首页|基于UDI的物联网技术在医疗器械全生命周期信息化管理的应用现状

基于UDI的物联网技术在医疗器械全生命周期信息化管理的应用现状

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医疗器械唯一标识(Unique Device Identification,UDI)是一种逐渐被全球医疗器械监管部门采纳的编码方式,是管理医疗器械的有力工具,但在应用过程中仍存在问题,比如将UDI码应用到低值耗材等.本文介绍了UDI的定义及其在国内外的实施情况,指出了UDI的实施在医疗器械生产环节、流通环节、使用环节、监管环节可以带来有益效果.通过UDI编码构建智能型物联网,能够实现医疗器械全程可追溯、耗材有效期及库存和不良事件上报等信息化管理.最后简单介绍了我院现行的医疗器械物流管理模式,及利用院内编码与UDI码相结合的使用情况,从而使得院内医疗器械信息得到更加有效的管理,有望建立一个规范的医疗器械追溯体系和科学的管理模式,为其他医疗机构管理医疗器械提供参考.
Application Status of Internet of Things Technology Based on UDI in Whole-Life Cycle Information Management of Medical Devices
Unique device identification(UDI)is a coding method that is gradually being adopted by global medical device regulatory authorities and is a powerful tool for managing medical devices.However,there are still problems in the application process,such as applying UDI codes to low value consumables.This paper introduced the concept of UDI for medical devices,including its definition and implementation both domestically and internationally,and pointed out that the implementation of UDI can bring beneficial effects in the production,circulation,use and supervision of medical devices.Building intelligent Internet of Things through UDI coding can realize information management such as full traceability of medical devices,expiration date of consumables,inventory and adverse event reporting.Finally,this paper briefly introduced the current medical device logistics management mode of our hospital and the use of hospital code combined with UDI code,so that the hospital medical device information can be managed more effectively,and it is expected to establish a standardized medical device traceability system and scientific management mode,which can provide a reference for other medical institutions to manage medical devices.

unique device identificationwhole-life cycle of medical deviceInternet of Thingsinformation management

周俏俏、路婧

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中山大学附属第六医院 医学工程处,广东 广州 510655

广州市黄埔区中六生物医学创新研究院,广东 广州 510799

医疗器械唯一标识 医疗器械全生命周期 物联网 信息化管理

广东省基础与应用基础研究基金

2023A1515220120

2024

中国医疗设备
中国整形美容协会

中国医疗设备

CSTPCD
影响因子:0.825
ISSN:1674-1633
年,卷(期):2024.39(6)
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