BiPAP 3D Printed Adapters

What are BiPAP Adapters?

Problem

COVID-19 patients in critical condition often require mechanical ventilation to provide sufficient oxygen into the lungs and body. As the number of patients requiring ventilation fluctuates and ventilator machines are limited in supply, hospitals can run out of machines faster than they can order new devices.
 

FDA Authorized Solution

Northwell Health, New York’s largest healthcare provider, designed 3D printed adapters that can be used to convert bi-level positive airway pressure (BiPAP) machines, typically used for patients suffering from sleep apnea, into functional invasive mechanical ventilators. 

The key component to converting the BiPAP machine is a small, plastic T-shape adapter, which can be easily produced on Formlabs stereolithography (SLA) 3D printers. Northwell designed these adapters to provide life-saving care to hospitalized COVID-19 patients in New York City, and used them on a number of patients in their New York City ICUs during the peak of the virus in the city. 

The FDA has now granted Formlabs Emergency Use Authorization (EUA) to 3D print the BiPAP adapters at its FDA-registered headquarters in Somerville, MA to aid hospitals in other hard-hit cities. 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.  

“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 the practice of medicine, meaning printing the adapters at scale in the hardest-hit areas is as easy as uploading a design and pressing print.” - Max Lobovsky, CEO and co-founder of Formlabs
 

Validation Status:

This design was developed in collaboration with Northwell Health. The design was successfully used to save lives in New York City. Northwell Health and Formlabs have been granted Emergency Use Authorization (EUA) by the FDA to produce and distribute the adapters.

Purchase BiPAP Adapters:

Formlabs has 150 3D printers at its FDA-registered headquarters in Somerville available to print these adapters, enabling the company to print up to 3,000 parts per day as the need arises. 

 

 

In Partnership With

Disclaimer

Formlabs has created this website and has become involved in varying degrees with the projects described here during a global medical crisis.  Formlabs is working on many projects to address global healthcare-related supply shortages around the world, but in trying to mitigate these shortages, patient safety is still Formlabs’ top concern. We must remind those who are helping to alleviate these shortages that masks, swabs, face shields, and other 3D printed products intended to prevent or treat COVID-19 are medical devices. These devices must be safe for their intended purpose and anyone considering the manufacturing of these products should consider the following items:

  • Formlabs is a manufacturer of 3D printing materials capable of fabricating finished devices according to their labeling and any other product manufactured from these materials should be verified and validated according to their intended purpose.

  • You may be fabricating a device that does not have the required regulatory approvals and clearances. If you are fabricating devices, follow the guidelines on the label for each material.  You may seek to obtain reliable regulatory advice. 

  • Please consider local regulations, material safety data sheets, software capabilities, sterilization requirements, and institutional requirements before 3D printing medical devices.

  • Regulatory agencies (such as the FDA) may consider expedited review of manufacturing information and/or premarket submissions.

Formlabs cannot warrant that any products not manufactured by Formlabs are suitable for their intended purpose.