Select Committee on Health Written Evidence

Memorandum by the Association of British Healthcare Industries (PS 16)



  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.


  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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