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BreathDirect reports that Underwriters Laboratory had completed BDR-19 testing, examining its safety and success in treating ventilatory failure.
FREMONT, CA: BreathDirect, a California-based medical device company, developers of an affordable, full-service ventilator developed in response to COVID-19, recently reported that Underwriters Laboratory, the world's largest independent testing agency, has completed BDR-19 testing, examining its safety and success in the treatment of ventilatory failure. UL decided that BDR-19 follows the standards set out in the new design guidelines for Emergency Use Ventilators of the Association for Medical Instrumentation Advancement.
Underwriters Laboratory compliance testing is recognized internationally, and as part of its submission to the FDA for Emergency Use Authorization, BreathDirect has submitted these findings so that the BDR-19 can be distributed to hospitals and other critical care settings across the U.S. As COVID-19 started to expand in record numbers, it comes at a crucial time, and as concerns increase, a high percentage of stockpiled ventilators do not have the potential to save critically ill COVID-19 patients.
Nearly half of the 140,000 ventilators added to the national stockpile since April, as stated earlier this month, are essential breathing devices that do not meet the required criteria necessary for treating acute respiratory distress syndrome (ARDS), the critical cause of death among patients with COVID-19. For complete ICU usage, only 10 percent of stockpiled ventilators are appropriate. The other 40 percent are transport devices usually used for limited periods - but with some sophistication to be used long enough to rehabilitate ARDS patients.
"From the outset, the BDR-19© was designed to be a permanent, long-term critical care ventilator, built primarily for intensive care units and capable of a full continuum of respiratory support," said Breath Direct founder and CEO Darren Saravis. We have been in productive dialogue with the FDA throughout engineering and development. It's been truly an iterative design process, the result being a low cost but high quality, multi-function ventilator that operates across a range of therapeutic needs. Our application for Emergency Use Authorization (EUA) is currently before the FDA for final scientific review, and we expect approval very shortly."
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