The Brazilian Health Regulatory Agency has approved the commercial manufacture of VITAL, a breathing device designed specifically to address the needs of coronavirus patients.
In late April, NASA announced the development of
Ventilator Intervention Technology Accessible Locally (VITAL), a ventilator
prototype designed specifically to address the COVID-19 pandemic. Since then, 28
manufacturers around the world have been licensed to make the device. Now
one of those licensees is preparing to begin production in Brazil.
Anvisa, Brazil’s counterpart to the U.S. Food and Drug
Administration, announced approval of this effort during an Aug. 24 press
conference with the licensee, a joint partnership between Russer, a medical
device manufacturer, and CIMATEC (Manufacturing and Technology Integrated
Campus), a nonprofit research and development institution.
“Throughout its history, NASA’s
missions to explore off Earth have benefited life on Earth and provided a means
through which the United States has been able to strengthen relationships
globally,” said NASA Administrator Jim Bridenstine. “During these
difficult times, we are particularly proud that the unparalleled expertise,
abilities, and passion of our workforce will aid other countries in their
response to the coronavirus pandemic.”
The ventilator prototype was designed at NASA’s Jet
Propulsion Laboratory in Southern California, where spacecraft engineers felt
compelled to contribute their know-how to address the pandemic. In just 37 days,
they completed a functional prototype of VITAL, which received emergency use authorization from the FDA on March 24.
JPL ultimately created two
versions of VITAL – a pneumatic version and another using compressed air. The
CIMATEC/Russer version is based on the pneumatic version. With
one-seventh the parts of a traditional ventilator, both versions models rely on
parts readily available in supply chains to avoid competing for components required
for traditional ventilators.
Designed specifically for the needs of COVID-19 patients,
rather than the wide range of ailments treated with traditional ventilators,
VITAL is simpler to build and more affordable. The CIMATEC/Russer model – which
goes by the acronym VIDA, or “life” in Portuguese – will be available
at a fraction of the cost of a traditional ventilator.
“This device benefits Brazil in multiple ways,”
said CIMATEC Director Leone Andrade. “It can help Brazilians combat the
virus while also providing an opportunity for industry.”
The 28 VITAL licensees were selected from 100 applicants based
on their ability to manufacture and deliver the ventilator. Several other manufacturers
around the world are far along in their own efforts to bring to market a
version of the ventilator, with JPL providing technical guidance.
“Our team is delighted to see how quickly the Brazilian
licensees were able to replicate our prototype design, upgrade it where
necessary, and also obtain local regulatory approval,” said Leon Alkalai, manager of the JPL Office of Strategic Partnerships and
VITAL project manager. “They did so in record time and we are truly
impressed with how quickly they were able to master the art and even improve on
VITAL’s initial design, which CIMATEC/Russer’s model is
based on, uses a pneumatic pump to circulate air into the ventilator and was
run through a battery of tests by the Icahn School of Medicine at Mount Sinai
in New York City. A modified design that relies on an air compressor could be deployed by a greater range of hospitals was tested at
the UCLA Simulation Center in Los Angeles before also receiving a ventilator
Emergency Use Authorization from the FDA.
For more information about NASA’s
work in fighting COVID-19, visit:
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Jet Propulsion Laboratory, Pasadena, Calif.
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Source: Jet Propulsion Laboratory