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Open ventilator evaluation framework: A synthesized database of regulatory requirements and technical standards for emergency use ventilators from Australia, Canada, UK, and US.
Kazlovich, Kate; Mishra, Soumya Ranjan; Behdinan, Kamran; Gladman, Aviv; May, Jesse; Mashari, Azad.
  • Kazlovich K; Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON, Canada.
  • Mishra SR; Department of Anesthesiology and Pain Management, Toronto General Hospital, University Health Network, Toronto, ON, Canada.
  • Behdinan K; Department of Mechanical and Industrial Engineering, University of Toronto, Toronto, ON, Canada.
  • Gladman A; Department of Mechanical and Industrial Engineering, University of Toronto, Toronto, ON, Canada.
  • May J; Mackenzie Richmond Hill Hospital, Toronto, ON, Canada.
  • Mashari A; Department of Anesthesiology and Pain Medicine, University of Toronto, ON, Canada.
HardwareX ; 11: e00260, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1611945
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.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: HardwareX Year: 2022 Document Type: Article Affiliation country: J.ohx.2022.e00260

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: HardwareX Year: 2022 Document Type: Article Affiliation country: J.ohx.2022.e00260