The scandal of medical device regulationBMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e7180 (Published 24 October 2012) Cite this as: BMJ 2012;345:e7180
- Fiona Godlee, editor, BMJ
Try describing Europe’s system for regulating medical devices and, as Peter McCulloch says in his editorial this week, the response from your audience will be incredulous (doi:10.1136/bmj.e7126). Read his description and see if you too find yourself asking, “How could this have come about?” It’s a question that now demands urgent remedy. If this was not already clear from recent BMJ investigations (BMJ 2011;342:d2748, BMJ 2012;344:e1410), a new investigation makes it uncontrovertibly so. Working with undercover reporters from the Telegraph newspaper, the BMJ’s Deborah Cohen has exposed a fragmented, poorly regulated, market driven system, with financial incentives to prioritise manufacturers’ interests over those of patients, and with no requirement for clinical evaluation of a device’s safety or effectiveness (doi:10.1136/bmj.e7090).
Armed with a fictitious hip implant modelled on one that was recalled on safety grounds in 2010, the reporters approached 14 of the 78 “notified bodies” to which the European Union delegates the job of certifying medical devices. The one to which they eventually submitted their glossy dossier was happy with the design and confirmed that it would approve the device subject to manufacturing documents and a factory visit.
Why did we decide to work with the Telegraph on this “secret shopping” exercise? Firstly, there was a clear and pressing public interest. Secondly, we took the view that the information could not have been obtained by other means. Thirdly, we were reassured by the fact that the BMJ has successfully used fake information to test various systems in the past. As part of a randomised trial published in 1998 (JAMA 1998;280:237-40), we sent out for peer review hundreds of copies of a research paper into which we had inserted errors. The reviewers were not told that the paper was a fake. For this study, as with the fictitious hip implant, we obtained approval for our plans from the BMJ’s ethics committee.
More famously, in 1868, the BMJ’s then editor Ernest Hart placed a newspaper advertisement in which he posed as a father seeking a foster mother for his illegitimate child. His aim was to expose the notorious Victorian practice of baby farming, in which unwanted infants were taken in to be nursed in exchange for payment, but were instead neglected and often killed. The advertisement received 333 replies and sparked a series of articles calling for reform (BMJ 28 March 1868, 301-2). According to the historian Peter Bartrip, the journal’s influence was crucial in achieving legislation.
If the latest undercover operation has similar effect, we will consider the means worthy of the end. Because legislation is what is now urgently needed to protect patients. McCulloch says this must go beyond the tinkering reforms proposed by the EU. Instead, he calls for a system of provisional licensing in which devices could only be marketed if they were being used within clinical studies of their safety and effectiveness. Whatever new system is proposed, he is right to say that it must have patient safety, not trade, at its heart.
Cite this as: BMJ 2012;345:e7180