Amanda Maxwell

The system that regulates medical devices in Europe is "not fit for purpose", and allows device manufacturers to have ultimate control over the fate of their products. That is the conclusion of a high-profile inquiry carried out in the UK by the British Medical Journal, along with Channel 4 Dispatches, a television documentary due to be televised tonight..

The investigators call for tighter regulatory controls, saying that the current system treats European patients as guinea pigs, allowing them to receive insufficiently tested devices. This is the second time this year European patients have been referred to as guinea pigs – the head of the US Food and Drug Administration, Dr Jeffrey Shuren, expressed similar views in January ( www.clinica.co.uk, 25 January 2011).

The inquiry’s conclusions are being aired just as the European Commission is working on the second major recent revision of the medical device directives – the “recast” – and it is yet to make final decisions about its proposals for change.

Together with similar views expressed by other sources, such as US regulators, the findings of this latest inquiry will contribute to the pressure on the European Commission’s Directorate General Health and Consumer Policy (DG Sanco) as it weighs up the pros and cons of stricter regulation and oversight. This is already tricky enough in an era where the importance of rapid access to innovative devices for individual patients, and for society at large, is well-recognised.

The investigators cite particular products as having failed patients, in the EU and the US, including devices manufactured by DePuy, Medtronic and Advanced Bionics. And medtech companies are also attacked for withholding information during the inquiry on the grounds that it was “vital confidential information”.

The investigators stress that the approval process for devices is far less stringent than that for drugs, “particularly in Europe”, and Professor Nick Freemantle of the University of Birmingham is seen asking why devices should be subject to “an inferior regulatory model”.

They question the device industry’s hold over surgeons, asking why more premarket clinical studies are not conducted to pick up device problems earlier.

The programme is expected to focus on emotive issues, without balancing the argument by highlighting benefits of advances in technology, mentioning the pressure from patients for faster access to innovative products, or explaining that benefits can often only be obtained along with concomitant risks.

Nevertheless, the investigation raises questions that the devices sector will find itself hard pressed to answer, particularly when it comes to the lack of transparency over medical devices.

The investigators say there is “a worrying lack of public information about the number of devices being used and their potential risks” and that even Freedom of Information requests made to the UK’s Medicines and Healthcare products Regulatory Agency for data on adverse events were refused as “overridden by medical device legislation”.

Publication and broadcasting of the results of the BMJ/ Channel 4 Dispatches inquiry coincides with the European Society of Cardiology’s decision to issue an official call for Europe to set up a “single, co-ordinated European system to oversee the evaluation and approval of medical devices”. In a statement released this morning, the ESC calls for notified bodies to be managed within the context of an integrated structure, with regulatory authorities directing applications for devices to appropriate specialist notified bodies. The society highlights the failure of the EU clinical data requirements to cover adequate clinical outcomes.