MHRA Tracking System Aims to Improve on Device Monitoring and Patient Alerts
Published date : 10 June 2013
Article date : 07 June 2013
A press release from the MHRA has announced that four NHS trusts (UK) will pilot a new tracking system which aims to improve on safety information received about high risk medical devices so that patients and healthcare professionals can be alerted more quickly on any potential safety problems. Such devices include breast implants, heart vales and pacemakers.
Unique device identifiers will be added to hospital patients' electronic records and national Hospital Episode Statistics databases. An analysis by the Clinical Practice Research Datalink (CPRD) will then enable the MHRA to better assess the performance of the devices and to trace patients in the event of a device recall or safety alert, without the need for multiple device registries.
This project is one of 11 established by the MHRA 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 2012. Many of these projects are still in early development because of their complexity but the MHRA reports progress in several key areas.
