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05 May 2020The 'Milano Ventilatore Meccanico' (MVM), the innovative device for assisted breathing born in Italy and developed in just over a month by extensive international scientific collaboration, has obtained the emergency certification of the FDA (Food and Drug Administration), the US certification body, and can therefore enter the facilities of hospitals in countries that recognize the American certification.

MVM has been specially designed to be easily and quickly produced anywhere: it is a safe and effective device, because it is equipped with an advanced control system that allows the different ventilation modes to act effectively but at the same time gently on the lungs, and is characterized by an open access project, and a simple mechanical design based on components that are easy to find on the market, so that it can be produced on a large scale, at low costs and in different countries. In Italy, the project was immediately supported by the INFN National Institute of Nuclear Physics, the Universities of Milano-Bicocca, Milano Statale, Naples Federico II, GSSI Gran Sasso Science Institute, the STIIMA and ISTP institutes of the CNR National Council of Research.

The rapid spread of CoViD-19 has dramatically envisaged for many of the countries affected by the pandemic a possible scarcity of fans compared to the number of patients. In fact, about 6% of people who contract CoViD-19 develop very serious lung complications, which require the use of a ventilator that pumps oxygen into the lungs and expels carbon dioxide when air is released. "When, from the early stages of the spread of the pandemic in our country, it was clear that many patients would need respiratory assistance, - explains the creator of the Cristiano Galbiati project , GSSI, INFN and Princeton University - we have immediately decided to make available our skills and our ability to work in collaboration to produce a new fan that could help face the crisis ".

"MVM represents a paradigmatic case: on the one hand it shows the fundamental role and the great impact that basic research, with its capacity for knowledge and technological innovation, has on society, and on the other it highlights the importance of international and multidisciplinary collaboration to face the great challenges of our times. The EUA FDA certification is an important goal and a great satisfaction for all of us: our Milan Mechanical Fan becomes a reality from a project, which we hope will help save many lives ", concludes Galbiati.

The MVM project was born on the idea and initiative of some scientists engaged in research on dark matter, an invisible component of our universe, with experiments at the INFN Gran Sasso Laboratories, and in Canadian laboratories. The creation of sophisticated experimental equipment for research in fundamental physics has allowed, in fact, the development of specific skills in the field of complex control systems and for the management of gases, similar to those used in lung ventilators. So the scientists decided to use these skills to create a new mechanical device for assisted breathing, and they started developing a first fan prototype at the technical assistance center for respirators of the SAPIO Life company in Vaprio d ' Adda, near Bergamo, in direct and continuous collaboration with the Physics Department of the State University of Milan. But bringing the MVM ventilator to patients obviously requires collaboration that does not stop at the field of particle physics. Therefore, scientists with specific skills, clinicians and health workers also collaborate on the project, and companies with Elemaster, who coordinated the participation of the other companies Nuclear Instruments, AZ Pneumatica, Saturn Magnetic, Bel Power Europe and Camozzi.

The development of the device under restrictions of mobility of people required the establishment of an experimental group in Lombardy that worked on forced stages, including Easter. Elemaster has made its laboratory available for the development of the first units and has created the entire electronic part of the fan, from the printed circuit board, produced by its division, to the complete assembly, created thanks to the contribution of all the other companies involved .

After careful testing and qualification processes of the performance of the first prototype with breathing simulators conducted with the Department of Medicine of the University of Milan-Bicocca at the San Gerardo Hospital in Monza, it was possible to build the first prototype in a few weeks industrialized that demonstrated the correctness and feasibility of conceptual design. Since March, the MVM project has been counting on the support and contribution of the CNR and subsequently also on the contribution of the other Lombard universities of Milan, Bergamo, Brescia, Pavia, Insubria. They also collaborate to exclude the emission of harmful substances during the operation of the fan and to obtain its approval by the certification bodies, researchers of the Department of Chemistry and Industrial Chemistry of the University of Pisa and of the IFC of the CNR, supported by the staff of the Gabriele Monasterio Tuscany Foundation, and of the SRA Instruments company. While, for the verification and certification procedures, the competent institutions were involved in Italy, and abroad the FDA Food and Drug Administration, the US Air Force and Health Canada.

The primary responsibility for submitting the project to the FDA for its certification was taken on by Elemaster, through its International Design Center. "We responded enthusiastically to the collaboration proposal received from the international scientific community," says Gabriele Cogliati, president and CEO of Elemaster Tecnologie Elettroniche. "Elemaster has made available a full-time team of over 40 specialists dedicated to project management, design, engineering and management of technological processes, development and production of printed circuits, with the task of developing, industrializing and create the first MVM prototypes in record time, also coordinating the other companies involved ". "This product meets all the international requirements and regulations of the project, the result of the contribution of the international scientific community, and has a revolutionary scope precisely by virtue of its simplicity and ease of use, which makes it replicable in all the countries of the world ". Also internationally, the MVM collaboration has grown rapidly, including in Canada CNL, TRIUMF, SNOLAB and Mc Donald Institute, under the guidance of the Nobel Prize for Physics Art McDonald of Queen's University, and in the United States scientists from Fermilab, of the Laboratory of Plasma Physics of Princeton and of various Universities. While at European level, researchers from the French CNRS IN2P3 Institute, the Spanish laboratory CIEMAT and the National Center for Polish Nuclear Research and several other Institutes and Universities have joined the project.