医疗机构医疗器械不良事件监管体系研究  

Research on the Supervision System of Medical Devices Adverse Event in Hospitals

作　　者：张丽[1] 

机构地区：[1]北京积水潭医院资产管理处,北京100035

出　　处：《中国医疗设备》2016年第4期177-179,共3页China Medical Devices

摘　　要：本文探讨了我国医疗器械不良事件监管工作存在的问题,并从医院的视角出发,提出我国医疗器械不良事件监管的对策建议。以医疗器械不良事件监管理论作为分析方法,结合目前医院医疗器械不良事件监管的实际情况,提出我国医疗器械不良事件监管工作的管理流程和管理体系。The paper discussed problems existing in the supervision system of medical devices adverse events in China. The paper proposed countermeasures and suggestions for the supervision of adverse events in the utilization of medical devices from the perspective of hospitals. By using the supervision theory for medical devices adverse events and combined with actual situation, the paper proposed the management flow path and management system.

关 键 词：医疗器械 不良事件监测 风险管理 质量控制 数字化医院 

分 类 号：R197[医药卫生—卫生事业管理]