医院在用医疗器械风险管理要点  

The Key Points for Risk Management of Medical Devices in Use in Hospitals

作　　者：吴文宇 肖霄 魏芬芳 Wu Wenyu;Xiao Xiao;Wei Fenfang(Shenzhen Institute of Pharmacovigilance and Risk Management,Shenzhen Guangdong 518000,China)

机构地区：[1]深圳市药物警戒和风险管理研究院,广东深圳518000

出　　处：《医疗装备》2023年第22期29-33,共5页Medical Equipment

基　　金：国家药品监督管理局药品评价中心2021年委托项目(《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(2021ZDB01)。

摘　　要：在用医疗器械风险管理是预防和控制医疗器械使用风险的重要手段,也是提高医疗安全的关键所在。该研究介绍了在用医疗器械风险管理的相关概念、具体内容(包括风险分析、风险评估和风险控制)、管理方法及管理措施,以及信息技术在其中的应用情况;结合实际工作经验和相关文献总结了目前我国医院在用医疗器械风险管理存在的问题,并提出可通过健全机制、培养人才、加强日常使用管理、制定风险管理计划和构建信息化管理系统等措施完善医院在用医疗器械风险管理机制,保障临床使用安全。Risk management of medical devices in use was an important means of preventing and controlling the risks of medical device use.The study introduced the relevant concepts,specific content(included risk analysis,risk assessment,and risk control),management methods and measures,as well as the application of information technology in risk management of medical devices in use.Based on practical work experience and relevant literature,this paper summarized the problems in risk management of medical devices in use in hospitals in China,and proposed measures such as improving mechanisms,cultivating talents,strengthening daily use management,developing risk management plans,and constructing information management systems to improve the risk management mechanism of medical devices in use in hospitals and ensure the safety of clinical use.

关 键 词：医疗器械 风险管理 模式 

分 类 号：R197.39[医药卫生—卫生事业管理]