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Extended use or reuse of N95 respirators during COVID-19 pandemic: An overview of national regulatory authority recommendations

Published online by Cambridge University Press:  22 April 2020

Leticia Mitiko Kobayashi
Affiliation:
Fundação Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Rio de Janeiro, RJ, Brazil
Bianca Ramos Marins
Affiliation:
Departamento de Saúde Coletiva, Universidade Federal do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil
Patrícia Cristina dos Santos Costa
Affiliation:
Departamento de Ciências Fisiológicas, Universidade Federal do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil
Hugo Perazzo
Affiliation:
Fundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, RJ, Brazil
Rodolfo Castro*
Affiliation:
Fundação Oswaldo Cruz, Escola Nacional de Saúde Pública Sergio Arouca, Rio de Janeiro, RJ, Brazil Universidade Federal do Estado do Rio de Janeiro, Instituto de Saúde Coletiva, Rio de Janeiro, RJ, Brazil
*
Author for correspondence: Rodolfo Castro, E-mail: rodolfoalcastro@gmail.com; rodolfo.castro@fiocruz.br.
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Abstract

Type
Letter to the Editor
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© 2020 by The Society for Healthcare Epidemiology of America. All rights reserved.

To the Editor—We read with great interest the article by Wang et al Reference Wang and Yu1 and the study by Cheng et al Reference Cheng, Wong and Chen2 that highlighted the vital role of N95 respirators for preventing SARS-CoV-2 transmission and COVID-19 among healthcare workers (HCWs). The protective role of N95 respirators in other respiratory diseases could be translated to tackle the COVID-19 pandemic. Reference Wang and Yu1 Preliminary results in Hong Kong demonstrated that the use of N95 respirators for triage, for medical care of suspected or confirmed cases and during aerosol-generating procedures, drastically reduced COVID-19 infection among HCWs. Reference Cheng, Wong and Chen2 We acknowledge that the effectiveness of N95 respirators to prevent SARS-CoV-2 transmission should be confirmed and their use in clinical practice should be supported during the COVID-19 pandemic. However, we are facing a scenario of global shortage in availability of personal protective equipment (PPE), including surgical masks and N95 respirators. Reference Feng, Shen, Xia, Song, Fan and Cowling3 Countries are in dispute over the insufficient number of manufacturers. With unfair markets and increasing prices, low- and middle-income countries are at risk of losing their ability to acquire PPE for their HCWs. Several studies have previously reported methods for PPE decontamination Reference Lemmer, Howaldt and Heinrich4 or reuse of N95 respirators. Reference Lin, Tang, Hung, Hua and Lai5

Globally, the discussion by health authorities regarding new approaches to managing the N95 respirator shortage is urgent. The extended use or reuse and/or implementation of decontamination methods of N95 respirators might be an alternative that can prevent SARS-CoV-2 transmission among HCWs during the COVID-19 pandemic. Therefore, we have summarized recommendations regarding the extended use or reuse of N95 respirators, and we provide an overview of published information by regulatory authorities, surveillance organizations, and ministries of health of several countries.

Two researchers independently scrutinized the websites of the regulatory authorities of countries or regions and of ministries of health that a members or associates of the International Coalition of Medicines Regulatory Authorities (ICMRA). 6 Following the screening of information up to April 10, 2020, information from each country or region was collected in an electronic database. We collected the date of publication and information and excerpts from the guidance document regarding the recommendations for extended and reuse of N95 masks or filtering face pieces (FFPs). Extended use was defined as use for longer periods without removing the respirator (eg, treating several patients or working for >1 shift without interruption), and reuse indicated that the respirator was removed, stored, and used at least 1 more time. 7

Overall, 27 countries or regions were screened: 5 countries (19%) only allowed extended use (Canada, France, Mexico, New Zealand and Sweden); 2 countries (7%) mentioned only reuse (Germany and Netherlands); and 3 countries (11%) recommended both strategies for rationing N95 respirators (Brazil, European region and the United States). No information was available on extended use or reuse of N95 respirators in the websites of 17 countries (63%). Some countries (Germany and Netherlands) recommended specific methods for N95 respirators decontamination, and others (Europe and United States) mentioned several options, leaving the decision to health services managers (Table 1). The following decontamination methods were mentioned: dry heat in a drying cabinet at 65–70°C (Germany); vaporous hydrogen peroxide (Netherlands, Europe, and the United States); ultraviolet germicidal irradiation and moist heat (Europe and the United States). The maximum duration of extended used ranged from 4 hours (France, New Zealand, and Sweden) to 40 hours (Mexico), and the maximum number of cycles of decontamination ranged from 2 (Germany) to 5 (United States).

Table 1. Recommendations for Extended Use or Reuse of N95 Respirators Among Health Professionals During COVID-19 Pandemic by Country and Regulatory Authority, 2020

Note. NR, not reported; FFP, filtering face piece.

a Countries, Regulatory Authority, for which was not possible to find specific recommendations related to N95 respirators: Australia, Therapeutic Goods Administration (TGA); Austria, Austrian Medicines and Medical Devices Agency (AGES MEA), Austrian Federal Office for Safety in Health Care; China, China Food and Drug Administration (CFDA); Denmark, Danish Medicines Agency; India, Ministry of Health and Family Welfare; Ireland, Health Product Regulatory Authority (HPRA); Italy, Italian Medicines Agency (AIFA); Japan, Pharmaceuticals and Medical Devices Agency (PMDA), and the Ministry of Health, Labour and Welfare (MHLW); Korea, Ministry of Food and Drug Safety (MFDS); Nigeria, National Agency for Food Drug Administration and Control (NAFDAC); Poland, The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB); Russia, Federal Service for Surveillance in Healthcare (Roszdravnadzor); Singapore, Health Sciences Authority Singapore (HSA); South Africa, Medicines Control Council (MCC); Spain, Spanish Agency of Medicines and Medical Devices (AEMPS); Switzerland, Swissmedic; United Kingdom, Medicines and Healthcare Products Regulatory Agency (MHRA).

b Update: date mentioned in the document.

