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Medical devices regulation needs to be overhauled, says cardiologist

BMJ 2011; 343 doi: (Published 14 October 2011) Cite this as: BMJ 2011;343:d6671
  1. Jacqui Wise
  1. 1London

The standards of evidence required for licensing medical devices should be the same as for drugs, Peter Wilmshurst told a Royal College of Surgeons meeting this week.

Dr Wilmshurst, a consultant cardiologist at the Royal Shrewsbury Hospital, gave his personal perspective on the need for an overhaul of medical devices regulation after his defence of three defamation claims.

The US medical device company NMT Medical sued Dr Wilmshurst after he spoke of his concerns about the migraine intervention with STARFlex technology (MIST) trial, in which he was the principal cardiologist (BMJ 2008;337:a2412, doi:10.1136/bmj.a2412). The defamation claims recently ended after almost four years when the company went into liquidation.

“I believe concerns about litigation have prevented some doctors from reporting adverse events,” Dr Wilmshurst told the meeting, called “New techniques and new technologies: ethics …

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