在用医疗器械风险管理制度初探和思考  

Analysis of the Current Situation and Countermeasures of Risk Management of Medical Devices in Use

作　　者：吴文宇 肖霄 魏芬芳 WU Wen-yu;XIAO Xiao;WEI Fen-fang(Shenzhen Institute of Pharmacovigilance and Risk Management,Guangdong Shenzhen 518024)

机构地区：[1]深圳市药物警戒和风险管理研究院,广东深圳518024

出　　处：《中国医疗器械信息》2023年第19期1-3,15,共4页China Medical Device Information

基　　金：国家药品监督管理局药品评价中心2021年委托项目(项目名称:在用医疗设备的安全风险管理模式研究);广东省药品监督管理局2021年科技创新项目(项目编号:No.2021ZDB01)。

摘　　要：目的:初步了解国内外有关在用医疗器械的制度标准和实施情况,发现国内该领域制度存在的问题并提出合理建议。方法:采用文献研究、比较研究等理论研究方法,检索国内外有关在用医疗器械的法律法规、操作标准、文献资料等,分析该领域的起源、现状及存在的问题等。结果:美欧等发达国家和地区该领域发展较早,制度和机构建设比较完善,监管职责相对清楚。我国该领域起步相对较晚,制度标准建设尚在起步阶段,尚存在法规落实不到位,多头监管,医护风险管理意识不强,在用器械风险管理计划不完善等问题。结论:应加强统一协调领导,加强监管执行力度,制定操作指南,制定风险管理计划,加强宣贯等。Objective:Learned the system standards and implementation of medical devices in use at home and abroad,found problems in domestic in this field and offered reasonable suggestions.Methods:Domestic and foreign laws and regulations,operating standards,literature,etc.on medical devices in use were retrieved,and to analyze the origin,current situation,and existing problems.Results:This field developed earlier in developed countries and regions such as the United States and Europe,with relatively complete systems and institutions,and relatively clear regulatory responsibilities.China started relatively late,the construction of institutional standards is still in its infancy,and there are problems such as inadequate implementation of laws and regulations,multiple supervision,weak awareness of medical and nursing risk management,and imperfect risk management plans for in-use devices.Conclusion:To strengthen unified coordination and leadership,strengthen supervision and implementation,formulate operational guidelines,formulate risk management plans,and strengthen publicity and implementation.

关 键 词：医疗设备 风险管理 医院 上市后 

分 类 号：R194[医药卫生—卫生事业管理]