我院近六年348例医疗器械不良事件报告分析  

Analysis of 348 Cases of Medical Device Adverse Event Reports During the Past Six Years in Our Hospital

作　　者：赵亚丽 殷志红[2] 刘小华[1] 韩凯 谭梦轩 ZHAO Yali;YIN Zhihong;LIU Xiaohua;HAN Kai;TAN Mengxuan(Department of Medical Equipment,The Fourth Hospital of Changsha,Changsha Hunan 410006,China;Department of Personnel,The Fourth Hospital of Changsha,Changsha Hunan 410006,China)

机构地区：[1]长沙市第四医院设备科,湖南长沙410006 [2]长沙市第四医院人事科,湖南长沙410006

出　　处：《中国医疗设备》2019年第9期132-135,共4页China Medical Devices

摘　　要：通过对本院近六年348例医疗器械不良事件报告数据进行汇总分析,指出目前我院在医疗器械不良事件报告及监测方面的发展现状,探讨我院医疗器械不良事件监测存在的问题,并总结规律提出合理的建议,以期为我院和相关机构在医疗器械不良事件监管体系构建,以及为医疗器械使用风险控制方面提供参考。Through the summary analyzing the reported data of 348 medical device adverse events of the hospital in the past six years,the present study pointed out the current development status of medical device adverse events report and monitoring and discussed the problems existed in the monitoring of medical device adverse events in our hospital.Then,the regular pattern and put forward some reasonable suggestions was summarized,so as to provide reference for the construction of the medical device adverse event supervision system and the risk control of medical device use in our hospital and related institutions.

关 键 词：医疗器械 不良事件 医疗器械分类 监管体系 

分 类 号：R197.39[医药卫生—卫生事业管理]