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New safety system will track implants

Mark Gould

Monday, 10 June 2013

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The UK's medicines and technology watchdog has announced details of a new tracking system that will improve the monitoring of high risk medical devices such as breast implants, heart valves and pacemakers.

Four NHS trusts are trialling the new system which it is hoped will ultimately incorporate unique device identifiers into hospital patient electronic records and national Hospital Episode Statistics databases and analysis by the Clinical Practice Research Datalink (CPRD).

The Medicines and Healthcare products Regulatory Agency (MHRA) says this will enable it to assess the performance of high-risk medical devices and to trace patients in the event of a device recall or safety alert, without the need for multiple device registries.

The project is one of 11 projects that the MHRA has established to strengthen the regulation of medical devices as part of its response to the review into PIP breast implants by Health Minister Lord Howe in May last year. Many of these projects are still in early development because of their complexity but the MHRA has made progress in these areas:

  • Adverse incident reporting: working with NHS England to improve levels of reporting of problems with medical devices in NHS trusts through enhanced Medical Device Liaison Officer roles. Adverse incident reporting increased by 25% in 2012 thanks to increased reporting by the public, manufacturers and private health organisations;
  • New National Breast Implant Registry: assisting the Department of Health with the re-establishment of a National Breast Implant Registry;
  • Review of UK and European notified bodies: the competence of UK notified bodies – who approve the safety of medical devices before they are sold – has been reviewed and joint audit programme for this year has been implemented to ensure that all European notified bodies are meeting consistently high standards when assessing high-risk medical devices;
  • Strengthening regulation in Europe: 116 responses were received in response to the MHRA’s public consultation on the European Commission’s proposals to improve medical device regulation. These were broadly supportive of the UK Government’s position that there must be tighter controls on notified bodies, better post-market surveillance of medical devices and more collaboration between national regulators;
  • New European reporting portal: leading on generating funding from other European countries to pilot new portal that will improve the safety monitoring of medical devices that are used in Europe.

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.”

Lord Howe, Health Minister 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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