基于真实世界数据的输液泵临床使用不良事件风险分析  

Risk analysis of adverse events in clinical use of infusion pumps based on real-world data

作　　者：江明尹 王道雄[1] 韩宝江 李强[1] 胡亚冰 谷亚芬 刘敦辉 孙冬杰[1] JIANG Ming-yin;WANG Dao-xiong;HAN Bao-jiang;LI Qiang;HU Ya-bing;GU Ya-fen;LIU Dun-hui;SUN Dong-jie(Department of Medical Equipment,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China)

机构地区：[1]华中科技大学同济医学院附属同济医院器材科,武汉430030

出　　处：《医疗卫生装备》2022年第10期67-71,87,共6页Chinese Medical Equipment Journal

基　　金：湖北省卫生健康科研基金资助项目(WJ2021M 134)。

摘　　要：以美国食品药品监督管理局(Food and Drug Administration,FDA)制造商和用户器械使用体验(Manufacturer and User Facility Device Experience,MAUDE)数据库中上报的输液泵不良事件为数据来源,分析了不良事件的表现形式、形成原因、引发后果及风险程度,从不良事件形成原因出发对输液泵临床使用人员、医疗机构设备管理者及设备生产厂商提出了相关建议,可为输液泵临床安全使用提供参考。The adverse events of infusion pumps reported in the Manufacturer and User Facility Device Experience(MAUDE)database of the U.S.Food and Drug Administration(FDA)were used as the data source to analyze the manifestations,causes,consequences and risks of adverse events.Some suggestions were put forward based on the causes of adverse events to infusion pump users,medical institution equipment managers and equipment manufacturers,and references were provided for ensuring infusion pumps'safety in clinical use.

关 键 词：输液泵 不良事件 真实世界数据 风险分析 医疗设备使用 

分 类 号：R318.6[医药卫生—生物医学工程] TH777[医药卫生—基础医学]