tel.
email

:
:

Dr. Gabrielle Colleran,
Consultant Radiologist
National Maternity Hospital
Holles St.
Dublin 2
11 March 2018

Dear Dr. Colleran,
I have reviewed physics QA records over the lifetime of the Siemens Sireskop fluoroscopy system in
the main X-Ray department at NMH Holies St. This system was originally commissioned in June 2006
and is now in service for 13 years.
The system has been subject to annual image quality measurments using a standard fluoroscopic test
object and has maintained stable image quality throughout the first 9-10 years of operation. However,
deterioration of image qualty in terms of low contrast visibility and spatial resolution, which impacts
ability to see small detail, has been observed since then. In one instance, image quality was found to be
significantly degraded, requiring significant engineering intervention by Siemens to restore adequate,
although sub-optimal performance. I understand also that this system is now formally classed 'end-of­
life' by Siemens and subject to continuing service and support on a 'reasonable endevours' basis.
I understand also that there have been persistent problems with system stability necessitating patient
transfers, cancellations and rescheduling. These issues have been consistently noted at the radiation
safety committee over the last number of years.
Given the nature of the workload of this equipment particularly for neo-natal imaging but also for adult
hysterosalpinography where high resolution imaging is essential, I consider the performance and
reliability to be sub-optimal.
Furthermore, It is important to remember that under previous SI478[2002] and new SI256[2018]
patient protection legislation, special attention must be given to the use of appropriate equipment for
the radiological examination of children.
Best Regards,

Niall Phelan MSc CPhys
Medical Physicist & RPA

 Analysis of the risks of failure of the Axiom
Sireskop SD System x-ray and fluoroscopy
machine

Table of contents
Background .................................................................................................................................................. 1
Fluoroscopy machine ................................................................................................................................. 2
Usage stats and details 2018:................................................................................................................... 3
Consequence of equipment failure .......................................................................................................... 3
Current controls:.......................................................................................................................................... 3
Recommendations ...................................................................................................................................... 4

Background
Fluoroscopy is an essential modality in a neonatal radiology department. For example, a common
fluoroscopic case is when a newborn baby vomits bile (bilious emesis). This is a neonatal
emergency due to the risk of volvulus, bowel ischemia and death; untreated. This is a basic
test that should be performed with haste in the maternity hospital where the infant is delivered.
Fluoroscopy is also necessary for the diagnosis of neonatal emergencies such as malrotation of
the small bowel with volvulus described above, where urgent surgery may be necessary and any
delay in imaging may have a significant negative impact on clinical outcome.
It is also vital for diagnosis of other forms of bowel obstruction including atresia, meconium ileus
and Hirschsprung’s disease.
The fluoroscopy machine is also used for hysterosalpingogram examinations for adult women
undergoing investigation of infertility – a service not provided in adult hospitals.
Newer technology currently offers faster examinations, a substantial reduction in radiation doses,
higher quality images, and new applications that allow better diagnosis.
Increase in spatial and temporal resolution leads to identification and diagnosis of smaller
pathologies with considerable impact on patient care. This is particularly important in neonates
where structures are much smaller and harder to visualise.

1

 Fluoroscopy machine
The Axiom Sireskop SD System (M7677, Serial #71050) x-ray and fluoroscopy machine in the Xray Dept. was installed on 01.07.2006 – it is now 12 years and 8 months old.
The obsolescence of the equipment has a direct impact on the quality of healthcare. Equipment
older than 10 years is regarded as being obsolete. Older equipment has a high risk of failure
and breakdown, causing delays in diagnosis and treatment of the patient and safety problems
both for the patient and the medical staff.
We have noted that in recent years the machine has become increasingly unreliable, for
example the machine may switch off without warning in the middle of an examination. Fortunately
to date this has not occurred at the critical point of a neonatal examination, however it is of
significant concern as an equipment failure mid-procedure could lead to a need to repeat the
examination: with associated increase in radiation exposure and delay in diagnosis. For an infant
with volvulus that delay could lead to further loss of bowel and a worse morbidity and
mortality.
With aging equipment there is also a decrease or loss of image quality and an increase in
radiation exposure. The risks of ionising radiation are higher in the paediatric population than in
adults. It is therefore particularly important that the dose area product (DAP) used in imaging
children should be as low as practicable whilst providing the clinician with diagnostic information.
There is a regulatory obligation to measure and optimise the radiation dose.
Maintenance will be impossible if no spare parts are available.
In December 2017 (14 months ago) the manufacturer Siemens informed the NMH that due to the
age of the machine, spare parts can no longer guaranteed. Siemens have assured the department
that they will remain committed to the support of this unit and will continue to provide service and
maintenance on a “reasonable endeavours” basis up until the point that they are unable to source
suitable replacement parts. However now that spare parts can no longer be guaranteed, there is a
risk of an unrepairable failure of the machine.
The Sireskop suffers from on-going failure issues intermittently leading to it having to be
shut down and restarted during examinations. Some of these examinations require the use of
a contrast and the exam cannot be recommenced if the equipment fails, as the contrast agent
could obfuscate the reporting of an exam if reporting is performed after a certain time period.
Because of this it would necessitate the exam having to be rescheduled on another day (to allow
full clearance of the contrast agent out of the patient). In many cases these examinations are used
in the diagnosis of critical pathologies where immediate surgery is necessitated and where an
alternative examination would not yield a result that would aid in surgical decision making with the
associated increased in morbidity and potentially mortality.
Because we are beyond the ‘end-of-life’ stage with the unit there is now a significant risk of
machine failure and complete breakdown, rendering a significant portion of the radiology
service in the hospital becoming unavailable. Such a risk would severely impact the NMH’s
ability to provide a diagnostic service and patients would need to be transferred to other hospitals
for x-ray and fluoroscopy. It should be noted that due to significant waiting lists in other hospitals
there would very likely be delays in getting appointments for non-emergency patients (some
radiology waiting lists are up to 2 years).
It should also be noted that parts have become dislodged in these machines at other site due to
wear-and-tear and old age. Should this happen while an infant was being examined the
2

