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Review Article
Challenges for the development of alternative low-cost ventilators during COVID-19 pandemic in Brazil
Rev Bras Ter Intensiva. 2020;32(3):444-457
Abstract
Review ArticleChallenges for the development of alternative low-cost ventilators during COVID-19 pandemic in Brazil
Rev Bras Ter Intensiva. 2020;32(3):444-457
DOI 10.5935/0103-507X.20200075
Views0ABSTRACT
The COVID-19 pandemic has brought concerns to managers, healthcare professionals, and the general population related to the potential mechanical ventilators’ shortage for severely ill patients. In Brazil, there are several initiatives aimed at producing alternative ventilators to cover this gap. To assist the teams that work in these initiatives, we provide a discussion of some basic concepts on physiology and respiratory mechanics, commonly used mechanical ventilation terms, the differences between triggering and cycling, the basic ventilation modes and other relevant aspects, such as mechanisms of ventilator-induced lung injury, respiratory drive, airway heating and humidification, cross-contamination risks, and aerosol dissemination. After the prototype development phase, preclinical bench-tests and animal model trials are needed to determine the safety and performance of the ventilator, following the minimum technical requirements. Next, it is mandatory going through the regulatory procedures as required by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária – ANVISA). The manufacturing company should be appropriately registered by ANVISA, which also must be notified about the conduction of clinical trials, following the research protocol approval by the Research Ethics Committee. The registration requisition of the ventilator with ANVISA should include a dossier containing the information described in this paper, which is not intended to cover all related matters but to provide guidance on the required procedures.
Keywords:Biomedical engineeringBrazilCOVID-19Positive pressure respirationRespiration, artificialSevere acute respiratory syndromeVentilators, mechanicalSee more
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Case reports Child Coronavirus infections COVID-19 Critical care Critical illness Extracorporeal membrane oxygenation Infant, newborn Intensive care Intensive care units Intensive care units, pediatric mechanical ventilation Mortality Physical therapy modalities Prognosis Respiration, artificial Respiratory insufficiency risk factors SARS-CoV-2 Sepsis