Select Committee on Health Written Evidence


Memorandum by The Medical Technology Group (PS 31)

PATIENT SAFETY

EXECUTIVE SUMMARY

  The Medical Technology Group (MTG) is a coalition of patient groups, research charities and medical devices manufacturers launched in 2000 to set a firm policy direction that is patient focused. The Group campaigns for an increased uptake of effective medical technology and improved access to medical technology for patients.

  Patient safety is a very relevant theme as recent and future advancements in medical technology can provide patients with the highest standards of protection. Robotics and minimally invasive devices are good examples in this respect, because they reduce the scope for human error.

  A series of stringent EU regulations ensure that medical devices are safe before being placed into the market. However, it is important to drive up clinical skills in the use of these technologies if we are to improve uptake of innovation by the NHS, an objective flagged by Lord Darzi in his recent review, and shared by the MTG. Proper training of physicians and surgeons is key to maintaining the safety of patients who are treated using new medical devices and government has a part to play here by ensuring that clinicians receive adequate training.

  Medical device manufacturers are increasingly facilitating clinical training and the MTG would urge government and those procuring on behalf of the NHS to consider this when evaluating the cost of devices. The constant downward pressure that public sector procurement activities exert on prices could have a negative impact on industry's ability to provide this training in the future. The alternative may be for government to fund a more widespread and systematic continuous professional development and training programme for healthcare professionals on the use of new technologies. MTG suggests that a medical technology education programme be created to train health professionals in how to use medical devices and equipment safely.

  Clinical practice can never be completely risk free. Patients, practitioners and indeed medical devices are all subject to a wide number of variables that are impossible to completely compensate for in all situations. Here again though, MTG believes that proper training and improved communications between medical device manufacturers, the NHS, health professionals and patients will help to maintain and improve safety.

  Minimally invasive procedures using newer medical technologies are now regularly performed in preference to older and more invasive open surgical procedures. These can often reduce the potential for procedure related complications, infections and mortality that are an inevitable risk of major open surgery, as well as often being favoured by patients.

  The MTG supports informed patient consent which includes detailed descriptions of risk, but would encourage information to be communicated in an unbiased and understandable way so as to allow patients to make informed choices about the use of specific technologies.

  The MTG welcomes initiatives such as PASA's Supply Chain Excellence Programme, NICE's Interventional Procedures Guidelines and MHRA's Medical Device Alerts where they fairly recognise the correct balance of risk, benefit and value to the NHS.

RESPONSE

  1.  The Medical Technology Group (MTG) is a coalition of patient groups, research charities and medical devices manufacturers launched in 2000 to campaign for patient access to effective medical technologies. The group is committed to supporting wide uptake of proven technologies such as insulin pumps, urinary catheters, pacemakers, radio-frequency ablation of tumours, diagnostic equipment, implantable cardioverter defibrillators (ICDs), orthopaedic implantable devices and cataract treatments, as well as ensuring the delivery of new innovations, which make a huge difference to the quality of life of people with long-term conditions. MTG also seeks a conducive research environment in which new innovations can be developed, and best practice spread throughout the NHS. MTG's objectives are to:

    —  Advance reforms that will ensure patient access to innovative medical technologies

    —  Recognise the work and contributions of leading medical professionals and institutions using technology to improve healthcare outcomes for patients

    —  Provide patients, clinicians and all stakeholders with accurate information about medical conditions and treatment options

  Some of the MTG achievements include increasing the uptake of pacemakers, drug-eluting stents and implantable cardioverter defibrillators (ICDs) which are now much more widely used in the NHS although patient access still remains a problem in some areas.

  2.  The MTG has significantly expanded over recent years and now includes more than twenty patient groups, three medical trade associations, twelve medical technology developers and manufacturers. See below for current list:

    Association of British Healthcare Industries (ABHI)

    Advanced Medical Technology Association (AdvaMed)

    Advanced Medical Optics (AMO)

    AntiCoagulation Europe

    Arrhythmia Alliance

    Arthritis Care

    Becton, Dickinson and Company (BD)

    Boston Scientific

    Bladder and Bowel Foundation

    British Cardiac Patients' Association

    Cardiomyopathy Association

    ConvaTec

    CRBard

    Eucomed

    Freeman Group

    Heart Research UK

    ICD Group

    ICD Patient and Family Support Group

    Johnson & Johnson

    International Alliance of Patients' Organisations

    INPUT

    IST Information and Support

    Lindsay Leg Club Foundation

    Medtronic

    National Heart Forum

    National Rheumatoid Arthritis Society (NRAS)

