基于Delphi法的手术室植入性医疗器械管理评价指标体系构建  

Construction of an Evaluation Indicator System for the Management of Implantable Medical Devices in Operating Theaters Based on the Delphi Method

作　　者：王维[1] 钱蒨健[1] 钱文静[1] 陈沅[1] WANG Wei;QIAN Qianjian;QIAN Wenjing;CHEN Yuan(Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200025)

机构地区：[1]上海交通大学医学院附属瑞金医院,上海200025

出　　处：《上海护理》2023年第9期31-35,共5页Shanghai Nursing

基　　金：2021年上海交通大学医学院护理科研重中之重项目(Jyhz2109);2022年中国医学装备协会手术室植入物管理规范团体标准项目(T/CAME118-2022);2023年上海交通大学医学院附属瑞金医院广慈卓越管理研究基金项目(2023655)。

摘　　要：目的 构建手术室植入性医疗器械管理评价指标体系,旨在规范手术室植入性医疗器械管理方法和流程。方法 2022年2-4月,以结构-过程-结果三维质量评价模式理论为框架,在参考相关文献的基础上拟定手术室植入性医疗器械管理评价指标体系,并采用德尔菲法对来自护理、院感、医疗器械领域的26名专家进行两轮专家函询,采用优序图法确定指标权重系数。结果 两轮专家函询的积极系数分别为92.0%和91.7%,专家权威系数分别为0.929和0.925,变异系数(CV)均<0.25,Kendall’s W值分别为0.354和0.376(均P<0.001),信度值为0.967。最终构建了包含3项一级指标、10项二级指标和35项三级指标的手术室植入性医疗器械管理评价指标体系。结论 基于Delphi法构建的手术室植入性医疗器械管理评价指标体系有较好的科学性和可靠性,可为手术室护理管理者提供参考,有利于临床开展科学、规范、统一的质量评价。Objective To construct an evaluation indicator system for the management of implantable medical devices in operating theaters,so as to standardize the management method and process of implantable medical devices in operating theaters.Methods From February to April 2022,based on the three⁃dimensional(structure⁃process⁃outcome)quality evaluation model,an evaluation indicator system for the management of implantable medical devices in operating theaters was drawn up by referring to relevant literature;then,26 experts in the fields of nursing,nosocomial infection and medical devices were consulted for two rounds by Delphi method;the weight coefficient for each indicator was determined by superiority chart.Results For the two rounds of expert consultation,the positive coefficient was 92.0%and 91.7%respectively,the authoritative coefficient was 0.929 and 0.925 respectively,the coefficient of variation(CV)was<0.25,Kendall's W was 0.354 and 0.376 respectively(P<0.001 for both),and the reliability value was 0.967.An evaluation indicator system for the management of implantable medical devices in operating theaters was finally constructed to consist of 3 first⁃level indicators,10 second⁃level indicators and 35 third⁃level indicators.Conclusion The evaluation indicator system for the management of implantable medical devices in operating theaters based on the Delphi method is scientific and reliable.It can provide a reference for nursing administrators in operating theaters and help to carry out scientific,standardized and unified quality evaluations in clinical practice.

关 键 词：手术室 植入性医疗器械 管理 质量评价 指标体系 德尔菲法 

分 类 号：R473[医药卫生—护理学]