浅谈医院医疗器械不良事件的三级制安全管理  

Discussion on the 3-level Security Management of Medical Device Adverse Events in the Hospital

作　　者：蔡梅华[1,2] 

机构地区：[1]上海市儿童医院 [2]上海交通大学附属儿童医院设备科,上海200040

出　　处：《中国医疗设备》2013年第10期91-93,共3页China Medical Devices

摘　　要：该文从医疗器械不良事件的定义及对其管理的要求出发,分析医院医疗器械不良事件管理的现状和不足,提出医院三级制安全管理模式,即院级管理的委员会制度、部门级管理的常设机构、临床级管理的监测员上报制度,以期更好地进行院内医疗器械不良事件的安全监测,避免不良事件的发生。This paper made analysis of the status quo and deficiencies of MDEA （Medical Device Adverse Events） in the hospital based on the definition of MDEA and corresponding management requirements. Then, the 3-level security management mode was put forward so as to realize the security monitoring of MDEA in the hospital and avoid occurrence of the adverse events, which included the committee system as the hospital-level management, the standing organization as the department-level management and the monitors reporting system as clinic-level management.

关 键 词：医疗器械不良事件 安全管理 不良事件监测 医疗器械管理 

分 类 号：F203[经济管理—国民经济] R197.39[医药卫生—卫生事业管理]