ABSTRACT
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 conformance with mandated technical standards for effective performance and device safety. 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, UK and 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.