324例可疑医疗器械不良事件报告分析  

Analysis of 324 doubted reports on adverse medical device event

作　　者：张京航[1] 张黎明[1] 梁伟[1] 

机构地区：[1]北京市药品不良反应监测中心,北京100024

出　　处：《中国药物警戒》2006年第3期138-140,144,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的对324例可疑医疗器械不良事件报告进行分析,评价报告可利用性,探索安全使用医疗器械监测手段及医疗器械不良事件监测模式。方法采用描述性分析的方法进行分析。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提供了有意义的启示,医疗器械不良事件监测模式初步形成。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。Objective we analyzed 324 reports on adverse event that doubted to be aroused by medical device to evaluate the usability of those reports,explore the method to monitoring security in the course of using medical device and the pattern to monitoring adverse event aroused by medical device.Method Use descriptive analysis methods to analyze those data.Result The adverse medical device event monitoring work offered a meaningful apocalypse on how to use medical device safely and effectively.The pattern of the adverse medical device event monitoring work has formed initially.Conclusion Strengthening the adverse medical device event monitoring work is a powefftrl instrument to insure public can use medical device safely.

关 键 词：医疗器械 不良事件监测 报告可利用性 监测模式 

分 类 号：R197.39[医药卫生—卫生事业管理] R95[医药卫生—公共卫生与预防医学]