Flaws in EU regulation of medical devices, says BMJ
24 October 2012
A joint undercover investigation by the BMJ and the Daily Telegraph has exposed flaws in the EU system used to grant market access for devices such as replacement hips, cardiac defibrillators, and breast implants.
The investigation involved submitting a fake application for a large diameter metal-on-metal total hip prosthesis for approval by a notified body in Slovakia—the commercial organisations charged with evaluating the safety and performance of medical devices across Europe by granting them a CE certificate.
The hip — whose specification was designed for the purposes of the investigation — had similar specifications to the DePuy ASR XL acetabular system — a device that has been recalled from the market after failing at unacceptable rates and releasing metal ions into patients’ blood. Nevertheless, last week the notified body provisionally allowed the product to go forward to certification.
One notified body authorised to certify products for medical use across Europe, has been secretly recorded admitting that it is “on the side of the manufacturer”.
ITC, a regulatory organisation in the Czech Republic was also prepared to consider licensing the product, despite widespread concerns about the use of large diameter metal-on-metal hip prostheses. In some countries, surgeons have been told not to use them.
One representative of ITC told reporters that his company would not put “obstacles” in the way of approving the device and said it was “on the side of the manufacturer and their products, not on the side of the patients”. Another notified body was recorded admitting that some of the dossiers for products legally on sale were “horrible” because of the deficiencies of the regulatory system. The ITC did not respond directly to any points later raised but said it complied “in full accordance with the law.”
The investigation raises serious questions over the safeguards protecting patients. The system of licensing medical devices and surgical implants works on a pan-European basis and regulators in this country refuse to disclose where products have been certified.
More than 70 private agencies are competing for business — meaning the system is susceptible to corrupt practices, such as those uncovered during the recent PIP breast implant scandal.
The regulatory system works in a similar way to the licensing process for household electrical appliances and toys rather than the far more rigorous system applied to approving drugs.
Medical experts last night condemned the regulators and demanded an urgent review to protect patients from another “inevitable” scandal in the wake of the problems surrounding PIP breast implants earlier this year.
Dr Carl Heneghan, a medical expert at Oxford University, who provided advice on the BMJ / Daily Telegraph investigation, said last night: “To put it bluntly device regulation is in disarray: the evidence requirements at the time of approval are woeful, the conduct of notified bodies is substandard, and individuals supposedly representing the regulatory system are conflicted and in many cases under qualified.
“This all means that the system now heavily favours manufacturers at the expense of patient safety.”