China Medical News

On April 3rd, China Food and Drug Administration (CFDA) released the Annual Report of 2012 Medical Device Adverse Events for the public, and according to this report, China's National Center for Adverse Drug Reaction (ADR) Monitoring has received more than 180,000 suspicious medical devices adverse event reports in the year 2012.

The top five most reported non-active medical devices were; disposable infusion devices, intrauterine devices, disposable sterile syringes, contact lens and indwelling needles; and these accounted for 38.62% of all reported adverse events.

When reviewing the reports based on where the reports came from, 71.24% were submitted by the healthcare facilities that were using the devices, 21.58% from distributors, 2.49% from manufacturers, and 4.69% from other institutions and individuals.

In terms of where the adverse event happened, 69.26% was in the hospital, 16.17% was at homes, and the rest were others, such as research centers.

In terms of who was operating the device when the adverse event occurred, 72.11% were by medical professionals, 2.34% by non-medical professionals and 12.2% were by patients, and the rest is unknown.

Among the adverse events, 12.95% resulted in serious injury and 0.06% leading to death.
(Source: CFDA news)