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Europe’s Device Certification System Flawed

October 25, 2012
Written by: , Filed in: Medical Ethics, Musculoskeletal Radiology
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Evaluation of medical devices in Europe appears to be a farce, judging from the results of a joint undercover investigation by the BMJ and the Daily Telegraph.

The medical journal and the newspaper submitted a fake certification application for a deliberately faulty total hip prosthesis. It was based on an actual prosthesis that had been recalled from the market because of a high failure rate and the release of possibly dangerous metal ions into patients’ bloodstreams.

Nevertheless, the Telegraph reported:

Regulatory bodies were prepared to approve a ‘toxic’ hip replacement.

A representative of ITC, a Czech company that certifies medical devices, was caught on a secret video saying that his company was “on the side of the manufacturer and their products, not on the side of the patients.”

ITC responded on its Web site that the video had been misleadingly edited and that because the undercover investigators never actually submitted their fake device or full technical information about it for certification, “it is not possible to say if the fictional product would comply with the legal requirements.”

Still, the investigation turned up enough other evident laxness to raise alarm bells. The stories were published earlier this week. You can find the BMJ stories here and the Telegraph stories here.

To be sold in the European Economic Area, products need a CE marking, certifying that the product complies with applicable laws and regulations. Private companies known as notified bodies—76 of them—are authorized to certify devices, theoretically after testing them. They make their money by charging certification fees.

Because manufacturers have 76 choices, each notified body has an obvious economic incentive to make it easy for devices to win certification. Test results are kept confidential. In fact, said Peter McCulloch, MD, in a BMJ editorial:

There is no requirement to show benefit or efficacy, and the safety certification does not have to be based on clinical data.

Dr. McCulloch is clinical reader in surgery at John Radcliffe Hospital in Oxford, England. His editorial concludes, with notable understatement, “A new system that improved scientific evidence of safety, required evidence of efficacy, and rewarded responsible innovation with protection against piracy would be well worth considering.”

Related seminar: Imaging Advances: Abdominal, Thoracic, Skeletal


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