Thursday, May 9, 2013

Experts call for transparency over medical devices

[Great idea from Europe:  construct a public website containing the data for companies  seeking approval of medical devices so the patients can make their own decisions....other researchers would comment on the data and those comments would be helpful to the those patients seeing device implants.]

The Telegraph (London)

Experts have called for an end to secrecy over the regulation of medical devices like hip implants and said safety data should be published online so that patients can make up their own minds.

Last year's investigation involved submitting a formal application for a “metal-on-metal” implant for approval in Slovakia, soon after a major health warning involving 40,000 “metal-on-metal” hips 

The recommendation follows a series of scandals involving medical devices, with a major health alert over “metal-on-metal” hips given to 40,000 Britons and breast implants sold 47,000 women.
Last year, an investigation by The Daily Telegraph found that European regulators were prepared to licence products which were exactly the same as products which had previously been banned because they were dangerous.
Under the system of regulation, products can be approved by a notified body in any EU state, and then must be accepted by every country - despite concerns that this means unscrupulous manufacturers can “shop around” until they find an organisation which will approve their device.
Writing in the British Medical Journal, a research team led by Edmund Neugebauer at Herdecke University in Germany has concluded that the current system puts patients at risk and was biased towards the interests of manufacturers.
The patient safety experts said greater transparency was needed about decisions to approve devices, which are now hidden from the public.
They also said that if products were in “high or medium-risk” categories, authorisation should be made by one central body, to stamp out the practice of shopping around.

In the Daily Telegraph investigation last autumn, regulators were secretly recorded boasting that they were “on the side of the manufacturer”.

The investigation involved submitting a formal application for a “metal-on-metal” implant for approval in Slovakia, soon after a major health warning involving 40,000 “metal-on-metal” hips subject to a major health alert last year after tests showed they could wear down and poison the bloodstream.

The official regulatory body there offered provisional approval for the design of the artificial hip, despite the specifications being similar to a product that had been withdrawn in the UK, America, Australia and other developed nations outside Europe.

The research team called for a central website, which would allow any member of the public to view the data about the safety and efficacy of a device, which was considered before it was approved.
“Poly Implant Prothese (PIP) breast implants show that the process cannot guarantee safe and effective patient care,” the authors wrote in the BMJ.

The certification process is inconsistent, opaque, and operates in the interests of manufacturers. It requires insufficient evidence of efficacy of the devices and no long-term follow-up of patients,” they wrote.

The researchers said that Europe needs “a central, transparent, and evidence-based regulation process for devices”, which can range from bandages to life support machines.

The public should be able to see the data supporting any decision to approve a product, they said.
Last year, John Howlett, head of the British Standards Institute, raised concerns that if a product is denied by one notified body, some manufacturers seek approval from another and pass the test of standard.

The authors of the latest report said the regulation process should be centralised.
They wrote: “Under the proposed legislation manufacturers of devices will still be free to choose to which of the 84 notified bodies they submit their application.

“We believe that approval of high and medium-risk devices ... should be done by a new public body similar to the European Medicines Agency (EMA) or that the EMA is given an extended mandate to carry out these assessments.”

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