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Abstract

Background

The shortage of FFP2 and FFP3 respirators posed a serious threat to the operation of the healthcare system at the onset of the COVID-19 pandemic.

Aim

Our aim was to develop and validate a large-scale facility that uses hydrogen peroxide vapour for the decontamination of used respirators.

Methods

A multidisciplinary and multisectoral ad hoc group of experts representing various organisations was assembled to implement the collection and transport of used FFP2 and FFP3 respirators from hospitals covering 86% of the Finnish population. A large-scale decontamination facility using hydrogen peroxide vapour was designed and constructed. Microbiological tests were used to confirm efficacy of hydrogen peroxide vapour decontamination together with a test to assess the effect of decontamination on the filtering efficacy and fit of respirators. Bacterial and fungal growth in stored respirators was determined by standard methods.

Results

Large-scale hydrogen peroxide vapour decontamination of a range of FFP2 and FFP3 respirator models effectively reduced the recovery of biological indicators: and spores, as well as model virus bacteriophage MS2. The filtering efficacy and facial fit after hydrogen peroxide vapour decontamination were not affected by the process. Microbial growth in the hydrogen peroxide vapour-treated respirators indicated appropriate microbial cleanliness.

Conclusions

Large-scale hydrogen peroxide vapour decontamination was validated. After effective decontamination, no significant changes in the key properties of the respirators were detected. European Union regulations should incorporate a facilitated pathway to allow reuse of appropriately decontaminated respirators in a severe pandemic when unused respirators are not available.

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/content/10.2807/1560-7917.ES.2022.27.11.2100119
2022-03-17
2024-11-21
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2022.27.11.2100119
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References

