Background

As a region, Latin America has been disproportionately affected by coronavirus disease 2019 (COVID-19). As of September 2020, seven of the twenty countries with the most COVID-19 deaths were in Latin America, with Brazil having the second-highest number of deaths behind the United States (Johns Hopkins University. COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU). https://coronavirus.jhu.edu/map.html, accessed on 15/Sep/2020). Latin America has been particularly vulnerable to COVID-19 due to income inequality ¹1. Roser M, Ortiz-Ospina E. Income inequality. https://ourworldindata.org/income-inequality (accessed on 10/Jun/2020).
https://ourworldindata.org/income-inequa... and underequipped public health systems ²2. Amnesty International. The cost of curing: health workers' rights in the Americas during COVID-19 and beyond. London: Amnesty International; 2020.^,33. Rubin R, Abbasi J, Voelker R. Latin America and its global partners toil to procure medical supplies as COVID-19 pushes the region to its limit. JAMA 2020; 324:217-9..

The COVID-19 pandemic has created major disruptions of the global personal protective equipment (PPE) supply chain, resulting in unprecedented shortages ⁴4. World Health Organization. Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages: interim guidance. Geneva: World Health Organization; 2020.^,55. Feinmann J. PPE: what now for the global supply chain? BMJ 2020; 369:m1910.. Few publications have discussed PPE availability in low- and middle-income countries, particularly in Latin America ³3. Rubin R, Abbasi J, Voelker R. Latin America and its global partners toil to procure medical supplies as COVID-19 pushes the region to its limit. JAMA 2020; 324:217-9.. Although Latin American ministries of health ⁶6. Ministerio de Salud. Recomendaciones para el uso apropiado de mascarillas y respiradores por el personal de salud en el contexto de COVID-19. Lima: Ministerio de Salud; 2020.^,77. Ministerio de Salud. Norma técnica de procedimientos de bioseguridad para la prevención del contagio de COVID-19: versión mayo 2020. Bogotá: Ministerio de Salud; 2020., medical societies ⁸8. Saavedra Trujillo CH. Consenso colombiano de atención, diagnóstico y manejo de la infección por SARS-COV-2/COVID-19 en establecimientos de atención de la salud. Recomendaciones basadas en consenso de expertos e informadas en la evidencia. Infectio 2020; 24(3 Suppl):1-153., and the Pan American Health Organization (PAHO) ⁹9. Pan American Health Organization. Response to COVID-19 in the Americas. Washington DC: Pan American Health Organization; 2020.^,1010. Pan American Health Organization. Aspectos técnicos y regulatorios sobre uso prolongado, reutilización y reprocesamiento de respiradores en períodos de escasez. Washington DC: Pan American Health Organization; 2020. have released PPE guidelines, we can still find reports of limited PPE for healthcare workers across the region ²2. Amnesty International. The cost of curing: health workers' rights in the Americas during COVID-19 and beyond. London: Amnesty International; 2020.^,1111. Delgado D, Wyss Quintana F, Perez G, Sosa Liprandi A, Ponte-Negretti C, Mendoza I, et al. Personal safety during the COVID-19 pandemic: realities and perspectives of healthcare workers in Latin America. Int J Environ Res Public Health 2020; 17:2798.^,1212. Pan American Health Organization. COVID-19 has infected some 570,000 health workers and killed 2,500 in the Americas. https://www.paho.org/en/news/2-9-2020-covid-19-has-infected-some-570000-health-workers-and-killed-2500-americas-paho (accessed on 10/Sep/2020).
https://www.paho.org/en/news/2-9-2020-co... .

While there have been shortages of all types of PPE, of particular importance are filtering facepiece (FFP) respirators, which filter inhaled air and are used to protect healthcare workers directly caring for COVID-19 patients ⁴4. World Health Organization. Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages: interim guidance. Geneva: World Health Organization; 2020.. Various FFP respirators exist, such as the N95, KN95, and FFP2 models ¹³13. N95Decon. N95 decontamination & reuse methods comparison matrix. https://www.n95decon.org/files/comparison-matrix (accessed on 25/May/2020).
https://www.n95decon.org/files/compariso... . We refer to all as respirators, unless specific make is relevant. This report aims to provide insight into health policy responses to respirator shortages in South America during the COVID-19 pandemic, focusing on quality regulation and extended use, reuse, and decontamination policies in Bolivia, Brazil, Colombia, and Peru (Table 1), which were chosen for inclusion based on existing institutional collaborations.

