UK MHRA Review of Medical Device Incidents Report Published

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published its annual report entitled Report on Devices Adverse Incidents, 2010. The document details 10,280 adverse incident reports in 2010. This was an increase of 13 % over the 2009 total. MHRA states;

“Despite the overall upward trend in reporting, we remain concerned at the level of reporting from health and social care staff. The previously reported downward trend may have levelled off, but the number of reports received still remains below the peak reached ten years ago.”

A most striking feature of the document is the contrast between the number of reports coming from the NHS compared with those coming from manufacturers. In the past ten years NHS reports have steadily declined from a peak in 2002 of over 5000 to current level of just over 3000. During the same period reports from manufacturers have increased from 1500 to just under 5000. This is no doubt due to an increased awareness of vigilance reporting requirements in industry. This is a view shared by MHRA which states;”The upward trend in reporting by medical device manufacturers has continued, with almost 1,000 more reports received in 2010. This can be attributed both to our ongoing, pro-active contact with manufacturers and to the continuing increase in the range and volume of medical devices available and in use.”

The full report can be found The full report can be found here.

Source: MHRA