roundtable Discussion Moderator: SreyRam Kuy, MD • Veterans Affairs (VA) Chief of Staff Peter O’Rourke • Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD • Jeff Shuren, MD, PhD, Director, Center for Devices and Radiological Health • Centers for Medicare and Medicaid Services Administrator Seema Verma (tentative) • Secretary of Health and Human Services Alex M. Azar (tentative) • Secretary of Defense James N. Mattis (tentative) • American Medical Association, Kathleen Blake, MD 0501 10 a.m. – 11:30 a.m. Session 2: VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA  Current Cardiac Device Monitoring in the VA • Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Affairs (VHA)  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of Real Time Locations System into The Clinical Assessment, Reporting, and Tracking System (CART) for Cardiac Catheterization Laboratories • Stephen Waldo, MD or Paul Varosy, MD Director, CART Program  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Speakers + John Rumsfeld, MD, American College of Cardiology 11:30 a.m. – 12:30 p.m. Lunch Break 12:30 p.m. – 2 p.m. Session 3: Infrastructure/Methodology Opportunities for Standing Up a Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, PhD (Harvard Medical School/Harvard School of Public Health) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of a Medical Device Registry; present short- and long-term opportunities  Efforts of the Office of the National Coordinator (ONC) for Health Information Technology • Don Rucker, MD (ONC)  Unique Device Identifier implementation efforts • Terrie Reed (FDA)  Strategically Coordinated Registry Networks – Linking Registries with other data sources • Art Sedrakyan, MD, PhD (Cornell/MDEpiNet)  Harmonization Efforts with National/International Registries • Danica Marinac-Dabic, MD, PhD, MMSC, FISPE (FDA/Center for Devices and Radiological Health (CDRH))  Patient -enabled evidence generation 0502 • Harlan Krumholz, MD (Yale University)  Active Surveillance via DELTA in National Registries • Fred Resnic, MD (Lahey Clinic) Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) 2 p.m. – 3:15 p.m. Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Thomas Concannon, PhD (RAND) Objective: How to begin development of the framework for a Medical Device Registry  Who should be at the table: What can we learn from Vascular Quality Initiative? • Jack Cronenwett, MD (Dartmouth)  How to build in the sustainability: Return of Investment Multi-stakeholder Analysis • Greg Pappas, MD, PhD (FDA/CDRH)  Privacy/Ethics issues • Robert M Portman, JD (Powers, Pyles, Sutter and Verville PC) Panel Discussion: Speakers + Mike Lauer, MD (National Institute of Health), Elise Berliner, PhD (Agency for Healthcare Research and Quality), Julia Skapik, MD (Cognitive Medical Systems), Kristi Mitchell (Avalere Health) 3:15 p.m. – 4:30 p.m. Panel: Pulling it All Together Objective: To summarize key points in the next steps toward building a Medical Device Registry Moderator: Harlan Krumholz, MD (Yale University) Panel: Bruce McIntosh, PharmD (VA) Art Sedrakyan, MD (Weill Cornell Medical College) Danica Marinac-Dabic, MD, PhD (FDA) Rachael Fleurence, PhD (National Evaluation System for Health Technology Coordinating Center) Closing Remarks VA Leadership – Dr. Carolyn Clancy Questions? Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 0503 May 2018 VA Medical Device Registry Summit Every day, doctors and nurses at VA medical centers across the country are innovating: creating ground breaking cures, developing novel procedures and performing lifesaving treatments. They do this because serving our nation’s heroes with excellence is their commitment. Today, we’re shining the spotlight on one example of this VA excellence. VA is convening thought leaders on medical device tracking, and partnering with sister agencies, FDA, CMS, HHS and DoD to ensure patient safety. Medical Device Registries are critically important because they allow us to notify patients about safety recalls, identify the exact device when patient shows up in ER with complications, and track & compare outcomes of implants. Partnering with these medical experts and sister agencies, VA is working to implement the largest health system device tracking program in the nation. On June 4, 2018, VA will be hosting a summit of thought leaders and sister agencies. The public is invited to participate. Medical Device Registry Summit GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW, Washington, DC 20420 June 4, 2018, 8:30 a.m. – 4:30 p.m. Interested parties may RSVP to attend in person, with space limited to the first 150 who RSVP. RSVP at rsvpprotocol@va.gov. The summit will also be broadcast live in two parts. The public can also register to watch online here: Link for the Medical Device Registry Summit Morning Session 1: https://www.webcaster4.com/Webcast/Page/89/25950 Link for the Medical Device Registry Summit Afternoon Session 2: https://www.webcaster4.com/Webcast/Page/89/25951 0504 Ha, Richard From: Sent: To: Subject: (b) (6) Thursday, May 31, 2018 9:35 AM Hayes-Byrd, Jacquelyn RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Of course.  Will do right now.    From: Hayes-Byrd, Jacquelyn Sent: Wednesday, May 30, 2018 9:24 PM To: (b) (6) Subject: FW: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit   Jack Can you provide Pete’s? (b) (6) Sent with Good (www.good.com)   From: (b) (6) Sent: Wednesday, May 30, 2018 1:04:16 PM To: McIntosh, Bruce (NCPS); Marinac-Dabic, Danica; Kuy, SreyRam (HOU); '(b) (6) GHLF'; 'Bruce Moskowitz'; 'Aaron (b) (6) (b) (6) Moskowitz'; 'Thomas Concannon'; '(b) (6) (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Please see the latest bios.     Still missing:  SreyRam Kuy, MD - VA  Peter O’Rourke  Bruce McIntosh, PharmD  (b) (6) MD  Robert M Portman  Kristi Mitchell  Carolyn Clancy  Seema Verma (tentative)  James N. Mattis (tentative)        Thank you,     __________________________________________________________________________________________ MSc  (b) (6) (b) (6)   Office of Surveillance and Biometrics CDRH FDA  1 0505 White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R(b) (6) Silver Spring MD 20993 Tel: 301-796  (b) (6) E-mail: fda.hhs.gov  (b) (6)         Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received.  