Approval of the BDR-19 for the critical care of patients with ventilatory insufficiency comes after an extended review process by FDA regulators to gauge its safety and performance
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Leading medical design firm, Nectar Product Development, and its affiliated medical device company, BreathDirect™, today announced that its BDR-19™ ventilator has received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).
Approval of the BDR-19™ for the critical care of patients with ventilatory insufficiency comes after an extended review process by FDA regulators to gauge its safety and performance. The resulting design and safety features incorporate new learnings and evolved care protocols for ventilation support of COVID-19 patients and others. The BDR-19™ is now authorized for immediate medical use throughout the U.S.
“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.”
FDA Emergency Use Authorization of the BDR-19™ comes at a vital time as governments, hospitals and medical facilities reassess ventilator inventories due to concerns that many stockpiled ventilators cannot meet the minimum requirements needed to treat Acute Respiratory Distress Syndrome (ARDS) and only 10% are suitable for full ICU critical care use. With cases still peaking in some areas and the threat of renewed surges, the BDR-19™ offers a cost-effective solution for institutions who must plan and prepare for an uncertain future.
“Looking ahead,” says Saravis, “we expect to see a steady demand for more capable, multi-functional ventilators from hospitals in the U.S. and abroad — including those in developing countries. California is at the ready, with affordable, U.S.-built, life-saving equipment that will ensure medical readiness for any contingency.”
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. These features may offer an attractive alternative to costly rentals during peak demand.
“All components of the BDR-19™ 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-19™ 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.
The BDR-19™ was developed by Nectar Product Development, a Long Beach, California-based medical device design and engineering firm, and produced in partnership with Evolve Manufacturing Technologies and Hubbell Inc. With a streamlined design that supports all phases of ventilation, the BDR-19™ can be rapidly produced at a substantially lower per-unit cost than other devices currently on the market. The BDR-19™ uses a U.S.-based supply chain and is manufactured in Fremont, Calif. At full-scale production, the company estimates that one ventilator can be built and successfully tested every 90 seconds.
Source: Company Press Release