    Pelvic Pain Support Network

    RNIB

    Roche Diagnostics

    SADS UK

    STARS

    St Jude Medical

    Stryker

    The Circulation Foundation

    The Heart Failure Foundation

    The Patients Association

    Transplant Support Network

    Zimmer

1.   What the risks to patient safety are and to what extent they are avoidable, including:

Role of human error and poor clinical judgment

  3.  Technology brings with it the ability to reduce "human error" and therefore improve safety. The MTG strongly recommends hospitals ensure that staff are given enough time for training to ensure they can utilize medical technology safely and to its fullest potential. They should also feel confident in educating patients about the balance of risks and benefits of medical devices used in their treatment. One of government's roles in supporting patient safety is to ensure that sufficient funding is available for staff training and communications that inform patients on the appropriate use of technology. Techniques such as computer assisted surgery should be supported where appropriate, as they offer great promise and current patient benefit, including improved consistency and surgical accuracy.

  4.  Training should also be tailored for surgeons as advanced technology and surgical techniques require familiarity and ongoing training to ensure the best results and improve patient safety. Government needs to recognise the value of training that major manufacturers provide when procuring medical devices. This training often takes place in state of the art facilities led by experts in the field and in the use of new medical devices. The constant drive by procurement to force down prices may mean that companies who provide such training are disadvantaged compared with those who do not (and can therefore supply at lower cost). The failure to recognise the wider training support package that major manufacturers provide as part of their price may lead to the NHS purchasing poor quality devices that are not supported with adequate training. The ultimate consequence may be compromised patient safety.

  5.  The MTG is supportive of the World Health Organisation World Alliance for Patient Safety and would encourage the Government and NHS to continue its engagement with the variety of projects it promotes. In particular the Safer Surgery Safe Lives initiative, launched on June 25th 2008, provides an excellent opportunity for the NHS to exchange views on best practice and have an awareness of efforts being made to protect patient safety across the globe.

Systems failures

  6.  Medical technology is strictly regulated by EU regulations such as the Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Medical Devices Directive. The main purpose of these directives is to allow free movement of medical devices throughout the European Community, whilst at the same time ensuring device performance and safety. The directives replace existing national systems in each Member State. In summary, these directives specify the essential requirements which must be met before any device can be placed on the market or put into service and which are intended to ensure that a device does not compromise the clinical condition or safety of the patient, the safety and health of users or, where applicable, any third party.

  7.  Medical devices should be used within a framework of guidelines and systems that act to promote safe and effective use. Inevitably, sometimes these systems fail. Continued training for staff to emphasise the importance of following procedures and implementing good incident reporting practices is crucial in addressing this issue. Thorough investigation of incidents involving medical technology is welcomed.

  8.  The MTG also recommends that pathways are in place to make sure that effective systems can be thoroughly but promptly produced when new medical devices are introduced into practice. This will reduce the risk of adverse incidents and enable a smoother uptake of new technology. Training for relevant staff to ensure they are competent in producing locally appropriate systems for new technology would be vitally important in this regard.

How far clinical practice can be risk-free; the definition of "avoidable" risk; whether the "precautionary principle" can be applied to healthcare

  9.  Clinical practice can never be completely risk free. Patients, practitioners and devices are all subject to a wide number of variables that are impossible to completely compensate for. The MTG therefore believes that only best practice and professional competence can avoid risks and the best precautionary approach is through awareness and training.

  10.  The MTG believes that the variety of possible circumstances makes a blanket approval of the precautionary principle for healthcare unlikely. Patient safety is paramount, however, there may be instances when there is an unknown level of risk, but it remains in the best interests of the patient to proceed. The MTG supports the fundamental principles of patient autonomy and beneficence in medical practice.

  11.  NICE, through its Interventional Procedures Guidelines, helps ensure that where possible medical procedures in use in the NHS are of a sufficient safety level for use in practice. The MTG welcomes the open nature of submissions for these guidelines which enables anyone to submit a procedure for consideration.

