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医疗器械不良事件智能化管理系统的设计与应用

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为解决传统医疗器械不良事件上报模式存在的上报不及时、信息不完整、流程烦琐及不良事件概念模糊等问题,设计一款医疗器械不良事件智能化管理系统,通过智能化管理模块实现对不良事件的便捷化实时上报、全流程监测,数据分析与总结功能.实际应用结果显示,该系统上线后医疗器械不良事件上报用时缩短、上报错误率降低,医务人员对医疗器械不良事件上报流程的满意度提高.
The Design and Application of an Intelligent Management System for Adverse Events of Medical Devices
In order to solve the problems existing in the traditional medical device adverse event reporting mode,such as delayed reporting,incomplete information,cumbersome process and unclear concept of adverse events,an intelligent medical device adverse event management system was designed.Through the intelligent management module,the functions of convenient real-time reporting,whole-process monitoring,data analysis and summary of adverse events were realized.The practical application results showed that after the system went online,the reporting time of medical device adverse events was shortened,the reporting error rate was reduced,and the satisfaction of medical personnel on the reporting process of medical device adverse events was improved.

Adverse events of medical devicesIntelligenceManagement systemReal-time reporting

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厦门大学附属中山医院 (福建厦门 361000)

医疗器械不良事件 智能化 管理系统 实时上报

2024

医疗装备
国家食品药品监督管理局北京医疗器械质量监督检验中心 北京市医疗器械检验所

医疗装备

影响因子:0.339
ISSN:1002-2376
年,卷(期):2024.37(2)
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