https://www.research.net/r/cdrhcustomerservice?sm=UcbfugmQLNUc0a7AE7WJWNqbmQCW8dh6L8vrch4XjDy8OdSZxGJUGQ8w CRWTw4AHOlHjM03RqVT0wMLQrUilPQ%3d%3d        From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov]   Sent: Tuesday, May 29, 2018 8:09 PM  To: (b) (6)  <(b) (6) fda.hhs.gov>; Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy,  (b) (6) (b) (6) SreyRam (HOU) ; '  GHLF' < ghlf.org>; 'Bruce Moskowitz'  <(b) (6) mac.com>; 'Aaron Moskowitz' <(b) (6) me.com>; 'Thomas Concannon'  <(b) (6) rand.org>; '(b) (6)  <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research)  (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; '  < ghlf.org>;    <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>;   < va.gov>;     < va.gov>;  (b) (6)  <(b) (6) va.gov>; (b) (6)    <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit      I attached the Bios and pictures for:     Merritt H. Raitt, MD,  Nicholas Giori, MD, PhD  Paul Varosy, MD  Bruce McIntosh, PharmD        Thanks,  Bruce      From: (b) (6)  [mailto:(b) (6) fda.hhs.gov]   Sent: Tuesday, May 29, 2018 12:14 PM  To: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>;  (b) (6) (b) (6) Kuy, SreyRam (HOU) ; '  GHLF' < ghlf.org>; 'Bruce Moskowitz'  <(b) (6) mac.com>; 'Aaron Moskowitz' <(b) (6) me.com>; 'Thomas Concannon'  <(b) (6) rand.org>; '(b) (6)  <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research)  (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; '  < ghlf.org>;    <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>;   < va.gov>;     < va.gov>;  (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)   <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit      Dear all,  2 0506   Please see attached the latest agenda and bios. Also, below is the list of the bios I am missing, if possible forward me by COB tomorrow, May 30.    SreyRam Kuy, MD - VA  Peter O’Rourke  Bruce McIntosh, PharmD  (b) (6) MD  Robert M Portman  Kristi Mitchell  Carolyn Clancy  Seema Verma (tentative)  James N. Mattis (tentative)        Best Regards,     __________________________________________________________________________________________ (b) (6) MSc  (b) (6)   Office of Surveillance and Biometrics CDRH FDA  (b) (6) White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R  (b) (6) Silver Spring MD 20993 Tel: 301-796  (b) (6) E-mail: fda.hhs.gov        Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received.  https://www.research.net/r/cdrhcustomerservice?sm=UcbfugmQLNUc0a7AE7WJWNqbmQCW8dh6L8vrch4XjDy8OdSZxGJUGQ8w CRWTw4AHOlHjM03RqVT0wMLQrUilPQ%3d%3d        From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov]   Sent: Friday, May 25, 2018 2:53 PM  To: Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU) ; '(b) (6)   (b) (6)  GHLF' < ghlf.org>; 'Bruce Moskowitz' <(b) (6) mac.com>; 'Aaron Moskowitz'  (b) (6) (b) (6) (b) (6) < me.com>; 'Thomas Concannon' < rand.org>; '   <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research) <(b) (6) va.gov>; '(b) (6)   <(b) (6) ghlf.org>; (b) (6)  <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  (b) (6)   (b) (6) <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)   <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  (b) (6) (b) (6) Cc:   < fda.hhs.gov>  Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit      Thanks Danica,     3 0507 I like the new format. I also changed myself from PhD to PharmD for the last panel discussion and removed (b) (6)   from Dr. (b) (6)  title. Regarding timing for the first session, I want each of the VA speakers to have at least 15 minutes,  that leaves 30 minutes for the panel discussion (I changed times for presentations for panel and this session).     Also, I think SreyRam mentioned Dr. (b) (6)  would be added to the last panel. SreyRam is in clinic today and will  review this later.      Thanks and enjoy the holiday everyone.  Bruce      From: Marinac‐Dabic, Danica [mailto:(b) (6) fda.hhs.gov]   Sent: Friday, May 25, 2018 1:28 PM  To: Kuy, SreyRam (HOU) ; '(b) (6)  GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz'  (b) (6) (b) (6) < mac.com>; 'Aaron Moskowitz' < me.com>; 'Thomas Concannon'  <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; '(b) (6)   <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research) <(b) (6) va.gov>; '(b) (6)   (b) (6) (b) (6) (b) (6) < ghlf.org>;   < va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>;   < va.gov>;    <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Cc: (b) (6)  <(b) (6) fda.hhs.gov>  Subject: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit      Removed FDA Commissioner’s name ( in the attached) version as just confirmed  by Dr. Shuren’s office that he will  represent the FDA/CDRH.  Still working on Don Rucker’s confirmation.   Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE    Director, Division of Epidemiology  Center for Devices and Radiological/OSB  White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6)   Silver Spring MD 20993; (301)796‐(b) (6)    The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.     (b) (6) fda.hhs.gov;     Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;        _____________________________________________  From: Marinac‐Dabic, Danica   Sent: Friday, May 25, 2018 12:56 PM  To: 'Kuy, SreyRam (HOU)' ; '(b) (6)  GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz'  (b) (6) (b) (6) < mac.com>; 'Aaron Moskowitz' < me.com>; 'Thomas Concannon'  <(b) (6) rand.org>; 'McIntosh, Bruce (NCPS)' <(b) (6) va.gov>; '(b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) < atlasresearch.us>; '  (Atlas Research)' < va.gov>; '   <(b) (6) ghlf.org>; '(b) (6)  <(b) (6) va.gov>; 'Hayes‐Byrd, Jacquelyn' ; '(b) (6)  <(b) (6) va.gov>; '(b) (6)  <(b) (6) va.gov>; '(b) (6)   (b) (6) (b) (6)  <(b) (6) va.gov>; '(b) (6)  <(b) (6) va.gov>; '(b) (6)   <(b) (6) va.gov>; '(b) (6)  <(b) (6) va.gov>; '(b) (6)  <(b) (6) va.gov>  (b) (6) (b) (6) Cc:   < fda.hhs.gov>  Subject: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit      4 0508      Sorry – did not attach the AGENDA/PROGRAM – attaching it now. Made formatting changes and added the times for  each presentation/panel discussion.    << File: PROGRAM  VA Medical Device Registry Summit FINAL DRAFT .docx >>      Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE    Director, Division of Epidemiology  Center for Devices and Radiological/OSB  White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6)   Silver Spring MD 20993; (301)796‐(b) (6)    The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.     