关键词: font-size:medium, ">低值医用耗材； 医疗器械唯一标识； 全生命周期管理； 实践探索

Abstract: he unique device identifier (UDI) management of medical consumables is the basis for the realization of fine management. The implementation of UDI can promote the standardized use of medical consumables. At present, the UDI management of medical consumables is mainly concentrated in the field of high-value medical consumables, and lack mature UDI management mode for low-value medical consumables. Taking disposable infusion set as the example, the project carried out a pilot study on data collaborative exploration of low-value medical consumables based on UDI from production to clinical application. Through the UDI coding and association of medical consumables in large, medium and small packages, code association management has been achieved in different loads and low-value medical consumables. Through the docking of the production enterprise and the medical institution information system, collaborative management of data has been achieved. Through UDI realized the tracking of dynamic data of medical consumables, completed the trace back of the full lifecycle data of low-value medical consumables, and met the requirements of NMPA for the management and control of adverse events of medical consumables, so as to provide data support for fine management.

Key words: Low-value medical consumables, Unique device identifier, Whole lifecycle management, Practice and management