A Review of Biomedical Devices: Classification, Regulatory Guidelines, Human Factors, Software as a Medical Device, and Cybersecurity
A Review of Biomedical Devices: Classification, Regulatory Guidelines, Human Factors, Software as a Medical Device, and Cybersecurity
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DOI：
10.1007/s44174-023-00113-9
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发表时间：
2023-08
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影响因子：
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通讯作者：
Felix Tettey;Santosh Kumar Parupelli;Salil Desai
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作者：
Felix Tettey;Santosh Kumar Parupelli;Salil Desai
生物医学设备在医疗保健系统中发挥着至关重要的作用，对患者的健康产生积极影响。本文旨在根据美国食品和药物管理局（FDA）的指导方针提供硬件和软件医疗器械的当前分类和子分类。概述了FDA对医疗器械开发的监管途径，如辐射电子产品验证、产品分类数据库、人道主义使用设备（HUD）、上市前批准、上市前通知和清除、上市后监督和重新分类。讨论了在生物医学器械开发中实施人为因素工程以减少用户错误、产品召回和有效安全使用风险的现状和优势。本文还回顾了诸如物联网（IoT）、作为医疗设备的软件、人工智能（AI）、机器学习（ML）、移动医疗设备和临床决策软件支持系统等不断发展的主题。全面讨论了第一个fda批准的用于诊断糖尿病视网膜病变的人工智能医疗设备。此外，还讨论了与软件驱动的AI/ML和物联网医疗设备相关的潜在网络安全相关风险，重点是政府法规。生物医学设备发展的未来趋势及其对患者护理和医疗保健系统的影响被阐明。
Biomedical devices provide a critical role in the healthcare system to positively impact patient well-being. This paper aims to provide the current classifications and subclassifications of hardware and software medical devices according to the Food and Drug Administration (FDA) guidelines. An overview of the FDA regulatory pathway for medical device development such as radiation-emitting electronic product verification, product classification database, Humanitarian Use Device (HUD), premarket approval, premarket notification and clearance, post-market surveillance, and reclassification is provided. Current advances and the advantages of implementing human factors engineering in biomedical device development to reduce the risk of user error, product recalls and effective safe use are discussed. This paper also provides a review of evolving topics such as the Internet of Things (IoT), software as medical devices, artificial intelligence (AI), machine learning (ML), mobile medical devices, and clinical decision software support systems. A comprehensive discussion of the first FDA-approved AI-medical device for the diagnosis of diabetic retinopathy is presented. Further, potential cybersecurity-related risks associated with software-driven AI/ML and IoT medical devices are discussed with an emphasis on government regulations. Futuristic trends in biomedical device development and their implications on patient care and the healthcare system are elucidated.