基于改良德尔菲的医疗器械不良事件报告质量评估体系研究探索  

Research on the Quality Evaluation System of Medical Device Adverse Event Report Based on Improved Delphi

作　　者：余超 徐玉茗 罗培 李穗 詹杨 周虎[2] YU Chao;XU Yu-ming;LUO Pei;LI Sui;ZHAN Yang;ZHOU Hu(Jiangxi Drug Adverse Reaction Monitoring Center,Jiangxi Nanchang 330006;The 98th Hospital of the Joint Logistics Support Force of the Chinese People’s Liberation Army,Jiangxi Nanchang 330001)

机构地区：[1]江西省药品不良反应监测中心,江西南昌330006 [2]中国人民解放军联勤保障部队第九O八医院,江西南昌330001

出　　处：《中国医疗器械信息》2021年第1期11-12,27,共3页China Medical Device Information

基　　金：江西省药品监督管理局科研项目(项目编号:2019JS21)。

摘　　要：如何加强医疗器械不良事件监测工作质量,巩固和完善医疗器械安全性监测综合评估体系,是当前备受关注的一项重要议题。研究旨在通过以文献分析为基础,探索基于改良德尔菲(Delphi)和概念操作化等方法探索医疗器械不良事件报告质量评估体系的构建,以加强医疗器械上市后风险管理。How to strengthen the quality of adverse event monitoring of medical devices,consolidate and improve the comprehensive evaluation system of safety monitoring of medical devices,is a general topic of concern.The purpose of this study is to explore the construction of the quality assessment system of adverse event reports of medical devices based on the literature analysis,the improved Delphi and concept operation,so as to strengthen the risk management of medical devices after marketing.

关 键 词：医疗器械不良事件监测 质量评估 德尔菲 

分 类 号：R197.39[医药卫生—卫生事业管理]