医疗器械唯一标识(UDI)国内外发展动态及在医疗机构管理中的应用  

The development trend of UDI of medical device and its application in management of medical institutions

作　　者：鄂恒 刘禹[1] 李丹[1] 沈岚[1] E Heng;LIU Yu;LI Dan(Department of Medical Equipment,Renmin Hospital of Wuhan University,Wuhan 430060,China)

机构地区：[1]武汉大学人民医院医疗设备处,湖北武汉430060

出　　处：《中国医学装备》2020年第4期187-190,共4页China Medical Equipment

摘　　要：医疗器械唯一标识(UDI)是实现医疗器械产品统一、规范和科学管理的基础,是解决医疗器械全球监管问题的国际语言、通用语言和专业语言。国际医疗器械监管机构论坛、美国、欧盟和日本等国家或组织都积极开展UDI相关研究工作,甚至将其纳入法规进行管理。在回顾UDI国外发展历程基础上总结国内UDI相关法规要求,并结合医疗机构管理工作实际需求,预测UDI未来在医疗机构管理中的应用前景,为其在医疗机构管理中的实践提供参考与建议,促进完善医疗器械质量安全监管体系。The Unique Device Identification(UDI) is the basis of the management with unification, standardization and science for medical device products, and it is an international language, a general language and a professional language for solving the global supervision problems of medical devices. At present, international medical device regulators forum(IMDRF), the United States, the European Union, Japan and other countries or organizations are actively carrying out UDI-related research work, and even incorporated it into regulations for management. On the basis of reviewing the development history of UDI abroad, this paper summarizes the requirements of domestically relevant law and regulation, and combines the actual needs of management work of medical institution to predict the application prospects of UDI in the management of medical institution in future so as to provide reference and suggestions for UDI in the management of medical institutes, and to promote the improvement of the quality and safety supervision system of medical devices.

关 键 词：医疗器械 唯一标识 医疗机构 信息化管理 

分 类 号：R197.39[医药卫生—卫生事业管理]