fda.hhs.gov;     Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;  (b) (6)       _____________________________________________  From: Marinac‐Dabic, Danica   Sent: Friday, May 25, 2018 12:47 PM  To: 'Kuy, SreyRam (HOU)' ; '(b) (6)  GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz  (b) (6) (b) (6) < mac.com>; Aaron Moskowitz < me.com>; Thomas Concannon  <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; (b) (6)  <(b) (6) atlasresearch.us>;  (b) (6)  (Atlas Research) <(b) (6) va.gov>; '(b) (6)  <(b) (6) ghlf.org>; (b) (6)    <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)   (b) (6) <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  (b) (6)  <(b) (6) va.gov>;  (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)   <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Cc: (b) (6)  <(b) (6) fda.hhs.gov>  Subject: MOST RECENT AGENDA + BIOS ‐ VA MEDICAL DEVICE REGISTRY SUMMIT         Hello Colleagues,   Attached please find the CLOSE TO FINAL DRAFT of the AGENDA ( in a slightly changed format – we hope you’d like it))  and  the WORKING DRAFT OF THE SPEAKERS BIOS ( the ones we had on file).    (copied) today if possible or early next week.  Please send the outstanding bios to (b) (6)    << File: VA Medical Device Summit Final.docx >>   << File: 2018 VA Registry Summit Bios Final.docx >>   Have a great weekend!  Danica       Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE    Director, Division of Epidemiology  Center for Devices and Radiological/OSB  White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6)   Silver Spring MD 20993; (301)796‐(b) (6)      << OLE Object: Picture (Device Independent Bitmap) >>   (b) (6) fda.hhs.gov;        5 0509 Ha, Richard From: Sent: To: McIntosh, Bruce (NCPS) Tuesday, May 29, 2018 12:30 PM (b) (6) Marinac-Dabic, Danica; Kuy, SreyRam (HOU); '(b) (6) (b) (6) 'Aaron Moskowitz'; 'Thomas Concannon'; '(b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: (b) (6) (b) (6) (b) (6) (b) (6) GHLF'; 'Bruce Moskowitz'; (Atlas Research); '(b) (6) (b) (6) (b) (6) RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Thanks Marta.    I have the bios and pictures for four VA speakers highlighted below and will add these to the document Danica started  Friday and send over to you today.     Bruce     From: (b) (6)  [mailto:(b) (6) fda.hhs.gov]   Sent: Tuesday, May 29, 2018 12:14 PM  To: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>;  (b) (6) Kuy, SreyRam (HOU) ; '  GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz'  <(b) (6) mac.com>; 'Aaron Moskowitz' <(b) (6) me.com>; 'Thomas Concannon'  (b) (6) (b) (6) (b) (6) (b) (6) < rand.org>; '  < atlasresearch.us>;   (Atlas Research)  <(b) (6) va.gov>; '(b) (6)  <(b) (6) ghlf.org>; (b) (6)   (b) (6) (b) (6) < va.gov>; Hayes‐Byrd, Jacquelyn ;    (b) (6) va.gov>;  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  (b) (6)  <(b) (6) (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)   (b) (6) (b) (6) (b) (6) < va.gov>;   < va.gov>  Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit     Dear all, Please see attached the latest agenda and bios. Also, below is the list of the bios I am missing, if possible forward me by COB tomorrow, May 30. SreyRam Kuy, MD - VA Peter O’Rourke Donald Rucker, MD Merritt H. Raitt, MD, Nicholas Giori, MD, PhD Paul Varosy, MD Bruce McIntosh, PharmD (b) (6) MD Robert M Portman Kristi Mitchell Carolyn Clancy Seema Verma (tentative) James N. Mattis (tentative) 1 0510 Best Regards,   __________________________________________________________________________________________ MSc (b) (6) (b) (6) Office of Surveillance and Biometrics CDRH FDA (b) (6) White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R(b) (6) Silver Spring MD 20993 Tel: 301-796(b) (6) E-mail: fda.hhs.gov Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/r/cdrhcustomerservice?sm=UcbfugmQLNUc0a7AE7WJWNqbmQCW8dh6L8vrch4XjDy8OdSZxGJUGQ8w CRWTw4AHOlHjM03RqVT0wMLQrUilPQ%3d%3d     From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov]   Sent: Friday, May 25, 2018 2:53 PM  To: Marinac‐Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU) ; '(b) (6)    GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz' <(b) (6) mac.com>; 'Aaron Moskowitz'  (b) (6) < me.com>; 'Thomas Concannon' <(b) (6) rand.org>; '(b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) < atlasresearch.us>;   (Atlas Research) < va.gov>; '   <(b) (6) ghlf.org>; (b) (6)  <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  (b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>;   < va.gov>;    <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Cc: (b) (6)  <(b) (6) fda.hhs.gov>  Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit     Thanks Danica,    I like the new format. I also changed myself from PhD to PharmD for the last panel discussion and removed (b) (6)   (b) (6) from Dr.   title. Regarding timing for the first session, I want each of the VA speakers to have at least 15 minutes,  that leaves 30 minutes for the panel discussion (I changed times for presentations for panel and this session).    Also, I think SreyRam mentioned Dr. (b) (6)  would be added to the last panel. SreyRam is in clinic today and will  review this later.     Thanks and enjoy the holiday everyone.  Bruce     From: Marinac‐Dabic, Danica [mailto:(b) (6) Sent: Friday, May 25, 2018 1:28 PM  To: Kuy, SreyRam (HOU) ; '(b) (6) <(b) (6) mac.com>; 'Aaron Moskowitz' <(b) (6) (b) (6) < rand.org>; McIntosh, Bruce (NCPS) <(b) (6) fda.hhs.gov]    GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz'  me.com>; 'Thomas Concannon'  va.gov>; '(b) (6)   2 0511 <(b) (6) atlasresearch.us>; (b) (6)  (Atlas Research) <(b) (6) va.gov>; '(b) (6)   (b) (6) (b) (6) (b) (6) < ghlf.org>;   < va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>;   < va.gov>;    (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>;   < va.gov>;   < va.gov>  Cc: (b) (6)  <(b) (6) fda.hhs.gov>  Subject: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit     Removed FDA Commissioner’s name ( in the attached) version as just confirmed  by Dr. Shuren’s office that he will  represent the FDA/CDRH.  Still working on Don Rucker’s confirmation.  Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E;     _____________________________________________  From: Marinac‐Dabic, Danica   Sent: Friday, May 25, 2018 12:56 PM  To: 'Kuy, SreyRam (HOU)' ; '(b) (6)  GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz'  (b) (6) (b) (6) < mac.com>; 'Aaron Moskowitz' < me.com>; 'Thomas Concannon'  <(b) (6) rand.org>; 'McIntosh, Bruce (NCPS)' <(b) (6) va.gov>; '(b) (6)   <(b) (6) atlasresearch.us>; '(b) (6)  (Atlas Research)' <(b) (6) va.gov>; '(b) (6)   (b) (6) (b) (6) (b) (6) < ghlf.org>; '  < va.gov>; 'Hayes‐Byrd, Jacquelyn' ; '(b) (6)  <(b) (6) va.gov>; '(b) (6)  <(b) (6) va.gov>; '(b) (6)   (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6)  < va.gov>; '  < va.gov>; '   <(b) (6) va.gov>; '(b) (6)  <(b) (6) va.gov>; '(b) (6)  <(b) (6) va.gov>  Cc: (b) (6)  <(b) (6) fda.hhs.gov>  Subject: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit      Sorry – did not attach the AGENDA/PROGRAM – attaching it now. Made formatting changes and added the times for  each presentation/panel discussion.   << File: PROGRAM  VA Medical Device Registry Summit FINAL DRAFT .docx >>    Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)   The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location.   (b) (6) fda.hhs.gov;   Excellent Customer Service is important to us.  Please take a moment to provide feedback regarding the customer service you have  received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; 3 0512       _____________________________________________  From: Marinac‐Dabic, Danica   Sent: Friday, May 25, 2018 12:47 PM  To: 'Kuy, SreyRam (HOU)' ; '(b) (6)  GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz  (b) (6) (b) (6) < mac.com>; Aaron Moskowitz < me.com>; Thomas Concannon  <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; (b) (6)  <(b) (6) atlasresearch.us>;  (b) (6)  (Atlas Research) <(b) (6) va.gov>; '(b) (6)  <(b) (6) ghlf.org>; (b) (6)    <(b) (6) va.gov>; Hayes‐Byrd, Jacquelyn ; (b) (6)   (b) (6) <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)  (b) (6)  <(b) (6) va.gov>;  (b) (6)  <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>; (b) (6)   <(b) (6) va.gov>; (b) (6)  <(b) (6) va.gov>  Cc: (b) (6)  <(b) (6) fda.hhs.gov>  Subject: MOST RECENT AGENDA + BIOS ‐ VA MEDICAL DEVICE REGISTRY SUMMIT      Hello Colleagues,  Attached please find the CLOSE TO FINAL DRAFT of the AGENDA ( in a slightly changed format – we hope you’d like it))  and  the WORKING DRAFT OF THE SPEAKERS BIOS ( the ones we had on file).  Please send the outstanding bios to (b) (6)  (copied) today if possible or early next week.   << File: VA Medical Device Summit Final.docx >>   << File: 2018 VA Registry Summit Bios Final.docx >>  Have a great weekend! Danica     Danica Marinac‐Dabic, MD, PhD, MMSc, FISPE   Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R‐ (b) (6) Silver Spring MD 20993; (301)796‐(b) (6)     << OLE Object: Picture (Device Independent Bitmap) >>  (b) (6) fda.hhs.gov;     4 0513 Ha, Richard Subject: Location: Medical Device Registry Summit - Weekly Planning Meeting - Final One! 7:30 am Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Fri 6/1/2018 7:30 AM Fri 6/1/2018 8:00 AM Tentative Recurrence: (none) Meeting Status: Not yet responded Kuy, SreyRam (HOU) Organizer: Required Attendees:'(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (5) Dear colleagues,    This is our FINAL 7:30 am planning call! Chance to tie up loose ends and finalize.    Here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Friday June 1, 2018 7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       Thank you SO MUCH for all your PHENOMENAL efforts!    Warmly,  SreyRam    SreyRam Kuy, MD, MHS, FACS  Special Advisor   Office of the Secretary  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875    1 0514 0515 Ha, Richard From: Sent: To: Subject: Attachments: Kuy, SreyRam (HOU) Thursday, May 31, 2018 5:54 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (5) Mock, Teresa J.; Medical Device Registry Summit - Weekly Planning Meeting - Final One! 7:30 am; Conference call line: 800-767-(b) (5) Code (b) (5) RSVP GUEST LIST Regitry Summit as of 5.31.18.xlsx; Medical Device Registry Summit Program June 4 2018 - Preliminary.docx; News Release - Medical Device Registry Summit - Dr. SreyRam Kuy 5-2018.docx Dear colleagues,    This is our FINAL 7:30 am planning call! Chance to tie up loose ends and finalize.  I attached up updated agenda (some  changes in order in the beginning to accommodate Secretary/Agency Leadership schedules.  Also attached is the latest  RSVP list as of 5/31/2018 at 2:50 pm.     Powerpoints:  We’re received 9 PowerPoints so far, from:  Fleurence, Giori, Majithia, McIntosh, Pappas, Raitt, Reed, Stake and Varosy.     Here’s the call‐in information:    Medical Device Registry Summit ‐ Planning Call  Friday June 1, 2018 7:30 am – 8:00 am Eastern  Conference call line:  800‐767‐(b) (5)  Code (b) (5)       Thank you SO MUCH for all your PHENOMENAL efforts!    Warmly,  SreyRam    SreyRam Kuy, MD, MHS, FACS  Special Advisor   Office of the Secretary  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW  Washington, DC 20420    Mobile:  713‐503‐4274  Office:  202‐461‐4875  1 0516 0517 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Device Registry Summit GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW Washington, DC 20420 June 4, 2018 8:30 a.m. – 4:30 p.m. 8:30 a.m. Welcome SreyRam Kuy, MD 8:35 a.m. Keynote Address Acting Secretary of Veterans Affairs Peter O’Rourke 8:45 a.m. – 10 a.m. Session 1: Value for Stakeholders Objective: To describe value of medical device registries to major stakeholders; identify the gaps; prioritize opportunities Value Roundtable Discussion Moderator: SreyRam Kuy, MD • Veterans Affairs (VA) Acting Secretary Peter O’Rourke • Food and Drug Administration (FDA) Jeff Shuren, MD, PhD, Director, Center for Devices and Radiological Health • Centers for Medicare and Medicaid Services Administrator Seema Verma (tentative) • American Medical Association, Kathleen Blake, MD Patient Perspective Christine Stake, Patient Governor, the ArthritisPower Patient Research Registry Leveraging the Medical Device Ecosystem Rachael Fleurence Ph.D., National Evaluation System for Health Technologies, FDA 10 a.m. – 11:30 a.m. Session 2: VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future 0518 Moderator: Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA  Current Cardiac Device Monitoring in the VA • Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Affairs (VHA)  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of Real Time Locations System into The Clinical Assessment, Reporting, and Tracking System (CART) for Cardiac Catheterization Laboratories • Paul Varosy, MD CART Program  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Speakers + Kristi Mitchell (Avalere Health) 11:30 a.m. – 12:30 p.m. Lunch Break 12:30 p.m. – 2 p.m. Session 3: Infrastructure/Methodology Opportunities for Standing Up a Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, PhD (Harvard Medical School/Harvard School of Public Health) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of a Medical Device Registry; present short- and long-term opportunities  Unique Device Identifier implementation efforts • Terrie Reed (FDA)  Strategically Coordinated Registry Networks – Linking Registries with other data sources • Art Sedrakyan, MD, PhD (Cornell/MDEpiNet)  Harmonization Efforts with National/International Registries • Danica Marinac-Dabic, MD, PhD, MMSC, FISPE (FDA/Center for Devices and Radiological Health (CDRH))  Patient -enabled evidence generation • Harlan Krumholz, MD (Yale University)  Active Surveillance via DELTA in National Registries (b) (6) • MD (Lahey Clinic) Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) 0519 2 p.m. – 3:15 p.m. Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Thomas Concannon, PhD (RAND) Objective: How to begin development of the framework for a Medical Device Registry  Who should be at the table: What can we learn from Vascular Quality Initiative? • Jack Cronenwett, MD (Dartmouth)  How to build in the sustainability: Return of Investment Multi-stakeholder Analysis • Greg Pappas, MD, PhD (FDA/CDRH)  Topic TBD (b) (6) (b) (6) • MD, PhD, FCCM (United Healthcare) Panel Discussion: Speakers + Julia Skapik, MD (Cognitive Medical Systems) 3:15 p.m. – 4:30 p.m. Panel: Pulling it All Together Objective: To summarize key points in the next steps toward building a Medical Device Registry Moderator: Harlan Krumholz, MD (Yale University) Panel: Bruce McIntosh, PharmD (VA) Art Sedrakyan, MD (Weill Cornell Medical College) Danica Marinac-Dabic, MD, PhD (FDA) Rachael Fleurence, PhD (National Evaluation System for Health Technology Coordinating Center, FDA) Closing Remarks VA Leadership – Dr. Carolyn Clancy Questions? Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 0520 May 2018 VA Medical Device Registry Summit Every day, doctors and nurses at VA medical centers across the country are innovating: creating ground breaking cures, developing novel procedures and performing lifesaving treatments. They do this because serving our nation’s heroes with excellence is their commitment. Today, we’re shining the spotlight on one example of this VA excellence. VA is convening academic leaders on medical device tracking, and partnering with sister agencies, FDA, CMS and DoD to ensure patient safety. Medical Device Registries are critically important because they allow us to notify patients about safety recalls, identify the exact device when patient shows up in ER with complications, and track & compare outcomes of implants. Partnering with these medical experts and sister agencies, VA is working to implement the largest health system device tracking program in the nation. On June 4, 2018, VA will be hosting a summit of thought leaders and sister agencies. The public is invited to participate. Medical Device Registry Summit GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW, Washington, DC 20420 June 4, 2018, 8:30 a.m. – 4:30 p.m. Interested parties may RSVP to attend in person, with space limited to the first 150 who RSVP. RSVP at rsvpprotocol@va.gov by Friday June 1, 2018. The summit will also be broadcast live in two parts. The public can also register to watch online here: Link for the Medical Device Registry Summit Morning Session 1: https://www.webcaster4.com/Webcast/Page/89/25950 Link for the Medical Device Registry Summit Afternoon Session 2: https://www.webcaster4.com/Webcast/Page/89/25951 0521 RSVP R R R R R R R R R R R R R Count Category Last Name SECVA Staff Bock SECVA Staff (b) (6) SECVA Staff SECVA Staff SECVA Staff VA Leadership Clancy VA Leadership Shelby VA Leadership Spickler Personal Guest (b) (6) VA Leadership Murphy SECVA Staff (b) (6) Family Family First Name Tonia Full Name Tonia Bock Carolyn Peter David C. Carolyn Clancy Peter Shelby David C. Spickler Thomas J. Thomas J. Murphy Honorific Ms. Mr. Ms. Ms. Ms. Dr. The Honorable Mr. Mr. Mr. Ms. Mr. Mr. Title Spouse Executive Secretary (b) (6) , Office of the Secretary (b) (6) to the Secretary (b) Center for Women Veterans (b) Office of Employment Discrimination Complaint Adjudication (6) Executive in Charge, Veterans Health Administration (6) Assistant Secretary for Human Resources and Administration Acting Chairman, Board of Veterans' Appeals Acting Under Secretary for Benefits Organizati Address 1 Address 2 City State  Phone Scheduler Email Fax Salutation Washingt 202‐461‐ Departme Room 1027810  DepartmenRoo (b) A810 Vermo Washingto (202) 461‐(b) Departme Roo (6) 810  Washingt Ms.  (6) Departme Roo 810  Washingt 202‐461‐ (b) (6) Ms.  Departme Suite 1575 I  Washingt 202‐461‐ Ms.  (b) (6) Departme Room 800 810  Washingt 202‐461‐ uests (colle Dr. Clancy Departme Room 200 810  Washingt 202‐461‐ Mr.  425 I StreetWashingt 202‐632‐ Mr.  Departme Room  Departme Room 520 1800 G  Departme VACO  1717 H  (b) (6) Office of Survivors Assistance Mrs. (b) Mrs. (6) Washingt 202‐461‐ Washingt 202‐461‐ (b) (6) Mr.  Ms.  Notes Preceden Swearing  (b) (6) (b) (6) (b) (6) 0522 (b) (6) (b) (6) @gmail.com @verizon.net (b) (b) (6) . @gmail.com (6) (b) (6) @gmail.com (b) (6) @gmail.com (b) (6) @hotmail.com (b) (6) @gmail.com (b) @southrun.org (6) (b) (6) @msn.com (b) (6) @comdt.uscg.mil (b) (6) @alionscience.com (b) (6) @mitre.org (b) (6) @gmail.com (b) (6) @gmail.com (b) @celero‐strat.com (6) (b) (6) @us.ibm.com (b) (6) @cisco.com (b) (6) @verizon.net (b) (6) @yahoo.com (b) (6) @gamil.com (b) (6) @yahoo.com (b) (6) n@cox.net (b) (6) @msn.com ( @gocluff.com b (b) (6) @gmail.com ) ((b) (6) @us.army.mil 6 (b) (6) ) @earthlink.net (b) (6) @yahoo.com (b) (6) @gmail.com (b) (6) @gmail.com (b) (6) @gmail.com (b) (6) @mac.com (b) @verizon.net (6) (b) (6) @verizon.net (b) (6) @crowell.com (b) (6) (b) (6) @gamil.com @yahoo.com (b) (6) @msn.com (b) (6) @us.ibm.com ( @gocluff.com b (b) (6) @mitre.org ) ( (6) (b) @yahoo.com 6 (b) ) @celero‐strat.com (6) (b) (6) @verizon.net (b) (6) (b) (6) , South Run Baptist Church 0523 RSVP Yes Count 1 yes yes yes 1 1 1 yes Yes Yes yes Yes 1 1 1 1 1 Organization Last Name First Name Full Name Title Phone 14‐253 (b) (6) (b) (6) VA National Center for  Patient Safety DHA MEDLOG American Medical Association Email (b) (6) (b) (6) va.gov 01‐619 Blake, MD, MPH Kathleen Kathleen Blake, MD, MPH @va.gov Vice President, Healthcare Quality (b) (6) l@mail.mil (b) @swcp.com (6) (b) (6) yes yes 1 1 yes yes yes 1 1 1 Yes yes yes yes yes 1 1 1 1 1 Optel Group  VACO, Secretary’s Center for Strategic  The RAND Corporation Concannon American Hospital Association (b) (6) Dartmouth‐Hitchcock Medical Center Cronenwett, M.D . (b) (6) Office of Quality, Safety and Value  (QSV) Sofware Developer ‐ Epic Rehabilitation & Prosthetics Services,  VA Central Office VHA Maximo National Evaluation System for health  Technology (NEST) Coordinating  Center Fleurence Computer Technology Associates, Inc. (b) (6) VA Palo Alto HCS Giori Health Data Link Inc.  (b) (6) BookZurman yes yes 1 1 U.S Food & Drug Administration VACO yes yes Yes yes 1 1 1 1 Quality Safety and Value VHA Integra  VHA Yale School of Medicine (b) (6) Thomas Thomas Concannon Senior Policy Researcher Jack L. Jack L. Cronenwett, M.D. Professor of Surgery (b) (6) Rachael Rachael Fleurence Nickolas Nicholas Giori 919‐665 202‐461 617‐794 312‐422 (b) (6) @optelgroup.com (b) (6) @va.gov (b) (6) rand.org (b) (6) @aha.org (b) (6) @dartmouth.edu 865‐280 202‐461 (b) (6) @va.gov> (b) (6) @epic.com 202‐372 410‐637 708‐606 (b) (6) va.gov (b) (6) @va.gov (b) (6) @masimo.com  Executive Director 301 346 Chief of Orthopedic Surgery. M.D, Ph.D. (b) (6) 317‐455 301‐535 (b) (6) @mdic.org (b .(b) @cta.com )(b) (6) va.gov (b) (6) (6) @healthdatalink.org (b) .(b) @bookzurman.com (6) (6) Speaker Speaker (b) (6) (b) (6) Gunnar William 301‐796 202‐461‐7148  William Gunnar National Director of Surgery Harold H. Hines 919‐395 (b) (6) 443‐253 202‐632 Professor of Medicine and Epidemiology and Public  203‐764 (b) (6) fda.hhs.gov William.Gunnar@va.gov (b) (6) (b) (6) Hines Jr. ( Dr. Krumholz) Harold H.  (b) (6) (b) (6) Yes Yes yes yes yes 1 1 1 1 1 FDA VA Medical Center, Iowa GHX Bradan Inc. DHA MEDLOG yes yes Yes Yes yes yes Yes Yes yes 1 1 1 1 1 1 1 1 1 VHA Johns Hopkins University  FDA Office of Acquisition and Logistics  Mayo Clinic  Summit MedTech Intelligence ECRI Institute Lahey Hospital and Medical Center yes yes yes 1 1 1 U.S Food & Drug Administration Marinac‐Dabic, MD, PhD, MMSc, FISPE   Danica (b) (6) Masimo VACO VA National Center for Patient Safety  (NCPS) Office of Quality, Safety and Value yes yes yes Yes Yes Yes yes yes Yes 1 1 1 1 1 1 1 1 1 McIntosh  American Hospital Association (b) (6) VHA Global Healthy Living Foundation Cerner Corporation Integra LifeSciences GHX Health Data Link, Inc. VHA Procurement & Logistics Office  301‐796 319‐339 404.977.   562‐338 301‐619 n  708‐ 449 240‐228 (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) 708‐786 507‐284 202.407. 610‐667 (b) .(b) (6) @va.gov (6) (6) (b) (6) @integralife.com (b) (b) .(b) (6) @va.gov (b) (6) .(b) (6) @yale.edu (6) (b) (6) (b) (6) @fda.hhs.gov (b) (6) (b) @va.gov (b) (6) (6) @ghx.com (b) (6) @bradan.io (b) (b) (6) @mail.mil (6) (b) (6) @va.gov (b) (6) @jhuapl.edu (b) (6) @fda.hhs.gov (b) (6) @va.gov (b) (6) @mayo.edu (b) (6) @summitllc.us (b) medtechintelligence.com (b) (6) (6) @ecri.org (b) (6) Bruce A. gmail.com Danica Marinac‐Dabic, MD, PhD,  MMSc, FISPE   Director, Division of Epidemiology Bruce A. McIntosh,  National Manager, Product Recall Office (b) (6) (b) (6) (b) (6) Speaker Speaker 301‐796 08‐606 02‐382 (b) (6) fda.hhs.gov (b) (6) @masimo.com (b) (6) @va.gov 312‐422 202 461  917‐455 (b) 484‐682 (6) 267‐455 (b) (6) va.gov Speaker (b) (6) @aha.org (b) (6) @va.gov (b) (6) ghlf.org (b) (6) @Cerner.com (b) (6) @integralife.com 312‐ 884 602‐653 (b) (6) (b) (6) @healthdata.link va.gov 0524 yes Yes 1 1 yes Yes YES 1 1 1 yes yes 1 1 yes yes yes Yes yes yes 1 1 1 1 1 1 yes Yes 1 1 yes yes yes yes 1 1 1 1 yes yes 1 1 United Healthcare (b) (6)  Dr. VA Portland Health Care System Raitt MD FDA Center for Devices and  Radiological Health (CDRH) Reed  VACO (b) (6) ECRI Institute Office of Cybersecurity  & Aerospace VACO, Secretary’s Center for Strategic  Harvard Medical School U.S Food & Drug Administration FDA  Cognitive Medical Systems RAND Corporation Sharon‐Lise, PHD Shuren, Dr. Simonyan, Dr. SkapiK, MD, MPH VACO George E. Wahlen Department of  (b) (6) Dr. (b) (6) Merritt H. Merritt H Raitt MD Terrie L.  (b) (6) 714‐252 (b) (6) (b) (6) (b) (6) 971‐757 (b) (6) 301‐796 2‐461 ‐825 (b) (6) fda.hhs.gov (b) (6) @va.gov (b) @ecri.org (6) (b) (6) @maryland.gov (b) (6) @va.gov Terrie L. Reed Senior Advisor Office of Surveillance and  Biometrics (b) (6) ‐767 ‐461 Normand Jeffrey Vaham Julia Sharon‐Lise T.Normand Professor, Dept. of Health Care Policy, Harvard  Medical School Professor, Dept. of Biostatistics, Harvard T.H. Chan  School of Public Health 617‐432 Dr. Jeffrey Shuren  Dr. Vaham Simonyan Julia Skapik, MD, MPH Director of the Center for Devices and  Radiological Health (CDRH) at FDA. Lead Scientist Chief Health Information Officer 301‐796 301‐796 703‐413 Christine E. Christine E. Stake (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Zenooz, Dr. Ashwini  Speaker Dr. Ashwini Zenooz (b) (6) @va.gov @hcp.med.harvard.edu (b) (6) fda.hhs.gov (b) (6) fda.hhs.gov (b) @cognitivemedicine.com (6) (b) @rand.org (6) (b) (6) @gmail.com 845‐323 303‐905 (b) @ghlf.org (6) (b) (6) va.gov 703‐598 202‐461 (b) (6) va.gov (b) (6) @wwt.com (b) (6) @va.gov (b) (6) @vva.org (b) (6) (b) (6) uhc.com Director VA National Cardiac Device Surveillance  Program Chief of Cardiology, (b) (6) Stake  SECVA Staff Global Healthy Living Foundation VHA Supply Chain Office VA Eastern Colorado  Health Care System World Wide Technology Inc. VHA Vietnam Veterans of America (b)   (6) Chief Medical Officer (CMO), VA Electronic Health  Record Modernization (EHRM)  202‐382‐4997  801‐726 (b) (6) (b) (6) (b) (6) Panel Speaker @va.gov @va.gov 0525 Ha, Richard From: Sent: To: Cc: Mitchell, Brian P. Friday, June 01, 2018 9:48 AM COS-PMO Hayes-Byrd, Jacquelyn; (b) (6) Tallman, Gary; Wagner, John (Wolf); Ullyot, John; (b) (6) ; , Ph.D Monday's remarks at the Medical Device Registry Summit 2018 06 04-2 Medical Device Registry Summit.docx; Medical Device Registry Summit Program June 4 2018 - Preliminary.docx (b) (6) Subject: Attachments: (b) (6) Sir,    Attached and below are brief opening remarks (5 mins.) for the Medical Device Registry  Summit, Monday morning, at 8:30, in Room 230.      The audience will consist of about 75 medical experts from federal agencies and the  healthcare community. About one third will be from VA. The purpose of the summit is to  advance collaborative efforts to create a national management and tracking system to unify,  expand, and improve existing medical devise registries. The main objectives of your remarks  are:    (a) to stress the importance of the collaboration and VA’s commitment to its success, and     (b) to thank our public and private partners for their participation in the summit and the  effort.     