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.
To better evaluate the medical electrical equipment the laboratories for testing will need to deploy in its management system, the process of Risk Management. This new theme is prescribed in the edition of ABNT NBR IEC 60601-1:2010, which will take effect from 2012 in Brazil. This research aims to show brief the process used to implement the Risk Management procedures for testing medical electrical equipment, to meet the new requirements of the series of ABNT NBR IEC 60601/80601 aiming at continuous improvement of the management systems of laboratories for testing accredited by INMETRO. The method used for the development of this research was the detailed study of two Brazilian editions of the General Standard, Collateral Standards, Particular Standard of infusion pumps and controllers, as well as the ABNT NBR ISO 14971:2009. After studying these Standards, some Risk Management files provided by manufacturers of medical electrical equipment were analyzed and performed the study of some tools used for the development of Risk Management, for example, FMEA, FTA and HAZOP. Trainings were also conducted to the whole laboratory for testing team. With these activities, it was possible to develop and deploy the necessary testing procedures in DEC-LEB/EPUSP and validate procedures for testing. An infusion pump for the validation of these procedures was used, along with all its accompanying documents. The final result was the training of DEC-LEB/EPUSP team for testing as new editions of the standards that incorporate Risk Management in their prescriptions, concluding that laboratories for testing must include appropriate procedures and training of their human resources.
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