医疗设备全生命周期质量管理体系构建

The construction of quality management system for the whole life cycle of medical equipment

医疗设备质量管理对于确保医疗设备在临床诊治过程中正常运行、保证医疗质量和患者安全至关重要。医疗设备质量管理过程应涵盖医疗设备使用全生命周期中的各种要素,包括但不限于:(1)医疗设备安装和验收;(2)医疗设备标识和档案管理;(3)医疗设备操作培训、考核与授权;(4)医疗设备预防性维护;(5)医疗设备维修;(6)医疗设备相关检定和校准;(7)医疗设备相关不良事件上报与分析;(8)医疗设备报废。结合中国医学科学院北京协和医院实践和成效,探析医疗设备全生命周期管理优化路径,为医院提升医疗设备管理水平提供参考。

Quality management of medical equipment is essential for ensuring normal functioning of medical equipment during clinical diagnosis and treatment,and for guaranteeing medical service quality and protecting patient safety.The quality management process of medical equipment should involve various elements throughout the life cycle of the equipment,including but not limited to(1)installation and acceptance of medical equipment;(2)labeling and archives management of medical equipment;(3)training,assessment and authorization regarding medical equipment operations(4)preventive maintenance of medical equipment;(5)repair of medical equipment;(6)inspection and calibration of medical equipment;(7)reporting and analysis of adverse events related to medical equipment;and(8)scrapping of medical equipment.