摘要
目的对医疗器械品种档案信息系统建设工作提出思考。方法介绍医疗器械品种档案概念及意义,通过分析其建设难点,提出医疗器械品种档案总体建设思路和体系架构。结果考虑到医疗器械品种档案建设长期性和复杂性,可按照建制度、搭平台、管数据三个步骤进行体系构建,从用户层、业务应用层、应用支撑层、数据资源层、基础设施层、安全、标准和运维管理等八个方面进行总体技术架构的设计。结论架构设计是系统建设的根本,其设计合理性对于系统建设成功与否至关重要,所提出的架构设计,对于推进医疗器械品种档案管理系统建设具有一定的参考作用。
Objective Thinking on the construction of the medical device type archives information system.Methods This paper introduces the concept and significance of medical device variety archives,and puts forward the overall construction idea and system framework of medical device variety archives by analyzing its construction difficulties.Results Considering the long-term nature and complexity of the construction of medical device variety archives,the system can be constructed in accordance with the three steps of system building,platform building and data management,and the overall technical architecture can be designed from the eight aspects of user layer,business application layer,application support layer,data resource layer,infrastructure layer,security,standards and operation and maintenance management.Conclusion Architecture design is the foundation of system construction,and its design rationality is very important for the success of system construction.The architecture design proposed in this study has a certain reference role for promoting the construction of medical device variety archives management system.
作者
马进
郭媛媛
王超
周和颐
MA Jin;GUO Yuanyuan;WANG Chao;ZHOU Heyi(Information Center of National Medical Products Administration,Beijing,100053)
出处
《中国医疗器械杂志》
2021年第3期310-314,共5页
Chinese Journal of Medical Instrumentation
基金
国家重点研发计划资助(2018YFC0117100)。
关键词
医疗器械品种档案
全生命周期管理
架构
信息化建设
medical device variety file
life cycle management
framework
information construction
