摘要
在医疗器械不良事件研究中,运用安全人机工程学的轨迹交叉理论,通过对40例上市后有源医疗器械伤害事件的案例研究,分析和归纳上市后有源医疗器械导致/可能导致伤害事件的发生原因,并依据直接原因,提出了伤害事件分型,从而建立了有源医疗器械不良事件致因模型,以期为上市后有源医疗器械的安全性评价提供基础理论支撑。
In research on medical device adverse events,tracks crossing theory can be applied to the cause and effect analysis on post-marketing active medical device accidents.Based on 40 post-marketing active medical device accidents,a medical device adverse events causation model is introduced.It provided the theoretical support for safety evaluation of post-marketing active medical devices.
出处
《中国药物警戒》
2011年第1期34-37,共4页
Chinese Journal of Pharmacovigilance
关键词
医疗器械不良事件
监测
伤害事件
致因模型
medical device adverse events
monitoring
accident
causation model