Respirator availability

Few reports quantify the respirator shortage in Latin America, and most data are from cross-sectional, convenience sample surveys of healthcare workers conducted in the early months of the pandemic. For example, in April 2020 the Inter-American Society of Cardiology surveyed healthcare workers from 20 Latin American countries and found only 56% of respondents had access to N95 respirators ¹¹11. Delgado D, Wyss Quintana F, Perez G, Sosa Liprandi A, Ponte-Negretti C, Mendoza I, et al. Personal safety during the COVID-19 pandemic: realities and perspectives of healthcare workers in Latin America. Int J Environ Res Public Health 2020; 17:2798.. A survey of surgeons in Brazil similarly found that 57% reported N95 respirator availability ¹⁴14. Ribeiro Junior MAF, DE-Campos T, Lima DS, Mattos Jr. AC, Pereira BM. The trauma and acute care surgeon in the COVID-19 pandemic era. Rev Col Bras Cir 2020; 47:e20202576.. A national survey from Colombia in April 2020 found nearly 90% of queried healthcare workers did not have respirators available at their institution ¹⁵15. Corcho C, Arrieta M, Patiño S, Barbosa S. Encuesta de bioseguridad del personal de la salud y ruta de atención de la pandemia SARS COV2-COVID-19. Epicrisis 2020; 12 apr. https://epicrisis.org/2020/04/12/encuesta-de-bioseguridad-del-personal-de-la-salud-y-ruta-de-atencion-de-la-pandemia-sars-cov2-covid-19/.
https://epicrisis.org/2020/04/12/encuest... , and another survey from Colombia’s Department of Cauca found 15% of healthcare workers reported having to obtain a respirator on their own for use at work in the previous week ¹⁶16. Mera-Mamián A, Delgado-Noguera M, Merchán-Galvis A, Cabra G, Calvache J. Conocimientos y necesidades del personal de salud sobre elementos de protección personal en el departamento del Cauca, durante la pandemia por coronavirus COVID-19. OSF Preprints 2020; 12 apr. https://osf.io/7agph/.
https://osf.io/7agph/... .

While there aren’t readily available data quantifying respirator availability in Bolivia or Peru, in our experience there are depleted stocks in both countries. In the rural department of Potosí, Bolivia, for example, only certain hospitals have access to respirators, which are designated for use in specific “COVID-center” areas. Smaller health facilities in Potosí lack access to respirators; should a patient with suspected COVID-19 infection arrive, they are directed to a hospital with a “COVID-center”, which may be several hours away. Consequently, many healthcare workers have resorted to purchasing their own respirators.

In response to severe shortages, in March 2020 Brazilian Health Regulatory Agency (Anvisa) advised rationing of respirators and donation of respirator stocks to the public health service ¹⁷17. Agência Nacional de Vigilância Sanitária. Orientações gerais: racionalização do uso de respiradores descartáveis nos estabelecimentos fabricantes de medicamentos, insumos farmacêuticos, produtos para saúde, cosméticos e saneantes. http://portal.anvisa.gov.br/documents/219201/4340788/Nota+t%C3%A9cnica+respiradores/c14b21ab-fab7-498b-bfe3-e576ed2b1e67 (accessed on 20/May/2020).
http://portal.anvisa.gov.br/documents/21... . By the end of May 2020, the governments of Brazil (Ministério da Saúde. Painel de leitos e insumos. https://covid-insumos.saude.gov.br/paineis/insumos/painel.php, accessed on 25/May/2020) and Colombia ¹⁸18. ARL han destinado $51.000 millones en elementos de protección personal. Dinero 2020; 6 apr. https://www.dinero.com/pais/articulo/coronavirus-colombia-entrega-de-elementos-de-proteccion-personal-desde-arl/287738.
https://www.dinero.com/pais/articulo/cor... reported national distribution of large quantities of respirators. PAHO ⁹9. Pan American Health Organization. Response to COVID-19 in the Americas. Washington DC: Pan American Health Organization; 2020., United Nations Children’s Fund ¹⁹19. United Nations Children's Fund. COVID-19: UNICEF is scaling up delivery of health and hygiene supplies across Latin America and Caribbean. https://www.unicef.org/press-releases/covid-19-unicef-scaling-delivery-health-and-hygiene-supplies-across-latin-america (accessed on 10/Sep/2020).
https://www.unicef.org/press-releases/co... , and the Colombian Red Cross ²⁰20. Cruz Roja Colombiana. Cruz Roja Colombiana activa plan de choque COVID-19 para brindar asistencia humanitaria en el Amazonas. https://www.cruzrojacolombiana.org/cruz-colombiana-roja-activa-plan-de-choque-covid-19-para-brindar-asistencia-humanitaria-en-el-amazonas/ (accessed on 10/Jun/2020).
https://www.cruzrojacolombiana.org/cruz-... have also been enlisted to provide respirators to regions where shortages have been most severe. However, without data quantifying need, it is difficult to determine the impact of these distributions on shortages. To that end, the U.S. Centers for Disease Control and Prevention (CDC) developed a PPE supply tracker, which includes a burn rate calculator that can be used by individual facilities to determine respirator supply needs (CDC. Personal protective equipment: NIOSH PPE tracker app. https://www.cdc.gov/niosh/ppe/ppeapp.html, accessed on 10/Sep/2020).

