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MPs call for tighter safety on medical implants

EU acting too slowly on implant safety measures, say MPs

Adrian O'Dowd

Friday, 02 November 2012

EU regulations governing the safety of medical implants such as metal-on-metal hip replacements should be tightened as a matter of urgency, according to a new report by the parliamentary science and technology committee.

MPs on the committee publishing their report Regulation of medical implants in the EU and the UK said there was evidence that manufacturers were seeking approval for devices in Member States that had the least stringent regulatory regimes.

In August 2010, two metal-on-metal hip implants manufactured by DePuy were recalled worldwide because data from the National Joint Registry (NJR) of England and Wales showed a large number of people had experienced problems and required a second hip replacement surgery.

The new report says recent recalls of metal-on-metal hip replacements and other faulty medical implants show that manufacturers and regulators must also publish more rigorous clinical data on the safety of new implants and be subject to greater scrutiny.

MPs said the problem arose from the fact that clinical data requirements for high-risk medical devices to be sold on the European Market were much less stringent than for new medicines.

They were unimpressed with the extent to which reliance on equivalence - similarity to an existing implant - rather than clinical investigations of the implant being approved, seemed acceptable in pre-market assessment.

The committee called for all clinical data used in the approval of a medical implant to be published without identifying patients or clinical trial participants, In addition, for products currently on the market, such data should be published immediately.

Another recommendation was that there should be a public record of every approach from a manufacturer to any notified body in the EU so that “forum shopping” – the practice where manufacturers shop around for the least stringent regulatory regimes in which to get their medical implants approved – could be identified.

Committee chair Andrew Miller, said: “Thousands of patients use medical implants in the UK every day without problem. When things do go wrong with implants however, it can ruin lives – as the complications with metal-on-metal hip replacements have sadly shown.

“We were shocked to hear about the practice of so-called 'forum shopping'. Much greater transparency is needed about the approval process so patients and doctors can have full confidence in the implants they are using.”

UK regulatory body the Medicines and Healthcare products Regulatory Agency (MHRA) was criticised in the report for its slow reaction to reports of problems with metal-on-metal hip replacements in Australia, which the MPs said meant patients had suffered needlessly.

Mr Miller added: “The EU and UK must improve the speed with which information from adverse incident reporting abroad is handled and acted upon. The NHS needs to develop better systems for dealing with reports of problems with medical implants.”

Responding to the report, Professor Norman Williams, president of the Royal College of Surgeons, said: “The college strongly supports the science and technology committee’s recommendation that an increase of transparency and accountability across the entire regulatory framework for medical implants is urgently needed.”

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