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

目的以医疗器械唯一标识(Unique Device Identification,UDI)体系为基础,设计基于UDI编码的医疗器械不良事件重点监测智慧管理平台。方法基于UDI编码和医疗设备全生命周期管理平台,融合移动互联网、工业互联网平台应用、大数据平台等先进架构理念和技术,采用Spring Cloud微服务架构和Kubernetes编排加Docker容器化技术,基于SpringCloud+Mybatis框架、使用Java语言、应用B/S架构,设计协同管理医疗器械不良事件重点监测智慧管理信息平台。平台支持多端多场景融合使用场景,医院、注册人和监测中心三方协同联动,实现不良事件重点监测信息化精准快捷上报。结果基于UDI的医疗器械不良事件重点监测智慧管理平台已收集不良事件及注册人采取的控制措施6例。该平台可实现不良事件高质量数据采集、多方信息精准推送、产品异常快速调查、企业控制措施快速反馈,有效提高医疗器械不良事件数据的准确性和风险发现、报告、处置、反馈的效率,实现医疗器械不良事件的全场景闭环智慧管理。结论该平台实现多家哨点单位由原始手工填报向信息化收集重点监测数据的转变,还可以推广到所有类别的医疗器械不良事件管理场景中,实现医疗器械不良事件的数据化、智能化管理。

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.