Respiratory protection masks: Reflections on the regulation and efficiency of the process in the COVID-19 pandemic

Detalhes bibliográficos
Autor(a) principal: Fust, Anna Maria Barreto Silva
Data de Publicação: 2021
Outros Autores: Cruz, Gleyce Carolina Santos, Vale, Renata de Freitas Dalavia, Venâncio, Lilian de Figueiredo, Neves, Mateus Henrique Mendonça, Bôas, Maria Helena Simões Villas, Feitoza-Silva, Michele
Tipo de documento: Artigo
Idioma: por
Título da fonte: Research, Society and Development
Texto Completo: https://rsdjournal.org/index.php/rsd/article/view/16805
Resumo: The COVID-19 pandemic has brought challenges to health worldwide, especially for countries with weaknesses in public policies, such as Brazil.The scarcity and low quality of masks made available at the beginning of the pandemic symbolized the fragility of the system and regulation, in addition to amplifying the risks to the health professional. Reflect on the regulation and publications related to mask processing and report the results obtained in the articles consulted on the safety and efficiency tests on the reuse of respiration masks allowed during pandemic. Cross-sectional descriptive observational study with secondary data collection, search and analysis of technical standards, legislation, health notes and guidelines. Results. Despite existing health legislation on DM (Medical Devices) and processing, the exceptionality in reuse was not matched to guidelines or rules by Anvisa to ensure efficiency and safety. The articles presented trials for viral inactivation, for filtration efficiency and integrity. There were 37 described essays added to five from a narrative review. Of the 42, 26 confirmed viral inactivation, 15 ensured filtration and 15 ensured post-processing integrity. The reuse of single-use products without specific rules makes Anvisa’s gaze urgent for scientific studies that direct new parameters and the development of new regulations, not only for masks, but for processes that must guarantee products with characteristics similar to that made available by the manufacturer before reuse.
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spelling Respiratory protection masks: Reflections on the regulation and efficiency of the process in the COVID-19 pandemicMáscaras de protección respiratoria: Reflexiones sobre la regulación y eficiencia del processo em la pandemia COVID-19 Máscaras de proteção respiratória: Reflexões sobre a regulação e eficiência do processo na pandemia de COVID-19MáscaraCOVID-19Dispositivo de proteção respiratóriaRegulação e fiscalização em saúde.MáscaraCOVID-19Dispositivo de protección respiratoriaRegulación e inspección en salud.MaskCOVID-19Respiratory protection deviceHealth regulation and supervision.The COVID-19 pandemic has brought challenges to health worldwide, especially for countries with weaknesses in public policies, such as Brazil.The scarcity and low quality of masks made available at the beginning of the pandemic symbolized the fragility of the system and regulation, in addition to amplifying the risks to the health professional. Reflect on the regulation and publications related to mask processing and report the results obtained in the articles consulted on the safety and efficiency tests on the reuse of respiration masks allowed during pandemic. Cross-sectional descriptive observational study with secondary data collection, search and analysis of technical standards, legislation, health notes and guidelines. Results. Despite existing health legislation on DM (Medical Devices) and processing, the exceptionality in reuse was not matched to guidelines or rules by Anvisa to ensure efficiency and safety. The articles presented trials for viral inactivation, for filtration efficiency and integrity. There were 37 described essays added to five from a narrative review. Of the 42, 26 confirmed viral inactivation, 15 ensured filtration and 15 ensured post-processing integrity. The reuse of single-use products without specific rules makes Anvisa’s gaze urgent for scientific studies that direct new parameters and the development of new regulations, not only for masks, but for processes that must guarantee products with characteristics similar to that made available by the manufacturer before reuse.La pandemia COVID-19 trajo desafíos de salud en todo el mundo, especialmente para países con debilidades en las políticas públicas, como Brasil. La escasez y baja calidad de las mascarillas puestas a disposición al inicio de la pandemia simbolizaba la debilidad del sistema y las regulaciones, además de haber amplificado los riesgos para los profesionales de la salud.  Reflexionar sobre la normativa y publicaciones relacionadas con el procesamiento de mascarillas e informar los resultados obtenidos en los artículos consultados sobre las pruebas de seguridad y eficiencia en la reutilización de mascarillas de protección respiratoria permitidas durante la pandemia.  