Quality regulation

Most Latin American countries rely on respirator imports ²¹21. Comisión Económica para América Latina y el Caribe. Restrictions on the export of medical products hamper efforts to contain coronavirus disease (COVID-19) in Latin America and the Caribbean. https://www.cepal.org/en/publications/45511-restrictions-export-medical-products-hamper-efforts-contain-coronavirus-disease (accessed on 10/Sep/2020).
https://www.cepal.org/en/publications/45... . For example, in Brazil, China remains the primary source of respirators (43.7%) approved by Anvisa, though the percentage manufactured in Brazil (33%) is increasing due to COVID-19-related demand (Anvisa. Banco de dados de produtos para saúde registrados. https://dados.anvisa.gov.br/dados/TA_PRODUTO_SAUDE_SITE.csv, accessed on 12/Jun/2020) Surging demand brings concerns about quality of imported respirators, which must meet specific particle filtration standards ⁴4. World Health Organization. Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages: interim guidance. Geneva: World Health Organization; 2020.. In the United States, imported respirators are tested to identify faulty products ²²22. Centers for Disease Control and Prevention. NPPTL respirator assessments to support the COVID-19 response. https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html?mod=article_inline (accessed on 20/May/2020).
https://www.cdc.gov/niosh/npptl/respirat... . Of the internationally manufactured N95 respirators tested by the end of May 2020, more than half had a minimum filtration below the required 95%.

Each country has its own regulatory authority tasked with ensuring quality of imported respirators (Table 1) ²³23. Pan American Health Organization. Regulation of medical devices in the context of COVID-19. Washington DC: Pan American Health Organization; 2020.. In response to quality concerns identified elsewhere ²²22. Centers for Disease Control and Prevention. NPPTL respirator assessments to support the COVID-19 response. https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html?mod=article_inline (accessed on 20/May/2020).
https://www.cdc.gov/niosh/npptl/respirat... , Anvisa issued a precautionary ban on certain respirators which did not meet filtration specifications ²⁴24. Agência Nacional de Vigilância Sanitária. Resolução-RE nº 1.552, de 15 de maio de 2020. Diário Oficial da União 2020; 18 may.. All of the banned respirators were manufactured in China, and were allowed to be re-registered as non-FFP masks. In May 2020, the Peruvian General Directorate of Medicines, Supplies and Drugs (DIGEMID) released a list of technical recommendations for imported respirators, including a list of international suppliers to confirm product legitimacy ²⁵25. Dirección Regional de Medicamentos, Insumos y Drogas. Consideraciones para la adquisición de respiradores de protección respiratoria (N95, FFP2, KN95 o equivalentes) importados. Lima: Dirección Regional de Medicamentos, Insumos y Drogas; 2020..

