安徽省2005年医疗器械不良事件报告分析

目的 结合安徽省医疗器械不良事件监测工作，为开展医疗器械不良事件监测提供技术参考。方法 利用国家药品不良反应监测中心数据库软件，对2005年全省39例医疗器械不良事件报告进行统计分析，对目前存在的问题和应对措施进行了初步探讨。结果 骨科植入物、宫内节育器等不良事件发生率较高。结论 应强化医疗器械不良事件报告制度，为保障公众用械安全服务。

Analysis of adverse events of medical devices reports in 2005 in Anhui province

Objective Based on adverse events monitoring situation of medical devices in Anhui province, to provide the technique supports to develop adverse events monitoring of medical treatment. Method Using database software from National ADR Monitoring Center, 39 reports received in Anhui province in 2005 were analyzed. The current problems and solutions were discussed. Result The incidence rate of adverse events associated with orthopedics transplants and temple to practice birth control the machine is higher than other medical devices. Conclusion The adverse event reporting system of medical devices should be strengthen to serve safety use of medical devices in Public.