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作 者:熊伟 袁鑫 聂涛 潘瑾 郑骏[1] 冯靖祎[1,2] XIONG Wei;YUAN Xin;NIE Tao;PAN Jin;ZHENG Jun;FENG Jingyi(Department of Clinical Engineering and Material Supplies,The First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou Zhejiang 310003,China;Key Laboratory of Clinical Evaluation Technology for Medical Device of Zhejiang Province,The First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou Zhejiang 310003,China)
机构地区:[1]浙江大学医学院附属第一医院医学工程与物资部,浙江杭州310003 [2]浙江大学医学院附属第一医院浙江省医疗器械临床评价技术研究重点实验室,浙江杭州310003
出 处:《中国医疗设备》2024年第11期82-86,共5页China Medical Devices
基 金:国家重点研发计划(2022YFC2407306);浙江省医药卫生科研面上项目(2021KY685)。
摘 要:目的建立科学的微量注射泵评价指标体系并开展评价,为医护人员选择优质产品提供依据,为产品改进优化提供建设性意见,为患者提供更精准、更有保障的医疗服务。方法通过专家小组讨论确定流量相对示值误差、流量示值重复性、输出精度、阻塞压力报警相对示值误差、接地电阻、识别注射器容量完备程度、显示界面可用性、电池满电量工作时长、内部结构稳定性和操作便捷性10个参数作为微量注射泵的评价指标体系,采用主客观赋权法对各指标权重进行赋值,建立品牌A~D微量注射泵对应的决策方案集与决策矩阵,并构造评价目标模型对各品牌微量注射泵进行综合评价与优劣排序。结果在以上10个主要指标的综合对比评价下,各品牌微量注射泵的评价目标值矩阵d_(i)=(0.32,0.84,0.57,0.56),即产品优劣排序为品牌B>品牌C>品牌D>品牌A。结论本研究建立的微量注射泵评价指标体系与评价方法具有一定的适用性,有助于医疗机构选购最合适的产品,同时为医疗器械评价指标体系的建立与评价方法研究提供了思路。Objective To establish a scientific micro-syringe infusion pump evaluation index system and carry out evaluation,provide a basis for medical staff to select high-quality products,provide constructive suggestions for product improvement and optimization,and provide patients with more accurate and guaranteed medical services.Methods Through expert group discussion,10 parameters includingflow relative indication error,flow indication repeatability,output accuracy,blocking pressure alarm relative indication error,grounding resistance,identification syringe capacity completeness,display interface availability,battery full charge working time,internal structure stability and operation convenience were determined as the evaluation index system of micro-syringe infusion pump.The weights of each index were assigned by the subjective and objective weighting method.The decision scheme set and decision matrix corresponding to brand A~D micro-syringe infusion pump were established,and the evaluation target model was constructed to comprehensively evaluate and rank the advantages and disadvantages of each brand micro-syringe infusion pump.Results Under the comprehensive comparative evaluation of the above 10 main indicators,the evaluation target value matrix of each brand micro-syringe infusion pump d_(i)=(0.32,0.84,0.57,0.56),the product was sorted as brand B>brand C>brand D>brand A.Conclusion The evaluation index system and evaluation method of micro-syringe infusion pump established in this paper has certain applicability,which is helpful for medical institutions to choose the most suitable products,and provides ideas for the establishment of medical device evaluation index system and the research of evaluation methods.
关 键 词:微量注射泵 医疗器械评价 指标体系 主客观赋权法 多属性决策 流量相对示值误差 阻塞压力报警相对示值误差
分 类 号:R197.39[医药卫生—卫生事业管理]
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