关键词: 医疗器械唯一标识, 医用耗材, 监管, 妇幼专科医院

Abstract:

 Unique device identifier （UDI） is the electronic ID card of medical device products， which helps to the standardization and normalization management of medical device consumables. The application， purchase， distribution and use of medical consumables are the important contents of standardized hospital management， and also the focus of hospital fine management. The implementation of UDI for medical consumables can improve the comprehensive management ability of medical institutions through accurate identification and intelligent management by information-based means. In accordance with the work requirements of NMPA， this study was based on the implementation of UDI in a Grade-A tertiary maternal and child specialized hospital， combined to the requirement of supply chain management of medical consumables，and made full use of the information system resources of the hospital， supplemented by intelligent management facilities and equipment， to achieve the correlation between hospital consumables coding， UDI coding， and medical insurance coding， and to achieve the informatization and intelligence of medical consumables management， supplement and improve the regulatory elements of health administrative authorities on medical institutions， medical personnel， and medical behavior. This study believes that although there are some problems in the implement of UDI management for medical consumables in our hospital， such as the products in UDI database are not complete， the difficulty of connecting hospital material management system with UDI database， and the difficulty of informatization management of“Three-Medical Linkage”， UDI is the basis of fine， standardized and scientific management of all medical consumables， which can ensure the safety and effectiveness of medical consumables，optimize financial management and patient self-service queries， achieve accurate financial settlement of medical consumables， financial management traceability， and a positive atmosphere where patients and their families are informed， and further enhance the capabilities of hospital management and social benefits.

Key words: Unique device identifier , （UDI）； , Medical consumables； , Supervise； , Maternal and child specialized hospital