"Subsalve" Oxygen Treatment Hood Gains FDA Emergency Use Authorization
Updated: Oct 8
People diagnosed with COVID-19 -- and the physicians treated them -- have just received another piece of arsenal to fight the virus – the FDA issued Emergency Use Authorization (EUA) for the "Subsalve" noninvasive ventilation helmet.
“This is a huge achievement for Michael Lombardy, his team, and the whole helmet industry,” said Aurika Savickaite, cofounder of www.HelmetBasedVentilation.com. “The FDA gave a green light for all the physicians to use the helmet for the COVID patients for noninvasive ventilation in the ICU settings, which is great.”
The helmets gained momentum with the onset of COVID-19 early this year, with countries like Italy leading the way and introducing the concept to hospitals, physicians, and manufacturers in the United States. With many advantages over invasive-type ventilation, the helmet gained great interest when able to be used in the right situations for patients fighting COVID-19.
Savickaite and her husband, David Lukauskas, started the website with the intention to share information about the noninvasive helmets when the COVID-19 pandemic struck, sharing the stories of physicians throughout the world, helmet manufacturers, and studies regarding helmet use. Savickaite, MSN, RN, was involved in the successful trial of the helmet ventilator in the ICU at the University of Chicago during a three-year study.
Advantages of the helmet include faster recovery time, shortening an ICU stay, less need to intubate, lower ICU mortality, minimal or no sedation, and less cost, due to faster recovery, less-invasive treatment, and lower-cost device.
However, these advantages were not being optimized, because some were hesitant to use "off-label" the FDA approved helmet, Savickaite said. It was more difficult to gain administrative approval for helmets – and there were some facilities that would not use the devices."
Now, with FDA EUA approval, the doors will open more easily, gaining faster approval from administrators, less paperwork, and a safer legal process for the treatment. With faster administrative approval, more clinicians will be able to access the helmets, and more patients can be treated.
“Hospitals should feel comfortable using this device and save more lives,” Savickaite said.
“I truly believe, this will help more COVID patients, and at the same time, physicians will notice how well (the helmet) works for respiratory distress. In the future helmet can be used for patients who don’t have COVID, but who require non-invasive ventilation,” Savickaite said.
For more information on the FDA approval for each helmet, got to the "Buy" page.