Quality characteristics of the Masi Peruvian mechanical ventilator manufacturing process.

ABSTRACT

Three hundred and ten rapid-manufactured mechanical ventilators, named Masi, were produced and validated in Peru, according to applicable standards. From these, a sample of 30 was taken and two ventilation parameters, tidal volume and peak inspiratory pressure, were statically analyzed using control charts and histograms. Results show that several points were outside estimated limits for Shewhart means and ranges charts, which could possibly be due to the quantity of equipment used for data recollection and the fact that the Masi team had over 20 engineers. Nevertheless, Masi ventilators met the tolerance required by their user´s manual and MHRA standard and Peruvian DIGEMID for every parameter.Clinical Relevance-This article shows the performance in the validation stage of the peruvian mechanical ventilator MASI built as an emergency response for the COVID-19 crisis.