三级综合医院医学装备质量与安全管理指标探讨  

Study on Indicators for Quality and Security Administration of Medical Devices in Grade III General Hospitals

作　　者：郑理华[1] 何兴华[1] 陈宇珂[1] 丁效军[1] 

机构地区：[1]广州军区广州总医院医学工程科,广东广州510010

出　　处：《中国医疗设备》2013年第8期89-90,131,共3页China Medical Devices

摘　　要：按照三级综合医院医学装备管理要求,提出质量与安全管理6项指标:大型医疗设备配置许可证以及操作人员上岗证;医学装备管理信息档案完备性及设备标识唯一性;列入国家强检目录的医疗器械定期进行计量检测及计量检定证书有效性;用于急救、生命支持系统的医学装备完好率;医用耗材和试剂的管理指标;医疗器械不良事件监测指标。为顺利通过等级医院评审提供参考。Six quality and security administration indicators were raised in this paper in accordance with requirements of medical devices management in Grade III general hospitals, which made a distinct definition of corresponding requirements and was of great reference value in classification of hospitals in China. These indicators involved the permissions for large medical devices and the licenses for their operators; completeness of the medical devices history record and unique identification for every device; regular calibration and inspection of medical devices listed in the national catalog of mandatory inspection and the certificates of calibrations and inspections; the work condition of the first-aid and life supporting medical devices; management indicators of medical consumables and reagents; indicators for adverse event reports of medical devices.

关 键 词：医学装备 质量管理 安全管理 条形码 计量检测 

分 类 号：R197.39[医药卫生—卫生事业管理]