China encourages public reports of adverse outcomes from medical devices

BEIJING, Jan. 4 (Chinese media) -- The public and organizations

should take part in reporting adverse outcomes from medical devices, the State

Food and Drug Administration (SFDA) of China said in a new regulation.

The regulation, released on Wednesday, was developed

by the SFDA and Ministry of Health.

Adverse outcomes are those in which approved devices

function properly but lead to unexpected injuries or deaths.

People discovering events that have caused or might

cause injury can report to provincial medical device monitoring centers or local

drug administrations.

Manufacturers, distributors and users of medical

apparatus mustreport deaths within five weekdays and events that might cause

severe injuries or death within 15 weekdays.

China introduced a nationwide monitoring and

re-evaluation system for adverse outcomes from medical devices in 2004. As of

2006, 31 provinces, autonomous regions and municipalities had set up provincial

institutions to deal with reporting such events.

Based on reports, the SFDA revoked the registration

certificates for polyacrylamide hydrogel, ordered the recall of extra corporeal

circulation circuits and had dialysis powder re-registered.