3D Printing Manufacturer Gets FDA Emergency Use Authorization for BiPAP-to-Ventilator Adapters
3D printing company Formlabs has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) to print bilevel positive airway pressure (BiPAP) adapters designed by New York’s Northwell Health. Formlabs is now shipping these adapters to hospital systems throughout the United States to combat the shortage of ventilators amidst COVID-19. The 3D printed adapters convert BiPAP machines, typically used for patients who have sleep apnea, into functional invasive mechanical ventilators.
We have received Emergency Use Authorization from the @US_FDA to #3Dprint bi-level positive airway pressure adapters designed by @NorthwellHealth. These adapters convert BiPAP machines used for patients suffering from sleep apnea, into functional invasive mechanical ventilators. pic.twitter.com/KwRgB9ecD8
— Formlabs (@formlabs) May 4, 2020
The key component to converting the BiPAP machine is a small, plastic T-shape adapter, which is easily produced on 3D printing machines in hospitals across the country. Formlabs will also produce these adapters at its FDA-registered headquarters in Somerville, Mass, to distribute to hospitals and government systems throughout the United States. Formlabs will allocate 150 3D printers at its headquarters towards printing these adapters, enabling the company to print up to 3,000 parts per day once production is fully ramped up.
“Prior to the COVID-19 pandemic, the FDA had only authorized a handful of EUAs over a 30 year period,” says Max Lobovsky, CEO and co-founder of Formlabs, in a release. “Formlabs’ EUA for BiPAP adapters signifies the need for these components and 3D printings’ unique ability to fill that need. 3D printing enables rapid iteration and prototyping of new, innovative medical equipment, while expediting the production process, shortening supply chains, and allowing for localized manufacturing. Hospitals around the country can also use Formlabs’ printers to create these adapters locally under their own practice of medicine, meaning printing the adapters at scale in the hardest-hit areas is as easy as uploading a design and pressing print.”
Northwell Health has been a key partner of Formlabs throughout the COVID-19 pandemic. The hospital system began working with Formlabs in 2018 and that partnership has led to the creation of 3D printed test swabs, in collaboration with the University of South Florida Health, and now 3D printed BiPAP adapters. Northwell designed these adapters to provide life-saving care to hospitalized COVID-19 patients during the peak of the virus in New York City. After using these adapters on a number of patients in their New York City ICUs during the peak of the virus in the city, Formlabs will now print these adapters at scale to aid hospitals in other hard-hit cities.
from Sleep Review https://www.sleepreviewmag.com/sleep-treatments/therapy-devices/ventilation-therapy-asv/3d-printing-manufacturer-gets-fda-emergency-use-authorization-for-bipap-to-ventilators-adapters/