Virgin Orbit Ventilators Granted Emergency Use Authorization
LONG BEACH, Calif., April 22, 2020 (Virgin Orbit PR) —Virgin Orbit, Sir Richard Branson’s responsive satellite launch company, announced today that regulators at the U.S. Food and Drug Administration (FDA) have granted an Emergency Use Authorization for the immediate delivery and use of a new “bridge” ventilator designed and built by the aerospace firm. With that authorization now in place, Virgin Orbit expects to begin delivering ventilators to hospitals within the next few days.
Guided by the medical expertise and clinical experience of the Bridge Ventilator Consortium — a group of doctors, medical researchers, and medical device engineers collaborating to advise multiple different low-cost ventilator efforts — Virgin Orbit has leveraged its extensive engineering design, manufacturing, and operational capabilities to quickly design a novel ventilator, test prototype units, and ramp up production of these devices.
The Virgin Orbit Ventilator is in essence a very simple, very reliable, mechanical device designed to automate common manual resuscitators (also known as bag valve masks, and often referred to colloquially by the proprietary name “Ambu-bag”). The system can be used to treat moderate hypoxic and/or hypercarbic respiratory failure – in most settings, this would include the majority of COVID-19 patients – freeing up existing, more sophisticated ventilators to be used on patients with the most severe symptoms.
Virgin Orbit has already begun manufacturing ventilators, and is currently producing at a rate of over 100 per week. With the emergency authorization now in hand, Virgin Orbit expects to deliver 100 units to California’s Emergency Medical Services Authority (EMSA) in the coming days. The company is already in discussions with other manufacturing partners in the U.S. and internationally to increase capacity to meet the enormous demand around the world.
“Our team is so grateful to have the opportunity to channel our energies in a way that can hopefully make a difference in this crisis. Our thanks and admiration go to the incredible doctors in the BVC, to the regulators at the FDA, to Governor Newsom, our community leaders and to every health provider out there!” said Virgin Orbit CEO Dan Hart. “Additionally, we are experiencing a great sharing of ideas and capabilities internationally. As dark a time as this is, it’s also a moment of extreme motivation and collaboration unlike anything we’ve ever seen before.”
“Healthcare workers around the world have repeatedly shown that they are true heroes. This is a time when we must all pull together and support them in every way we can,” says Virgin Group founder Richard Branson. “I’m incredibly proud of the Virgin Orbit team. They have worked creatively and tirelessly in responding to the needs of the medical community, getting the ventilators designed, built and approved within one month.”
While working to develop and manufacture these ventilators, the Virgin Orbit team has also continued to forge ahead on its primary mission of improving access to space for small satellites. The company recently completed a cryogenic captive carry test flight, the last major development test of its LauncherOne rocket program. The team is now preparing for its final wet dress rehearsals in anticipation of an orbital Launch Demo expected soon.
6 responses to “Virgin Orbit Ventilators Granted Emergency Use Authorization”
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Looks like April will end with ‘only’ 50,000 odd deaths in the month. Likely May will be the same. Hopefully summer’s heat beats it down until Fall. I have not heard of hospitals running out of ventilators yet. And the rate chart looks like it has leveled off. I have not heard yet how the US is going to control the infection rate as we turn back on. Everything I’ve heard is from overseas. They seem much more on top of this than we are. It’s going to be a rough year, hopefully we won’t have such a breakout that we have to resort to these minimal machines. Because if we do it’ll probably mean that most of our medical staff have gotten infected as well. I have not heard of any programs to teach skilled persons off the street how to monitor a patient and regulate a breathing machine yet. You’d need a program like that if you were going to employ these make shift machines.
Nothing says medical quality like a water bottle as the pump reservoir… Is that *really* the best they could do???
I see it as a good reductive mechanical design. A Haas VF-1 could pour out parts for about 100 a day I’d estimate. It just assumes, as it would have to, skilled operators. It’s my understanding that you don’t just pump air into someone. You have to regulate the artificial respiration. So if we have to operate a lot of these make shift systems, they’ll need operators. Likely more technicians than we have now. If we were in such an emergency then it’s likely those very technicians will themselves be down for the count because of the lack of the proper protective equipment.
I agree. In fact you could probably do a lot more than 100 a day on a Haas VF-1 if you stacked the rough-sawn part blanks and machined them in batches.
The real problem, as you point out, is that the design includes no real-time monitoring of the patient. When paramedics use these breathing assist bags on field-intubated patients, the paramedics are the monitors.
It’s not a water bottle, it’s a manual breathing assist bag that’s standard equipment for paramedics who have to intubate patients in the field. The mechanical lash-up Virgin Orbit designed just squeezes the thing rhythmically with a motor and cam instead of human hands.
You apparently don’t watch Chicago Med, Chicago Fire, Station 19 or either of the 911 shows.
Look at the damn picture. It’s not a bag of any kind whatsoever. It’s basically a plastic water bottle…