3D Printed Ventilator Part Receives Emergency FDA Approval

3D printing company Formlabs just received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to 3D print bi-level positive airway pressure (BiPAP) adapters. The BiPAP adapters are designed by New York's largest healthcare provider Northwell Health. The first 3D printing manufacturer to receive a EUA, Formlabs is now shipping the FDA-approved adapters to hospitals and healthcare facilities all over the United States. This will help alleviate the current shortage of ventilators used to provide life-saving treatment for patients suffering from COVID-19.

Bilevel positive airway pressure (BiPAP) machines use mild air pressure to keep airways open during sleep. The machines are prescribed to people diagnosed with sleep apnea, a disorder which occurs when a person has intermittent but consistent pauses in breathing (or periods of shallow breathing) during sleep.

This small adapter can be printed at hospitals all over the United States. Formlabs is also printing them at their FDA-registered headquarters for distribution within the country using 150 3D printers. Their goal is to produce 3,000 adapters per day once production is fully up to scale. (Image courtesy of Formlabs.)

Northwell Health began collaborating with Formlabs in 2018. Their partnership has been particularly fruitful in producing components to help healthcare workers combat the spread of COVID-19, as well as in treating patients who had contracted the deadly virus. These components include FDA-approved 3D-printed test swabs and now the T-shaped adapter for converting BiPAP machines into life-saving ventilators. Formlabs also produced ventilator mask designs and prints to help in the ongoing treatment of those affected by the pandemic.

Bottom Line

The adapters from Northwell Health and Formlabs were first implemented in treatment of patients in intensive care units at hospitals in New York City when the outbreak of COVID-19 peaked. The ongoing help of the 3D printing community to battle COVID-19 will continue as the world keeps fighting this horrible new outbreak.