医疗器械不良事件报告覆盖范围窄，质量有待提高。
The scope that the reports covered is narrow and the quality needs to be raised.
开展医疗器械不良事件监测和报告工作是十分重要的。
It is important to carry out the work of monitoring and reporting the adverse events of medical instruments.
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。
OBJECTIVE: To discuss the concepts and methods of medical device adverse event monitoring and risk man-agernent .
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 is one of the most important methods to guarantee the safety of post-marketing products.
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。
Results The adverse medical device event monitoring work offered an early warning function on how to use medical device safely and effectively.
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。
Conclusion Strengthening the adverse medical device event monitoring work is a powerful instrument to insure public can use medical device safely.
目的结合安徽省医疗器械不良事件监测工作，为开展医疗器械不良事件监测提供技术参考。
Objective Based on adverse events monitoring situation of medical devices in Anhui province, to provide the technique supports to develop adverse events monitoring of medical treatment.
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。
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.
结果医疗器械安全质量通过医疗器械不良事件报告、医疗器械召回和医疗器械追踪得以实现。
Results Management of medical devices for safety and quality is to be achieved by means of reports of adverse events, recall and follow-up of medical devices.
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。
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.
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.
目的通过对广东省2007年接收的可疑医疗器械不良事件报告表进行统计分析，为进一步开展监测工作提供参考。
Objective By analyzing the Medical Device Administration Events (MDAE) reports of Guangdong Province in 2007, to provide references for monitoring work.
本文介绍了医疗器械不良事件产生的原因、监测的意义，并对我院在该领域开展的相关工作具体方法措施等进行了探讨。
This article explains the reasons that medical adverse events occurred and the meaning of monitoring, and explores the concrete measures of the related field in author's hospital.
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。
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.
本文就我国目前一次性无菌医疗器械的质量状况做出调查，分析目前发生一次性无菌医疗器械不良事件的主要原因，提出改进质量与管理意见。
In this dissertation, the major causes of the current occurrence of adverse events on SUD are analyzed on the basis of their quality condition researches.
本文就我国目前一次性无菌医疗器械的质量状况做出调查，分析目前发生一次性无菌医疗器械不良事件的主要原因，提出改进质量与管理意见。
In this dissertation, the major causes of the current occurrence of adverse events on SUD are analyzed on the basis of their quality condition researches.
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