California-based medical device company BreathDirectTM, developers of an affordable, full-service ventilator designed in response to COVID-19, announced that Underwriters Laboratory, the world’s largest independent testing organization, has completed testing of the BDR-19©, evaluating its safety and performance to treat ventilatory insufficiency. UL determined that the BDR-19© meets the criteria established in the Association for the Advancement of Medical Instrumentation’s latest design guidance (CR501:2020 and CR502:2020) for Emergency Use Ventilators.
Underwriters Laboratory conformity testing is recognized across the globe, and BreathDirect has submitted these results as part of its submission to the FDA for Emergency Use Authorization so the BDR-19© can be distributed to hospitals and other critical care settings across the U.S. This comes at a vital time as COVID-19 continues to spread in record numbers. As concerns grow, a high percentage of stockpiled ventilators do not have the capability to save critically ill COVID-19 patients.
As reported earlier this month, of the 140,000 ventilators added to the national stockpile since April, almost half are basic breathing devices that do not meet the minimum requirements needed to treat Acute Respiratory Distress Syndrome (ARDS), the main cause of death among COVID-19 patients. Only 10% of stockpiled ventilators are suitable for full ICU use. The other 40% are transport devices normally used for short periods – but with some sophistication to be used long enough for ARDS patients to recover.
“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.”
While the BDR-19© is initially being tested as a ventilator to treat respiratory insufficiency, BreathDirect will seek a 510(k) from the FDA in the future, which will allow the device to be marketed as a critical care ventilator once clearance is received.
Because of the BDR-19’s low cost and comprehensive capabilities, rural hospitals, medical centers, and senior centers can stockpile with confidence for surge conditions this winter and for use beyond the pandemic.
“Having completed the UL testing process, we’re readying for immediate production, once the FDA gives us the green light under the EUA,” says Saravis. “Parts are sourced in the US, and at-the-ready in San Jose, California and our manufacturing partners at Evolve Manufacturing in the East Bay are finalizing the full assembly process. We can have ventilators ready to ship to medical facilities in time to meet expected surge demands.”
The BDR-19© is further distinguished from emergency/temporary devices by its streamlined design and functionality. The system is easy to learn due to its intuitive layout and tactile operation. BDR-19’s parts and materials are built to last, so the ventilator is exceptionally reliable but easy to service if necessary. Hospital centers will, in many instances, be able to make repairs and parts-replacements themselves.
When COVID-19 first gripped the country, and ICU doctors were scrambling to save lives, Darren Saravis pivoted overnight to build a team that could design and produce a top-tier, affordable ventilator. After months of continuous improvements in capabilities, the ventilator is now awaiting final sign off. “Looking ahead, we expect to see a growing demand for ventilators with more capability, from hospitals in the U.S. and abroad, including poor and developing countries. We’ll be at the ready, with affordable, U.S.-made, life-saving equipment.”