GovWire

MHRA responds to misleading Sunday Post article

Medicines and Healthcare products Regulatory Agency

April 26
15:53 2016

Sir,

Your article Deadly toll of dodgy NHS gear. Thousands killed or seriously injured by faulty equipment (24 April), is not only misleading but could lead to an increase of concern not just amongst healthcare professionals but also amongst patients.

There are hundreds of thousands of medical devices used in healthcare settings every day and they have helped to transform the lives of many millions of people every year.

It is vitally important, however, that where incidents do occur they are reported to us through our Yellow Card system so we can properly investigate and, where appropriate issue updated advice.

Adverse incident reports involving medical devices represents a small proportion of this use and do not necessarily mean the medical device was at fault. When incidents do occur, we review the information rapidly and take robust action to protect patients where this becomes necessary.

Where there is a problem with a device that requires action from healthcare professionals we send details to all affected health establishments in the UK and publish details of the problem on our website.

Improving the rates and quality of reporting from healthcare professionals is one of our key priorities and were working with NHS England and our colleagues in the devolved administrations to make adverse incident reporting easier.

We are working together to improve the overall management of medical device incidents in health services in the UK, this is through the appointment of Medical Device Safety Officers with specific roles designed to support improved patient safety.

John Wilkinson,

Director of DevicesMHRA.

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