The Colombian National Institute for Food and Drug Surveillance (Invima) eased the approval process for PPE imports ²⁶26. Instituto Nacional de Vigilancia de Medicamentos y Alimentos. Coronavirus COVID-19. https://www.invima.gov.co/en/coronavirus-covid-19 (accessed on 06/Jun/2020).
https://www.invima.gov.co/en/coronavirus... . However, given concerns about respirator quality, easing regulations risks quality issues. The registration data required by Invima for respirator imports include manufacturer, production date, and origin country health authority certification. Invima does not specifically address filtration quality concerns, but does provide a list of approved domestic suppliers ²⁶26. Instituto Nacional de Vigilancia de Medicamentos y Alimentos. Coronavirus COVID-19. https://www.invima.gov.co/en/coronavirus-covid-19 (accessed on 06/Jun/2020).
https://www.invima.gov.co/en/coronavirus... .

The Bolivian State Agency for Medicines and Health Technologies (AGEMED) has not provided clear guidance on respirator standards ⁷7. Ministerio de Salud. Norma técnica de procedimientos de bioseguridad para la prevención del contagio de COVID-19: versión mayo 2020. Bogotá: Ministerio de Salud; 2020..

Extended use, reuse, and decontamination

When respirator shortages cannot be alleviated by increased production or importation, extended use or reuse of respirators may be permitted. The World Health Organization (WHO) states that reprocessing and decontamination of respirators should only be done when facing critical shortages, and only if the functional integrity can be maintained ⁴4. World Health Organization. Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages: interim guidance. Geneva: World Health Organization; 2020.^,1010. Pan American Health Organization. Aspectos técnicos y regulatorios sobre uso prolongado, reutilización y reprocesamiento de respiradores en períodos de escasez. Washington DC: Pan American Health Organization; 2020.. The WHO ⁴4. World Health Organization. Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages: interim guidance. Geneva: World Health Organization; 2020., PAHO ¹⁰10. Pan American Health Organization. Aspectos técnicos y regulatorios sobre uso prolongado, reutilización y reprocesamiento de respiradores en períodos de escasez. Washington DC: Pan American Health Organization; 2020., and N95Decon ¹³13. N95Decon. N95 decontamination & reuse methods comparison matrix. https://www.n95decon.org/files/comparison-matrix (accessed on 25/May/2020).
https://www.n95decon.org/files/compariso... , a consortium focused on protocols for N95 respirator decontamination, present several decontamination techniques which do not compromise the filtration capability of respirators, including UV-C irradiation, hydrogen peroxide vapor, and moist heat. While the WHO states respirator decontamination is potentially feasible in low- and middle-income countries ⁴4. World Health Organization. Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages: interim guidance. Geneva: World Health Organization; 2020., few low- and middle-income countries have policies in place ²⁷27. Kobayashi LM, Marins BR, Costa P, Perazzo H, Castro R. Extended use or reuse of N95 respirators during COVID-19 pandemic: an overview of national regulatory authority recommendations. Infect Control Hosp Epidemiol 2020; 1-3..

In Brazil, respirators may be reused under the following conditions: the respirator must be inspected to ensure functional integrity, and used by the same healthcare worker who is also wearing a face shield ²⁷27. Kobayashi LM, Marins BR, Costa P, Perazzo H, Castro R. Extended use or reuse of N95 respirators during COVID-19 pandemic: an overview of national regulatory authority recommendations. Infect Control Hosp Epidemiol 2020; 1-3.. However, Anvisa does not specify decontamination techniques for respirators ²⁸28. Agência Nacional de Vigilância Sanitária. Nota Técnica GVIMS/GGTES/ANVISA nº 04/2020 orientações para serviços de saúde: medidas de prevenção e controle que devem ser adotadas durante a assistência aos casos suspeitos ou confirmados de infecção pelo novo coronavírus (SARS-CoV-2). Brasília: Agência Nacional de Vigilância Sanitária; 2020. and states that guidelines for decontamination should be determined by the Hospital Infection Control Commission along with individual facilities ²⁸28. Agência Nacional de Vigilância Sanitária. Nota Técnica GVIMS/GGTES/ANVISA nº 04/2020 orientações para serviços de saúde: medidas de prevenção e controle que devem ser adotadas durante a assistência aos casos suspeitos ou confirmados de infecção pelo novo coronavírus (SARS-CoV-2). Brasília: Agência Nacional de Vigilância Sanitária; 2020..

