广东省2007年可疑医疗器械不良事件报告分析与思考

Analysis of the Medical Device Adverse Events Reports in 2007 in Guangdong Province

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。方法采用描述性方法对2007年的报告表进行统计分析。结果广东省可疑医疗器械不良事件报告数量较低,主要来源于使用单位。宫内节育器、一次性使用输液器和羊肠线等医疗器械的不良事件发生较多。结论加强对医疗器械不良事件监测工作的宣传与培训,提高医疗器械不良事件报告表的数量和质量。

Objective By analyzing the Medical Device Administration Events（MDAE） reports of Guang- dong Province in 2007,to provide references for monitoring work. Methods Statistic analysis of data in 2007 by using narrative method.Results The number of MDAE reports is lower,mainly come from medical departments and most of the adverse events are about intrauterine device （IUD）, disposable infusion set and medical suture thread, Conclusion We should enhance the advocacy and training work of MDAE monitoring to improve the report＇s quantity and quality.