中国医疗设备2024，Vol.39Issue(5)：80-86,132,8.DOI:10.3969/j.issn.1674-1633.2024.05.014
基于UDI的医疗器械不良事件重点监测智慧管理平台的设计与应用
Design and Application of Intelligent Management Platform for Medical Device Adverse Event Monitoring Based on UDI
摘要
Abstract
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.关键词
医疗器械唯一标识/重点监测/智慧管理平台/多方协同/快速反馈机制Key words
unique device identification/key monitoring/intelligent management platform/multi-party collaboration/fast feedback mechanism分类
医药卫生引用本文复制引用
李霞,黄琳,杨建卫,杨锋,陈雷..基于UDI的医疗器械不良事件重点监测智慧管理平台的设计与应用[J].中国医疗设备,2024,39(5):80-86,132,8.基金项目
国家"十四五"医疗器械不良事件重点监测项目. （）