Internal and external media will be present. Dr. SreyRam Kuy will introduce you. You will speak  from the podium and depart immediately afterwards.     The summit’s program is also attached. Jackie will have hardcopies for you.     V/r    (b) (6)    • (b) (6)  • Department of Veterans Affairs • Office 202‐461‐(b) (6)  • Cell 202‐203‐(b) (6)     DRAFT 2: Medical Device Registry Summit Monday, June 4, 2018 Good morning. Thank you, Doctor [SreyRam Kuy, MD], for that introduction and for taking charge of this summit. 1 0526 I’d also like to thank our key partners in this effort:  Dr. Danica Marinac-Dabic [dan-NEE-sa Ma-RIN-ac DA-bic] of FDA,  Dr. Thomas Concannon at RAND,  Dr. and Dr. from the Global Healthy Living Foundation. (b) (6) (b) (6) (b) (6) [  Also VA’s Dr. Bruce McIntosh, and Acting COS Jacquelyn Hayes-Byrd and her team, who have all worked very hard to make this summit a success. (b) (6) 2 (b) (6) 0527 Finally, I’d like to thank two people who are not here but who have been driving forces in the development of medical device registries — Dr. Bruce Moskowitz and Mr. Aaron Moskowitz of the Biomedical Research & Education Foundation. A few days ago, we announced a major decision:  to move forward with a multi-billion-dollar contract to modernize VA’s electronic health records,  by adopting the same EHR platform used by DoD,  with a few additional functions to accommodate the special needs of Veterans. Today we’re here to talk about one way to make the most out of the new EHR system. 3 0528 In the past few years, VA has worked with DoD to develop a Joint Patient Safety Reporting program to learn from reported healthcare system vulnerabilities, including the inability to identify specific patient implants. o Now we’re looking to expand that collaboration to include the Food & Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), as well as our Community Care partners. o So we have organized this summit to bring together industry and academic leaders and sister-agency experts to map out a strategy for launching the largest medical device-implant tracking program in the Nation. Medical devices are a $170 billion business, accounting for 6 percent of U.S. health spending in 2013. o Implantable device sales are estimated to have been $43 billion in 2011 and are expected to reach $74 billion this year. But for all that money, it’s hard to know what works best for patients — and what puts them at greater risk. o Current tracking systems don’t provide enough clinical detail, or they aren’t linked to VA’s EHR system. o Adverse Event Reports are mandatory for hospitals and manufacturers, but they don’t provide enough information for us to tell which patients are affected. The solution is a nationwide medical implant registry that enables us to identify and manage patients with implanted medical devices and biological implants, no matter where they receive their care. 4 0529 Such a system would enable us to —  measure quality & compare outcomes,  monitor patient safety,  recall faulty devices,  notify patients about safety recalls,  know the exact device in question when patient shows up in ER with complications,  and track clinical follow-up. The system must be implementable in the short term via VA’s CPRS and VistA, and able to interface in the long term with VA’s new EHR system. With a well-managed medical device tracking system, and a fully integrated EHR system linking VA and DoD and our Community Care providers: o We will know, from day one, what implants a Veteran has received on active duty, so nothing is lost when a Veteran enters our care. o We will know how those implants have performed for each Veteran. o We will also know how the same implants have performed for all other Veterans and active-duty servicemembers. o We will be able to identify and address the concerns of individual Veterans about their implants. o We will also be able to see whether other patients have experienced the same issues, to better assess the risk. 5 0530 o And we will be able to share that information with other providers and with device manufacturers, which will mean both better design and better use of implants. The result will be safer, more efficient, more patient-centered care — not just for Veterans, but for all implant recipients. Congress has mandated that we track medical implants, and this administration is committed to fielding the very best, inclusive, patient-centered implant tracking system. We can’t do that without the collaboration of our sister agencies and nongovernmental partners. o So we greatly appreciate your participation in this summit. Thank you for being here. I look forward to hearing about your discussions later. ###   6 0531 DRAFT 2: Medical Device Registry Summit Monday, June 4, 2018 Good morning. Thank you, Doctor [SreyRam Kuy, MD], for that introduction and for taking charge of this summit. I’d also like to thank our key partners in this effort: • Dr. Danica Marinac-Dabic [dan-NEE-sa Ma-RIN-ac DA-bic] of FDA, • Dr. Thomas Concannon at RAND, • Dr. (b) (6) (b) (6) and Dr. [ from the Global Healthy Living Foundation. (b) (6) • Also VA’s Dr. Bruce McIntosh, (b) (6) (b) (6) and Acting COS Jacquelyn Hayes-Byrd and her team, who have all worked very hard to make this summit a success. 0532 1 Finally, I’d like to thank two people who are not here but who have been driving forces in the development of medical device registries — Dr. Bruce Moskowitz and Mr. Aaron Moskowitz of the Biomedical Research & Education Foundation. A few days ago, we announced a major decision: − to move forward with a multi-billiondollar contract to modernize VA’s electronic health records, − by adopting the same EHR platform used by DoD, − with a few additional functions to accommodate the special needs of Veterans. Today we’re here to talk about one way to make the most out of the new EHR system. 0533 2 In the past few years, VA has worked with DoD to develop a Joint Patient Safety Reporting program to learn from reported healthcare system vulnerabilities, including the inability to identify specific patient implants. o Now we’re looking to expand that collaboration to include the Food & Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), as well as our Community Care partners. o So we have organized this summit to bring together industry and academic leaders and sister-agency experts to map out a strategy for launching the largest medical device-implant tracking program in the Nation. Medical devices are a $170 billion business, accounting for 6 percent of U.S. health spending in 2013. 