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[1]王丽华陈璐江永苏静.外来医疗器械及植入物质量管理评价指标体系构建研究[J].中国卫生质量管理,2025,32(10):74-79.[doi:10.13912/j.cnki.chqm.2025.32.10.15]
　WANG Lihua,CHEN Lu,JIANG Yong.Research on the Construction of an Evaluation Index System for Quality Management of Loaner Medical Devices and Implants[J].Chinese Health Quality Management,2025,32(10):74-79.[doi:10.13912/j.cnki.chqm.2025.32.10.15]

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外来医疗器械及植入物质量管理评价指标体系构建研究

《中国卫生质量管理》[ISSN:1006-7515/CN:CN 61-1283/R] 卷: 32 期数: 2025年10期页码: 74-79 栏目: 卫生技术评估专栏出版日期: 2025-10-15

Title:: Research on the Construction of an Evaluation Index System for Quality Management of Loaner Medical Devices and Implants

作者:: 王丽华陈璐江永苏静; 江苏大学鼓楼临床医学院

Author(s):: WANG Lihua; CHEN Lu; JIANG Yong; Drum Tower Clinic School of Medicine,Jiangsu University

关键词:: 外来医疗器械; 植入物; 质量管理; 指标体系; 德尔菲法

Keywords:: Loaned Medical Devices; Implants; Quality Management; Index System; Delphi Method

分类号:: R197.39；TH77

DOI:: 10.13912/j.cnki.chqm.2025.32.10.15

文献标志码:: A

摘要:: 目的构建外来医疗器械及植入物质量管理评价指标体系。方法以三维质量结构模型为理论框架，通过文献分析、小组讨论以及专家函询构建指标体系，运用层次分析法计算各级指标权重。结果构建了包含结构、过程、结果3个一级指标12个二级指标及31个三级指标的评价体系，每个三级指标均有对应的评价方法或计算公式。两轮函询专家积极系数分别为96%和100%，权威系数分别为0.885和0.915，肯德尔协调系数分别为0.129和0.170（P＜0.001），所有指标权重一致性检验CR均＜0.1。结论外来医疗器械及植入物质量管理评价指标体系具有科学性、可靠性和特异性，可用于外来医疗器械及植入物各环节质量监测与控制，促进其同质化和精细化管理。

Abstract:: ObjectiveTo construct an evaluation index system for the quality management of loaner medical devices and implants.MethodsUsing the three-dimensional quality structure model as the theoretical framework, the index system was developed through literature analysis, group discussions, and expert consultation. The analytic hierarchy process was employed to calculate the weights of indicators at all levels.ResultsAn index system comprising 3 primary indicators, 12 secondary indicators, and 31 tertiary indicators was established, with each tertiary indicator having a corresponding evaluation method or calculation formula. The expert participation rates in the two rounds of consultation were 96% and 100%, respectively, with authority coefficients of 0.885 and 0.915, and Kendall’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.Conclusion The evaluation index system for the quality management of loaner medical devices and implants is scientific, reliable, and specific. It can be utilized for quality monitoring and control across all stages of loaned medical devices and implants, facilitating their homogeneous and refined management.

参考文献/References:

［1］中华人民共和国卫生部.医院消毒供应中心第1部分管理规范:WS 310.1-2016［S］.2016.［2］崔倩,李漫春,詹朦,等.2008-2021年医院CSSD外来医疗器械及植入物管理现状Meta分析［J］.中国感染控制杂志,2022,21(5):430-438.［3］张凯,高海燕,韩杰,等.国内医疗机构CSSD外来手术器械用后处理及说明书提供情况调查［J］.中国消毒学杂志,2019,36(8):620-622.［4］蔡吟花,王绍鑫,叶华,等.上海市医疗机构外来医疗器械与植入物管理现况调查［J］.上海预防医学,2019,31(7):551-554,563.［5］中华人民共和国卫生部.医院消毒供应中心第2部分清洗消毒及灭菌技术操作规范:WS 310.2-2016［S］.2016.［6］中华人民共和国卫生部.医院消毒供应中心第3部分清洗消毒及灭菌效果监测标准:WS 310.3-2016［S］.2016.［7］张青,钱黎明.外来医疗器械清洗消毒及灭菌技术操作指南［M］.北京:北京科学技术出版社,2018:6-10,33.［8］徐琴,钱维明,赵体玉,等.1166家公立医院手术外来医疗器械管理现状调查［J］.中国护理管理,2022,22(10):1477-1481.［9］肖华丽,周金艳,屈梅香,等.门诊患者突发意外事件应急防御安全指标体系构建［J］.中国卫生质量管理,2023,30(1):21-25.［10］崔锦,陈香萍,隋伟静,等.ICU护士跨专业合作核心能力指标体系的构建［J］.中国护理管理,2021,21(6):839-844.［11］张琦,方幸,徐建鸣.护理质量指标研究进展［J］.中国卫生质量管理,2019,26(3):5-8,13.

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更新日期/Last Update: 2025-10-15