中国医疗设备2024，Vol.39Issue(7)：36-41,48,7.DOI:10.3969/j.issn.1674-1633.2024.07.006
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
摘要
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分类
医药卫生引用本文复制引用
熊伟,孙静,胡梦雅,王之晨,张倩,冯靖祎..基于动物实验的国产腔镜吻合器开模样机可用性评价[J].中国医疗设备,2024,39(7):36-41,48,7.基金项目
国家重点研发计划(2022YFC2407306) （2022YFC2407306）
浙江省自然科学基金(LQ21H180009 （）
LQ20C100001) （）
浙江省医药卫生科研面上项目(2021KY685). （2021KY685）
