3123例可疑医疗器械不良事件报告分析

目的了解医疗器械不良事件发生的特点及规律。方法对2007年湖南省3123例可疑医疗器械不良事件报告进行回顾性分析。结果医疗器械不良事件主要来源于医疗机构使用单位；涉及植入材料和人工器官、注射穿刺器械、医用缝合材料及粘合剂、医用高分子材料及制品、口腔科材料的不良事件居前5位；涉及患者男女比例为0．49：1；不良事件报告数量地区间有较大差异。结论应加强医疗器械不良事件监测的培训，提高监测质量，将医疗器械风险降至最低。

Analysis of 3 123 Reports on Suspected Medical Device Adverse Event

Objective To understand the characteristic of medical device adverse events （MDAE）. Methods 3 123 reports on suspected MDAE collected by Hunan Center for ADR Monitoring in 2007 have been analyzed retrospectively. Results Reprots mainly come from medical departments and other using units. The number of adverse events involved implant materials and artifical organs, injection and puncture devices, medical suture materials and adhesives, medical polymer materials, dental materials are top 5. The rate between men and women is 0.49 to 1. The report number in different regions are likely to be very different. Conclusion In order to provide effective information and reduce the risk of MDAE, we should strengthen the training of MDAE monitoring to improve the monitoring quality.