骨科植入物不良事件发生原因分析及预防措施:1309例可疑医疗器械不良事件报告分析  

Causes assessment and precautions of 1309 case reports related to orthopedics implants

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

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 [4]北医三院,北京100191

出　　处：《现代仪器》2011年第3期36-38,35,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：目的归纳总结骨科植入物常见不良事件表现,分析发生的原因,并提出针对性的预防措施。方法对1309例骨科植入物可疑医疗器械不良事件进行统计分析,并结合国内外文献分析结果进行归纳总结。结果骨科植入物常见的不良事件包括表现为断裂、排异反应、伤口不愈合、松动、疼痛、弯曲变形等,这些事件的发生可能包括产品自身、操作者以及患者等方面的原因。结论骨科植入物可疑医疗器械不良事件表现种类较多,原因较为复杂,需要进一步加强骨科植入物的医疗器械不良事件监测工作。Objective To generalize and summarize the most common adverse event manifestations related to orthopedics implants, To provide some pertinent suggestions of precautions .Methods To generalize and summarize on the basis of statistics ＆ assessment to 1309 case reports related to orthopedics implants, together with the home and abroad literature review, Results The most common adverse event manifestations related to orthopedics implants include fracture, rejection reaction, wound fail to heal ,loosening, pain, distortion and so on. the possible causes are related to products themselves, operators and patients. Conclusion The adverse event manifestations related to orthopedics implants are multiple, the causes are not so easy to analyze, which need to further strengthen orthopedics implants adverse event monitoring.

关 键 词：骨科植入物 不良事件 分析 预防措施 

分 类 号：TH77[机械工程—仪器科学与技术]