工业互联网视角下医用耗材UDI信息化管理实践探讨

Practice Discussion UDI Information Management for Medical Consumables based on Industrial Internet

医用耗材全生命周期管理涵盖了其生产、流通、临床应用等多个环节,全过程追溯与风险控制管理对保障临床安全使用有重要意义。医疗器械唯一标识(unique device identification,UDI)系统的实施为医用耗材的全生命周期管理提供了依据,但是目前我国推进实施的UDI仅包含医用耗材的产品信息和生产信息,且医用耗材全生命周期管理的部分环节相互孤立,难以实现数据的追溯管理。工业互联网作为一种全新的产业和应用生态,其出现为医用耗材的全生命周期管理提供了技术支持。在本研究中中日友好医院医工处探索性建立了一种基于工业互联网的医用耗材UDI信息化管理平台,通过工业互联网联通了医用耗材生产、流通、临床应用和监管等环节,通过节点解析管理实现不同环节不同系统之间数据的对接共享,以医用耗材UDI为标识贯穿整个生命周期管理过程,实现了对单一医用耗材的全生命周期数据的追溯管理与风险控制管理,丰富了医用耗材UDI的应用信息,也为工业互联网在医疗领域的创新应用进行了有益探索。

The whole life cycle management of medical consumables covers the process of its production,logistics,clinical application.The whole process of data tracing and risk control management is important for the safety of clinical use.The implementation of the unique device identification(UDI)system provides the unique identification for the whole life cycle management of medical consumables.But at present,UDI only contains the device identifier and production identifier of medical consumables,and each process of the whole life cycle of medical consumables is isolated from each other,so it is difficult to realize the trace management of data.As the new industry and application ecology,industrial internet provides technical support for the whole life cycle management of medical consumables.In the study,Medical Engineering Department of China-Japan Friendship Hospital explores and establishes a medical consumables UDI management platform based on the industrial internet.The platform connects the production,logistics,clinical application and national supervision of medical consumables through the industrial internet.Through node analysis and management,data among different systems in different links can be shared on the platform.The platform runs through the whole life cycle management process with the medical consumables UDI as the unique identifier,which realizes the trace management and risk control management of the whole life cycle data of a single medical consumables,and enriches the application information of medical consumables UDI,and also makes a beneficial exploration for the innovative application of industrial internet in the medical field.