Memorandum by the Association of British
Healthcare Industries (PS 16)
PATIENT SAFETY
EXECUTIVE SUMMARY
The Association of British Healthcare Industries
(ABHI) is the lead industry association for the medical device
sector in the UK. The ABHI works to ensure that best and most
appropriate medical technologies are made available to clinicians
and patients.
The British medical technology sector is constantly
working to produce new products aimed at increasing patient safety.
Medical technologies can help increase patient safety in a number
of ways- from infection resistant devices through to medical advances
that help reduce the amount of time patients spend in hospital,
helping to protect patients from risk.
Medical devices are regulated under EU legislation.
These controls ensure that medical devices work for their intended
purpose and that the benefits to the patients and public outweigh
the risks. The practice of reusing single use medical devices
has developed in recent years. Single Use sterile disposable devices
avoided all risk of cross contamination, it is highly questionable
whether re-processing can ever make those devices as safe as they
originally were.
Current procurement practices commonly focus
on cost rather than a product's ability to improve patient outcome
and safety. Clear procurement processes should be devised to include
the assessment of product quality and the long term impact on
patients, ensuring patient safety and outcome, rather than solely
cost as the key factor in procurement decisions.
The medical technology sector is highly dynamic
with new treatments frequently released on to the market. Full
and comprehensive training is vital to make these technologies
as safe as possible. Medical technology companies undertake a
huge amount of training, the costs of which are often ignored
when procurement decisions are being made, this undervalues medical
technologies, if this practice was to continue it could lead to
a reduction in the amount of training being offered to clinicians
and a reduction in the take-up of technologies.
THE ABHI RESPONSE
1. The Association of British Healthcare
Industries (ABHI) is the lead industry association for the British
medical technology sector, representing around 200 companies whose
output makes up for around eighty per cent of the industry's total.
Our membership includes some of the leading businesses in the
sector in the UK right the way through to small independent companies.
Our members produce essential products for the NHS- everything
from life support machines through to latex gloves. The medical
technology sector is highly innovative and makes an increasing
contribution to the wealth of the nation. Within the sector there
are a large number of SMEs, as well as UK multinationals. It is
estimated that our sector has approximately 2000 SMEs. The medical
technology sector in the UK is valued at around £8 billion
and provides 46,000 high value jobs in the UK.
1. What the risks to patient safety are and
to what extent they are avoidable, including:
How far clinical practice can be risk-free; the
definition of "avoidable" risk; whether the "precautionary
principle" can be applied to healthcare
2. Advances in medical technologies that
lead to new surgical techniques reduce the risk to patients. Procedures
such as keyhole surgery and heart stenting are far less intrusive
than traditional surgical techniques and have the additional benefit
of reducing the length of time patients spend in hospital.
3. Medical devices are regulated under EU
legislation to ensure that they work for their intended purpose
and that the benefits to patients and the public outweigh the
risks. The CE mark is the sign that this assessment has been made.
Like any product medical devices are not risk free but remain
under constant monitoring even after being placed on the market.
This robust monitoring and assessment system ensures that devices
are constantly assessed for new potential dangers. However it
is recognised that once a device has received the CE mark the
benefits of using the product outweigh any potential harm that
may occur.
4. A very specific risk to patient safety
is the practice of re-using single use devices. If a single-use
device is reused there is a strong probability that it has not
been fully decontaminated and that its functional properties have
been impaired during re-processing. This risk has been exacerbated
in recent years by the emergence of commercial re-processors in
some parts of continental Europe who claim, against all the evidence,
to be able to reprocess single-use devices safely. The UK authorities
issue guidance which advises against reprocessing single-use devices
but should do more to ensure that the practice is eliminated and
take steps to prevent commercial re-processing from becoming established
in the UK. This is a complex technical and legal subject which
is summarised in the attached annex A.
2. What the current effectiveness is of the
following in ensuring patient safety:
Local and regional NHS bodies and other organisations
providing NHS services (including primary and community care,
and mental health services)
5. According to the National Audit Office
the NHS spends £1 billion a year on infection control with
nine per cent of all hospital patients acquiring an infection
during their stay. Medical technology manufacturers have developed
a full range of products that are infection resistant and could
help cut the number of infections that occur in hospitals each
year. Current procurement practices commonly focus on cost rather
than a product's ability to improve patient outcome and safety.
Clear procurement processes should be devised to include the assessment
of product quality and the long term impact on patients, this
would help to ensure that patient safety and outcome, rather than
solely cost is the key factor in procurement decisions.
6. Correct diagnosis at multi-disciplinary
clinics is crucial to placing patients along the correct patient
pathway. This leads to shorter hospital waits, reducing the risk
to patients. Misdiagnosis can lead to a patient being prescribed
potentially life threatening treatments and spending more time
in hospital. All GPs should have access to state-of-the-art diagnostic
technologies in order ensure all patients receive a quick correct
diagnosis.
Education for Health Professionals-
7. The medical technology sector is highly
dynamic, with new treatments and product iterations frequently
released on to the market. Training for new technologies needs
to be of the highest standard. Medical technology manufacturers
undertake a huge amount of training in medical devices. Procurement
practices generally fail to take the costs of this training into
account. This leads to new medical technologies being grossly
undervalued. If this undervaluing of medical technologies continues
it could lead to a reduction in the amount of training being offered
to clinicians and a reduction in the take-up of technologies.
8. The NHS needs to encourage the spread
of medical technologies throughout the whole NHS. Medical technologies
offer a range of different treatments for similar conditions.
