Following on from C4 Dispatches programme, this week's BMJ explores device regulation

Published date : 22 May 2011
Article date : 22 May 2011

This week’s BMJ is sobering reading for anyone interested in medical devices. In an editorial by Peter Wilmshurst (who is being sued for comments he allegedly made about the STARFlex device) and a series of feature articles, the present regulation and approval processes of medical devices in the United Kingdom and Europe are heavily criticised. The article examines the European device approval process by which privately funded companies determine whether devices meet regulatory standards, and compares it to the US system where the correspondence between regulators and companies is freely available on the Internet (here at Which Medical Device, we have found these letters extremely useful sources of information). Regulators are not required to prove a device has a clinical benefit in Europe, only that it does what it is said to do. The ASR hip features heavily, as in the Dispatches  programme earlier in the week. Other devices mentioned include the Birmingham Hip Resurfacing, the ASR XL large metal on metal bearing, and the Sapien heart valve.
The difficulty in obtaining data about devices in Europe extends to recalls. One researcher depressingly found it almost impossible to obtain information about the reason for UK device recalls.
But how to proceed? The relationship between clinicians, regulators and industry is necessarily complex. Clinicians are essential to the development of new devices and have to have a role in their development, but the incentives involved may even unintentionally skew the reporting of results. Clinicians must bear in mind that they are the often the last line of defence between patients and industry and proceed with caution when new devices are involved, whatever the regulators and the companies say. The disincentives for companies to report early problems with devices are similarly powerful – there may be a lot to lose in terms of reputation and financial cost.
Furthermore, it is clear that developing and marketing a new hip replacement, an area in which new devices may only represent an incremental improvement in outcomes for patients, has a different risk/benefit profile to new devices for patients with a serious condition for which there is no other good treatment. Patients need to have access to the potential benefits of new technologies, but not at any cost.

The flurry of media activity around this issue has lead to questions being asked in Parliament and may, in due course, lead to a change in regulation. However, it remains to be seen whether the regulators can improve safety without stifling innovation. Making public all available information about medical devices would be an excellent first step. 

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