深圳推广实施UDI促"三医联动"新发展的实践思考

Practice and Thinking of UDI Promoting the New Development of"Joint Reformation for Public Health Services,Medical Insurance,and Medical Production-Circulation"

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中文摘要：自2019年以来,医疗器械唯一标识(UDI)推广应用工作正在全国范围内分阶段、分步骤实施.深圳市先行先试,严格按照国家和省市相关政策要求落实相关工作,在UDI政策、标准、技术和应用等多个层面进行了探索,以标准先行、行业宣贯、企业培训、平台应用全方位建设医疗器械追溯体系,UDI的推广实施已取得实质性成效.深圳市形成"一个平台支撑,两个端口发力,三个部门联动,四个标准指引"的工作模式,搭建全省首个UDI追溯平台并于2021年10月14日正式上线启用,以UDI编码为关键信息,采集医疗器械的生产、流通和临床使用信息,为落地实施UDI工作提供技术支撑、精准监管和智慧监管.该平台现已通过数据接口等方式采集了来自深圳400余家制造商的8万多种产品(UDI-DIs),深圳30余家甲级三级医院的100余万条临床患者使用信息.目前,深圳市正以UDI追溯平台作为推动UDI实施工作的实际"抓手",有序扩大UDI实施企业范围,增加医疗机构试点,丰富数据对接方式.本研究总结了深圳市UDI推广实施过程中遇到的挑战以及应对策略和方法,梳理了深圳市推广UDI实施的成效做法,旨在以推广UDI工作为契机,形成推动"三医联动"应用示范效应和可复制的经验总结,为全面实现深圳市医疗器械全生命周期精准追溯和深圳市医疗器械产业高质量发展贡献力量.

外文摘要：The promotion and application of unique device identifier(UDI)is being carried out in stages and steps throughout the nation since 2019.Shenzhen has strictly implemented relevant work in accordance with national and provincial/municipal policies,and carried on the fruitful exploration in UDI policy,standard,technology and application.It has built a medical device traceability system through comprehensive efforts in standard-setting,industry promotion,enterprise training,and platform application.The promotion and implementation of UDI has achieved substantial results.It has established a model of"one platform as the foundation,two areas to make efforts,three-department collaboration and four-standard guarantee".On 14th October 2021,the Shenzhen UDI tracing platform was officially launched which was built for technical support to implement UDI work.The platform collects the information of production,cir-culation and clinical use of medical devices and uses UDI as the main key.Currently,the platform has collected information of over 80 000 products(UDI-DIs)from more than 400 manufacturers in Shenzhen,more than 1 000 000 pieces of clinical use information from 30 top Shenzhen grade A tertiary hospitals.The tracing platform for UDI in Shenzhen has been built into an actual means to promote UDI work.Currently,the implementation scope of UDI is being expanded in an orderly manner,medical institutions are being added to pilot projects,and data docking methods are being enriched.This study summarizes the challenges encountered in the implementation of UDI and the strategies and methods for addressing them,reviews the achievements of UDI promotion in Shenzhen,and aims to take advantage of the promotion of UDI work as an opportunity to form a replicable experience summary for promoting the application of the"Joint Refor-mation for Public Health Services,Medical Insurance,and Medical Production-Circulation"and creating a demonstration effect,in order to contribute to the realization of precise traceability of medical devices throughout their life cycle and the high-quality development of Shenzhen's medical device industry.

外文关键词：

Unique device identifier(UDI)Tracing platform for UDI in ShenzhenJoint reformation for public health services,medical insurance,and medical production-circulationWhole life cycle supervisionData docking

作者：

孙勇

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作者单位：

深圳市标准技术研究院,广东深圳 518033

关键词：

医疗器械唯一标识(UDI) 深圳市医疗器械唯一标识(UDI)追溯平台三医联动全生命周期监管数据对接

基金：

中国药品监督管理研究会2023年度研究课题

项目编号：

出版年：

2024

中国医药导刊

国家食品药品监督管理局信息中心

中国医药导刊

影响因子：1.408

ISSN：1009-0959

年,卷(期)：2024.26(5)