从1309例骨科植入物可疑不良事件分析谈医疗器械监测工作存在的问题  

Talk about the issues of adverse event monitoring from the assessment of 1309 case reports related to orthopedics implants

作　　者：张素敏[1,2] 徐婧[1] 杜晓曦[2] 张亮[1] 秦永清 王晓庆 

机构地区：[1]华中科技大学同济医学院,武汉430030 [2]国家食品药品监督管理局药品评价中心,北京100045 [3]中国医疗器械行业协会,北京100035

出　　处：《现代仪器》2011年第3期46-48,51,共4页Modern Instruments

基　　金：十一五"国家科技支撑计划"基层重点医疗器械装备标准配置与示范工程"项目子课题"医疗器械上市后安全性监测框架模式的构建及实例研究

摘　　要：目的分析医疗器械不良事件监测报告收集、分析评价及控制各环节可能存在的问题,并提出改进建议。方法在对1,309例骨科植入物可疑医疗器械不良事件进行统计分析的基础上,结合国内外文献研究结果进行归纳总结。结果我国医疗器械不良事件监测工作可能存在的问题包括报告率极低,生产企业积极性不高,分析评价水平需要进一步提升,控制措施需要更加及时和适宜等。结论需要进一步加强医疗器械我国的医疗器械不良事件监测工作。Objective To explore the possible issues in the process of case reports collectng, analyzing and actions taking, to provide some suggestions. Methods To generalize and summarize on the basis of Statistics ＆ assessment to 1309 case reports related to Orthopedies implants. togcthcr with the Home and abroad literature review. Resttlts The issues in the process of medical dcvicc adverse event monitoring include the much lower reporting rate, manufacturers reporting consciousness, the ability of assessment need to be improved, the actions takcn should be much more timely and appropriate. Conclusion Medical device adverse event monitoring need to be turther strengthen in our country.

关 键 词：骨科植入物 不良事件 分析 监督 问题 

分 类 号：TH77[机械工程—仪器科学与技术]