1028例医疗器械不良事件报告的回顾性分析

A Retrospective Analysis of 1028 Adverse Events of Medical Device Reports

目的对1 028例医疗器械不良事件发生的特点及规律进行统计分析,为医疗器械不良事件监测工作提供建议。方法采用回顾性分析方法,对贵阳市2012年收集的1 028例医疗器械不良事件报告进行综合分析。结果宫内节育器引起的严重不良事件所占比例较高。基层用户上报意识有待提高。医疗器械不良事件报告质量有待提高。结论加强宫内节育器的监测。从开展有针对性的宣传培训、建立健全医疗器械不良事件监测网络两方面提高不良事件监测工作水平。

Objective To provide suggestion for MDAEs monitoring with analyzing the features of the 1 028 reports of MDAEs. Methods With retrospective case study, this paper analyzed 1 028 MDAE reports in Guiyang during 2012. Results The intrauterine device （IUD） caused the higher proportion of adverse events with serious degree. Monitoring consciousness of grassroots users needs to be improved. The quality of the reports should be enhanced. Conclusions More attention should be paid to monitoring on IUD. The level of MDAEs monitoring should be improved through carrying out targeted training and publicity, establishing and improving MDAEs monitoring network,