Formlabs receives FDA go-ahead to print BiPAP adapters
3D printing company Formlabs has received emergency use authorisation (EUA) from the U.S. Food and Drug Administration (FDA) to print bi-level positive airway pressure (BiPAP) adapters designed by Northwell Health, a New York healthcare provider.
Formlabs is now shipping these adapters to hospital systems throughout the U.S. to combat the shortage of ventilators and provide life-saving treatment to Covid-19 patients. The 3D printed adapters convert BiPAP machines, typically used for patients suffering from sleep apnoea, into functional invasive mechanical ventilators.
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, MA to distribute to hospitals and government systems throughout the United States. It 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.
Max Lobovsky, CEO and co-founder of Formlabs, said: “Prior to the Covid-19 pandemic, the FDA had only authorised a handful of EUAs over a 30-year period. 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 localised 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 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 care to hospitalised 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.
The industry’s response to Covid-19 is a seminal moment for 3D printing, and Formlabs is positioned to assist the medical community in providing critical supplies and equipment to combat Covid-19.