| 基于伤害流行病学模型的医疗器械不良事件分类研究 |
| |
| 引用本文： | 文强,唐晓红,刘晓岚,朱舒兵,熊学财.基于伤害流行病学模型的医疗器械不良事件分类研究[J].中国药物警戒,2011,8(11):658-661. |
| |
| 作者姓名： | 文强 唐晓红 刘晓岚 朱舒兵 熊学财 |
| |
| 作者单位： | 重庆市药品不良反应监测中心,重庆,400014 |
| |
| 基金项目： | 重庆市科委软科学项目(CSTC,2010CE0186) |
| |
| 摘 要： | 当前医疗器械不良事件监测已成为上市后医疗器械风险管理的重要研究方向.本文基于伤害流行病学模型,重点研究了与医疗器械不良事件发生机制相关的四类因素及其相互的关系,从而提出了医疗器械不良事件分类类型.
|
| 关 键 词： | 医疗器械 不良事件 伤害 流行病学 风险管理 分类 |
The Study on Classification of Medical Device Adverse Events Based on Epidemiological Model of Injure |
| |
| WEN Qiang,TANG Xiao-hong,LIU Xiao-lan,ZHU Shu-bing,XIONG Xue-cai.The Study on Classification of Medical Device Adverse Events Based on Epidemiological Model of Injure[J].Chinese JOurnal of Pharmacovigilance,2011,8(11):658-661. |
| |
| Authors: | WEN Qiang TANG Xiao-hong LIU Xiao-lan ZHU Shu-bing XIONG Xue-cai |
| |
| Institution: | WEN Qiang TANG Xiao-hong LIU Xiao-lan ZHU Shu-bing XIONG Xue-cai(Center for ADR Monitoring of Chongqing,Chongqing 400014,China) |
| |
| Abstract: | Nowadays,medical device adverse events(MDAE) monitoring has become the more important research direction of the post-marketing medical device risk management.The study,based on the epidemiological model of injure,analysed 4 sorts of the mechanism-related factors of MDAE and then raised the viewpoint on the classification of MDAE. |
| |
| Keywords: | medical device adverse events injure epidemiology risk management classification |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
|
