As the COVID-19 crisis mounts and more people are getting seriously ill, we are hearing a rising crescendo of alarming news around the world that hospitals are running out of medical supplies and life-saving equipment like ventilators. It hasn’t helped that global supply chains are now struggling to keep up amid the disruptions brought on by widespread lockdowns, and other drastic measures intended to contain the pandemic’s spread. As a result, we’re seeing not only panic-buying and price-gouging of high-demand consumer items, but also shortages of essential things that healthcare professionals and their severely sick patients need.
Faced with these dire realities, some companies are contributing their expertise to help deal with these increasing scarcities. In Italy, where overwhelmed hospitals are running out of critical components, Italian startup Isinnova met the challenge by 3D printing replacements for respirator valves, which are used in so-called “venturi” (or air-entrainment) masks. These valves are vital because they regulate the amount of oxygen that’s mixed with room air, which a COVID-19 patient can then breathe in with the help of a machine. Without such a component, COVID-19 patients who exhibit extreme respiratory distress and who need mechanized help to breathe — will likely die.
Isinnova was able to manufacture 100 of the valves in the timeframe of only 24 hours, after a local hospital in Brescia put out a public call for help. Their usual supplier had informed them they could not produce enough of the single-use valves in time — which can only be used up to 8 hours — for the 250 patients who were already in the hospital’s intensive care ward.
“There were people with their lives in danger, and we acted. Period,” Isinnova founder Cristian Fracassi told Healthcare IT News. “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.”
Making Masks From an Open Source Design
To create the valves, the Isinnova team used a filament extrusion system, where a wiry, plastic material was melted down to set down the design, layer by layer. Isinnova had to reverse-engineer the design to create three different prototypes, as they were unable to get their hands on the original files from the patent holder. Isinnova’s version of the valve cost only $1 to make; however, the team may now face legal action from the patent holder, Intersurgical, the maker of the $11,000 CPAP Hood System, which includes the valve as part of its design.
Despite this development, the Isinnova team remains undaunted. Besides rapidly prototyping and manufacturing the valves, and installing a 3D printer in the Brescia hospital so that medical staff can print them on demand, the company has now also assisted another hospital by using 3D printing to adapt a snorkeling mask to address the shortage of CPAP masks (continuous positive airway pressure), which are also used for patients who need help in breathing.
In this case, Decathlon, the company that owned the Easybreath snorkeling mask design, chose to collaborate with Isinnova by providing them with the original computer files, which were then modified to accommodate this enhanced function, via a 3D printed component that connects the full-face plastic mask to a ventilator. Dubbed “Charlotte,” this open source design is now available for free download so that those who have access to a 3D printer can produce as these life-saving components as needed.
As the shortages in medical equipment grow worldwide, many hospitals are now turning to crowdsourcing, 3D printing and other alternatives to meet the skyrocketing demand. As scores of healthcare workers mobilize worldwide to tackle the all-too-real threat of the coronavirus pandemic, their safety and those of their patients means that we will likely have to reconsider regulations and the pace of local safety approval processes (for instance, the Charlotte mask has yet to be certified as a biomedical device but is already being tested in the hospital as the situation in Italy becomes more desperate). Ultimately, we’ll need to think about redesigning how global supply chains and industries are currently structured, in order to make them more adaptable and agile in unprecedented emergencies such as the one we are now facing.
Read more over at Isinnova.