Quality assessment of emergency corrective maintenance of critical care ventilators within the contexto of COVI019 in São Paulo, Brazil

Abstract:

This technical report presents the quality assessment process for the emergency corrective maintenance of critical care ventilators in a node, IPT-POLI, of a voluntary network that is part of the initiative +Maintenance of Ventilators, led by the National Service of Industrial Training (SENAI) and its Integrated Manufacturing and Technology Center (CIMATEC) to perform maintenance on unused mechanical ventilators in the context of the COVID-19 pandemic in Brazil. A procedure was established for the quality assessment of equipment subjected to corrective emergency maintenance, covering the essential aspects of the three primary standards (ABNT NBR IEC 60601-1: 2010+A1:2016, ABNT NBR ISO IEC 62353: 2019, and ABNT NBR ISO 80601-2-12:2014) for performance and safety assessment. A set of nine critical care ventilators was evaluated considering the following parameters: leakage current, protective ground resistance, control accuracy, delivered oxygen test, and alarms. The evaluated ventilators underwent corrective emergency maintenance before performance and safety assessments. In the electrical safety tests, all equipment presented values prescribed for the standard. However, the assessment of ventilator parameters revealed that their performance was below the standard. Finally, quality assessment reports were sent to the clinical engineering departments at hospitals. Thus, it can be concluded that criteria selection for the quality assessment in critical care ventilators is crucial and of great significance for future pandemic scenarios, such as the situation experienced during the COVID-19 pandemic.

Reference:
ALVARADO, Alembert Eistein Lino; ROSA, Diego Antonio de Oliveira; MELLO, Sara Gomes; DIAS, Marcelo Sanches; BARBOSA, Mario Fernando; BARROS, Kelvis do Nascimento; LEMOS, Bruno Alexandre; VITORASSO, Renato de Lima; BARTHOLOMEU, Victor Paheco; AMERICANO, Pedro Parik; SILVA FILHO, Edison; MORAES, José Carlos Teixeira Barros; FERREIRA JUNIOR, Antonio Francisco Gentil; MORIYA, Henrique Takachi. Quality assessment of emergency corrective maintenance of critical care ventilators within the context of COVI019 in São Paulo, Brazil. In: BRAZILIAN CONGRESS IN BIOMEDICAL ENGINEERING, 27., 2020, Vitoria. Proceedings... p.1415-1419.

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https://escriba.ipt.br/pdf_restrito/177010.pdf

Reference:
 ALVARADO, Alembert Eistein Lino; ROSA, Diego Antonio de Oliveira; MELLO, Sara Gomes; DIAS, Marcelo Sanches; BARBOSA, Mario Fernando; BARROS, Kelvis do Nascimento; LEMOS, Bruno Alexandre; VITORASSO, Renato de Lima; BARTHOLOMEU, Victor Paheco; AMERICANO, Pedro Parik; SILVA FILHO, Edison; MORAES, José Carlos Teixeira Barros; FERREIRA JUNIOR, Antonio Francisco Gentil; MORIYA, Henrique Takachi.Quality assessment of emergency corrective maintenance of critical care ventilators within the contexto of COVI019 in São Paulo, Brazil. Global Clinical Engineering Journal, v.4, n.1, p.27-37, 2021.

Access to the article on the Journal website:
https://globalce.org/index.php/GlobalCE/article/view/108/70

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