Among the suspicious medical devices, the top ten passive medical devices include disposable infusion sets and disposable sterile syringes.
On May 27, the State Food and Drug Administration announced the 2015 National Medical Device Adverse Event Monitoring Report. According to the report, last year, the National Center for Adverse Drug Reaction Monitoring received a total of 321,000 copies of the Suspicious Medical Device Adverse Event Report Form, an increase of 21.1% over 2014.
According to the report, according to calculations, in 2015, China reported an average of 240 suspicious medical device adverse events per million people, an increase of 42 compared with 2014.
In addition, in all reported incident reports, there were 184 suspicious incidents of deaths caused by medical device adverse events, and 47,000 suspicious reports of serious injuries, the total number of which increased by 15.2% compared with 2014, accounting for the total number of reports. 14.7%.
Among the suspicious medical devices reported, the top ten passive medical devices include disposable infusion sets, disposable sterile syringes, intrauterine devices, vitreous thermometers, general sphygmomanometers, and catheters. The top ten suspected devices that enter the active medical device include monitors, infusion pumps and syringe pumps, electronic sphygmomanometers , hemodialysis machines, electrocardiographs, ventilators, and baby incubators.
The official website of the Food and Drug Administration shows that at present, the monitoring of medical device adverse events in China is based on the principle of “suspicious immediate reportâ€. In addition, the medical device adverse events are mainly caused by the design defects of the products, the inaccurate or insufficient instructions for the registered audit, that is, the quality of the products is qualified, and therefore should be related to medical device quality accidents, violations or human error. The medical accidents are separated.
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