The Colombian Infectiology Association (ACIN) ⁸8. Saavedra Trujillo CH. Consenso colombiano de atención, diagnóstico y manejo de la infección por SARS-COV-2/COVID-19 en establecimientos de atención de la salud. Recomendaciones basadas en consenso de expertos e informadas en la evidencia. Infectio 2020; 24(3 Suppl):1-153. and Colombian Emergency Medicine Association (ACEM) ²⁹29. Asociación Colombiana de Especialistas em Medicina de Urgencias y Emergencias. Elementos de protección personal (EPP) para el sector hospitalário: pandemia de COVID-19. Bogotá: Asociación Colombiana de Especialistas em Medicina de Urgencias y Emergencias; 2020. provided guidance on reuse and decontamination. ACIN recommends the UV-C irradiation, hydrogen peroxide vapor, or microwave techniques for respirator decontamination, or, alternatively, the use of elastomeric respirators or powered air-purifying respirators ⁸8. Saavedra Trujillo CH. Consenso colombiano de atención, diagnóstico y manejo de la infección por SARS-COV-2/COVID-19 en establecimientos de atención de la salud. Recomendaciones basadas en consenso de expertos e informadas en la evidencia. Infectio 2020; 24(3 Suppl):1-153.. ACEM ²⁹29. Asociación Colombiana de Especialistas em Medicina de Urgencias y Emergencias. Elementos de protección personal (EPP) para el sector hospitalário: pandemia de COVID-19. Bogotá: Asociación Colombiana de Especialistas em Medicina de Urgencias y Emergencias; 2020. outlines four decontamination techniques, including UV-C irradiation, hydrogen peroxide vapor, and moist heat, but encourages individual institutions to develop their own protocols. Some hospitals in Colombia have implemented protocols using UV-C irradiation or hydrogen peroxide vapor; however, this is limited to large hospitals in more populated cities.

The Peruvian Institute for Health Technology Assessment and Research (IETSI) published a review in March 2020 on guidelines for extended use and reuse of respirators ³⁰30. Instituto de Evaluación de Tecnologías en Salud e Investigación. Uso y re-uso de respiradores N95 en estados de escasez. Lima: Instituto de Evaluación de Tecnologías en Salud e Investigación; 2020. (Reporte Breve, 12).. In response, DIGEMID released its own guidelines ⁶6. Ministerio de Salud. Recomendaciones para el uso apropiado de mascarillas y respiradores por el personal de salud en el contexto de COVID-19. Lima: Ministerio de Salud; 2020.. Extended use is permitted for up to 12 hours, as long as fit and function is maintained, and respirators may be reused up to five times. DIGEMID also presents various methods for decontamination, but states that healthcare facilities should develop their individual protocols ⁶6. Ministerio de Salud. Recomendaciones para el uso apropiado de mascarillas y respiradores por el personal de salud en el contexto de COVID-19. Lima: Ministerio de Salud; 2020..

We are not aware of any documents specific to Bolivia which address extended use or reuse of respirators. Certain facilities reportedly have the capabilities to decontaminate with UV radiation or ethylene oxide, which are methods endorsed by the WHO ⁴4. World Health Organization. Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages: interim guidance. Geneva: World Health Organization; 2020.^,1313. N95Decon. N95 decontamination & reuse methods comparison matrix. https://www.n95decon.org/files/comparison-matrix (accessed on 25/May/2020).
https://www.n95decon.org/files/compariso... . However, in hospitals without those capabilities, respirators have been decontaminated by washing with bleach or quaternary ammonium, a process known to compromise respirator filtration.

Conclusions

Our experience suggests respirator shortages remain in Bolivia, Brazil, Colombia, and Peru, but data are limited. In order to quantify the need for respirators in the region, we must obtain more data, and individual facilities should use tools such as the CDC burn rate calculator to guide supply management. As countries work to increase supply in the short term, regulatory agencies must take steps to ensure that imported respirators meet filtration specifications. Likewise, countries should work to increase domestic respirator production in order to minimize the effect of future supply chain disruptions. Reuse and decontamination of respirators should be permitted in the setting of critical shortages, but hospitals must develop protocols to guarantee decontamination methods used do not compromise respirator function. Ultimately, the access to quality respirators is necessary to make sure that healthcare workers caring for COVID-19 patients is safe, and must be a top priority across the region.

References

Publication Dates

History