基于V模型的大型医学影像设备应用质量评价方法的研究.pdfVIP

专 栏 FEATURES 基于V模型的大型医学影像设备应用质 量评价方法的研究 Study on the Application Quality Evaluation Method for Digital Medical Equipment Based on the V Model 储呈晨，郑蕴欣，姜瑞瑶， [摘要] 为了规范大型医学影像设备应用质量管理，保障其临床使用质量和安全，从临床使用环 王龙辰，毕帆，杨海，许修，李斌 节和售后保障环节角度，利用V模型验证思想，提出了一种在用大型医学影像设备质量验证V模 上海交通大学附属第六人民医院 医学 型。在V模型的指导下，对各层级建立验证问题发现机制，系统地管理在用大型医学影像设备质 装备处，上海 200233 量，帮助医院设备管理者开展设备的运行优化、维修策略制定、性能评估和安全管理等工作。 [关键词] 大型医学影像设备；应用质量；V模型 Abstract: In order to standardize the management of large medical imaging equipment and safeguard the application quality and safety in clinical, this paper proposed a V-model quality verification method for large medical equipment from two aspects (clinical application and after-sale services). Under the guidance of V model, the problem verification and discovery mechanism was established at all levels, which made large medical equipment managed in a systematic way and help the equipment managers to CHU Cheng-chen, ZHENG Yun-xin, optimize the operation of the equipment, plan the maintenance strategy, evaluate performance, control the JIANG Rui-yao, WANG Long-chen, safety of equipment and do the other work in the hospital. BI Fan, YANG Hai, XU Xiu, LI Bin Key words: large medical imaging equipment; application quality; V model Department of Medical Equipment, Shanghai Jiao Tong University Affiliated [中图分类号] R319 ；R445 [文献标志码] A Sixth People’s Hospital, Shanghai 200233, doi ：10.3969/j.issn.1674-1633.2016.10.002 China [文章编号] 1674-1633(2016)10-0006-03 0 引言 针对目前一些医院在医疗设备维护维修方面过分依赖售后 2015 年 10 月21 日国家食品药品监督管理总局发布了 服务方，不能全面、科学地对服务后的设备质量进行有效 [1] ，第三章中详细规定 《医疗器械使用质量监督