Improved checks pledged on medical ‘devices’

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MINISTERS claim detailed action will be taken to ensure better checks are made on medical implants before they are used by the NHS.

Critics say that in contrast to the exhaustive tests for new drugs, devices are not required to go through trials.

A report by MPs in October prompted by the scandals of metal-on-metal hip implants and PIP breast implants called for better use of evidence in approvals.

In a Commons debate on Wednesday, Andrew Miller, chairman of the Science and Technology Committee, said it was “crucially important” to get the pre-market approval process for medical implants in the EU right.

He said once an implant had been approved in any EU member state the manufacturer placed the CE mark on the device and was free to put it on the market in all European countries without further controls.

He added: “What’s more, if they’ve previously been to a regulator who has said that device isn’t up to scratch and they go to another one and get approval, the first part of the information is ridiculously regarded as commercial in confidence, something that clearly must be changed.”

There were 70 notifying bodies in Europe and concerns had been raised that some “may not have the same high standards”.

Mr Miller underlined the need for NHS decision makers to have better access to data, and bidders should be required to “provide the fullest and most transparent data about the trials that have been conducted about the design of the product, about the regulatory processes it has gone through, including the ones that have failed”.

Health Minister Norman Lamb said negotiations began last year to “overhaul” the regulation system in Europe, due for completion in 2017. The UK is also taking action, and one idea is for an approved list of experts bodies must consult when assessing clinical evidence, which must be transparent.

“Current practice in the NHS means clinicians take into account a number of factors before using a device, including the clinical evidence provided and the track record of the manufacturer. I would expect this principle to apply to all medical devices used in the NHS.”

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