基于UDI的医疗器械精细化管理实践及应用规范化探讨

The Practice of Medical Device Refined Management Based on UDI and Discussion on the Application Normalization

目的:介绍国家首批试点医疗机构通过医疗器械唯一标识(UDI)进行医疗器械精细化管理的实践方案,并提出UDI在行业应用实践环节需进一步优化规范的内容。方法:通过对国内UDI应用现状和趋势分析,结合医疗器械管理的相关规定及政策要求,阐述我院以UDI为基础建立的医疗器械全生命周期精细化管理的具体做法及优势,并通过具体案例对实践中遇到的问题进行了分析,提出UDI应用层面规范性建议。结果和结论:我院实践经验表明,UDI可以满足医疗机构对于医疗器械精细化管理的需要并符合未来的发展趋势,同时需要行业共识与规范化推进才能更好地为医疗器械行业数字化转型提速增效。

Objective:To introduce the practice of the first batch of national pilot hospitals to carry out the refined management of medical devices based on unique device identification(UDI),and propose the content that needs to be further optimized and standardized in the industry UDI application practice.Methods:This article analyzes the current status and trend of the application of UDI,combined with the relevant regulations and policy requirements of medical device management,and elaborates the specific methods and advantages of our hospital to establish the refined management of the entire life cycle of medical devices based on UDI.The article also analyzes the problems encountered in practice through specific cases,and puts forward normative recommendations on the UDI application level.Results and Conclusion:Through the practical experience of our hospital,UDI can meet the needs of medical institutions for the refined management of medical devices and conform to the future development trend.At the same time,industry consensus and standardization are required to better accelerate the digital transformation of the medical device industry.