医疗设备计量检测标准化管理问题探讨  

Discussion on Standardization Management of Medical Equipment Measurement and Testing

作　　者：黄晨 王宝月 HUANG Chen;WANG Bao-yue(Medical Electrical Laboratory,Jilin Institute of Medical Device Inspection,Jilin Changchun 130062;Department of Electrodiagnosis,Jilin FAW General Hospital,Jilin Changchun 130011)

机构地区：[1]吉林省医疗器械检验研究院医用电气检验室,吉林长春130062 [2]吉林省一汽总医院电诊科,吉林长春130011

出　　处：《中国医疗器械信息》2024年第13期43-46,共4页China Medical Device Information

摘　　要：医疗设备计量检测一直是备受各级医疗系统重视的议题,然而,由于医疗设备的多样性、来源的广泛性,以及医疗机构水平和层次差距较大等原因,其标准化进程尚未与医疗产业的发展完全同步,这种不匹配在很大程度上限制了检测工作的精确性和准确性,进而对医疗服务质量产生了不利影响,给患者的就医体验带来了负面效应。深入探讨医疗设备计量检测的标准化管理问题,具有重要的理论和实践意义,具有现实紧迫性。文章以医疗设备计量检测标准化管理问题探讨为主题,按照理论联系实际和“是什么?”“为什么?”“怎么办?”的思路,层层递进分别论述了相关概念、主要要点、工作流程及注意事项等内容,并简要介绍了无菌化条件背景下实施医疗设备计量检测的方式方法。The article explores the issue of standardized management in the metrological testing of medical equipment,a topic that has been of great concern at all levels of the healthcare system.However,due to the diversity of medical equipment,the broad range of sources,and significant disparities in the levels and standards of medical institutions,the process of standardization has not kept pace with the development of the medical industry.This mismatch greatly limits the precision and accuracy of testing work,adversely affecting the quality of medical services and negatively impacting patients’experiences.Therefore,it is of significant theoretical and practical importance and of urgent relevance to delve into the standardized management issues of medical equipment metrological testing.The article adopts a step-by-step approach,linking theory with practice and addressing the questions of“What is it?”,“Why is it necessary?”,and“How can it be achieved?”.It discusses relevant concepts,key points,workflows,and precautions,and briefly introduces methods for conducting metrological testing of medical equipment under sterile conditions.

关 键 词：医疗设备 计量检测 标准化管理 无菌化背景 

分 类 号：A715[哲学宗教—马克思主义哲学]