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目的 设计医疗机构医疗器械不良事件监测系统评判模型,对医疗器械不良事件监测系统进行的全面、科学的评价,为国家管理部门实施对医疗机构的考核提供科学的方法.方法 使用德尔菲法确立指标权重,使用系统分析法建立医疗器械不良事件监测系统的综合评价体系,使用模糊综合评判方法建立数学模型.结果 本研究建立的评价模型适合作为评价工具,为国家管理部门在考核、评价医疗机构医疗器械不良事件监测系统方面提供科学的指导方法.结论 综合评价体系中的评价指标、指标权重等数据应在实际应用中持续地改进和完善.

Objective To develop an evaluation model for medical device-related events (MDRE) monitoring system in medical institutions,which can be used to evaluate the MDRE system comprehensively and scientifically,and provide a scientific method for administrative authorities to assess medical institutions in China.Methods Index weight was established by Delphi method.A comprehensive assessment of MDRE monitoring system was established by system analysis method.Mathematical model was established by fuzzy comprehensive evaluation method.Results The evaluation model established in the study was suitable for assessment,and could provide scientific guidance for national administrative authorities to evaluate MDRE.Conclusion The evaluation index,index weight and other data in the comprehensive evaluation system should be improved continuously during practical application.