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Milano Ventilatore Meccanico (MVM): certified by the FDA and available for production

di lettura
13 maggio 2020

The innovative assisted breathing device of MVM, born in Italy and developed thanks to a broad international scientific cooperation, has obtained the EUA (Emergency Use Authorization) certification of the Food and Drug Administration and can therefore enter the hospitals of the countries that recognise the US certification.

The rapid spread of CoViD-19 has dramatically predicted a possible shortage of ventilators with respect to the number of patients in many countries.

The innovative MVM device was born from an open access project to be easily and quickly produced anywhere at a low cost:

  • it is equipped with an advanced control system that enables different ways of ventilation that act effectively but delicately on the lungs.
  • its simple mechanical design is based on components that are easy to find on the market, so it can be produced on a large scale.

The creator of the project Cristiano Galbiati of GSSI, INFN and Princeton University explains: “MVM represents a paradigmatic case: on the one hand it shows the essential role that basic research has on society, and on the other it highlights the importance of an international and multidisciplinary cooperation to face great challenges. The EUA certification by the FDA is an important milestone: it has turned Milano Ventilatore Meccanico from a project into reality, which we hope will help to save many lives ".

From prototype to crowdfunding

The MVM project was born from the idea and initiative of some scientists involved in research on dark matter, with experiments at the INFN Laboratories of Gran Sasso, and in Canadian laboratories. The creation of sophisticated experimental equipment for research in fundamental physics has allowed the development of specific skills on complex control systems and for the management of gases, similar to those used in lung ventilators.

These experts have started the development of a first ventilator prototype at the technical service center dedicated to respirators of the company SAPIO Life in Vaprio d’Adda, near Bergamo, in cooperation with the Department of Physics of the State University of Milan.

But to bring the MVM ventilator to the patients, the contribution of scientists, clinicians, health professionals and some companies headed by Elemaster was essential:

Elemaster has made a team of more than 40 specialists and its laboratory available for the development of the first units and created the entire electronic part of the ventilator and subsequently presented the project to the FDA for certification.

After testing and qualifying processes of the performance of the first prototype with breathing simulators, it was possible to create the first industrialised prototype in a few weeks which proved correctness and feasibility of the conceptual design.

MVM is made up of pneumatic solenoid valves and not of mechanical switches. Its modular design adapts well to the exchange of components based on availability in different parts of the world. The design of the ventilator is of open access.

The final project will be published on arXiv.org and will be granted under license according to CERN OHL v2.0 by the Air Foundation. ­

The members of the MVM International Cooperation have undertaken this project using their own resources and have set up a crowdfunding campaign.

Partners

The INFN (National Institute for Nuclear Physics) coordinated the development of electronics. In a few days, the researchers designed the prototype of the board that houses the microcontroller and manages the solenoid valves, pressure and oxygen sensors and created the Graphic User Interface that allows to view the patient's vital parameters on an LCD display.

GSSI - Gran Sasso Science Institute participates in the project from the very beginning with Cristiano Galbiati, full professor of Physics of the GSSI and Prof. Fernando Ferroni, networking and communication facilitator with the scientific community on an international level.

The CNR National Research Council of Italy involved physicists and engineers from the Institute for Plasma Science and Technology (ISTP) and from the Institute of Intelligent Industrial Systems and Technologies for Advanced Manufacturing  (STIIMA). The activity of the researchers mainly concerned the optimisation of the circuit and fluidic implementation (valves and regulators), sensors (of flow and pressure), intelligent control and support for clinical validation.

The University of Milano-Bicocca has involved not only its researchers, but also companies, research institutes, anesthesiology doctors of the San Gerardo Hospital in Monza who, thanks to their skills on lung ventilation and clinical experience with COVID-19 patients, were able to define and test the characteristics of the device.

The University of Milan La Statale has been involved since the beginning for the construction of mechanical parts for the first prototype. Currently researchers are involved to contribute in creating the user interface of the device and in preparing the technical documentation of the product.

The University of Bergamo, thanks to several different engineering skills, created and tested a technological solution of a high social impact with the aim of helping to respond quickly.

The University of Naples Federico II is one of the proponents of the MVM project with Giuliana Fiorillo, full professor at the Department of Physics 'Ettore Pancini', and member of the international coordination group that maintains contacts with all those who want to offer contributions as well as with researchers / companies of third countries who want to replicate the project.

The University of Pisa participates in the project to verify the absence of potentially harmful compounds released by the materials and components that make up the ventilator.

Main foreign institutions

Collaboration has grown rapidly also internationally, including the CNL, TRIUMF, SNOLAB and the Mc Donald Institute, under guidance of the Nobel Prize winner Arthur McDonald of the Queen’s University from Canada, scientists of Fermilab, of the Princeton Plasma Physics Laboratory and different other universities from the United States. From Europe, researchers of the IN2P3 Institute of the CNRS in France have joined the project, as well as the CIEMAT laboratory in Spain and the National Centre for Nuclear Research in Poland and several other Institutes and Universities.

"We participated with great enthusiasm in the development of the MVM project," comments the Nobel Prize winner in Physics Arthur McDonald. "Personally, it has been an extraordinary experience to collaborate in an international team covering such a wide range of skills, working hard to help save human lives in this difficult time."


For more information

MVM Mechanical Ventilator Milano

Open source paper

Funding campaign