Xu Yulin
University of Shanghai for Science and Technology, Shanghai, 200093.
Zhongguo Yi Liao Qi Xie Za Zhi. 2020 Apr 8;44(4):319-321. doi: 10.3969/j.issn.1671-7104.2020.04.008.
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.
医疗器械风险管理覆盖医疗器械的整个生命周期，这对患者的生命安全和健康状况具有重要意义。现有的医疗器械风险管理，尤其是研发阶段的风险分析，往往流于形式。研发产品在临床应用场景中面临的特殊风险未得到很好解决。本研究通过对便携式急救呼吸机临床应用过程中几个特殊危险源的分析，证明了在医疗器械研发阶段将风险分析与临床应用相结合的必要性和重要性。