Emergency use authorization (EUA) by the US Food and Drug Administration (FDA) allows the use of unapproved medical products or unapproved use of approved medical products. Currently, PPE items, in vitro diagnostic tests, and ventilators are included in the FDA EUA to tackle the COVID-19 pandemic. However, the FDA still does not allow sharing or reusing N95 respirators. 8 Considering the COVID-19 pandemic specifically, the Centers for Disease Control and Prevention (CDC) published guidance regarding extended use and limited reuse of N95 respirators. Possible methods for decontamination cited as the most promising by the CDC were vaporous hydrogen peroxide, ultraviolet germicidal irradiation, and moist heat. 9 In Brazil, the National Health Surveillance Agency (ANVISA) allowed the hospital infection control commissions (CCIHs) at each health service to create protocols for reuse by the same professional: use, withdrawal, packaging, assessment of integrity, time of use, and criteria for disposal. 10

The impact of the COVID-19 pandemic in each country or region might be influenced by the number of cases, the proportion of patients needing hospitalization, and the infrastructure of healthcare systems. Health authorities should consider global PPE shortages and should define feasible recommendations for extended use or reuse or decontamination of N95 respirators. Regulatory agencies of few countries empowered health services managers to implement strategies for decontamination and/or reuse procedures. The Ministry of Labor and Social Affairs of Germany described the recommended decontamination method for N95 respirators in detail (ie, dry heat at 65–70°C in a drying cabinet for 30 minutes). On the other hand, up to 60% of the screened countries did not report any recommendations for extended use or reuse or decontamination of N95 respirators. In summary, we have provided some evidence that regulatory authorities are trending toward relaxing regulations during the PPE shortage. The extended use and reuse of N95 respirators have become the last resort because it is crucial to maintain HCW protection during the COVID-19 pandemic.

Acknowledgments

Financial support

No financial support was provided relevant to this article.

Conflicts of interest

All authors report no conflicts of interest relevant to this article.

Supplementary material

To view supplementary material for this article, please visit https://doi.org/10.1017/ice.2020.173

References

Wang, Q, Yu, C. The role of masks and respirator protection against SARS-CoV-2. Infect Control Hosp Epidemiol 2020 [Epub ahead of print]. doi: 10.1017/ice.2020.83.CrossRefGoogle ScholarPubMed
Cheng, VCC, Wong, SC, Chen, JHK, et al. Escalating infection control response to the rapidly evolving epidemiology of the coronavirus disease 2019 (COVID-19) due to SARS-CoV-2 in Hong Kong. Infect Control Hosp Epidemiol 2020 [Epub ahead of print]. doi: 10.1017/ice.2020.58.CrossRefGoogle ScholarPubMed
Feng, S, Shen, C, Xia, N, Song, W, Fan, M, Cowling, BJ. Rational use of face masks in the COVID-19 pandemic. Lancet Respir Med 2020 Epub ahead of print]. doi: 10.1016/S2213-2600(20)30134-X.CrossRefGoogle ScholarPubMed
Lemmer, K, Howaldt, S, Heinrich, R, et al. Test methods for estimating the efficacy of the fast-acting disinfectant peracetic acid on surfaces of personal protective equipment. J Appl Microbiol 2017;123:11681183.10.1111/jam.13575CrossRefGoogle ScholarPubMed
Lin, TH, Tang, FC, Hung, PC, Hua, ZC, Lai, CY. Relative survival of Bacillus subtilis spores loaded on filtering facepiece respirators after five decontamination methods. Indoor air 2018 May 31 [Epub ahead of print]. doi: 10.1111/ina.12475.CrossRefGoogle ScholarPubMed
International Coalition of Medicines Regulatory Authorities Membership Country/Region and Regulatory Authority websites. http://www.icmra.info/drupal/participatingRegulatoryAuthorities. Published 2017. Accessed April 10, 2020.Google Scholar
Recommended guidance for extended use and limited reuse of N95 filtering facepiece respirators in healthcare settings. Centers for Disease Control and Prevention website. https://www.cdc.gov/niosh/topics/hcwcontrols/recommendedguidanceextuse.html. Updated March 2020. Accessed April 10, 2020.Google Scholar
N95 respirators and surgical masks (face masks). US Food and Drug Administraion website. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-and-surgical-masks-face-masks. Updated April 2020. Accessed April 5, 2020.Google Scholar
Decontamination and reuse of filtering facepiece respirators. Centers for Disease Control and Prevention website. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html. Updated April 2020. Accessed April 10, 2020.Google Scholar
Guidelines for health services: prevention and control measures that should be adopted when assisting suspected or confirmed cases of infection with the new coronavirus (SARS-CoV-2) [in Portugese]. ANVISA website. http://portal.anvisa.gov.br/documents/33852/271858/Nota+T%C3%A9cnica+n+04-2020+GVIMS-GGTES-ANVISA-ATUALIZADA/ab598660-3de4-4f14-8e6f-b9341c196b28. Published March 30, 2020. Accessed March 31, 2020.Google Scholar
Figure 0

Table 1. Recommendations for Extended Use or Reuse of N95 Respirators Among Health Professionals During COVID-19 Pandemic by Country and Regulatory Authority, 2020

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