江苏省医疗器械生产企业不良事件监测的问题及对策  

The Problems and Countermeasures of Adverse Event Monitoring in Medical Device Manufacturing Enterprises in Jiangsu Province

作　　者：王敏慧 马游 贾国舒 梁毅[1] Wang Minhui;Ma You;Jia Guoshu;Liang Yi(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing Jiangsu 211198,China;Department of Production Supervision of Medical Devices,Jiangsu Provincial Drug Administration,Nanjing Jiangsu 210008,China)

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198 [2]江苏省药品监督管理局医疗器械生产监管处,江苏南京210008

出　　处：《医疗装备》2024年第2期57-60,共4页Medical Equipment

摘　　要：医疗器械不良事件监测是实施上市后监管、确保公众用械安全的重要手段,是医疗器械安全监管的重要组成部分。2018年国家市场监督管理总局和国家卫生健康委员会发布了《医疗器械不良事件监测和再评价管理办法》,要求建立国家医疗器械不良事件监测信息系统,助推医疗器械不良事件监测工作的法制化、规范化、信息化建设发展。近年来,医疗器械生产企业和监管部门及机构积极响应法律法规有关要求,逐步重视并优化不良事件监测工作,着力控制医疗器械风险。该研究选取50家江苏省内医疗器械生产企业开展现场检查,并对这50家企业的不良事件报告进行收集分析,聚焦医疗器械不良事件监测存在的问题,据此提出相应的对策,以期保障公众用械安全。As an important means of implementing post market supervision and ensuring the safety of public use of medical devices,adverse event monitoring of medical devices is an important component of medical device safety supervision.In 2018,the State Administration for Market Regulation and the National Health Commission issued the"Management Measures for Monitoring and Re evaluation of Adverse Events in Medical Devices",which requires the establishment of a national medical device adverse event monitoring information system to promote the development of legal,standardized,and information-based construction of medical device adverse event monitoring work.In recent years,legal and regulatory requirements were actively responded to by medical device manufacturing enterprises,regulatory departments,and institutions,gradually emphasizing and optimizing adverse event monitoring work,and effectively controlling medical device risks.In this study,with selection of 50 medical device manufacturing enterprises in Jiangsu Province for on-site inspections,adverse event reports from these 50 enterprises were collected and analyzed.With the focus on the problems in monitoring adverse events of medical devices,corresponding countermeasures were proposed to ensure the safety of public use of medical devices.

关 键 词：医疗器械 生产企业 不良事件监测 江苏省 医疗器械监管 对策 

分 类 号：R197.31[医药卫生—卫生事业管理]