If you look at the example of diabetes care, medical technology
manufacturers offer a broad range of insulin pumps; the type of
pump offered to each patient can have a huge bearing on their
well being. If clinicians are unaware of the full range of treatments
that is available to patients they cannot prescribe the one that
is most suitable for a particular patient. It is vital that clinicians
are made aware of all treatments.
September 2008
Annex A
Why the Reuse of Single-Use Devices is
a serious Health and Ethical Problem.
Single-use medical devices (often sterilised
by the manufacturer) were developed in response to clinical need.
Despite careful reprocessing, the multiple use of the same device
on different patients is associated with the risk of cross-contamination.
Single-use sterile disposable devices ("SUDs") avoided
this risk. They also offered significant convenience in the form
of SUD procedure packs. For decades, SUDs have demonstrated their
value in healthcare. Today there are devices that are so sophisticated
that they cannot be made except in single-use form.
In recent years, certain companies have offered
the facility of reprocessing SUDs, claiming that they were not
only saving money but actually producing a device which was safer,
cleaner and better than the original. These claims—particularly
those relating to device quality—are questionable in principle
and are not demonstrated in practice.
When designing a medical device, the manufacturer
begins by defining what that device must do and producing a technical
requirements specification. One of the most fundamental aspects
of the design is whether the device is intended to be reusable
or whether it is to be discarded after a single use. If the device
is to be used once only, it is designed for that purpose. By definition,
a device which is designed to be single-use is not a device that
is designed to be reused. Accordingly, any third party who subsequently
claims that he can take a used single-use device, process it and
replace it on the market is in fact declaring that he has safely
and properly developed a new and different medical device—one
that is reusable and no longer single-use.
In normal circumstances, that third party would have
to place the CE marking on this new device. In practice, the re-processor
is normally working as a contractor to the owner of the device
(usually a hospital) and title to the device is kept by the original
owner. It can well be argued that nevertheless the reprocessed
device is being put into service for a second time and therefore
comes with the requirements of the Regulations to be CE marked
by the third party re-processor. However, as yet, this point has
not been taken by the authorities.
It is a bold claim that a used SUD can be processed
in such a way that it is fit for use—let alone "better
than the original". To substantiate that claim, that third
party must have design and development files demonstrating that
he has done all the work and conducted all the testing necessary
to demonstrate the safety and effectiveness of the new product.
We question whether in practice this is the case. We further question
whether it is even possible, since the third party does not have
and has no right to receive the original manufacturer's design
files.
Moreover, the challenge facing that third party is
formidable. He has taken a used single-use product, which has
become both contaminated and altered by the physical effects of
being used, and is claiming that he has reversed those physical
effects; that he has thoroughly cleaned the device; and that he
has sterilised it. How can he be confident of doing so? He has
no knowledge of either of the original device specifications or
of the exact conditions of use (or indeed reuse, if he is proposing
to place the product on the market for the third and subsequent
uses). There is no scientific basis on which he can proceed. Each
used single-use device presents a new and different challenge,
making validation of his redesign and reprocessing impossible.
Consequently, each time a used single use product
is reprocessed and placed back on the market, it presents a risk
to both the clinician and the patient that is different and greater
than the original use of the SUD.
Evidence confirms that many SUDs cannot be properly
cleaned and sterilised. It is common to find SUDs that are complex
in their construction and materials. Such devices are often relatively
expensive—for example, coronary catheters and wound stapling
devices. The cost of these products may make it superficially
attractive to re-use them. However, the reality is that they cannot
be cleaned. Tests on such devices that purport to have been reprocessed
and made fit for re-use show that the device is contaminated with
tissue and debris. They also show that the device is physically
damaged from its previous use, and possibly also from being reprocessed.
It should be a basic principle that the clinician
should make a conscious choice to use a reprocessed SUD and not
an original device. However, when devices are unpacked and laid
out for use, what notice or indication will there be that a SUD
has been reprocessed?
Even more important, a patient should give informed
consent to be treated with a re-used SUD and not with an original
product. However, there is not notice given and no possibility
of informed consent,
One of the fundamental controls in the Medical
Device Regulations is the reporting of adverse events. This is
not done with re-used SUDs. Indeed, there is normally no indication
on the device or its packaging that is has been reprocessed. Nor
is the new manufacturer (the re-processor) normally identified
on the product or its packaging. Consequently, it is a commonplace
that any complaints are made to the original manufacturer rather
than to the new manufacturer/re-processor.
As a result, there is no record of the reliability
of reprocessed SUDs nor is there a record of the adverse events
caused by them. Why should this be allowed? Particularly since
the identification of adverse events and the implementation of
appropriate corrective action is one of the most potent means
of ensuring that devices are safe and effective.
There is no evidence that the claimed economies
of using reprocessed devices are real. Many of the relevant factors—such
as insurance for the increased risk of using reprocessed SUDs—are
not taken into account. Nor is it possible to calculate any real
overall savings (or indeed increased costs) when there is no proper
record or survey of adverse events, and when in any case an adverse
event is far more likely to be associated with the manufacturer
of the original SUD and not with the third party manufacturer
of the new reusable device. One significant case of patient (or
clinician) cross-contamination will outweigh any number of apparent
savings.
In summary, the practice of reprocessing and
reusing SUDs is unacceptable on clinical, scientific, ethical
and legal grounds. It would also not be surprising if the costs
were greater than the use of a new SUD.
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