Open Ventilator Evaluation Framework: A Synthesized Database of Regulatory Requirements and Technical Standards for Emergency Use Ventilators from Australia, Canada, UK, and US

The development of emergency use ventilators has attracted significant attention and resources during the COVID-19 pandemic. To facilitate mass collaboration and accelerate progress, many groups have adopted open-source development models, inspired by the long history of open-source development in software. According to the
Open-source Hardware Association (OSHWA), Open-source Hardware (OSH) is a term for tangible artifacts - machines, devices, or other physical things - whose design has been released to the public in such a way that anyone can make, modify, and use
them. One major obstacle to translating the growing body of work on open-source ventilators into clinical practice is compliance with regulations and technical standards for the effective performance and safety of medical devices. This is exacerbated by the inherent complexity of the regulatory process which is tailored to traditional centralized development models, as well as the rapid changes and alternative pathways that have emerged during the pandemic. As a step in addressing this challenge, this paper provides developers, evaluators, and potential users of emergency ventilators with the
first iteration of a pragmatic, open-source assessment framework that incorporates existing regulatory guidelines from Australia, Canada, the UK, and the USA. We also provide an example evaluation for one open-source emergency ventilator design. The evaluation process has been divided into three levels: 1. Adequacy of open-source project documentation; 2. Clinical performance requirements, and 3. Conformance with technical standards.

在新冠疫情（COVID-19 pandemic）期间，急救用呼吸机的研发工作吸引了大量关注与资源投入。为推动大规模协作、加快研发进度，诸多团队借鉴软件领域开源开发的悠久历史经验，采用了开源研发模式。根据开源硬件协会（Open-source Hardware Association, OSHWA）的定义，开源硬件（Open-source Hardware, OSH）指一类有形物理制品——包括机械、设备或其他实物，其设计已向公众公开，任何人均可对其进行制造、修改与使用。将日益丰富的开源呼吸机研发成果转化为临床应用的主要障碍之一，是需满足医疗设备有效性能与安全相关的法规及技术标准要求。针对传统集中式研发模式量身定制的监管流程本身固有复杂性，叠加疫情期间涌现出的监管政策快速调整与替代审批路径，进一步加剧了这一难题。为应对这一挑战，本文为急救呼吸机的研发者、评估者与潜在使用者提供了首个务实的开源评估框架（第一版），该框架整合了澳大利亚、加拿大、英国及美国现行的监管指南。同时，本文还针对一款开源急救呼吸机设计方案提供了示例评估。本次评估流程分为三个层级：1. 开源项目文档完备性；2. 临床性能要求；3. 技术标准符合性。