De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response

  1. Akshay Kothakonda
  2. Lyla Atta
  3. Deborah Plana
  4. Ferrous Ward
  5. Chris Davis
  6. Avilash Cramer
  7. Robert Moran
  8. Jacob Freake
  9. Enze Tian
  10. Ofer Mazor
  11. Pavel Gorelik
  12. Christopher Van
  13. Christopher Hansen
  14. Helen Yang
  15. Yao Li
  16. Michael S. Sinha
  17. Ju Li
  18. Sherry H. Yu
  19. Nicole R. LeBoeuf
  20. Peter K. Sorger

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Abstract

The rapid spread of COVID-19 and disruption of normal supply chains has resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information describing design and performance criteria for PAPRs represents a substantial barrier to mitigating shortages. We sought to apply open-source product development (OSPD) to PAPRs to enable alternative sources of supply and further innovation. We describe the design, prototyping, validation, and user testing of locally manufactured, modular, PAPR components, including filter cartridges and blower units, developed by the Greater Boston Pandemic Fabrication Team (PanFab). Two designs, one with a fully custom-made filter and blower unit housing, and the other with commercially available variants (the “Custom” and “Commercial” designs, respectively) were developed; the components in the Custom design are interchangeable with those in Commercial design, although the form factor differs. The engineering performance of the prototypes was measured and safety validated using National Institutes for Occupational Safety and Health (NIOSH)-equivalent tests on apparatus available under pandemic conditions at university laboratories. Feedback was obtained from four individuals; two clinicians working in ambulatory clinical care and two research technical staff for whom PAPR use is standard occupational PPE; these individuals were asked to compare PanFab prototypes to commercial PAPRs from the perspective of usability and suggest areas for improvement. Respondents rated the PanFab Custom PAPR a 4 to 5 on a 5 Likert-scale 1) as compared to current PPE options, 2) for the sense of security with use in a clinical setting, and 3) for comfort compared to standard, commercially available PAPRs. The three other versions of the designs (with a Commercial blower unit, filter, or both) performed favorably, with survey responses consisting of scores ranging from 3 to 5. Engineering testing and clinical feedback demonstrate that the PanFab designs represent favorable alternatives to traditional PAPRs in terms of user comfort, mobility, and sense of security. A nonrestrictive license promotes innovation in respiratory protection for current and future medical emergencies.

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  1. Version published to 10.3389/fbioe.2021.690905
  2. ScreenIT

    SciScore for 10.1101/2021.03.25.21252076: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisThe tests were carried out across several university laboratories on the filters, blowers, power systems, control and warning systems, and the seals between components.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: Thank you for sharing your code and data.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Given the limitations imposed by pandemic conditions, it was necessary to use substitute tests in university laboratories rather than use a NIOSH-specific apparatus at a commercial pre-certification laboratory. PanFab PAPRs passed all of the performed tests, in various combinations of commercial and custom components. User feedback on the PAPRs was obtained from clinicians inexperienced in using PAPRs and technical research staff who routinely use PAPRs in a major Boston-area hospital. The PanFab Custom Design scored favorably as compared to the traditionally manufactured PAPRs (primarily from ILC Dover) available to hospital staff. Challenges in design, testing, and regulatory approval: During early specification and prototyping, we faced significant challenges in locating relevant design criteria for PAPRs: there also exists very limited information in the public domain on testing equipment that could be used to validate prototypes based on physical properties and objective engineering criteria. Answers to questions such as minimum time of continuous operation required, relevant material characteristics for facepiece fabrics, and appropriate materials for components in the pathway for inhaled, filtered air were not readily available. We therefore sought out experts with relevant expertise. Substantial time and effort would have been saved had a centralized resource of information been available. To streamline the process for future crises, we have consolidated relevant info...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

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  3. Version published to 10.1101/2021.03.25.21252076v1 on medRxiv