医疗器械严重伤害事件分析评价方法的探讨

摘要

医疗器械严重伤害事件是发现医疗器械风险信号的重要来源,也是做好医疗器械不良事件监测工作的重要内容.本文结合工作实践,对医疗器械严重伤害事件的分析评价方法进行了研究和探讨,提出了医疗器械严重伤害事件分析评价的工作程序.%Serious medical device adverse events are not only the important source to ifnd the risk signals of medical devices, but also serve as the important part of medical device adverse event monitoring. In combination with practical work, this paper studied and discussed the analysis and evaluation method of serious medical device adverse events, and proposed corresponding work process.