一次性单孔腹腔镜穿刺器评价指标体系的建立与应用  

The Establishment and Application of Evaluation Index System for Disposable Single-Port Laparoscopic Trocar

作　　者：卢如意 孙静[1,2] 张倩[1,2] 熊伟 潘瑾 冯靖祎[1,2] Lu Ruyi;Sun Jing;Zhang Qian;Xiong Wei;Pan Jin;Feng Jingyi(Department of Clinical Engineering and Information Technology,The First Affiliated Hospital of Zhejiang University,Hangzhou Zhejiang 310003,China;Key Laboratory of Clinical Evaluation Technology for Medical Device of Zhejiang Province,The First Affiliated Hospital of Zhejiang University,Hangzhou Zhejiang 310003,China)

机构地区：[1]浙江大学医学院附属第一医院医工信息部,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：《医疗装备》2021年第21期1-3,16,共4页Medical Equipment

基　　金：“十三五”国家重点研发计划项目(2017YFC0114100,2017YFC0114107,2017YFC0114102)。

摘　　要：目的建立一套有效的一次性单孔腹腔镜穿刺器评价指标体系,面向国产与进口之间、不同品牌之间的一次性单孔腹腔镜穿刺器开展临床应用评价,以期为厂家提供改进提升一次性单孔腹腔镜穿刺器功能、性能等方面的建议。方法采用文献回顾、小组讨论、头脑风暴、专家访谈等方法,拟定一次性单孔腹腔镜穿刺器评价指标体系草案及专家咨询问卷,采用德尔菲法确定评价指标,应用层次分析法构建判断矩阵得到评价指标权重,最后通过各层次指标权重系数层次单排序及层次总排序一致性检验得到一次性单孔腹腔镜穿刺器评价指标体系。结果采用德尔菲法最终得到一次性单孔腹腔镜穿刺器一级指标2项,二级指标11项,专家权威程度在满意范围之内。结论该研究所建立的一次性单孔腹腔镜穿刺器评价指标体系,专家参与度高、积极性好、权威程度高,评价结果可参考。Objective Establish an effective evaluation index system for disposable single-port laparoscopic trocar,and carry out clinical application evaluation for domestic and imported&different brands disposable single-port laparoscopic trocar to provide suggestions for product manufacturers to improve the function and performance of disposable single-port laparoscopic trocar.Methods Literature review,group discussion,brainstorming,expert interviews and other methods were adopted to develop a disposable single-port laparoscopic trocar evaluation index system and an expert consultation questionnaire.The Delphi method was used to determine the evaluation indexes,and the analytic hierarchy process was used to construct the judgment matrix to obtain the evaluation indexes'weights,and finally the single-port laparoscopic trocar evaluation index system was obtained through the single-level ranking of the index weight coefficients of each level and the consistency test of the total ranking.Results 2 first-level indexes and 11 second-level indexes of the disposable single-port laparoscopic trocar were obtained by Delphi method,and the authority of experts was within the satisfactory range.Conclusion The set of evaluation index system for disposable single-port laparoscopic trocar established in this study has high expert participation,good enthusiasm and high authority,indicating that the results can serve as references.

关 键 词：单孔腹腔镜穿刺器 评价指标体系 权重 变异系数 德尔菲法 层次分析法 

分 类 号：R197.3[医药卫生—卫生事业管理]