医疗器械不良事件监测初探

Discussion on Medical Device Adverse Event Monitoring

通过剖析医疗器械不良事件的定义及产生的原因,探讨影响医疗器械不良事件报告的因素、医疗器械不良事件报告范围和原则,强调了开展医疗器械不良事件监测工作的重要性。

To analyze the definition and causes of medical devices adverse events（MDAE）, to discuss the factors,scope and principles of reporting MDAE. The importance of medical device adverse event monitoring is emphasized in this paper.