Medical adverse event is one of injuries caused not by diseases but by diagnosis and treatment process.
医疗不良事件是指因诊疗活动而非疾病本身造成的损害。
OBJECTIVE: To discuss the concepts and methods of medical device adverse event monitoring and risk man-agernent .
目的：初步探讨医疗器械不良事件监测和风险管理的概念和方法。
Aim By analyzing adverse medical device event reports received in Anhui province, to promote instructional function of adverse medical device event monitoring to ensure safe use of medicine in public.
目的通过对收集到的医疗器械不良事件信息的汇总分析，发挥医疗器械不良事件监测工作的指导作用，以保障公众用械安全。
Results The adverse medical device event monitoring work offered an early warning function on how to use medical device safely and effectively.
结果医疗器械不良事件监测工作为安全有效使用医疗器械起到了预警作用。
The investigation and calculation method on the use of embeded medical device in medical institution in the area shows the actual status of the monitoring work on the adverse event of medical device.
通过对辖区内医疗机构使用植入医疗器械情况的调研统计，了解目前医疗器械不良事件监测工作的现状。
Conclusion Strengthening the adverse medical device event monitoring work is a powerful instrument to insure public can use medical device safely.
结论加强医疗器械不良事件监测工作是确保安全使用医疗器械的有力手段。
Focusing on the phenomena that the reported adverse event of medical device is quite low, we use the method to analyze the cause on the base of actual monitoring management.
针对辖区内医疗器械不良事件报告率低的现象，结合现行的监测管理模式，查找并分析原因。
Medical device adverse event monitoring is one of the most important methods to guarantee the safety of post-marketing products.
医疗器械不良事件监测是确保上市医疗器械安全有效的重要手段之一。
Medical device adverse event monitoring system in Canada were reviewed in this article, aim to provide some reference to China's system construction.
本文综述了加拿大医疗器械不良事件监测系统，旨在为我国医疗器械不良事件监测和再评价体系的建设提供参考。
Medical device adverse event monitoring system in Canada were reviewed in this article, aim to provide some reference to China's system construction.
本文综述了加拿大医疗器械不良事件监测系统，旨在为我国医疗器械不良事件监测和再评价体系的建设提供参考。
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