16706例可疑医疗器械不良事件报告分析

Statistic Analysis of 16706 Medical Device Administration Events Reports

目的:分析总结江苏省2012年度可疑医疗器械不良事件(Medical Device Administration E v e n t s,M D A E)发生情况及其特点,为进一步合理监测评价及临床合理使用提供参考。方法:采用回顾性分析的方法,对江苏省药品不良反应监测中心数据库中2012年度MDAE报告16706例,进行统计分析。结果:江苏省MDAE报告数量较多,但报告质量有待提高。植入材料和人工器官引起的不良事件所占比例较高。结论:加强对MADE风险的认识,建立健全医疗器械不良事件监测网络及报告制度,保障公众用械安全。

Objective：To analyze and summarize the characteristics of the Medical Device Administration Events reports in 2012 in Jiangsu Province to provide references for rational and safe medication in clinical practice. Methods：With retrospective analysis, analyze 16706 MDAE reports in Jiangsu province in 2012. Results：The number of MDAE reports is upper, but the scope that the reports covered needs to be raised. Most of the adverse events are about implant materials and artiifcial organs. Conclusion：To strengthen the understanding of MADE risk, monitoring should be strengthened to ensure safety use of medical devices in public.