便携急救呼吸机基于临床使用的特殊风险  

Special Risk of Using Portable Emergency Ventilator Based on Clinical Application

作　　者：许玉林[1] XU Yulin(University of Shanghai for Science and Technology,Shanghai,200093)

机构地区：[1]上海理工大学,上海市200093

出　　处：《中国医疗器械杂志》2020年第4期319-321,共3页Chinese Journal of Medical Instrumentation

摘　　要：医疗器械风险管理包括医疗器械的全生命周期,对保障患者的生命安全和身体健康具有重大的意义。现有医疗器械的风险管理特别是研发阶段的风险分析往往流于形式,很容易忽略掉研发产品在临床应用场景下所面临的特殊风险。该研究通过便携急救呼吸机临床应用过程面临的几个特殊危害源分析举例,来证明医疗器械研发阶段的风险分析和临床实际应用相结合的必要性和重要性。Risk management of medical devices covers the whole life cycle of medical devices, which is of great significance to the life safety and health condition of patients. The existing risk management of medical devices, especially the risk analysis in the research and development stage, often becomes a mere formality. The special risks faced by the research and development products in the clinical application scenarios are not well addressed. This study proves the necessity and importance of the combination of risk analysis and clinical application in the research and development stage of medical devices by the analysis of several special hazard sources in the process of clinical application of portable emergency ventilator.

关 键 词：风险管理 便携急救呼吸机 特殊风险 

分 类 号：R197.39[医药卫生—卫生事业管理]