基于轨迹交叉理论的有源医疗器械不良事件致因模型研究

The Study of Active Medical Device Adverse Events' Causation Model Based on Tracks Crossing Theory

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.