UDI在医疗器械经营企业信息化建设中的实践

目的基于医疗器械唯一标识(Unique Device Identification,UDI)构建流通企业全流程信息化管理体系。方法通过升级优化企业现有ERP系统、WMS系统增加UDI条码识别功能,同时与国家药品监督管理局UDI数据库对接,实现医疗器械从供应商到流通企业到下游客户UDI的全流程可追溯。结果实现了对于生产企业已经赋UDI码的医疗器械扫码出入库,并以UDI唯一标识为线索实现ERP、WMS、SPD多个信息系统协同。结论基于UDI的医疗器械信息化管理体系提高医疗器械出入库及库房管理效率和精细度,降低了流通企业物流管理成本,为实现医疗器械全生命周期闭环管理和全流程追溯打下良好的数据基础,为医疗器械经营企业的UDI推进提供实践参考。

Practice of UDI in Information Construction of Medical Device Enterprises

Objective To construct full process information management system for enterprises based on unique device identification(UDI).Methods By upgrading and optimizing the existing ERP system and WMS system of the enterprise,UDI barcode identification function was added,At the same time,it was connected with the UDI database of National Medical Products Administration,so as to realize the traceability of the whole process of medical devices from suppliers to circulation enterprises to customers.Results It realized the scan code of medical device which were assigned UDI code in the production enterprise,and coordinate multiple information systems including ERP,WMS and SPD with UDI.Conclusion UDI-based medical device information management system improves the efficiency of the access and fineness of warehouse management,reduces the logistics management cost of circulation enterprises,lays a good data foundation for realizing the life circle closed loop management and full process traceability of medical devices,and provides reference for medical device distributing enterprises to promote the practice of UDI.