临床应用评价促进国产腔镜吻合器研发设计  

Promotion of Clinical Application Evaluation for Research&Development and Design of Domestic Laparoscopic Stapler

作　　者：熊伟 孙静[1] 孙斐 冯靖祎[1,2] XIONG Wei;SUN Jing;SUN Fei;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》2023年第11期116-121,共6页China Medical Devices

基　　金：国家重点研发计划(2022YFC2407306)。

摘　　要：目的通过开展国产腔镜吻合器手板样机的临床模拟应用评价,快速寻找吻合器样机的不足之处和改进点,助推其研发设计进程,使其更好地满足临床实际应用需求。方法搭建国产腔镜吻合器手板样机临床真实应用场景模拟平台,遴选临床专家,采用专家评价法,从腔镜吻合器的性能、可用性、有效性、易用性、易学性和满意度等维度开展手动和电动腔镜吻合器手板样机的应用评价。结果两款吻合器样机所有性能指标评价结果为“优秀”或“良好”的占比均能达到80%以上,穿刺器匹配性、枪杆旋转、钳头弯转、抓取操作和保险开关等指标有很大改进空间。系统可用性量表评价结果表明,该手动腔镜吻合器手板样机比市面上60.43%的同类产品可用性更好,电动腔镜吻合器手板样机比市面上76.45%的同类产品可用性更好;有用性、满意度、易用性量表结果表明,手动腔镜吻合器手板样机有效性、易用性、易学性和满意度均不如电动款。结论本文开展的国产腔镜吻合器手板样机应用评价工作将临床医护人员的器械使用经验、实际需求、器械缺陷和优化改进方案直接反馈给研发团队,避免不必要的研发资源消耗,提高研发效率和进程,能够为国产腔镜吻合器行业发展提供经验参考。Objective Through the clinical simulation application evaluation of domestic laparoscopic stapler prototype,to quickly found the shortcomings and improvements of the stapler prototype,to promote its research&development(R&D)and design process to better meet the needs of clinical practical application.Methods A simulation platform for the clinical real application scenario of domestic laparoscopic stapler prototype was established.Clinical experts were selected,and expert evaluation methods were adopted to carry out application evaluation of manual and electric laparoscopic stapler prototypes from the dimensions of performance,usability,effectiveness,ease of use,ease of learning and satisfaction.Results The proportion of all performance indicators of the two stapler prototypes as“excellent”or“good”could reach more than 80%,but there was a lot of space for improvement in the indicators such as trocar matching,gun barrel rotation,jaw bend,grasping operation and safety switch.The system usability scale evaluation results showed that the manual laparoscopic stapler prototype had better usability than 60.43%of similar products on the market,and the electric laparoscopic stapler prototype had better usability than 76.45%of similar products on the market.The results of usefulness,satisfaction,and ease of use scale showed that the manual laparoscopic stapler prototype was inferior to the electric model in terms of effectiveness,ease of use,ease of learning and satisfaction.Conclusion The application evaluation of domestic laparoscopic stapler prototype carried out in this paper directly feeds the device experience of clinical staff,actual needs,device defects,device optimization and improvement plans to the R&D team,and it can avoid unnecessary R&D resource consumption,improve R&D efficiency and process,and provide experience reference for the development of domestic laparoscopic stapler industry.

关 键 词：临床应用评价 腔镜吻合器 性能指标 可用性量表(SUS) USE量表 

分 类 号：R197.39[医药卫生—卫生事业管理]