医疗器械不良事件监测管理及案例分析  

Monitoring and Management of Adverse Events in Medical Devices and Case Analysis

作　　者：孙俊忠[1] SUN Jun-zhong(The Second Afliated Hospital of Anhui Medical University Anhui Hefei 230601)

机构地区：[1]安徽医科大学第二附属医院,安徽合肥230601

出　　处：《中国医疗器械信息》2018年第21期155-156,160,共3页China Medical Device Information

基　　金：国家卫健委能力建设和继续教育中心课题(项目名称:医院器械管理能力建设体系研究;项目编号:JJJX20180001(KT))

摘　　要：目的:确保医疗器械不良事件上报工作的及时性和有效性。方法:通过对选取的三个不良事件的案例分析及改进,结合实际情况对已有的医疗器械不良事件管理体系提出改进。结果:通过对选取的不良事件的分析改进,进一步完善了院内各项管理流程制度等。结论:医疗器械不良事件监测与管理工作需要落到实处并持续改进。Objective： Ensure the timeliness and efciency of medical device adverse event reporting. Method： Through analyzing of three adverse events selected,then based on the fact,making improvements on existing medical device adverse event management system. Conclusion： Through analyzing and improving of adverse events,making further more improvement on hospital management procedure and system. Result： Doing practical work and making continuous improvement on medical device adverse event monitoring and management.

关 键 词：医疗器械 不良事件 分析 改进 

分 类 号：R197.39[医药卫生—卫生事业管理]