Regulatory and Safety Considerations in Deploying a Locally Fabricated, Reusable Face Shield in a Hospital Responding to the COVID-19 Pandemic

  1. Arash Mostaghimi
  2. Marc-Joseph Antonini
  3. Deborah Plana
  4. Philip D. Anderson
  5. Brandon Beller
  6. Edward W. Boyer
  7. Amber Fannin
  8. Jacob Freake
  9. Richard Oakley
  10. Michael S. Sinha
  11. Leanne Smith
  12. Christopher Van
  13. Helen Yang
  14. Peter K. Sorger
  15. Nicole R. LeBoeuf
  16. Sherry H. Yu

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Abstract

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  1. Version published to 10.1016/j.medj.2020.06.003
  2. ScreenIT

    SciScore for 10.1101/2020.04.11.20061960: (What is this?)

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

    Table 1: Rigor

    NIH rigor criteria are not applicable to paper type.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Design and cutting of the transparent visor and the foam pad: The transparent visor was designed using InkScape software to match the pegs of the 3D-printed headband.
    InkScape
    suggested: (Inkscape, RRID:SCR_014479)
    Study subjects were provided with a fact sheet and verbal consent was obtained (Partners Healthcare IRB: 2020P00910, Supplementary Material 1).
    Partners Healthcare
    suggested: (Partners HealthCare Biobank, RRID:SCR_001316)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Lessons Learned: The global pandemic has put extreme pressure on health care systems and highlighted many weaknesses in the highly centralized supply chains that have developed for critical medical supplies. Local manufacturing represents an alternative source of supply in an emergency that has potential to rapidly address these shortages. Community-level disaster resilience is well-recognized as essential in responses to both natural disasters and public health emergencies,14 but the role of local manufacturing and maker communities in medical supply chains has not previously been considered part of such resiliency. We strongly believe that this should change and that such change will require refinement of regulatory and institutional policies. Hospitals should integrate individuals with engineering and manufacturing expertise into their incident command structure and prioritize longitudinal relationships with the local fabrication and maker communities well before an emergency happens. Our experience highlights the fact that individuals with the necessary medical, engineering and managerial experience already exist in many academic medical centers; such individuals need to be included in future pandemic planning. The creation of research protocols for PPE testing could also bring much needed innovation in normal times. Studies over a period of at least 15 years by the US National Academies of Sciences and other US government bodies15 have repeatedly highlighted the need for...

    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

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2020.04.11.20061960v1 on medRxiv