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中国医药导刊 ›› 2020, Vol. 22 ›› Issue (3): 211-216.

所属专题: 医疗器械唯一标识专栏 智慧监管专栏

• 医疗器械唯一标识专栏 • 上一篇    

现阶段UDI体系在医疗机构中的建设与应用

张涵宇1, 郭红1, 田宗梅3, 王爱英2, 王慧宇2, 谈春荣1*   

  1. 首都医科大学附属北京世纪坛医院物资设备中心采购处1,
         医学工程处2, 信息中心3, 北京 100038
  • 收稿日期:2020-04-20 修回日期:2020-03-23 出版日期:2020-03-31 发布日期:2020-05-14
  • 基金资助:
    首都医科大学附属北京世纪坛医院青年基金(项目编号:2017-Q10;项目名称:医用耗材临床使用监管信息系统软件的构建与应用)

Current Unique Devices Identification (UDI) System Construction and Practice in Medical Institutions

  1. Department of Procurement1, Department of Medical Engineering2, Information Center3,
         Beijing Shijitan Hospital, Capital Medical University, Beijing 100038,China
  • Received:2020-04-20 Revised:2020-03-23 Online:2020-03-31 Published:2020-05-14
  • Supported by:
    医用耗材临床使用监管信息系统软件的构建与应用

摘要: 目的:2019年8月我国发布《医疗器械唯一标识系统规则》,正式开启医疗器械唯一标识(UDI)体系的建设工作。根据该体系的初期实施情况设计并建设基于UDI的医院医用耗材标准化、精细化、信息化的全生命周期管理体系。方法:通过医用耗材标准化建设、信息系统改造、医用耗材多模式管理等手段打造医用耗材全生命周期管理体系。结果:基于UDI的医用耗材信息化管理体系建设改进了院内医用耗材管理体系架构,并实现了院内外医用耗材数据的互联互通,从而提高了物流管理效率和精细度,为降低医疗风险和加强临床使用监管提供有力的系统支持。结论:通过开展基于UDI的医用耗材信息化管理体系建设,实现了院内医用耗材供应与使用端的双向追溯管理以及院内外物流基础信息的统一化和标准化,为进一步开展卫生技术评估评价、耗材成本控制、临床诊疗效果评估等工作打下良好的基础。

关键词: font-size:medium, ">医用耗材信息化管理;医疗器械唯一标识;全生命周期管理体系;医用耗材追溯

Abstract: Objective: In August 2019, Unique Device Identification (UDI) Regulations of Medical Devices was issued, which officially initiate the construction of UDI system of medical devices in China. According to the initial implementation of the system, we propose to design and build a standardized, refined and informationalized full life-cycle management system of medical consumables in the hospital. Methods: The full life-cycle management system of medical devices is built by means of standardization construction, information system reform and multi-mode management. Results: The medical consumables management architecture was upgraded and the information exchange between outside and inside hospital was realized by fitting on the initial state of national UDI system, and efficiency and accuracy of logistics management was improved, which can provide powerful support to reduce clinical risk and enhance the supervision of clinical application. Conclusion: By developing the information system of medical consumable management based on UDI, we realize the bidirectional traceability management between medical consumables supply and consume, and standardize logistics basic information both inside and outside hospital, which build a consolidated foundation on health technology assessment, material cost control and evaluation of clinical diagnosis and treatment effect for the furture.

Key words: font-size:medium, ">Medical consumables information management;Unique Device Identification; Full life cycle management system; Medical consumable traceability

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