应用生命链跟踪法监管医疗器械供应商的探索  

Study on the Life Chain Tracking Method for Supervision of Medical Device Suppliers

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8期85-86,171,共3页China Medical Devices

摘　　要：本文提出以生命链跟踪法来进行合格供应商监管的新模式,通过整合多个部门及工作人员的工作,对医疗器械的全生命周期进行监管,从而达到对合格供应商全程监管,保证医院使用医疗器材的安全性。The life chain tracking method was proposed in this paper as a new methodology for supervision of qualified medical device suppliers. Through collaboration of multiple departments in supervising the whole life cycle of medical devices, the whole-process supervision of qualified suppliers of relevant medical devices was accomplished, which guaranteed the security of medical devices utilization in hospitals.

关 键 词：医疗器械管理 生命链跟踪法 全程监管 供应商管理 资质审查 

分 类 号：R197.39[医药卫生—卫生事业管理]