  1. World Health Organization (WHO). Rational use of personal protective equipment (PPE) for coronavirus disease (COVID-19). Technical Guidance Publications. Geneva: WHO; 2020. Available from: https://www.who.int/publications/i/item/rational-use-of-personal-protective-equipment-for-coronavirus-disease-(covid-19)-and-considerations-during-severe-shortages
  2. The European Parliament and the Council of the European Union. Regulation 2016/425 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC. Official Journal of the European Union. Luxembourg: Publications Office of the European Union. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0425&rid=4
  3. United States. (US) Food and Drug Administration (FDA). US FDA letter to the Battelle Institute, 6 Jun, 2020. Silver Spring: FDA; 2020. Available from: https://www.fda.gov/media/136529/download
  4. Rutala WA, Weber DJ. Disinfectants used for environmental disinfection and new room decontamination technology. Am J Infect Control. 2013;41(5) Suppl;S36-41.  https://doi.org/10.1016/j.ajic.2012.11.006  PMID: 23622746 
  5. Schwartz A, Stiegel M, Greeson N, Vogel A, Thomann W, Brown M, et al. Decontamination and Reuse of N95 Respirators with Hydrogen Peroxide Vapor to Address Worldwide Personal Protective Equipment Shortages During the SARS-CoV-2 (COVID-19) Pandemic. Applied Biosafety: J ABSA Internat, 2020;25:67-70. Available from: https://journals.sagepub.com/doi/pdf/10.1177/1535676020919932
  6. Rodriguez-Martinez CE, Sossa-Briceño MP, Cortés JA. Decontamination and reuse of N95 filtering facemask respirators: A systematic review of the literature. Am J Infect Control. 2020;48(12):1520-32.  https://doi.org/10.1016/j.ajic.2020.07.004  PMID: 32652253 
  7. Viscusi DJ, Bergman MS, Eimer BC, Shaffer RE. Evaluation of five decontamination methods for filtering facepiece respirators. Ann Occup Hyg. 2009;53(8):815-27. PMID: 19805391 
  8. United States. (US) Food and Drug Administration (FDA). Final report for the Bioquell hydrogen peroxide vapor (HPV) decontamination for reuse of N95 respirators. Silver Spring: FDA; 2016. Available from: https://www.fda.gov/media/ 136386/download
  9. Fischer RJ, Morris DH, van Doremalen N, Sarchette S, Matson MJ, Bushmaker T, et al. Effectiveness of N95 respirator decontamination and reuse against SARS-CoV-2 virus. Emerg Infect Dis. 2020;26(9):2253-5.  https://doi.org/10.3201/eid2609.201524  PMID: 32491983 
  10. Polkinghorne A, Branley J. Evidence for decontamination of single-use filtering facepiece respirators. J Hosp Infect. 2020;105(4):663-9.  https://doi.org/10.1016/j.jhin.2020.05.032  PMID: 32473179 
  11. Seresirikachorn K, Phoophiboon V, Chobarporn T, Tiankanon K, Aeumjaturapat S, Chusakul S, et al. Decontamination and reuse of surgical masks and N95 filtering facepiece respirators during the COVID-19 pandemic: A systematic review. Infect Control Hosp Epidemiol. 2021;42(1):25-30.  https://doi.org/10.1017/ice.2020.379  PMID: 32729444 
  12. Peltier RE, Wang J, Hollenbeck BL, Lanza J, Furtado RM, Cyr J, et al. Addressing decontaminated respirators: Some methods appear to damage mask integrity and protective function. Infect Control Hosp Epidemiol. 2020;41(12):1446-8.  https://doi.org/10.1017/ice.2020.332  PMID: 32669135 
  13. O’Hearn K, Gertsman S, Webster R, Tsampalieros A, Ng R, Gibson J, et al. Efficacy and safety of disinfectants for decontamination of N95 and SN95 filtering facepiece respirators: a systematic review. J Hosp Infect. 2020;106(3):504-21.  https://doi.org/10.1016/j.jhin.2020.08.005  PMID: 32800824 
  14. Sickbert-Bennett EE, Samet JM, Clapp PW, Chen H, Berntsen J, Zeman KL, et al. Filtration efficiency of hospital face mask alternatives available for use during the COVID-19 pandemic. JAMA Intern Med. 2020;180(12):1607-12.  https://doi.org/10.1001/jamainternmed.2020.4221  PMID: 32780113 
  15. Heinonen K, Kulmala I, Humppi T. Process and device for generating vaporous hydrogen peroxide. Patent. 2017. Available from: https://patents.google.com/patent/FI127118B/en?oq=FI127118B
  16. Hakkarainen H. Disinfecting device and method for disinfecting. Patent. 2018. Available from: https://patents.google.com/patent/WO2018050956A1/en?oq=WO+2018%2f050956+Al
  17. Finnish Standards Association (SFS). SFS-EN 14683:2019+AC:2019 for bacterial and fungal growth. Medical face masks - Requirements and test methods - European Standards. Helsinki: SFS; 2022. Available from: https://sales.sfs.fi/fi/index/tuotteet/SFS/CEN/ID2/1/798521.html.stx
  18. iTec Inc. SFS-EN 149:2001+A1:2010 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking. Newark: iTec Inc; 2022. Available from: https://standards.iteh.ai/catalog/standards/cen/f440f60a-91c1-497b-815e-4e9d46436256/en-149-2001a1-2009
