基于质量功能展开的新型医院感染预防控制医疗检测装置设计研究  

Design research on a novel medical detection device for hospital infection prevention and control based on quality function deployment

作　　者：刘诗蕊 彭哲龚 刘本德[2] 漆炼 Liu Shirui;Peng Zhegong;Liu Bende;Qi Lian(School of Industrial Design,Hubei University of Technology,Wuhan 430068,China;Emergency Center Department,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430074,China)

机构地区：[1]湖北工业大学工业设计学院,武汉430068 [2]华中科技大学同济医学院附属协和医院急救中心,武汉430023

出　　处：《中国医学装备》2025年第4期143-149,共7页China Medical Equipment

基　　金：湖北省科技厅重点攻关项目(2020FCA022)。

摘　　要：目的:设计并优化基于通过质量功能展开(QFD)的新型医院感染预防控制医疗检测装置,提升医疗检测的安全性与预防控制效能。方法:通过QFD方法对医院感染预防控制装置的设计需求进行系统分析,整合用户需求并转化为具体的技术特性,设计基于QFD的新型医院感染预防控制医疗检测装置。采用实验室测试、模拟临床测试和华中科技大学同济医学院附属协和医院50例新型冠状病毒感染受试患者小规模临床试验,评估该装置在临床中的操作便捷性、结果可靠性和安全性。结果:设计出一款集样品处理、反应检测与病原体灭活于一体的密闭式检测装置,降低操作风险,提升检测效率。实验室测试该装置的检测灵敏度为97.5%,特异度为95.2%,重复性误差<±1.5%;模拟临床中检测时间由传统设备检测的30 min缩减为21 min;临床试验检测50例受试者的检测准确率为96.8%,每项平均检测时间为3.5 min。结论:通过QFD方法设计并优化的新型医院感染预防控制医疗检测装置,能够提高医疗检测的安全性和效率,降低操作过程中的生物安全风险,为医疗检测设备在医院感染预防控制设计提供重要理论支撑。Objective:To design and optimize a novel medical detection device of prevention and control for nosocomial infection based on quality function deployment(QFD),so as to enhance the safety and prevention efficiency of medical test.Methods:The design requirements of the device of prevention and control for nosocomial infection were systematically analyzed through QFD method.The requirements of users were integrated and converted into special technical characteristics.And then,the novel medical detection device of prevention and control for nosocomial infection based on QFD was designed.Laboratory testing,simulated clinical testing,and a small-scale clinical trial involved 50 patients from Union Hospital,Tongji Medical College,Huazhong University of Science and Technology were adopted to assess the convenience of operation,and reliability and safety of the results of this device in clinical work.Results:A closed detection device that integrated processing sample,reaction detection and pathogen inactivation was designed,which could reduce operational risks and improve detection efficiency.The sensitivity and specificity of the detection of this device were respectively 97.5%and 95.2%in test of laboratory,and error of repeatability was less than±1.5%.The test time of that was shortened from 30 min of test by conventional equipment to 21 min.The accuracy rate of that in testing 50 patients of clinical trial was 96.8%,and average testing time of each case was 3.5 minutes.Conclusion:The novel medical detection device of prevention and control for nosocomial infection that is designed and optimized by QFD method can effectively enhance the safety and efficiency of medical test,and reduce biosafety risks during operations process.It can provide important theoretical support for the design of medical test device in prevention and control for nosocomial infection.

关 键 词：医院感染预防控制 医疗检测设备 质量功能展开(QFD) 病原体胶体金法 设备设计 

分 类 号：R197.39[医药卫生—卫生事业管理]