 resulting injury could likely be catastrophic as these parts are generally very heavy (in the
amount of kilos).
Because the machine is quite old the mechanical drivers have become stiff resulting in staff
experiencing muscular strains trying to pull the equipment into position.
It is unknown the extent to which we could lower patient dose using up-to-date equipment but it
would be significant and there is a regulatory obligation to achieve the lowest dose possible
especially in paediatrics. The image quality during the examination should also be seriously
considered as the monitors are almost 13 years old.

Usage stats and details 2018:

Infant x-rays = 1,971 (split between portable and x-ray Dept. - all infants referred from the Baby
Clinic were done in the X-ray Dept.).


Adult x-rays = 220 (vast majority in the X-ray Dept.).



Hysterosalpingogram examinations = 250 (patients with infertility - service not provided in adult
hospitals e.g. SVUH and this service could not be run without access to these exams).



Infant contrast studies = 31 (almost all were performed to rule out malrotation - these are
true emergencies and there can be no delay in performing the examination as if
confirmed, the infant must be transferred immediately for surgery).

Consequence of equipment failure
A temporary equipment failure mid-procedure may result in a non-diagnostic study. This would
require the examination to be repeated – resulting in an increased overall radiation exposure to the
patient. This could also result in an unacceptable delay in diagnosis with significant potential
consequences for the patient.

A prolonged or unrepairable equipment failure would mean that NMH could no longer provide a
fluoroscopy service for its patients. Neonates suspected of having malrotation with volvulus would
require emergency transfer to either CUH Temple Street or OLCH Crumlin for investigation. In sick
neonates the transfer itself is not without risk. It also can be a difficult experience for
accompanying parents. It is of note, that CUH Temple Street is having significant issues with its
fluoroscopic machine which is also beyond end of life.

Current controls:
1.

Use of portable/otherwise located x-ray machines in certain cases (only used for general xrays, not fluoroscopy).

2.

Informal collaboration with external hospitals to take patients in event of machine breakdown.

3.

Onsite maintenance and break/fix by the Clinical Engineering Dept.

4.

Maintenance contract with Siemens (suppliers) which will remain in place after the end of life
date (31.12.2017) and is renewed annually.
3

 Notes on current controls (secondary (control) risk):
1.

Portable/otherwise located x-ray machines may not be easily available/accessible when
required and will NOT allow fluoroscopy.

2.

External hospital collaboration is informal at this time and as it cannot be scheduled and thus
external hospitals may not take patients in event of machine breakdown. Temple Street is also
experiencing significant reliability issues with its own fluoroscopy machine, and there is a very
possible scenario where OLCH Crumlin is the only fluoroscopy service in Dublin.

3.

Onsite Clinical Engineering Dept. for maintenance and break/fix will likely be hindered by
potential lack of replacement parts.

4.

A maintenance contract with Siemens (suppliers) will be similarly likely be hindered by potential
lack of replacement parts.

Recommendations
It is recommended that the fluoroscopy machine be replaced. The consequences of equipment
failure are such that NMH cannot be without a reliable fluoroscopy service.
In the case of infants with suspected malrotation and volvulus, equipment failure or delay due to
equipment breakdown poses a significant clinical risk of bowel ischemia with risk of additional
morbidity and death.
If the system is not replaced, given the risks to patient safety, we may have to suspend the
provision of flouoroscopic services for infants and if so, all of these emergent cases will require
transfer to either TSCUH and OLCHC with the associated risk of delay and additional costs.

4