医疗器械不良事件监测与风险管理浅议

Medical Device Adverse Event Monitoring and Risk Management

目的:初步探讨医疗器械不良事件监测和风险管理的概念和方法。方法:介绍美国、欧盟和有关国际组织在该领域的有关进展,分析医疗器械上市后风险管理可采取的主要措施,并对我国在该领域的相关工作进行简要回顾和展望。结果与结论:我国在该领域的相关工作刚刚起步,尚缺乏系统化,法规和技术体系等亟待完善。

OBJECTIVE: To discuss the concepts and methods of medical device adverse event monitoring and risk man- agernent .METHODS:The regulations on the medical device vigilance in the US,EU and some international organizations were introduced, the rnain regulatory measurements of the risk management for the marketed medical devices were discussed, and some works compketed in the past and to be done in the next stage were outlined .RESULTS & CONCLUSION: The system of medical device vigilance in China is only beginning to formulate,there are a lot of work to be planned and accomplished.