The novel Mechanical Ventilator Milano for the COVID-19 pandemic
Alessandro Abbà, C. Accorsi, P. Agnes, E. Alessi, P. Amaudruz, A. Annovi, F. Ardellier Desages, Sudie E. Back, Carme Macià Badia, J. Bagger, V. Basile, G. Batignani, A. Bayo, Ben Bell, Manuel Beschi, Denise Biagini, G. Bianchi, S. Bicelli, Dorothy Bishop, T. Boccali, Andrea Bombarda, Silvia Bonfanti, W. Bonivento, M. Bouchard, M. Breviario, S. J. Brice, Ryan Brown, J. M. Calvo-Mozota, L. Camozzi, Marie-Lys Camozzi, A. Capra, M. Caravati, Massimo Carlini, Andrea Ceccanti, B. Celano, J. M. Cela Ruiz, C. Charette, Giacomina Cogliati, M. Constable, C. Crippa, Giorgio Alberto Croci, S. Cudmore, C. E. Dahl, A. Dal Molin, M. Daley, C. Di Guardo, Giuseppe D’Avenio, O. Davignon, M. Del Tutto, J. M. de Ruiter, Amanda Devoto, Pablo Diaz Gomez Maqueo, Fabio Di Francesco, M. Dossi, E. Druszkiewicz, M. Dūma, E. Elliott, D. Farina, Carlos Fernandes, F. Ferroni, G. Finocchiaro, G. Fiorillo, R. Ford, Giuseppe Foti, Rodney Fournier, D. Franco, C. Fricbergs, F. Gabriele, C. Galbiati, P. Garcı́a-Abia, Angelo Gargantini, L. Giacomelli, F. Giacomini, F. Giacomini, L. S. Giarratana, Sarah Gillespie, Donato De Giorgi, Tsinuel Girma, R. Gobui, D. Goeldi, F. Golf, P. Gorel, G. Gorini, E. Gramellini, Giuseppe Grosso, F. Guescini, Emma Guêtre, G. Hackman, Theresa A. Hadden, W. Anthony Hawkins, Kazuhiro Hayashi, A. Heavey, G. Hersak, N. P. Hessey, G. Hockin, Katelyn Hudson, Aldo Ianni, C. Ienzi, V. Ippolito, C.C. James
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.