The idea that 3D printing could be used to help respond to the COVID-19 pandemic may have first been triggered by work being performed in Chiari, Italy. Our friends at 3D Printing Media Network broke the story that local 3D printing users were able to provide 3D-printed valves for reanimation devices at a hospital in short supply. Since the news broke, there have been several updates demonstrating how an emergency 3D printing project can evolve into something even more viable in just a brief period of time.
The story began with the editor of one of Brescia’s newspapers contacting the founder of The FabLab in Milan, Massimo Temporelli, about the need for a valve for Venturi oxygen masks at a hospital in Chiari, which the machine’s supplier could not provide quickly. The hospital is at the frontlines of the coronavirus outbreak in Northern Italy, where, several days ago, the director of one facility’s emergency department has said they are reaching the saturation point for new patients. These masks are the type one might typically associate with hospitals, drawing in a controlled amount of air from the surrounding environment, with the valves acting as key components.
After reaching out to a number of 3D printer users, Temporelli found Isinnova, whose founder Cristian Fracassi was able to rush to the site with 3D printer in tow. Fracassi rapidly designed a copy and 3D printed replacement valves in just a few hours. By the following day, it was reported that the 3D-printed valves functioned as designed and 10 patients were able to receive treatment.
Since the initial story broke, several developments have taken place, but not all positive. Whereas the first replacements were made using filament extrusion systems, batch production of nylon replacement valves was subsequently performed using polymer laser powder bed fusion (PBF) by local 3D printing provider Lonati SpA.
As discussed in the Italian language video below, Fracassi has not yet shared the STL file for the valve, despite numerous requests, because he believes that hospitals should check with the manufacturer for spare parts first. He also believes that the part should be made with a high-end industrial system to ensure that it can be made with the proper accuracy. A translation of the video can be found here.
However, a user on GrabCAD created a similar model that is available through the 3DMN forum dedicated to the topic. A physics simulation of this second valve model is embedded below.
Isinnova then went on to design a 3D printable adapter for converting a snorkeling mask into a “non-invasive ventilator” for COVID-19 patients. According to the company, they received a request from a former doctor from Gardone Valtrompia Hospital, who believed that 3D printing could be used to address a possible shortage of C-PAP masks for sub-intensive oxygen therapy potentially needed to treat breathing issues stemming from the coronavirus outbreak. Working with French snorkel manufacturer Decathlon, Isinnova designed a 3D printable part that could connect a snorkeling mask to a ventilator. The subsequent prototype was tested at the hospital and demonstrated that it could function. To purportedly prevent someone to profit off of the model, the company patented the design and claims that it will provide it for free and will not receive any royalties from Decathlon.
After word got out about Isinnova’s original 3D printable valve, concerns were raised that the company could be sued for copyright infringement. Though they have not yet received any legal threats, Fracassi said that the concerns were legitimate. Stories that the makers were sued were inaccurate however. The printable valve might cost roughly $1 to manufacture additively. Assertions that the original part cost $11,000 were incorrect however.
As an entryway into how AM can be used in an emergency situation, Isinnova’s story is an illustrative one. First and foremost, it demonstrates how the ability to rapidly fabricate an item can potentially serve vital purposes in an emergency situation (a capability that the medical and military sectors have long been promoting for 3D printing).
In these situations, it’s always possible that sensational stories can drive attention to the parties involved, in this case local 3D printing businesses. Because the name of the hospital has not yet been disclosed, we are not able to validate the success of the printed part. For that reason, it’s important to have some skepticism about the nature of the story.
Other issues brought up, and repeatedly stressed by Isinnova and others linked to the story, are the fact these are medical devices, which generally require specific medical guidelines to ensure safety of use. Isinnova and the hospital agreed to forego such usually-necessary formalities due to the emergency at hand. While this may help streamline the process of obtaining regulatory approval for similar 3D-printed medical components in the future, it does not mean that this should be a regular practice outside of emergency situations.
3D printed parts are notorious for their inherent porosity, meaning that bacteria can accumulate in microscopic pores. Additionally, medical device manufacturing takes place in specialty clean rooms, where sanitized equipment is used and parts are handled according to specific guidelines to ensure that no bacteria is transmitted during the production process. Similarly, porosity and strength along the Z-axis of printed parts can lead to fatigue and reduced strength in the 3D printed parts, so they may not last as long or be able to withstand the same rigorous use as traditionally manufactured parts. All of this means that, in the case of pandemic as we are currently experiencing, medical devices 3D-printed outside of a clean room could help patients immediately, but may lead to the transmission of disease in the long run.
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