9922155_xxlBAPRAS has responded to recommendations from the independent review led by Professor Terence Stephenson into how medical devices are handled within the MHRA.

Graeme Perks, BAPRAS President and Consultant Plastic Surgeon, said the organisation was strongly supportive of the ‘useful and practical recommendations’ which they believe, if funded and implemented, will be an important step in improving patient safety and driving standards.

“A key recommendation put forward in the report is that patient records should be used to track what medical devices are given to patients,” Mr Perks explained.

“BAPRAS has continually pushed for the creation of a compulsory register for medical devices and as well as being part of the International Collaboration of Breast Registry Activities (ICOBRA), our Association is already working on a UK specific database pilot with Clinical Practice Research Datalink (CPRD), a research service jointly funded by the NHS National Institute for Health Research (NIHR) and the MHRA,” he said.

As cosmetic dermal fillers are classed as medical devices this is potentially a significant step in the right direction to improving this part of cosmetic practice also.

“The review recommends that the MHRA needs to communicate more effectively with the public and patients; simplifying communication and involving the public more in active reporting of adverse incidents and decision making,” Mr Perks explained.

“We believe this is critical and would mirror our own focus on patient outcome reporting and standard setting,” he said.

Another key recommendation points to the MHRA making information available on the safety and effectiveness of medical devices more widely, in order to support professionals in their choice of the appropriate device for their patient.

“BAPRAS would strongly welcome this move because, as the PIP implant crisis brought to light, practitioners are often influenced by marketing pressures in their decision making and we would like to see this process better informed through reliable information from the MHRA instead,” Mr Perks concluded.

The report also advises that the MHRA plays a leading role in Europe to ensure that regulations are fit for purpose and help meet the needs of patients. BAPRAS and the British Association of Aesthetic Plastic Surgeons (BAAPS) continue to be at the centre of the debate on regulation of Aesthetic Services and devices in Europe through the British Standards Institution (BSI).

A further recommendation puts forward that devices should be as important as medicines and that the MHRA should set up a new group of experts to advise it, called the Devices Expert Advisory Committee.

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