低值医用耗材全生命周期UDI管理探索与实践  

Exploration and Practice of UDI Management in the Whole Lifecycle of Low-Value Medical Consumables

作　　者：陈学斌[1] 奚圆[1] 陈帅 高敏[1] 张铁山[1] 高海鹏[1] 安峥[1] CHEN Xuebin;XI Yuan;CHEN Shuai;GAO Min;ZHANG Tieshan;GAO Haipeng;AN Zheng(Biomedical Engineering Department, China-Japan Friendship Hospital, Beijing 100029, China;Shandong Weigao Group Medical Polymer Co. , Ltd, Shandong Weihai 264200, China)

机构地区：[1]中日友好医院医工处,北京100029 [2]山东威高集团医用高分子制品股份有限公司,山东威海264200

出　　处：《中国医药导刊》2020年第6期427-432,共6页Chinese Journal of Medicinal Guide

摘　　要：医用耗材的医疗器械唯一标识(unique device identifier,UDI)管理是实现其精细化管理的基础,UDI标识的实施能够促进医用耗材的规范使用。目前,医用耗材的UDI管理主要集中在高值医用耗材领域,缺少成熟的低值医用耗材的UDI管理模式。本研究以一次性输液器为例,试点开展了基于UDI的低值医用耗材从生产、流通到临床应用的探索研究,通过对大、中、小包装的医用耗材UDI赋码与关联,实现不同载量、低值医用耗材“一物一码”的关联管理;通过生产企业与医疗机构信息系统的对接,实现数据的协同管理;通过UDI实现医用耗材动态数据的追踪,完成了低值医用耗材全生命周期数据的追溯,满足了国家药品监督管理局对医用耗材不良事件管控的要求,为精细化管理提供数据支持。The unique device identifier(UDI)management of medical consumables is the basis for the realization of fine management.The implementation of UDI can promote the standardized use of medical consumables.At present,the UDI management of medical consumables is mainly concentrated in the field of high-value medical consumables,and lack mature UDI management mode for low-value medical consumables.Taking disposable infusion set as the example,the project carried out a pilot study on data collaborative exploration of low-value medical consumables based on UDI from production to clinical application.Through the UDI coding and association of medical consumables in large,medium and small packages,code association management has been achieved in different loads and low-value medical consumables.Through the docking of the production enterprise and the medical institution information system,collaborative management of data has been achieved.Through UDI realized the tracking of dynamic data of medical consumables,completed the trace back of the full lifecycle data of low-value medical consumables,and met the requirements of NMPA for the management and control of adverse events of medical consumables,so as to provide data support for fine management.

关 键 词：低值医用耗材 医疗器械唯一标识 全生命周期管理 实践探索 

分 类 号：R197.39[医药卫生—卫生事业管理]