The regulation of medical devices

BMJ 2011; 342 doi: http://dx.doi.org/10.1136/bmj.d2822 (Published 15 May 2011)
Cite this as: BMJ 2011;342:d2822

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  1. Peter Wilmshurst, consultant cardiologist
  1. 1Royal Shrewsbury Hospital, Shrewsbury SY3 8XQ, UK
  1. peter.wilmshurst{at}tiscali.co.uk

Unsatisfactory, unscientific, and in need of a major overhaul

Two linked features (doi:10.1136/bmj.d2748 and doi:10.1136/bmj.d2905),1 2 an analysis article (doi:10.1136/bmj.d2973),3 several commentaries, and a research study (http://dx.doi.org/10.1136/bmjopen-2011-000155) highlight the unsatisfactory and unscientific way that medical devices are approved for use particularly in Europe; the failures in regulatory oversight during clinical use; and the lack of transparency in publishing research findings, device related complications, and competing interests.

Competing interests have an unhealthy influence on drug prescription. Drug companies publish selective data aided by clinical researchers, who accept payment to be gift authors of ghost written articles.4 Universities that receive research funding from industry can turn a blind eye to misreporting of research. Publication bias is compounded by medical journals that are seduced by the financial gains from reprint sales if they publish positive outcomes of industry sponsored research.5 Opinion leaders are paid to endorse drugs at advertising seminars, disguised as scientific symposiums, and doctors attend because they receive lavish entertainment.6 Some doctors even accept bribes from companies to prescribe their drugs.7 As a result patients may receive inappropriate drugs. But the competing interests around medical devices are even greater.

In the European Union drugs are approved by a single organisation, the European Medicines Agency, after submission of evidence of safety and efficacy in controlled trials. A medical device, however, may obtain a CE (European conformity) mark for use in the whole EU from one of dozens of notified bodies.2 3 Usually there is no need to provide proof of clinical efficacy. For …

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