Feature Medical Device Regulation

EU approval system leaves door open for dangerous devices

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7173 (Published 24 October 2012) Cite this as: BMJ 2012;345:e7173
  1. Deborah Cohen, investigations editor
  1. 1BMJ, London WC1H 9JR, UK
  1. dcohen{at}bmj.com

Deborah Cohen describes the reaction of notified bodies to a fake dangerous hip implant

When the BMJ and Daily Telegraph visited the notified body EVPU in northern Slovakia, its offices were lined with burnt-out kettles and toasters, testimony to the “safety” tests that take place in the building. EVPU is one of the private companies that assesses whether electrical products are safe to be sold throughout the European Union. It decides whether to award a product a CE certificate to allow it to be sold across Europe.

But, the company’s activities are not restricted to licensing kettles and toasters to see if they blow up when plugged in—under European rules, the firm is also authorised to certify medical implants such as hips and knee prostheses.

The European system of regulation has sparked widespread concern over whether medical experts are really at the vanguard of deciding which devices can be implanted in patients.

The BMJ and the Daily Telegraph therefore decided to investigate the rigour of the licensing process—amid allegations that dozens of private companies are competing with one another to offer a certificate for problematic devices. Was profit being put before patient safety?

Undercover journalists approached EVPU, claiming to represent a fictitious Chinese company, Changi, that wanted to get a new large diameter metal-on-metal total hip replacement onto the market in Europe.

In order to test the system, the “new” hip implant was modelled on a device now recalled throughout the world, the DePuy ASR. The US orthopaedic giant—part of Johnson and Johnson—had to recall thousands of hip implants after it emerged that the device failed at unacceptable rates and produced raised levels of metal ions in patients’ blood.

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