基于医疗器械唯一标识(UDI)管理模式的探索与实践

Exploration and Practice of UDI-Based Management Mode

2019年8月27日国家药监局发布《医疗器械唯一标识系统规则》,初步提出医疗器械唯一标识(UDI)的应用设想;2019年12月10日UDI数据库建成,医疗器械、药品、耗材逐渐走向一物一码、追溯有源的规范化、正式化管理。随着上述政策的出台、落实,如何通过基于UDI的医疗器械管理模式,提高医院的供应链管理质量、保障临床医疗业务的顺利开展,成为医院发展中必须面对的挑战。厦门大学附属心血管病医院作为福建省UDI试点示范单位,在福建省和厦门市市场监督局的指导下,通过加强组织管理、提高信息化和互联互通水平、多部门协同,坚持以服务临床为中心,以提高医院运营管理水平和患者满意度为目标,通过UDI与国家数据库、医院运营管理信息、医保编码、物价编码、字典编码、不良事件上报系统的数据对接,积极探索基于UDI的高值耗材管理新模式。

The State Food and Drug Administration issued the Medical Device Unique Identification System Rules on August 27,2019,which initially proposed the application concept of the medical device unique identification;Later on December 10,2019,the medical device unique identification database was established,and medical devices,drugs,and medical consumables gradually towards standardized and formalized management of one item,one code,and traceability.With the promulgation and implementation of the above policies,how to improve the quality of hospital supply chain management and ensure the smooth development of clinical medical services through the medical device management model based on the Unique Medical Device Identification(UDI)has become a challenge that hospitals must face in their development.Under the guidance of Fujian and Xiamen Medical Products Administration,Xiamen Cardiovascular Hospital(hereinafter referred to as Xiamen Heart Hospital)constantly strengthen organizational management,improve the level of informatization and interconnection,collaborate with multi-departments and take clinical service as the central task.In order to improve the level of hospital operation management and patients’satisfaction,Xiamen Heart Hospital actively exploring a new way of high value medical consumables management based on UDI,througth connecting UDI with data of National Medical Products Administration,hospital operation and management information,medical device insurance code,price code,material code and medical devices adverse events reporting system.