  19. Wilkinson IJ, Pisaniello D, Ahmad J, Edwards S. Evaluation of a large-scale quantitative respirator-fit testing program for healthcare workers: survey results. Infect Control Hosp Epidemiol. 2010;31(9):918-25.  https://doi.org/10.1086/655460  PMID: 20658919 
  20. Zhuang Z, Bergman M, Lei Z, Niezgoda G, Shaffer R. Recommended test methods and pass/fail criteria for a respirator fit capability test of half-mask air-purifying respirators. J Occup Environ Hyg. 2017;14(6):473-81.  https://doi.org/10.1080/15459624.2017.1296233  PMID: 28278067 
  21. Grossman J, Pierce A, Mody J, Gagne J, Sykora C, Sayood S, et al. Institution of a novel process for N95 respirator disinfection with vaporized hydrogen peroxide in the setting of the COVID-19 pandemic at a large academic medical center. J Am Coll Surg. 2020;231(2):275-80.  https://doi.org/10.1016/j.jamcollsurg.2020.04.029  PMID: 32353399 
  22. Perkins DJ, Villescas S, Wu TH, Muller T, Bradfute S, Hurwitz I, et al. COVID-19 global pandemic planning: Decontamination and reuse processes for N95 respirators. Exp Biol Med (Maywood). 2020;245(11):933-9.  https://doi.org/10.1177/1535370220925768  PMID: 32397762 
  23. Russo R, Levine C, Grady C, Peixoto B, McCormick-Ell J, Block T, et al. Decontaminating N95 respirators during the Covid-19 pandemic: simple and practical approaches to increase decontamination capacity, speed, safety and ease of use. medRxiv. 2020 . https://doi.org/10.1101/2020.08.17.20177022 
  24. Jatta M, Kiefer C, Patolia H, Pan J, Harb C, Marr LC, et al. N95 reprocessing by low temperature sterilization with 59% vaporized hydrogen peroxide during the 2020 COVID-19 pandemic. Am J Infect Control. 2021;49(1):8-14.  https://doi.org/10.1016/j.ajic.2020.06.194  PMID: 32599102 
  25. Widmer AF, Richner G. Proposal for a EN 149 acceptable reprocessing method for FFP2 respirators in times of severe shortage. Antimicrob Resist Infect Control. 2020;9(1):88.  https://doi.org/10.1186/s13756-020-00744-3  PMID: 32552867 
  26. Oral E, Wannomae K, Connolly R, Gardecki J, Leung HM, Muratoglu O. Vaporized H2O2 decontamination against surrogate viruses for the reuse of N95 respirators in the COVID-19 emergency. medRxiv. 2020. Preprint  https://doi.org/10.1101/2020.06.25.20140269 
  27. United States Centers for Disease Control and Prevention (CDC). Biosafety in Microbiological and Biomedical Laboratories. Appendix B: Decontamination and Disinfection. 5th edition. Atlanta: CDC; 2009. Available from: https://www.cdc.gov/labs/pdf/CDC-BiosafetyMicrobiologicalBiomedicalLaboratories-2009-P.PDF
  28. Ludwig-Begall LF, Wielick C, Dams L, Nauwynck H, Demeuldre P-F, Napp A, et al. The use of germicidal ultraviolet light, vaporized hydrogen peroxide and dry heat to decontaminate face masks and filtering respirators contaminated with a SARS-CoV-2 surrogate virus. J Hosp Infect. 2020;106(3):577-84.  https://doi.org/10.1016/j.jhin.2020.08.025  PMID: 32889029 
  29. National Institute for Public Health and the Environment, Ministry of Health, Welfare and Sport (RIVM). Reuse of FFP2 masks. Bilthoven: RIVM; 2020. Available from: https://www.rivm.nl/en/documenten/reuse-of-ffp2-masks
  30. Levine C, Grady C, Block T, Hurley H, Russo R, Peixoto B, et al. Use, re-use or discard? Quantitatively defined variance in the functional integrity of N95 respirators following vaporized hydrogen peroxide decontamination during the COVID-19 pandemic. J Hosp Infect. 2021;107:50-6.  https://doi.org/10.1016/j.jhin.2020.10.007  PMID: 33075406 
  31. Lieu A, Mah J, Zanichelli V, Exantus RC, Longtin Y. Impact of extended use and decontamination with vaporized hydrogen peroxide on N95 respirator fit. Am J Infect Control. 2020;48(12):1457-61.  https://doi.org/10.1016/j.ajic.2020.08.010  PMID: 32805321 
  32. European Commission (EC). Council Directive 89/656/EEC of the Council of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16 (1) of Directive 89/391/EE). Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31989L0656&from=en
  33. European Centre for Disease Prevention and Control (ECDC). Cloth masks and mask sterilisation as options in case of shortage of surgical masks and respirators Use of cloth face masks for protection against COVID-19 in clinical settings. Stockholm: ECDC; 2020. Available from: https://www.ecdc.europa.eu/en/publications-data/cloth-masks-sterilisation-options-shortage-surgical-masks-respirators
  34. Simpson S, Kaufmann MC, Glozman V, Chakrabarti A. Disease X: accelerating the development of medical countermeasures for the next pandemic. Lancet Infect Dis. 2020;20(5):e108-15.  https://doi.org/10.1016/S1473-3099(20)30123-7  PMID: 32197097 
  35. Simpson S, Chakrabarti A, Robinson D, Chirgwin K, Lumpkin M. Navigating facilitated regulatory pathways during a disease X pandemic. NPJ Vaccines. 2020;5(1):101.  https://doi.org/10.1038/s41541-020-00249-5  PMID: 33110630 
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