0534 3 o Implantable device sales are estimated to have been $43 billion in 2011 and are expected to reach $74 billion this year. But for all that money, it’s hard to know what works best for patients — and what puts them at greater risk. o Current tracking systems don’t provide enough clinical detail, or they aren’t linked to VA’s EHR system. o Adverse Event Reports are mandatory for hospitals and manufacturers, but they don’t provide enough information for us to tell which patients are affected. The solution is a nationwide medical implant registry that enables us to identify and manage patients with implanted medical devices and biological implants, no matter where they receive their care. 0535 4 Such a system would enable us to — • measure quality & compare outcomes, • monitor patient safety, • recall faulty devices, • notify patients about safety recalls, • know the exact device in question when patient shows up in ER with complications, • and track clinical follow-up. The system must be implementable in the short term via VA’s CPRS and VistA, and able to interface in the long term with VA’s new EHR system. With a well-managed medical device tracking system, and a fully integrated EHR system linking VA and DoD and our Community Care providers: o We will know, from day one, what implants a Veteran has received on 0536 5 active duty, so nothing is lost when a Veteran enters our care. o We will know how those implants have performed for each Veteran. o We will also know how the same implants have performed for all other Veterans and active-duty servicemembers. o We will be able to identify and address the concerns of individual Veterans about their implants. o We will also be able to see whether other patients have experienced the same issues, to better assess the risk. o And we will be able to share that information with other providers and with device manufacturers, which will mean both better design and better use of implants. 0537 6 The result will be safer, more efficient, more patient-centered care — not just for Veterans, but for all implant recipients. Congress has mandated that we track medical implants, and this administration is committed to fielding the very best, inclusive, patient-centered implant tracking system. We can’t do that without the collaboration of our sister agencies and nongovernmental partners. o So we greatly appreciate your participation in this summit. Thank you for being here. I look forward to hearing about your discussions later. ### 0538 7 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Device Registry Summit GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW Washington, DC 20420 June 4, 2018 8:30 a.m. – 4:30 p.m. 8:30 a.m. Welcome and Introduction of Participants and Organizations* Acting Secretary of VA Peter O’Rourke 8:45 a.m. – 10 a.m. Session 1: Value for Stakeholders Objective: To describe value of medical device registries to major stakeholders; identify the gaps; prioritize opportunities Patient Perspective Christine Stake, Patient Governor, the ArthritisPower Patient Research Registry Leveraging the Medical Device Ecosystem Rachael Fleurence Ph.D., National Evaluation System for Health Technologies Value Roundtable Discussion Moderator: SreyRam Kuy, MD • Veterans Affairs (VA) Acting Secretary Peter O’Rourke • Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD • Jeff Shuren, MD, PhD, Director, Center for Devices and Radiological Health • Centers for Medicare and Medicaid Services Administrator Seema Verma (tentative) • American Medical Association, Kathleen Blake, MD 0539 10 a.m. – 11:30 a.m. Session 2: VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: Danica Marinac-Dabic, MD, PhD, MMSC, FISPE – FDA  Current Cardiac Device Monitoring in the VA • Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Affairs (VHA)  Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data • Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System  Medical Device Tracking in Cardiology: The integration of Real Time Locations System into The Clinical Assessment, Reporting, and Tracking System (CART) for Cardiac Catheterization Laboratories (b) (6) • MD CART Program  Building Future-State Model for VHA Implant Tracking • Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Speakers + Kristi Mitchell (Avalere Health) 11:30 a.m. – 12:30 p.m. Lunch Break 12:30 p.m. – 2 p.m. Session 3: Infrastructure/Methodology Opportunities for Standing Up a Medical Device Registry – Short and Long-Term Moderator: Sharon-Lise Normand, PhD (Harvard Medical School/Harvard School of Public Health) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of a Medical Device Registry; present short- and long-term opportunities  Unique Device Identifier implementation efforts • Terrie Reed (FDA)  Strategically Coordinated Registry Networks – Linking Registries with other data sources • Art Sedrakyan, MD, PhD (Cornell/MDEpiNet)  Harmonization Efforts with National/International Registries • Danica Marinac-Dabic, MD, PhD, MMSC, FISPE (FDA/Center for Devices and Radiological Health (CDRH))  Patient -enabled evidence generation • Harlan Krumholz, MD (Yale University)  Active Surveillance via DELTA in National Registries (b) (6) • MD (Lahey Clinic) 0540 Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) 2 p.m. – 3:15 p.m. Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Thomas Concannon, PhD (RAND) Objective: How to begin development of the framework for a Medical Device Registry  Who should be at the table: What can we learn from Vascular Quality Initiative? • Jack Cronenwett, MD (Dartmouth)  How to build in the sustainability: Return of Investment Multi-stakeholder Analysis • Greg Pappas, MD, PhD (FDA/CDRH)  Privacy/Ethics issues • Robert M Portman, JD (Powers, Pyles, Sutter and Verville PC)  Topic TBD (b) (6) (b) (6) • MD, PhD, FCCM (United Healthcare) Panel Discussion: Speakers + Julia Skapik, MD (Cognitive Medical Systems) 3:15 p.m. – 4:30 p.m. Panel: Pulling it All Together Objective: To summarize key points in the next steps toward building a Medical Device Registry Moderator: Harlan Krumholz, MD (Yale University) Panel: Bruce McIntosh, PharmD (VA) Art Sedrakyan, MD (Weill Cornell Medical College) Danica Marinac-Dabic, MD, PhD (FDA) Rachael Fleurence, PhD (National Evaluation System for Health Technology Coordinating Center) Closing Remarks VA Leadership – Dr. Carolyn Clancy Questions? Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 0541