湖南省2006年可疑医疗器械不良事件报告分析

Statistic analysis of adverse events of medical device reports in 2006 in Hunan province

目的通过对湖南省2006年全省医疗器械不良事件报告的基本情况进行统计分析,为开展医疗器械不良事件监测工作提供技术支持。方法采用描述性方法,使用Excel表格和Foxpro软件对2006年收集到的1330份报告进行统计分析,对存在的问题和应对措施进行了初步的探讨。结果湖南省医疗器械不良事件报告主要来源于医疗机构及其他使用单位,宫内节育器、骨科植入材料和医用缝合线等不良事件发生率较高。结论应加强医疗器械不良事件监测工作的培训,提升报表质量,使之成为公众用械安全的有效信息。

Objective Provide the technique supports for MD AES monitoring by analyzing the Hunan provincial basic situation. Method Add up and analyze 1330 reports in 2006 by using excel tablet foxpro and narrative methods, and discuss initinlly the problems and solutions, Result Reprots mainly come from medical departments and other using units, and the AEs accurances ofintra-uterine devices, Orthopaedic Implants and medical suture thread is high. Conclusion We should enhance the training work of AEs monitoring to improve the report quality in order to provide effective information for MD safe use.