胰岛素泵可用性评价  

Usability Evaluation of Insulin Pumps

作　　者：邓振进 周倩 秦婷 吴碧涛 陈新平 谢莉凤 石蓉 DENG Zhen-jin;ZHOU Qian;QIN Ting;WU Bi-tao;CHEN Xin-ping;XIE Li-feng;SHI Rong(Hunan Institute for Drug Control;Sinocare Inc.)

机构地区：[1]湖南省药品检验检测研究院 [2]三诺生物传感股份有限公司

出　　处：《中国标准化》2024年第21期236-243,共8页China Standardization

基　　金：湖南省自然科学基金科药联合项目“胰岛素泵的可用性研究”(项目编号:2024JJ8231)资助。

摘　　要：目的:从医疗器械安全有效性评价角度出发,利用总结性评价的方法对贴敷式胰岛素泵人机交互的可用性进行研究。方法:通过识别贴敷式胰岛素泵使用有关的重要特征、经常使用的功能、与可用性相关的危险(源)和危险情况以及基本的操作功能,利用总结性可用性测试的方法来验证和确认贴敷式胰岛素泵的可用性,通过招募预期使用人群来进行产品的可用性评价,模拟真实使用场景,获取普通用户群组(包括未成年糖尿病患者群组)和临床医护人员关于贴敷式胰岛素泵可用性的真实评价与反馈,对验证和确认数据进行分析和评估;结果:通过总结性可用性测试发现贴敷式胰岛素泵结果表明,两组关键任务正确使用率基本达90%及以上,产品不存在不可接受的使用风险,表明贴敷式胰岛素泵系统可用性较佳;该产品由专业医护人员和非专业人员使用无显著差异(P>0.05)。结论:本文提供了一款贴敷式胰岛素泵可用性测试的方案和测试结果分析方法,为市场上同类产品采用总结性可用性测试进行可用性研究提供指导和参考。Objective:From the perspective of evaluating the safety and effectiveness of medical devices,this paper aims to research the usability of human-machine interaction of insulin patch pumps through a summative evaluation method.Method:By identifying important characteristics related to the use of insulin patch pumps,frequently used functions,usability-related hazards and hazardous situations,and basic operational functions,the usability of insulin patch pumps is verified and confirmed through summative usability testing.Usability evaluation of the product is conducted by recruiting the intended users to simulate real usage scenarios,obtaining genuine evaluations and feedback on the usability of insulin patch pumps from ordinary user groups(including underage diabetic patient groups)and clinical medical staff,and analyzing and assessing the verification and confirmation data.Result:The result of summative usability testing shows that the correct usage rate for key tasks generally reached 90%and above,and there is no unacceptable use risk,indicating good system usability of the insulin patch pumps.And there is no significant difference in the use of insulin patch pumps between professionals and non-professionals(P﹥0.05).Conclusion:This paper provides a usability testing scheme and a method for analyzing test results for a insulin patch pump.It provides guidance and reference for usability studies using summative usability testing for similar products in the market.

关 键 词：胰岛素泵 可用性 风险分析 关键任务 

分 类 号：TH77[机械工程—仪器科学与技术]