Wednesday, December 4, 2024

FDA approves 3D printed adapters that turn BiPAP machines into ventilators

The U.S. Food and Drug Administration (FDA) has granted Formlabs, a leading 3D printing company, an emergency approval to 3D-print adapters that can be used to manufacture much-needed ventilators. Bi-level positive airway pressure (BiPAP) adapters, designed by Northwell Health, New York’s largest healthcare provider, can convert the existing sleep apnea machines into functional invasive mechanical ventilators.

3D-printed BiPAP adapters
3D-printed BiPAP adapters

The necessary adapters can be easily manufactured using 3D printing. They are T-shaped and made of a synthetic resin. The company plans to use 150 3D printers at its Somerville, Massachusetts facility to print these small, plastic adapters – around 3000 per day. The devices will eventually be distributed to hospitals and local governments across the United States.

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,” said Max Lobovsky, CEO and co-founder of Formlabs. “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.

Formlabs is already supporting the healthcare sector worldwide with several projects to combat COVID-19. So far, the company and its partners have developed test strips for test swabs, adapters for face protection, and parts for rapid test kits.

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