EU regulators have not done enough to ensure the safety of medical devices before they are approved for widespread use, according to a British Medical Journal and Channel 4 Dispatches investigation.
Device approval in Europe is quicker than in the U.S. and is generally regarded as more favorable to industry. However, not everyone sees the EU system as better for patients. "We don't use our people as guinea pigs in the U.S.," CDRH head Jeffrey Shuren said in a conference call to reporters earlier this year when comparing the two systems.
As Peter Wilmshurst, a consultant cardiologist points out in the BMJ report, a medical device may obtain a CE mark for use in the whole EU from one of dozens of notified bodies. And typically, there is no need to provide proof of clinical efficacy. He also notes that clinicians, journals and memeber of the device industry cannot be trusted to police themselves, and penalties for such misconduct as failure to report adverse events related to devices need to enhanced.
The BMJ-Channel 4 investigation looks at last year's recall of DePuy's articular surface replacement hip prostheses from the market. The recall followed years of denial by the company that the ASR implants had caused pain and disability in patients, according to author Deborah Cohen. Now DePuy faces litigation in a number of countries because metal debris from wear of the implant led to a reaction that destroyed the soft tissues surrounding the joint in a number of patients.
"[I]f lessons are not learnt from this latest episode in the chequered history of hip implant failures, it may also prove costly for the reputations of the regulators and the orthopaedic community," Cohen writes.
"I think we have to rethink the whole system of how devices come onto the market and whether we should be doing things a bit differently from what we are now," adds Professor Stephen Graves, orthopaedic surgeon and director of the Australian National Joint Replacement Registry.