Design and Application of Intelligent Management Platform for Medical Device Adverse Event Monitoring Based on UDI
Objective Based on the unique device identification(UDI)system of medical devices,to design an intelligent management platform for medical device adverse event monitoring based on UDI coding.Methods Based on UDI coding and medical equipment life cycle management platform,the advanced architecture concepts and technologies such as mobile Internet,industrial Internet platform application and big data platform were integrated,and the Spring Cloud microservice architecture,Kubernetes orchestration and Docker containerization technology were adopted.The SpringCloud+Mybatis framework,Java language and B/S architecture were used to design an intelligent management information platform for collaborative management of medical device adverse event monitoring.The platform supported multi-terminal and multi-scenario integration,and the hospital,registrant and monitoring center worked together to achieve accurate and fast reporting of adverse event key monitoring information.Results The intelligent management platform for key monitoring of medical device adverse events based on UDI has collected 6 cases of adverse events and control measures taken by registrants.The platform could realize high-quality data collection of adverse events,accurate push of multi-party information,rapid investigation of product abnormalities,and rapid feedback of enterprise control measures,which effectively improved the accuracy of medical device adverse event data and the efficiency of risk discovery,reporting,disposal and feedback,and realized the full-scene closed-loop intelligent management of medical device adverse events.Conclusion The platform realizes the transformation of multiple sentinel units from the original manual reporting to the information collection of key monitoring data,and can also be extended to all categories of medical device adverse event management scenarios to realize the data and intelligent management of medical device adverse events.
国家科技期刊平台
NSTL
万方数据
维普
