Public to have access to research on medical implants

Published date : 11 September 2012
Article date : 11 September 2012

The Telegraph (UK) reports that for the first time, the public will be able to access details of the clinical research behind medical devices and their safety record since coming on to the market. The rules are being drawn up by the European Commission in the wake of the Poly Implants Protheses breast implant and metal-on-metal hips issues.

Under the current system, the clinical evidence to support devices and the records of adverse incidents linked with them are not openly available. Apparently, manufacturers must share some information with a "nominated body" of their choice which authorises their products for use but it cannot be seen by the public or by independent scientists because of European Union regulations.

British regulators run a voluntary system so surgeons can report concerns about medical devices but the EU confidentiality rules mean their data is not published and patients and doctors are not advised about these concerns. 

In January, The Sunday Telegraph disclosed that thousands of Britons had been given metal-on-metal hip implants which were found to poison the body, with some devices having failure rates of up to 50 per cent. Weeks later, the MHRA issued a warning that 49,000 people with the implants should undergo checks throughout their lifetime and undergo further operations to replace the devices if problems were found.

The article says that the new proposals from the EC are due to be published within weeks and are expected to recommend that three directives on medical devices, passed during the 1990s, are rewritten.

Due to the single European market, devices used in this country can be manufactured elsewhere, then authorised by a "notified body" in any of the 27 EU member states. That meant that in the case of the PIP implants, a company in Germany was responsible for the quality of devices produced in France and imported for use in women around the world, including Britain.

The MHRA is also calling for more rigorous standards to ensure that the clinical evidence to support the application for a licence is more consistently and robustly scrutinised.

Read the full article here

Source: Telegraph (UK), 11 September 2012

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