摘要
为了提高我院医疗器械不良事件监测管理水平,分析总结了我院近5年的医疗器械不良事件监测管理工作。2012年到2015年共计上报可疑医疗器械不良事件34件,2016年共计上报56件,2017年上半年共计上报42件。分析在医疗器械不良事件监管工作中存在的不足,探讨改进提高的方法,为其他医院开展医疗器械不良事件监管工作提供参考。
In order to improve the monitoring and management level of medical device adverse events in our hospital, the monitoring and management of medical device adverse events in our hospital in the last 5 years were analyzed and summarized. From 2012 to 2015, a total of 34 suspected medical device adverse events were reported, 56 cases were reported in 2016 and 42 cases were reported in the frst half of 2017. The defciencies of the medical devices adverse event monitoring and management were analyzed, meanwhile, the room for improvement was discussed, which might be useful for the other hospitals’ medical devices adverse event monitoring and management.
作者
张洋
戴建荣
王得水
ZHANG Yang;DAI Jianrong;WANG Deshui(Department of Equipment,National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciencesand Peking Union Medical College,Beijing 100021,China)
出处
《中国医疗设备》
2018年第8期160-162,166,共4页
China Medical Devices
关键词
医疗器械
医疗器械不良事件
不良事件监测管理
监测体系
medical device
medical devices adverse event
adverse event monitoring and management
monitoring system
