医疗器械不良事件监测与评价体系的实施方案分析

目的:通过应用医疗器械不良事件监测与评价系统,实现对医疗器械病例报告及相关资料的快速收集和及时处理,提升科室在使用医疗器械时的风险识别、分析、控制能力,有效保障患者生命安全.方法:建立不良事件管理机构,完善管理制度,基于Visual Studio 2008平台建立监测系统,充分发挥系统的在线报告、评价、分析及预警等功能.结果:通过监测系统实现对可疑不良事件的发现、报告、评价和控制,确保医疗器械使用安全.结论:使用医疗器械不良事件监测系统,对保障患者的生命安全具有重要意义

Analysis the implementation scheme of medical device adverse event monitoring and evaluation system

Objective:The system can realize rapid collection and treatment the medical case report and information through applicant the medical device adverse event monitoring and evaluation system. The system can promote the ability of risk identification and analysis about department of medical device. So hospital can guarantee the safety of patients. Methods:The management mechanism and management system of adverse event was established and improved to ensure safety. To establish a monitoring system that based on the Visual Studio 2008 platform and give full play to the function of the system to complete the Monitor. Results:The suspicious adverse events were identified, reported, evaluated and controlled through the system. So the system can ensure the safe of medical equipment. Conclusion:It is important that we use the medical device adverse event monitoring system to the life of patients’ safety.