After Weathering Scandals, UK Appoints New Medical Device Oversight Official

Posted 18 February 2015 By Michael Mezher

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The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has appointed a prominent academic figure, Dr. Peter Nightingale, to be the chair of its newly formed expert group on medical devices—a position intended to help UK regulators strengthen oversight of the UK's medical device sector.

Background

In 2014, an independent review of the UK’s MHRA concluded that the agency needs to bolster its oversight of medical devices and increase its engagement with the medical device clinical community.

The review, headed by Professor Terence Stephenson, chair of the UK Academy of Medical Royal Colleges, was conducted in light of recent highly publicized cases of faulty medical devices in Europe.

For more information on recent medical devices scandals, see our coverage of the PIP breast implant scandal and metal-on-metal hip implants.

The review argues that “MHRA must take devices as seriously as medicines,” and makes 12 recommendations for the agency to improve the safety of medical devices.

A New Expert Group

One of the key outcomes of the review was the formation of the Devices Expert Advisory Committee (DEAC), which replaces the previous Committee on the Safety of Devices (CSD).

The formation of the DEAC seeks to address some of the criticisms raised in the review of the CSD. Unlike MHRA’s Commission on Human Medicines (CHM), the CSD does not have a statutory basis, and can only provide advice to the agency. The report calls the timeliness of that advice into question, as the CSD only meets three times per year. This means that MHRA typically reacts to crises without CSD input. Also, because the CSD is made up of roughly 400 unpaid members, it is not as agile as the reviewers feel is necessary.

MHRA responded to Stephenson’s review in a press release in July 2014. In the release, MHRA accepted all of the recommendations in the review. The agency said it would establish the DEAC by April 2015 and had begun to recruit a chairperson for the 12 member committee. MRHA said the committee “will be linked to a network of specialist sub-groups and ad-hoc groups to deliver specialist advice” to the agency.

DEAC’s First Chair

Dr. Peter Nightingale has extensive experience in the medical community. His appointment comes after serving as the president of the Royal College of Anaesthetists and as vice chair of the Academy of Medical Royal Colleges, where Stephenson served as chair.

Nightingale’s appointment was welcomed by MHRA Devices Director John Wilkinson, who said Nightingale’s “will be invaluable in helping the agency as it responds to the demands of the future.”

 

MHRA Press Release

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Categories: Medical Devices, Government affairs, News, Europe, MHRA

Tags: DEAC, Devices Expert Advisory Committee, Committee on the Safety of Devices, CSD

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