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Tim Kelleher, British Medical Journal, European Society of Cardiology

Clinical Articles, Featured


Regulatory controls and safety testing for cardiovascular devices in Europe are in need of reform, according to calls from the European Society of Cardiology (ESC) set out by a paper1 published recently in the European Heart Journal.

The report outlines flaws in the current device approval system, as well as potential solutions, discussed at the ESC’s Policy Conference on the Clinical Evaluation of Cardiovascular Devices held earlier this year.  The regulation and safety of medical devices in Europe were also the subject of a recent joint investigation by The British Medical Journal and Channel 4’s Dispatches.  ‘The truth about going under the knife’ examined instances of faulty devices, as well as the relative ease of gaining approval in Europe, and reluctance of some manufacturers to disclose data on device safety.

The report recommends new levels of transparency, with the relevant content of dossiers prepared by companies when submitting their devices disclosed to physicians, to illustrate their technical performance before use.  The ESC report also calls for comprehensive registries of devices and their outcomes, with every physician having a responsibility to report complications of device.

Alan Fraser screengrabProfessor Alan Fraser, who chaired the ESC Policy conference on device evaluation, commented to Arrhythmia Watch: “We should ask what clinical evidence has been collected to support their use, before advising managers which devices to purchase for our patients”.  He urges cardiologists to “contribute to registries which monitor the performance of implanted devices, and…report any instances of unexpected device failure promptly”.  Both a lack of transparency regarding specific data, and of registries compiling high-risk devices were key problems listed by a survey2 which accompanied the Dispatches investigation, published recently in BMJ Open.

Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) Kent Woods expressed concerns about the current system when interviewed by investigators, but said that “if we were to inhibit innovation by imposing a more burdensome regulatory regime we would have to have some extra evidence that the burden actually provided a greater degree of patient safety”.  The ESC report asserts that such thinking “ignores the fact that some innovations are led by advances in technology (‘solutions seeking applications’) rather than being produced in response to identified clinical needs,” further insisting that “being at the forefront of technological advances also implies responsibilities to ensure that new treatments are safe and effective”.

The ESC report also recommends that obtaining expert advice should be an integral part of the regulatory process, representatives being nominated by major medical associations in Europe to be members of the main advisory committees.  “Academic experts should produce detailed recommendations on how the clinical performance of high-risk (class III) medical devices should be established,” Fraser said.

Legislative decisions on the matter are to be taken by the European Council and the European Parliament in the next few years.  Professor Fraser asserts that major change will not come easily, and any cardiologist wishing to see improvements must seize their chance to influence the debate: “The ESC, with colleagues from other medical associations, is now considering recommendations for cardiovascular implantable electronic devices. The preliminary proposals will be presented at a special session during the ESC Congress in Paris on 28th August 2011”.


1 Fraser AG, Daubert  JC, Van de Werf F, et al. Clinical evaluation of cardiovascular devices – principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology. Eur Heart J. Doi 10.1093/eurheartj/ehr171.

2 Heneghan C, Thompson M, Billingsley M, Cohen D.  Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. BMJ Open 2011. doi:10.1136/bmjopen-2011-000155.

Published on: June 8, 2011

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