Faulty implants: Europe-wide regulation on medical implants

The European Commission is not acting quickly enough to protect patients from potential harm from medical implants, a parliamentary committee warns. Current Europe-wide regulation on medical implants, such as hip replacement joints, is too slow to change, they say. The EC is revising the regulation, but changes are not expected to take effect until at least 2015.

Faulty implants: Europe-wide regulation on medical implants The report comes after recent concerns about the safety of hip implants. "I think in the interests of patients we would get a better system in place if the commission speeded up the process to revise current regulations," said Andrew Miller, chairman of the Science and Technology Select Committee. Under the present system new devices must gain the Europe-wide mark of approval - the CE mark - from one of 70 regulatory organisations, known as notified bodies. The committee raised concerns that notified bodies might vary in quality and that manufacturers might be shopping around for regulators based in the country with the least stringent regulations. "There is an urgent need for more transparency in the regulatory system so that patients and doctors know where their implant is coming from, and crucially whether the product has previously been turned down by other regulatory bodies," Mr Miller said.

'Inadequate' safety testing

He is calling for there to be a public record every time a manufacturer approaches a notified body for approval, allowing this "forum shopping" to be spotted more easily. The report also warns some patients may be given medical implants that have had little known safety testing, as currently regulators may rely on safety information gathered from similar, equivalent products. This means an implant may be used across the European Union without evidence of its own safety and performance, the report says. The committee recommends that for all medical implants that are currently in use, any existing data must be published immediately. It also calls for compulsory reporting by doctors of any faulty products they come across. "The British Association of Aesthetic Plastic Surgeons is pleased that the government has moved to better regulate all CE-marked medical devices, and in particular, we praise the call for all existing evidence on medical devices to be published immediately," said consultant plastic surgeon and former BAAPS president Nigel Mercer. "Without these changes the public cannot be sure that they can ever be safe from another PIP-like fiasco." Professor Norman Williams, president of the Royal College of Surgeons, agreed there urgently needed to be an "increase of transparency and accountability across the entire regulatory framework for medical implants".