外来医疗器械及植入物质量管理评价指标体系构建研究

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中图分类号：R197.39;TH77 文献标识码：A

Research ontheConstructionof anEvaluationIndexSystemfor QualityManagementofLoaner MedicalDevicesand Implants/WANG Lihua，CHEN Lu，JIANG Yong， et al.//Chinese Health Quality Management，2025 ，32（10） ：74-79

AbstractObjectiveTo construct an evaluation index system for the quality management of loaner medical devices and implants.MethodsUsing the three一dimensionalquality structure model as the theoreticalframework，the index system was developed through literature analysis，group discussons，and expert consultation.Theanalytic hierarchy process was employed to calculate the weights of indicators at allevels.ResultsAn index system comprising 3 primaryindicators，12 secondaryindicators，and3ltertiary indicators was established，witheachtertiary indicatorhavingacorresponding evaluation methodor calculation formula.Theexpert participationrates inthe two roundsof consultation were 96% and 100% ，respectively，with authority coefficients of O.885 and O.915，and Kendal's coefficients of concordance of 0.129 and 0.170（ P<0.001 ）.The consistency tests for the weights of all indicators were all <0.1 ·ConclusionThe evaluation index system for the quality managementof loaner medical devices and implants is scientific，reliable，and specific.Itcan beutilized forquality monitoring and controlacrossall stagesofloaned medical devices and implants，facilitating their homogeneous and refined management.

Key words Loaned Medical Devices； Implants;Quality Management; Index System; Delphi Method First-author's address Drum Tower Clinic School of Medicine，Jiangsu University，Nanjing，Jiangsu，21ooo8，China

外来医疗器械是由器械供应商根据外科手术需求，租赁给医院使用，主要用于与植入物相关手术的器械[1]。（剩余7377字）