1090例医疗器械不良事件报告的回顾性分析

Retrospective Analysis of 1090 Medical Device Adverse Event Reports

采用回顾性分析方法,对1090例可疑医疗器械不良事件报告进行统计,通过对报告来源、患者信息、医疗器械信息、不良事件情况等重点项目的分析,得到沈阳市医疗器械不良事件发生的特点、规律,总结监测工作开展的现状,提出监测工作中存在的问题并分析原因,为监测工作的进一步开展提供依据。

The retrospective analysis method was used to count 1090 suspicious medical device adverse event reports.Through analysis of key items such as report sources,patient information,medical device information,and adverse event conditions,we obtained the medical device adverse events in Shenyang.Features,regularities,summarize the status quo of the monitoring work,put forward the problems existing in the monitoring work and analyze the reasons,and provide a basis for the further development of the monitoring work.