基于动物实验的国产腔镜吻合器开模样机可用性评价
Usability Evaluation of the Domestic Laparoscopic Stapler Prototype Based on Animal Experiments
熊伟 1孙静 1胡梦雅 1王之晨 1张倩 1冯靖祎2
作者信息
- 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 医学工程与物资部,浙江 杭州 310003;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
- 折叠
摘要
目的 通过开展基于动物实验的国产腔镜吻合器开模样机可用性评价,获取临床医护人员关于器械可用性的真实评价与反馈,帮助研发人员及时调整方案,提升器械可用性水平.方法 搭建一个适合腔镜吻合器用于结直肠、胃、肝胆胰和肺部相关手术操作的模拟场景,招募医生用户和护士用户,采用专家评价法,从操作可用性和系统可用性角度评价手动腔镜吻合器和电动腔镜吻合器的可用性.结果 手动和电动腔镜吻合器开模样机操作可用性问卷大多数题目平均得分为3～4分,表明其操作可用性总体处于与其他国产品牌相当的水平,基本得到了用户的认可;2款吻合器系统可用性评级分别为D和B-,前者系统可用性只优于市面上26.20%的同类产品,不在可接受范围,后者系统可用性优于市面上65.61%的同类产品,在可接受范围但仍需进一步提升.结论 本研究开展的基于动物实验的国产腔镜吻合器开模样机可用性评价为快速获取用户体验、发现或减少人因工程等问题提供了一套可选择的解决方案,能够促进器械优化改进、加速国产医疗器械上市进程.
Abstract
Objective Through the usability evaluation of domestic laparoscopic stapler prototypes based on animal experiments,to obtain the real evaluation and feedback from clinical medical staff regarding the usability of devices to help research and development personnel adjust the scheme in time and improve the usability level of devices.Methods A simulated scenario suitable for the use of laparoscopic stapler in colorectal,gastric,hepatobiliary,pancreatic and pulmonary related surgical procedures was set up.Doctor and nurse users were recruited and expert evaluation method was used to evaluate the usability of manual laparoscopic stapler and electric laparoscopic stapler from the perspective of operational usability and system usability.Results The average score of most questions in the operation usability questionnaire for manual and electric laparoscopic stapler prototype was between 3 points and 4 points,indicating that the operational usability was generally at the same level as other domestic brands,basically recognized by users.The usability ratings of two stapler system were D and B-,with the former system's usability only better than 26.20% of similar products on the market,falling outside the acceptable range,while the latter system's usability was better than 65.61% of similar products on the market,within an acceptable range but still in need of further improvement.Conclusion The usability evaluation of domestic laparoscopic stapler prototype based on animal experiments conducted in this study provides a set of alternative solutions for quickly obtaining user experience,identifying or reducing human factors engineering issues,which can promote the optimization and improvement of devices and accelerate the marketing process of domestic medical devices.
关键词
动物实验/腔镜吻合器/可用性/SUS量表/专家评价法Key words
animal experiment/laparoscopic stapler/usability/system usability scale/expert evaluation method引用本文复制引用
基金项目
国家重点研发计划(2022YFC2407306)
浙江省自然科学基金(LQ21H180009)
浙江省自然科学基金(LQ20C100001)
浙江省医药卫生科研面上项目(2021KY685)
出版年
2024
国家科技期刊平台
NSTL
万方数据