摘要
目的基于国内医用手术机器人的可用性测试现状,探讨企业、临床、检测等相关各方对手术机器人可用性测试的共性认知,并比较各方在可用性测试需求和关注点上的差异,为可用性测试标准的制定提供参考。方法根据医疗器械监管对可用性的一般要求,围绕可用性测试需求、实验流程等要素设计问卷;对数据进行分析,重点考察由共性题揭示的不同受访者关于不同类型手术机器人可用性的认知差异与共识。结果基于收集的60份问卷分析发现,所有受访者均重视手术器械的基础作用和模拟手术环境的必要性,将手术任务完成率视为关键客观指标。不同类型手术机器人的可用性测试在辅助设备需求、辅助设备作用和关键客观指标上存在显著差异,试验设计有所不同。结论本研究调查了国内医用手术机器人可用性测试的现状,并通过多层次分析揭示了不同受访者在测试中的共性认知和各类型手术机器人的特定需求,为制定统一的测试标准提供了科学依据,有助于推动手术机器人在医疗领域的应用与发展。
Objective Based on current status of usability testing of medical surgical robots in China,to explore the common perceptions of enterprises,clinical practitioners and testing agencies regarding the usability testing of surgical robots,and to compare the differences in their needs and concerns regarding usability testing,aiming to provide reference for the formulation of usability testing standards.Methods According to the general requirements of medical device regulation on usability,questionnaires were designed based on factors such as usability testing needs and experimental processes.Data were analyzed to explore on the differences and consensus revealed by common questions among different respondents regarding the usability of different types of surgical robots.Results Analysis of the 60 collected questionnaires revealed that all respondents emphasized the fundamental role of surgical instruments and the necessity of simulating the surgical environment,identifying the completion rate of surgical tasks as a key objective indicator.There were significant differences in the usability testing of different types of surgical robots in terms of auxiliary equipment needs,the role of auxiliary equipment and key objective indicators,with variations in experimental design.Conclusion This study investigated the current status of usability testing of medical surgical robots in China and revealed the common perceptions of different respondents and the specific needs of various types of surgical robots in testing through multi-level analysis.It provides scientific evidence for the formulation of unified testing standards and helps promote the application and development of surgical robots in the medical field.
作者
郑勇
孟祥峰
李澍
张超
王浩
ZHENG Yong;MENG Xiangfeng;LI Shu;ZHANG Chao;WANG Hao(School of Medical Devices,Shenyang Pharmaceutical University,Shenyang Liaoning 117004,China;Institute for Medical Device Control,National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国医疗设备》
2025年第6期1-6,共6页
China Medical Devices
基金
国家重点研发计划(2022YFC2409601)。
关键词
医用手术机器人
可用性测试
医疗器械监管
人因工程
medical surgical robot
usability testing
medical device regulation
human factors engineering
