关键词: 医疗器械不良事件, 监测, 医疗器械安全性, 生产企业

Abstract: Objective To conduct investigation on how the second-and-third-class medical device manufacturers in Guangdong Province monitor adverse events and what problems exist in their work. Methods To collect information on how the second-and-third-class medical device manufacturers in Guangdong Province monitor adverse events, enter the information into EpiData 3.02 software and conduct statistical analysis in Excel software. Results The investigation reveals that 59.1% of enterprises have full-time professional personnel to monitor adverse events. However, personnel are generally not sufficiently well-educated and lacking in work experience. 75.7% of enterprises have set up the working group, which consists of business executives and personnel from quality control department, administrative department and production department, to monitor adverse events. However, training on monitoring adverse events is not sufficient in these enterprises. Safety information on products is mainly collected through products tracking(91.9%) and consumer complaints(66.8%). Insufficient knowledge on adverse events(83.2%) is the major factor that hinders the monitoring work. Conclusion Problems such as insufficient knowledge, inadequate monitoring system and low-quality monitoring in adverse events monitoring exist in the second-and-third-class medical device manufacturers. Training and supervision should be strengthened to tackle these problems.

Key words: medical device adverse event, adverse event monitoring, medical device safety, manufacturer