MHRA publishes review of medical device incidents in 2010
Published date : 09 October 2011
Article date : 09 October 2011
According to the UK Medicines and Healthcare products Regulatory Agency (MHRA), 2010 saw a total of 10,280 reports of adverse incidents, 13% more than 2009. In 177 of 279 cases where a fatality was reported, there was no established link with the device. Where there was a serious injury, no link with the device was identified in 1,359 of 2,022 cases. 730 manufacturer undertakings were made to improve designs, processes or quality systems.
The range of medical devices supervised by the MHRA is wide and includes assistive technologies, diagnostic devices, pacemakers as well as cardiovascular, imaging and orthopaedic devices. In the latter category, advice about metal-on-metal hip implants featured in 2010, and the MHRA works with the National Joint Registry and the British Orthopaedic Association to ensure a collaborative approach to monitoring devices.
The full report can be found here.
The range of medical devices supervised by the MHRA is wide and includes assistive technologies, diagnostic devices, pacemakers as well as cardiovascular, imaging and orthopaedic devices. In the latter category, advice about metal-on-metal hip implants featured in 2010, and the MHRA works with the National Joint Registry and the British Orthopaedic Association to ensure a collaborative approach to monitoring devices.
The full report can be found here.