Estudio observacional descriptivo transversal con recolección de datos secundarios, búsqueda y análisis de normas técnicas, legislación, notas y guías de salud. A pesar de la legislación de salud existente sobre DM (dispositivos médicos) y procesamiento, la excepcionalidad de la reutilización no se combinó con las pautas o reglas de Anvisa para garantizar la eficiencia y la seguridad. Los artículos presentaron pruebas de inactivación viral, eficiencia e integridad de la filtración. Se agregaron 37 ensayos descritos a cinco de una revisión narrativa. De los 42, 26 demostraron inactivación viral, 15 garantizaron la filtración y 15 garantizaron la integridad después del procesamiento. La reutilización de productos de un solo uso sin reglas específicas hace que sea urgente para Anvisa buscar estudios científicos que orienten nuevos parámetros y también el desarrollo de nuevas regulaciones, no solo para mascarillas, sino para procesos que deben garantizar productos con características similares a las fabricadas. disponible por el fabricante antes de su reutilización.A pandemia de COVID-19 trouxe desafios para a saúde de todo o mundo, em especial para os países com fragilidades em políticas públicas, como é o caso do Brasil. A escassez e a baixa qualidade das máscaras disponibilizadas no início da pandemia simbolizaram a fragilidade do sistema e da regulamentação, além de ter amplificado os riscos ao profissional de saúde.  Refletir sobre a regulação e publicações relacionadas ao processamento de máscaras e relatar os resultados obtidos nos artigos consultados sobre os ensaios de segurança e de eficiência no reúso de máscaras de proteção respiratória permitido durante a pandemia. Estudo observacional descritivo transversal com coleta de dados secundários, busca e análise de normas técnicas, legislações, notas e orientações sanitárias. Apesar das legislações sanitárias sobre DM (Dispositivos Médicos) e processamento existentes, a excepcionalidade no reúso não foi pareada a diretrizes ou regras pela Anvisa para garantir a eficiência e segurança. Os artigos apresentaram ensaios para a inativação viral, para eficiência da filtração e integridade. Foram 37 ensaios descritos somados a cinco oriundos de uma revisão narrativa. Dos 42, 26 comprovaram inativação viral, 15 garantiram a filtração e 15 a integridade posterior ao processamento. O reúso de produtos de uso único, sem regras específicas, torna urgente o olhar da Anvisa para estudos científicos que direcionem novos parâmetros e ainda o desenvolvimento de novos regulamentos, não só para máscaras, mas para processos que devem garantir produtos com características semelhantes ao disponibilizado pelo fabricante antes da reutilização.Research, Society and Development2021-07-04info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://rsdjournal.org/index.php/rsd/article/view/1680510.33448/rsd-v10i8.16805Research, Society and Development; Vol. 10 No. 8; e3310816805Research, Society and Development; Vol. 10 Núm. 8; e3310816805Research, Society and Development; v. 10 n. 8; e33108168052525-3409reponame:Research, Society and Developmentinstname:Universidade Federal de Itajubá (UNIFEI)instacron:UNIFEIporhttps://rsdjournal.org/index.php/rsd/article/view/16805/15179Copyright (c) 2021 Anna Maria Barreto Silva Fust; Gleyce Carolina Santos Cruz; Renata de Freitas Dalavia Vale; Lilian de Figueiredo Venâncio; Mateus Henrique Mendonça Neves; Maria Helena Simões Villas Bôas; Michele Feitoza-Silvahttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessFust, Anna Maria Barreto SilvaCruz, Gleyce Carolina SantosVale, Renata de Freitas Dalavia Venâncio, Lilian de Figueiredo Neves, Mateus Henrique Mendonça Bôas, Maria Helena Simões Villas Feitoza-Silva, Michele2021-08-21T18:46:59Zoai:ojs.pkp.sfu.ca:article/16805Revistahttps://rsdjournal.org/index.php/rsd/indexPUBhttps://rsdjournal.org/index.php/rsd/oairsd.articles@gmail.com2525-34092525-3409opendoar:2024-01-17T09:37:15.723152Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)false
dc.title.none.fl_str_mv Respiratory protection masks: Reflections on the regulation and efficiency of the process in the COVID-19 pandemic
Máscaras de protección respiratoria: Reflexiones sobre la regulación y eficiencia del processo em la pandemia COVID-19
Máscaras de proteção respiratória: Reflexões sobre a regulação e eficiência do processo na pandemia de COVID-19
title Respiratory protection masks: Reflections on the regulation and efficiency of the process in the COVID-19 pandemic
spellingShingle Respiratory protection masks: Reflections on the regulation and efficiency of the process in the COVID-19 pandemic
Fust, Anna Maria Barreto Silva
Máscara
COVID-19
Dispositivo de proteção respiratória
Regulação e fiscalização em saúde.
