Texas-based team seeks EUA for 3D printed emergency ventilator

A team of physicians and engineers developed a hands-free resuscitator bag compression device that can be utilized as an emergency ventilator during the COVID-19 pandemic.

As the pandemic goes on and a shortage of vital equipment, including ventilators, continues, a number of companies and research teams from all over have worked to create alternative options. One such alternative is this collaboration from researchers at Texas Tech University Health Sciences Center El Paso and The University of Texas at El Paso, with contributions from Bessel, Ansys and Stratasys (NSDQ:SSYS).

The Texas Breather (TM) is designed to fall into the FDA’s new category of devices that qualify for emergency use authorization (EUA), the emergency use resuscitator systems (EURS). It includes an adjustable degree of compression and respiratory rate with a simple design that includes no software, according to a news release.

After Dr. Robert Stump and Dr. Scott Crawford from Texas Tech’s El Paso health sciences center (TTUHSC) brought the idea to UTEP Keck Center staff engineer Luis Ochoa, the wheels were in motion and six versions of a Texas Breather prototype were developed within a week.

Once the prototype came into play, medical device professionals from Bessel joined the fray, as Ansys worked with engineers from the UTEP Keck Center to create simulations and Stratasys donated materials for fabrication, as well as some prototypes. The engineers selected polycarbonate as the material for the almost entirely 3D printed assembly.

Researchers conducted qualification testing with the IngMar Respitrainer, QuickLung and ASL 5000 TM breathing stimulators from the TTUHSC Training and Educational Center for Healthcare Simulation (TECHS).

The creators intend for the Texas Breather to be used as a stopgap alternative for assisting with COVID-19 patients when invasive ventilator machines are unavailable. The device has been submitted for review by the FDA as the team seeks EUA, but it has not yet been approved for use by any regulatory body.

“The team developed this device in pandemic-timescale,” Bessel CEO Chris Danek. “Doctors and engineers worked closely together to establish and refine the design. The combination of additive manufacturing, simulation, and rapid testing was the only way to know within an acceptable timeframe that the device would be able to meet its requirements.”

University of Maryland School of Medicine interventional pulmonology program director Dr. Ashutosh Sachdeva also confirmed that there is a potential role for the Texas Breather for emergency use during the pandemic.

“The controlled compression of the manual resuscitator bag appears to limit concern for over-pressure and potential for barotrauma seen in manual use of the manual resuscitator bag, and would also eliminate the need for 1:1 care for patients for whom use of a manual resuscitator bag is indicated in the face of unavailable mechanical ventilators,” Sachdeva said. “This is important both because we are short-staffed and to limit exposure of our staff to SARS-COV-2.”