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中国医药导刊 ›› 2022, Vol. 24 ›› Issue (9): 924-927.

所属专题: 医疗器械唯一标识专栏

• 专栏:医疗器械唯一标识 • 上一篇    下一篇

医疗器械唯一标识(UDI)在经营领域的应用探索与实践

刘一静, 李旭莹, 梅淞, 卓越*, 许斌   

  1. 波科国际医疗贸易(上海)有限公司, 上海 200023
  • 收稿日期:2022-12-06 修回日期:2022-10-09 出版日期:2022-09-28 发布日期:2022-09-28

Exploration and Practice of Unique Device Identifier (UDI) Application in the Field of Medical Device Distribution

  1. BSC Int′l Medical Trading (Shanghai) Co., Ltd., Shanghai 200023, China
  • Received:2022-12-06 Revised:2022-10-09 Online:2022-09-28 Published:2022-09-28

摘要: 医疗器械唯一标识(unique device identifier, UDI)是医疗器械产品的“身份证”。UDI唯一性的特征,有助于快速、准确识别产品,为各环节数据的互联互通提供了依据。UDI在我国的推行,有力助推了医疗器械从生产、经营、到最终临床使用全链条联动,从而提升医疗器械全生命周期监管效能和卫生管理效率。经营环节作为医疗器械全生命周期中承上启下的重要环节,应积极应用UDI进行医疗器械管理,在“工业4.0”新时代背景下,利用先进的技术手段,推进医疗器械供应链实现透明化、可视化、智能化。本研究基于我公司作为首批UDI示范单位的应用实践,详细阐述经营渠道管理中应用UDI的探索与思考,为提升行业内渠道管理效能、助力UDI在我国实施提供借鉴和思路。

关键词: font-size:medium, ">医疗器械唯一标识(UDI);经营环节;医疗器械供应链;医疗器械全生命周期;工业4.0

Abstract: The unique device identifier (UDI) is the "identity card" of medical devices.The feature of uniqueness of UDI can help to identify medical devices quickly and accurately, and provides a basis for data interconnection of various links. The implementation of UDI in China has effectively boosted the linkage of the whole chain of medical devices from production, distribution to final clinical use, thus improving the regulatory and health management efficiency of medical devices in the full life cycle. Distribution is an important link in the whole life cycle of medical devices, where UDI should be actively applied for medical device management. Under the background of the new era of “industry 4.0”, advanced technological means should be used to promote the transparency, visualization and intelligence of the medical device supply chain. Based on the application practice of the authors’ company as the first batch of Model Unit of Medical Device UDI, this paper elaborates the exploration and thinking on the application of medical device UDI in distribution channel management, so as to provide reference and ideas for improving the efficiency of channel management in the industry and the implementation of UDI in China.

Key words: Unique device identifier (UDI), Distribution, Medical device supply chain, The whole life cycle of medical devices, Industrial 4.0

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