探讨医学工程学科在医疗器械不良事件监测中的作用

摘要

Objective:To study biomedical engineers’ working function in medical device adverse events monitoring.Methods: According to the core function of biomedical engineering discipline and the related theory of adverse events, we analyzed the complexity and difficulty of medical device adverse event monitoring, pointed out the major jobs of biomedical engineers and combined with the medical device maintenance case analysis.Results: The risk management of medical device is the working focus of biomedical engineers. Biomedical engineers have professional advantages in medical device adverse event monitoring.Conclusions: Based on discipline advantages and working core functions, the biomedical engineers can report high quality medical device adverse events and analyze and deal with them in time.%目的：探讨医学工程技术人员在医疗器械不良事件监测中的工作职能。方法：参照医学工程学科核心功能与医疗器械不良事件的相关理论知识，分析医疗器械不良事件监测的复杂性和难点问题，指出医学工程技术人员工作重点所在，并结合实际设备维修案例进行分析。结果：医疗器械的风险管理是医学工程技术人员的工作重心，医学工程技术人员在医疗器械不良事件监测中具有专业优势。结论：医学工程技术人员的学科专业优势及核心职能是监测、上报医疗器械的检测结果，并能够及时分析和处理医疗器械的不良事件。