Abstract
This paper presents the Mechanical Ventilator Milano (MVM), a novel intensive therapy mechanical ventilator designed for rapid,
large-scale, low-cost production for the COVID-19 pandemic. Free of moving mechanical parts and requiring only a source of
compressed oxygen and medical air to operate, the MVM is designed to support the long-term invasive ventilation often required
for COVID-19 patients and operates in pressure-regulated ventilation modes, which minimize the risk of furthering lung trauma.
The MVM was extensively tested against ISO standards in the laboratory using a breathing simulator, with good agreement between
input and measured breathing parameters and performing correctly in response to fault conditions and stability tests. The
MVM has obtained Emergency Use Authorization by U.S. Food and Drug Administration (FDA) for use in healthcare settings during
the COVID-19 pandemic and Health Canada Medical Device Authorization for Importation or Sale, under Interim Order for Use
in Relation to COVID-19. Following these certifications, mass production is ongoing and distribution is under way in several
countries. The MVM was designed, tested, prepared for certification, and mass produced in the space of a few months by a unique
collaboration of respiratory healthcare professionals and experimental physicists, working with industrial partners, and is
an excellent ventilator candidate for this pandemic anywhere in the world.
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