摘要
目的:为满足医疗器械不良事件重点监测数据的收集和统计需求,运用互联网技术设计智能监测云平台。方法:基于重点监测品种的产品特性及不良事件分析,开发了一个集多用户使用、线上移动端数据收集及后台电脑端数据监测统计为一体的线上报告系统。结果:通过使用高效便捷的线上报告系统,成功收集了重点品种监测数据,简化了数据填报流程,提升了不良事件的上报积极性和报告质量,便于监测机构实时监测和分析数据,从而有效发现潜在风险点。结论:线上报告系统的设计与应用是对医疗器械不良事件信息智慧化监测新途径的探索,为医疗器械不良事件重点监测的深入研究提供了新的视角。
Objective:To meet the requirements for collecting and analyzing key surveillance data on medical device adverse events,this study leverages internet technology to design an online intelligent monitoring cloud platform.Methods:Based on the product characteristics and adverse event analysis of key monitoring devices,a multi-user online reporting system was developed,integrating mobile terminal data collection and computer terminal data monitoring and statistical analysis.Results:The efficient and user-friendly online reporting system successfully collected key surveillance data,streamlined data entry processes,enhanced reporting compliance and quality of adverse event reports,and enabled real-time monitoring and analysis by surveillance institutions,which facilitated the effective identification of potential risk factors.Conclusion:The design and implementation of this online reporting system represent an exploration of intelligent monitoring approach for medical device adverse event information.It provides new perspectives for in-depth research on key surveillance of medical device adverse events.
作者
罗培
焦卫红
易欢
徐瑾
刘睿娟
张永知
LUO Pei;JIAO Wei-hong;YI Huan;XU Jin;LIU Rui-juan;ZHANG Yong-zhi(Jiangxi Drug Adverse Reaction Monitoring Center,Jiangxi Nanchang 330006)
出处
《中国医疗器械信息》
2025年第17期23-26,共4页
China Medical Device Information
基金
江西省药品监督管理局科研项目(项目名称:江西省基于微信端收集医疗器械不良事件报告模式的可行性研究,项目编号:2023JS41)。
关键词
医疗器械
不良事件
重点监测
信息化
medical devices
adverse events
key monitoring
informatization
