医疗机构快速导入UDI管理的“UDI公共服务平台”模型初探

A Preliminary Study on the Model of“UDI Public Service Platform”for the Rapid Importation of UDI Management in Medical Institutions

目的推进医疗器械唯一标识(Unique Device Identification,UDI)在医疗机构或企业的落地应用,助力医用耗材的精细化管理。方法利用国家UDI数据库的DI数据资源和国药集团中国医疗器械有限公司标准化医疗器械大数据库,通过建立"UDI公共服务平台"的计算机系统,对医疗机构或企业的数据进行DI的对码及不规范数据的规范化转换。同时,增加或改造医疗机构或企业数据字典的字段内容。结果实现医疗机构或企业数据字典的DI数据对应,确保医用耗材数据唯一性,并规范医疗机构或企业现有数据字典内容,为医用耗材的供应链精细化合规管理打下数据基础。结论UDI公共服务平台的模型探索,有助于推进UDI在医疗机构的导入与深度应用,为我国各类型医疗机构导入UDI提供有效助力,也为监管机构更好地服务医疗机构,提供示范和借鉴经验。

Objective To promote the application of unique device identification(UDI)system in medical institutions and companies,to facilitate the fine management of medical consumables.Methods The DI data resources of the national UDI database and the standardized medical device database of China National Medical Device Co.,Ltd were used.Through the establishment of the computer system of"UDI public service platform",the data of medical institutions and companies were DI coded and the standardized conversion of non-standard data was carried out.At the same time,the field content of medical institutions and companies’data dictionary was added or modified.Results The DI data correspondence of medical institutions and companies’data dictionary was realized,and ensured the the uniqueness of medical consumables data standardized the contents of existing data dictionaries of medical institutions or enterprises,and it laid a data foundation for the fine compliance management of medical consumables supply chain.Conclusion The model exploration of UDI public service platform promotes the importation and in-depth application of UDI in medical institutions in China,and provides demonstration and reference experience for regulators to better serve medical institutions.