  12.  The PASA's Supply Chain Excellence Programme (SCEP) launched in 2004 seeks to obtain the best value for money the NHS spends each year on goods and services. However, whilst overall savings are welcomed, we believe that cost cutting should never be allowed to compromise patient safety. Wherever possible, when purchasing comparable medical technology, preference should be given to the market option with the highest safety standard. See also point 4 above. Procurement should seek to understand the added value of the training that reputable manufacturers provide as part of their product offering. Procurement currently tends to simply compare headline price rather than considering the complete package of device, training and price. Procurement also tends to fail to consider long term cost implications and patient benefits in its focus on lower initial or short term prices.

  13.  Medical Device Alerts are another useful mechanism to enable safe use of medical technology. Issued by the Medicine & Healthcare Products Regulatory Agency (MHRA), they help alert healthcare providers to problems with medical devices. The MTG is also supportive of initiative such as the recently released guide to Medical Devices released by MHRA. Devices in Practice—a guide for health and social care professionals is an excellent example of how the safety of medical devices can be improved by helping users to ensure they undertake simple but effective measures before, during and after use. It is especially important as the use of devices moves to the community (as highlighted by Chapter 7 of the guidance) where the same rigorous protocols for use that are found in a hospital, aren't available. As emphasized by the guidance "all practices and organisations in the public, independent and voluntary sectors must provide adequate arrangements for training in the safe use of medical devices. This also includes agencies providing staff to the care sector."

  14.  Many minimally invasive treatments are now regularly performed in preference to older and more invasive open surgical procedures. These can often reduce the potential for procedure related complications, infections and mortality that are an inevitable risk of major open surgery, as well as often being favoured by patients. An early and more precise deployment of these technologies would reduce the need for surgical revision and re-implantation. Use of advanced surgical techniques, including computer assisted surgery, can benefit patients by ensuring accuracy and reducing potential complications. The opportunities to perform minimally invasive procedures in lower cost environments, taken together with faster recovery times, will also generate both economic and patient access benefits. Arterial disease of the leg is a case in point, where early access to minimally invasive treatments such as balloon angioplasty and stenting may prevent later major open vascular surgery or even amputation.

  15.  Respecting patient autonomy may well involve patients' freedom to choose new and experimental medical technology which may well bear risks hence informed consent is paramount. Particularly for patients who have been diagnosed with a condition known to have a high morbidity and mortality, there should be an acknowledgement of their right to choose a course of treatment with a chance of success, even if it is associated with significant risk. The role such patients play in the advance of medical science and technological innovation also needs to be recognized. In addition, doctors should remain free to act in the best interest of patients, and if this objectively includes using medical technology with the hope of a positive outcome this should be supported.

  16.  In particular, patients lacking capacity safeguards that use representatives provided by the Independent Mental Capacity Advocacy Service (established by the Mental Capacity Act 2005) should also be given the chance to benefit from the use of emerging medical technology without the risk of being exploited.

The role of public perceptions of risk in determining NHS policy

  17.  Public perceptions of risk are sometimes inconsistent and based on irrational beliefs and understandings of probability. We support the trend of increasingly informed consent which includes detailed descriptions of risk, but would encourage that health professionals are trained to provide this information in such a manner that it can be weighed on balance by patients. The MTG would be concerned if inaccurate perceptions of risk were causing patients to avoid treatments which could be potentially beneficial. To avoid medical technology being unduly perceived as dangerous, we would encourage the NHS to undertake a concerted effort to ensure that prospective patients receive accurate information to allow them to make informed choices.

  18.  Public and patient information is thus closely linked to perceptions of risk. Independent and well evidenced information related to medical technology available on the market should be communicated in a comprehensible way so that it is easily understandable by a lay person before making a decision about its safety. This will enhance transparency and build trust between patients and health professionals. Technology developers and manufacturers also have a responsibility to clearly communicate information to patients and professionals in a way that is directly relevant and easy to understand.

  19.  We believe that patients need to play a growing role in their own care and must be encouraged to use self-determined sources of information which drive awareness of their condition and what they can do to better control it. The NHS needs to provide high quality and easily accessible safety and performance information about the different technological solutions available on the market and, at the same time, ensure that patients can get a full picture rather than a restricted cut of what is provided in the locally.

2.   What the current effectiveness is of the following in ensuring patient safety:

Education for health professionals

  20.  The MTG is concerned that, at present, investment in health professionals' training is inadequate and this could impact adversely on patient safety. Training could be provided with the technology but the government needs to ensure that the highest standards of education are maintained among the staff, in particular nurses. Therefore, we believe that a medical technology education programme should be created to train health professionals in how to use medical devices and equipment safely. See also point 4 above.

September 2008






 
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Prepared 30 October 2008