医疗设备全生命周期质量与安全管理探讨  

Discussion on quality and safety management of medical equipment life cycle

作　　者：彭任君 吴响军 刘林[2] 蔡东江[1] 肖统生[1] 廖华明[1] PENG Ren-jun;WU Xiang-jun;LIU Lin;CAI Dong-jiang;XIAO Tong-sheng;LIAO Hua-ming(Department of Medical Engineering;Department of Information,Huizhou First People＇s Hospital,Huizhou 516003,Guangdong,China)

机构地区：[1]惠州市第一人民医院医学工程部,广东惠州516003 [2]惠州市第一人民医院信息部,广东惠州516003

出　　处：《生物医学工程与临床》2018年第4期463-468,共6页Biomedical Engineering and Clinical Medicine

基　　金：惠州市科技专项(2017Y048)

摘　　要：医疗设备是医疗、科研、教学、临床学科工作最基本要素,质量与安全管理目的是保证在用医疗设备符合行业技术标准,处于安全、准确和有效的工作状态,满足临床正常诊疗需求。医疗设备质量与安全管理贯穿整个设备的采购引进、安装验收、培训考核、维护保养和维修、应急管理、计量管理、效益分析、临床使用安全和风险控制、档案管理、报废处置等全生命周期全过程。笔者探讨医疗设备全生命周期质量与安全管理相关控制措施,以提升设备管理水平。Medical equipment is the most basic element in medical, scientific research, teaching, and clinical disciplines. The aim of quality and safety management is to ensure that being used medical equipment meets the technical standards of the industry and is in safe, accurate and effective working state and meet the clinical requirement of normal diagnosis and treatment. Medical equipment quality and safety management is expressed throughout the life cycle in purchase introduction,installation acceptance, training assessment, maintenance and repair, emergency management, measurement management,benefit analysis, clinical use safety and risk control, file management and disposal. The aim of this review is to discuss the medical equipment life cycle quality and safety management related control measures for improving the equipment management level.

关 键 词：医疗设备 全生命周期 质量 安全 管理 

分 类 号：R319[医药卫生—基础医学]