基于工业互联网的医用耗材UDI管理模式试点探索  

Pilot Exploration of UDI Management Mode of Medical Consumables Based on Industrial Internet

作　　者：安峥[1] 陈学斌[1] 高敏[1] 张铁山[1] 高海鹏[1] 奚圆[1] AN Zheng;CHEN Xuebin;GAO Min;ZHANG Tieshan;GAO Haipeng;XI Yuan(Biomedical Engineering Department, China-Japan Friendship Hospital, Beijing 100029,China)

机构地区：[1]中日友好医院医工处,北京100029

出　　处：《中国医药导刊》2020年第5期344-350,共7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)管理是实现其临床精细化管理的基础。目前不同医疗机构医用耗材的精细化管理模式不同,如医疗机构内部自建码赋码的管理模式、有国家药品监督管理局目前试点的UDI管理,但都存在追溯数据少和“数据孤岛”的问题。本研究基于医院的探索实践,介绍一种基于工业互联网的医用耗材UDI信息化管理平台,该管理平台通过综合管理模式和点对点模式分别实现对高值医用耗材和低值医用耗材的UDI数据管理,真正实现了医用耗材全生命周期生产、流通、临床应用、国家监管环节静态数据和动态数据的追溯管理。The unique device identifier(UDI)management of medical consumables is the basis for the realization of fine clinical management.At present,there are different fine management modes of medical consumables in different medical institutions,including the self-built code assignment management mode in medical institutions and the UDI management currently piloted by National Medical Produts Administration(NPMA).But there are problems such as little traceability data and"data silos".Based on exploration and practice of the hospital,this study introduces a UDI management platform for medical consumables based on industrial internet.The medical consumables management platform is implemented in UDI data management of high-value medical consumables and low-value medical consumables respectively through integrated management mode and point-to-point mode.It really realized the traceability management of static data and dynamic data throughout the life cycle production,distribution,clinical application,and national supervision of medical consumables.

关 键 词：医用耗材 医疗器械唯一标识 工业互联网 管理模式 试点探索 

分 类 号：R197.39[医药卫生—卫生事业管理]