Trusts to track high-risk devices
Four NHS trusts are taking part in a new tracking system trial to improve monitoring of high risk medical devices, the MHRA has announced.
The project will track breast implants, heart valves and pacemakers, incorporating unique device identifiers into patient electronic records and national Hospital Episode Statistics databases, as well as analysis by the Clinical Practice Research Datalink (CPRD).
It will enable the MHRA to better assess the performance of high-risk medical devices and to trace patients in the event of a device recall or safety alert.
The four trusts are: Freeman Hospital in Newcastle, Christie Hospital in Manchester, Leeds General Infirmary and Birmingham University Hospital.
John Wilkinson, the MHRA’s director of medical devices, said: “The PIP breast implants episode is believed to be a case of deliberate fraud but it highlighted areas where medical devices regulation need strengthening in the UK and in Europe.
“The new tracking system for medical devices that we are piloting is still in the early stages of development, but we hope it will help us to improve the safety information we receive so that we can alert patients and healthcare professionals about potential safety problems faster.
“This is one of 11 projects we established in response to the recommendations made by Lord Howe. We have already made good progress in a number of these and establishing an audit programme that ensures that European notified bodies – which assess the safety of medical devices before they are sold – meet consistently high standards was a key aim for us. We are continuing to work hard to ensure that the regulatory system is protecting patients from unsafe medical devices.”
Health minister Lord Howe said: “Protecting the health and well-being of people who have been given medical devices is vitally important. Serious lessons need to be learned from the PIP scandal.
“The MHRA has identified new measures to help improve the monitoring of medical devices including implants. I hope its ongoing work, and the work of the Department, will reassure the public that we have identified the lessons and have taken steps to act on them.”
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