Unable to obtain the original blueprints for the valves because of medical manufacturing regulations, Cristian Fracassi and Alessandro Romaioli of Isannova reverse-engineered one, creating and testing three possible working prototypes.
Although going against established protocol, the team were able to produce 100 3D-printed valves in 24 hours and at a cost of approximately $1 per unit. This is in stark contrast to the $11,000 it costs Intersurgical, the patent holder, to make the CPAP Hood System, of which the valve is a small part.
The printed valves have already gone on to successfully treat patients in Brescia and another hospital has already got in contact with Fracassi and Romaioli for assistance. The team have not publicly released the designs, stating that they are working for free and believe, where possible, the valves should be produced clinically.
WHY IT MATTERS
L’Ospedale di Chiara in Brescia was unable to procure the valves from its regular supplier, who informed the hospital that they would not be able to make any more in time to treat the 250 patients already in their intensive care unit, as the increased demand due to the COVID-19 outbreak had cleared them out.
The valves are an essential component of breathing apparatus used to treat patients suffering from coronavirus, a virus that primarily targets the lungs and air-passages. They are single-use and designed to be used for up to 8 hours at a time, meaning the number of valves needed far outnumbers the Hoods.
THE LARGER PICTURE
Italy has suffered over 5,476 fatalities so far (23 March) from COVID-19, surpassing China as the country with the highest death rate. The virus seems to be affecting the country worst, with 43% of confirmed cases so far resulting in death and a Case Fatality Rate of approximately 8.3%, over double the estimated world average.
Intensive care units across the country have already been filled and the country is enduring a complete lockdown while essential services try and get the situation under control.
ON THE RECORD
Cristian Fracassi responded to his involvement in the project: “There were people with their lives in danger, and we acted. Period.”
He added: “If we acted fast, it was only because with 3D-printing you can quickly attempt a small production that would be impossible on an industrial scale,” before clarifying that the official valves were of a higher quality.
Michele Fiani, who also took part in the project, highlighted the importance of collaboration in this uncertain time: “I hope that all the people understand that we have to work together [to] stop this pandemic. All of us have to stay safe and have to use our skills to help [those] who need it”.
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