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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.

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.

SUBMITTER: Kazlovich K

PROVIDER: S-EPMC8752315 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The "place-consciousness" of public health professionals is on the rise as spatial analyses and Geographic Information Systems (GIS) are rapidly becoming key components of their toolbox. However, "place" is most useful at its most precise, granular scale - which increases identification risks, thereby clashing with privacy issues. This paper describes the views and requirements of public health professionals in Canada and the UK on privacy issues and spatial data, as collected through a web-based survey.Perceptions on the impact of privacy were collected through a web-based survey administered between November 2006 and January 2007. The survey targeted government, non-government and academic GIS labs and research groups involved in public health, as well as public health units (Canada), ministries, and observatories (UK). Potential participants were invited to participate through personally addressed, standardised emails.Of 112 invitees in Canada and 75 in the UK, 66 and 28 participated in the survey, respectively. The completion proportion for Canada was 91%, and 86% for the UK. No response differences were observed between the two countries. Ninety three percent of participants indicated a requirement for personally identifiable data (PID) in their public health activities, including geographic information. Privacy was identified as an obstacle to public health practice by 71% of respondents. The overall self-rated median score for knowledge of privacy legislation and policies was 7 out of 10. Those who rated their knowledge of privacy as high (at the median or above) also rated it significantly more severe as an obstacle to research (P < 0.001). The most critical cause cited by participants in both countries was bureaucracy.The clash between PID requirements - including granular geography - and limitations imposed by privacy and its associated bureaucracy require immediate attention and solutions, particularly given the increasing utilisation of GIS in public health. Solutions include harmonization of privacy legislation with public health requirements, bureaucratic simplification, increased multidisciplinary discourse, education, and development of toolsets, algorithms and guidelines for using and reporting on disaggregate data.

Dataset Information

Open ventilator evaluation framework: A synthesized database of regulatory requirements and technical standards for emergency use ventilators from Australia, Canada, UK, and US.

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