Vapor H 2 O 2 sterilization as a decontamination method for the reuse of N95 respirators in the COVID-19 emergency

  1. Ebru Oral
  2. Keith K. Wannomae
  3. Rachel Connolly
  4. Joseph Gardecki
  5. Hui Min Leung
  6. Orhun Muratoglu
  7. Anthony Griffiths
  8. Anna N. Honko
  9. Laura E. Avena
  10. Lindsay G. A. McKay
  11. Nick Flynn
  12. Nadia Storm
  13. Sierra N. Downs
  14. Ralph Jones
  15. Brandon Emmal

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Abstract

There are a variety of methods routinely used in the sterilization of medical devices using hydrogen peroxide (H 2 O 2 ) including vaporization, plasma generation and ionization. Many of these systems are used for sterilization and are validated for bioburden reduction using bacterial spores.

Here, we explored the benefits of using vaporized H 2 O 2 (VHP) treatment of N95 respirators for emergency decontamination and reuse to alleviate PPE shortages for healthcare workers in the COVID-19 emergency. The factors that are considered for the effective reuse of these respirators are the fit, the filter efficiency and the decontamination/disinfection level for SARS-CoV-2, which is the causative virus for COVID-19 and other organisms of concern in the hospital environment such as methicillin-resistant Staphylococcus aureus or Clostridium difficile . WE showed that the method did not affect fit or filter efficiency at least for one cycle and resulted in a >6 log reduction in bacterial spores and >3.8 log reduction in the infectious SARS-CoV2 load on N95 respirators.

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  1. Version published to 10.1101/2020.04.11.20062026v2 on medRxiv
  2. ScreenIT

    SciScore for 10.1101/2020.04.11.20062026: (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 Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    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:
    A limitation of the experiment is the static application of virus to the respirators unlike the clinical use cases where there is active air flow through the respirator via inhalation by the healthcare worker. This may enable the penetration of the aerosolized droplets containing the virus deeper into the respirator. Further study of the infective virus load in clinically used respirators can determine if this is a factor to be considered for decontamination methodology. While we present results for the technical and bioburden evaluation of this decontamination method for N95 respirators, there are many other considerations such as financial, and logistical ones for any medical institution to decide on a decontamination method, if any, to utilize for this emergency use situation. The results presented here are not meant to constitute a stand-alone recommendation.

    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 10.1101/2020.04.11.20062026v1 on medRxiv