The BDR-19 critical care ventilator has received emergency use authorization from the US FDA, according to Nectar Product Development and BreathDirect.
The companies report that the BDR-19 differentiates itself from many of the temporary/emergency ventilators launched throughout the pandemic by
- Pairing full functionality with simplified operability in a device that can be rapidly mobilized and learned
- An intuitive interface anticipates the need for rapid cross-training of medical staff in the US and internationally.
- The mobile unit requires minimal space in the ICU, is highly durable, and uses universal patient circuits and accessories
- Hospital centers will typically be able to make repairs and parts replacements to the BDR-19 in-house, and
- The ventilator can be kept in storage for long periods without the need for regular maintenance
“We designed the BDR-19 as a continuous use, critical-care ventilator, built primarily for intensive care units and capable of a full continuum of respiratory support,” said BreathDirect founder and CEO Darren Saravis. “We have been in productive dialogue with the FDA as new protocols for care of COVID-19 patients have evolved. The result of our ongoing engineering enhancements is a safe, durable, easy-to-use machine that incorporates the learnings from respiratory therapists and ER physicians over this long pandemic year.”
“Looking ahead,” says Saravis, “we expect to see a steady demand for more capable, multi-functional ventilators from hospitals in the US and abroad — including those in developing countries. California is at the ready, with affordable, US-built, life-saving equipment that will ensure medical readiness for any contingency.”
“All components of the BDR-19TM are sourced in the U.S., resulting in a secure and stable supply chain,” said Saravis. “Our manufacturing partners at Evolve Manufacturing in Fremont, California have designed and readied their assembly lines so that we can have ventilators ready to ship to medical facilities within weeks.”
“Evolve Manufacturing has built an assembly process that will allow a BDR-19TM ventilator to roll-off the manufacturing line every 15 minutes — a remarkable pace for a medical device of this nature,” says Noreen King, CEO & Founder of Evolve Manufacturing Technologies. “We have been able to combine speed with a manufacturing process that meets the high bar for quality control and safety.”
The EUA for the BDR-19 ventilator follows successful safety and performance testing by the internationally recognized Underwriters Laboratory (UL), in accordance with the Association for the Advancement of Medical Instrumentation latest design guidance.