Máscara
COVID-19
Dispositivo de protección respiratoria
Regulación e inspección en salud.
Mask
COVID-19
Respiratory protection device
Health regulation and supervision.
title_short Respiratory protection masks: Reflections on the regulation and efficiency of the process in the COVID-19 pandemic
title_full Respiratory protection masks: Reflections on the regulation and efficiency of the process in the COVID-19 pandemic
title_fullStr Respiratory protection masks: Reflections on the regulation and efficiency of the process in the COVID-19 pandemic
title_full_unstemmed Respiratory protection masks: Reflections on the regulation and efficiency of the process in the COVID-19 pandemic
title_sort Respiratory protection masks: Reflections on the regulation and efficiency of the process in the COVID-19 pandemic
author Fust, Anna Maria Barreto Silva
author_facet Fust, Anna Maria Barreto Silva
Cruz, Gleyce Carolina Santos
Vale, Renata de Freitas Dalavia
Venâncio, Lilian de Figueiredo
Neves, Mateus Henrique Mendonça
Bôas, Maria Helena Simões Villas
Feitoza-Silva, Michele
author_role author
author2 Cruz, Gleyce Carolina Santos
Vale, Renata de Freitas Dalavia
Venâncio, Lilian de Figueiredo
Neves, Mateus Henrique Mendonça
Bôas, Maria Helena Simões Villas
Feitoza-Silva, Michele
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Fust, Anna Maria Barreto Silva
Cruz, Gleyce Carolina Santos
Vale, Renata de Freitas Dalavia
Venâncio, Lilian de Figueiredo
Neves, Mateus Henrique Mendonça
Bôas, Maria Helena Simões Villas
Feitoza-Silva, Michele
dc.subject.por.fl_str_mv Máscara
COVID-19
Dispositivo de proteção respiratória
Regulação e fiscalização em saúde.
Máscara
COVID-19
Dispositivo de protección respiratoria
Regulación e inspección en salud.
Mask
COVID-19
Respiratory protection device
Health regulation and supervision.
topic Máscara
COVID-19
Dispositivo de proteção respiratória
Regulação e fiscalização em saúde.
Máscara
COVID-19
Dispositivo de protección respiratoria
Regulación e inspección en salud.
Mask
COVID-19
Respiratory protection device
Health regulation and supervision.
description The COVID-19 pandemic has brought challenges to health worldwide, especially for countries with weaknesses in public policies, such as Brazil.The scarcity and low quality of masks made available at the beginning of the pandemic symbolized the fragility of the system and regulation, in addition to amplifying the risks to the health professional. Reflect on the regulation and publications related to mask processing and report the results obtained in the articles consulted on the safety and efficiency tests on the reuse of respiration masks allowed during pandemic. Cross-sectional descriptive observational study with secondary data collection, search and analysis of technical standards, legislation, health notes and guidelines. Results. Despite existing health legislation on DM (Medical Devices) and processing, the exceptionality in reuse was not matched to guidelines or rules by Anvisa to ensure efficiency and safety. The articles presented trials for viral inactivation, for filtration efficiency and integrity. There were 37 described essays added to five from a narrative review. Of the 42, 26 confirmed viral inactivation, 15 ensured filtration and 15 ensured post-processing integrity. The reuse of single-use products without specific rules makes Anvisa’s gaze urgent for scientific studies that direct new parameters and the development of new regulations, not only for masks, but for processes that must guarantee products with characteristics similar to that made available by the manufacturer before reuse.
publishDate 2021
dc.date.none.fl_str_mv 2021-07-04
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info:eu-repo/semantics/publishedVersion
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dc.identifier.uri.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/16805
10.33448/rsd-v10i8.16805
url https://rsdjournal.org/index.php/rsd/article/view/16805
identifier_str_mv 10.33448/rsd-v10i8.16805
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/16805/15179
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Research, Society and Development
publisher.none.fl_str_mv Research, Society and Development
dc.source.none.fl_str_mv Research, Society and Development; Vol. 10 No. 8; e3310816805
Research, Society and Development; Vol. 10 Núm. 8; e3310816805
Research, Society and Development; v. 10 n. 8; e3310816805
2525-3409
reponame:Research, Society and Development
instname:Universidade Federal de Itajubá (UNIFEI)
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instacron_str UNIFEI
institution UNIFEI
reponame_str Research, Society and Development
collection Research, Society and Development
repository.name.fl_str_mv Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)
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