Panorama of notifications about adverse events and technical complaints related to facemasks

• Autor(a) principal: Matos, Rafael Christian de
• Data de Publicação: 2022
• Outros Autores: Nunes , Adriane Zacarias, Silva, Elisângela Alves, Dias, Edilânia Castro, Dutra, Ramon da Silva, Silveira, Aline Magalhães de Matos da
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1930
• topic: Facemasks; Adverse Events; Product Health Surveillance; Pandemic; Máscaras; Eventos Adversos; Vigilância Sanitária de Produtos; Pandemia; Tecnovigilância; NOTIVISA; Prevenção; Biossegurança

Introduction: In the daily routine of Health Professionals, mainly in the midst of the Sars-CoV-2 pandemic, facemasks are important devices; however, there is no post market control for these products. Objective: Evaluate the Adverse Events (AE) and Technical Complaints (TC) related to  facemasks and respirators, to list and categorize the public health problems involving these products. Method: Cross-sectional, descriptive, retrospective and documental study with a quantitative approach, including data from January 2010 to May 2020 available in the Notivisa system. The analyzed data had national coverage and were reclassified, when necessary, according to their category (EA or QT). Results: 443 notifications were included in the study containing 519 claims (AE and TC). The data distribution on the analized decade presented an accentuated decrease; the Southeast region had the highest prevalence of claims in Brazil. Most of the notifying companies were health establishments and the highest prevalence of health events found were Adverse Events that affected the user when fixing strips and nose clips (such as detachment of the nose clip and breaking of the fixation straps during use),  indicating serious biosecurity problems. Conclusions: This study characterized the Adverse Events and the Technical Complaints in facemasks focusing on health promotion and indicating the necessity of sanitary monitoring  improvement of the products.