工艺与制造英文2023被引 86
生物医学器械综述：分类、监管指南、人因工程、医疗器械软件及网络安全
A Review of Biomedical Devices: Classification, Regulatory Guidelines, Human Factors, Software as a Medical Device, and Cybersecurity
Felix Tettey, Santosh Kumar Parupelli, Salil Desai · North Carolina Agricultural and Technical State University
摘要整理
生物医学器械在医疗卫生系统中发挥关键作用，对患者健康产生积极影响。本文根据美国食品药品监督管理局（FDA）指南，阐述了硬件和软件医疗器械的现行分类及子分类体系。介绍了FDA医疗器械开发的监管途径，包括放射性电子产品验证、产品分类数据库、人道主义用途器械（HUD）、上市前批准、上市前通知与许可、上市后监测及重新分类等环节。讨论了在生物医学器械开发中实施人因工程的最新进展和优势，以降低用户错误风险、减少产品召回并确保安全使用。本文系统综述了物联网（IoT）、医疗器械软件、人工智能（AI）、机器学习（ML）、移动医疗器械和临床决策支持系统等新兴领域的发展动态。重点阐述了FDA首次批准的用于糖尿病视网膜病变诊断的AI医疗器械的应用情况。进一步分析了与软件驱动型AI/ML和IoT医疗器械相关的网络安全风险，强调了政府监管的重要性。最后展望了生物医学器械开发的未来趋势及其对患者护理和医疗卫生系统的影响。
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