The National Museum of Health and Medicine in Silver Spring, Maryland, is currently featuring a face mask developed at Naval Undersea Warfare Center Division, Keyport as part of its exhibit titled "Military Medical Innovation: The Future is Here," which opened July 2024. The exhibit marks the second year in a row the museum has featured the mask.
NUWC Division, Keyport developed the mask in collaboration with other military organizations in response to the urgent need for personal protective equipment during the COVID-19 pandemic. The project was led by the U.S. Forces Korea COVID-19 Task Force under the FDA Emergency Use Authorization Act, with funding provided primarily by the Coronavirus Aid, Relief and Economic Security Act.
The museum’s collections also contain masks from two other teams involved in the effort, one from the U.S. Coast Guard Academy and another led by U.S. Army Capt. Edward Bullard. The museum received the masks from the Warfighter Expeditionary Medicine and Treatment Project Management Office, U.S. Army Medical Materiel Development Activity and U.S. Army Medical Research and Development Command in Dec. 2020, according to Alan Hawk, collections manager of the museum's historical collections.
NUWC Division, Keyport Director of Innovation Eric Seeley, who oversaw the design process for NUWC Division, Keyport’s mask, said its selection for inclusion in the museum highlights the command's ability to quickly mobilize its advanced additive manufacturing and engineering expertise to address unexpected challenges.
“This demonstrates how rapidly a Warfare Center can respond to urgent technical requirements during a crisis such as the COVID-19 pandemic,” Seeley said.
NUWC Division, Keyport developed its mask—a reusable filtering mask available in four sizes—in collaboration with the Army Medical Research & Development Command and Army Combat Capabilities Development Command Chemical Biological Center.
The team faced a significant learning curve, as its expertise up to that point had been primarily in the realm of military engineering and design, not regulated or medical device development.
“We knew how to design things, but we'd never done anything in the medical realm before,” said Seeley. “So, it was not just a matter of designing the mask itself, but also learning all the rules associated with medical devices. We didn't know them; we discovered them over time.”
The team submitted its mask to the National Institute for Occupational Safety and Health for N95 certification, and according to NUWC Division, Keyport Mechanical Engineer Keegan Webster, who led the certification effort, all four versions achieved a filter efficiency of 98 percent.
Dr. Tylor Connor, acting chief medical advisor for the U.S. Forces Korea COVID-19 Task Force mask effort, emphasized that this certification status is considered investigational as the mask is still a prototype.
“While one requirement of a NIOSH-certified N95 mask is a minimum filtration efficiency of 95 percent, other manufacturing controls and quality systems are needed to achieve certification,” said Connor. “Future project aims could include establishing quality control processes that support the mixed-method manufacturing approach while simultaneously satisfying regulatory requirements. Successfully achieving this could accelerate regulated device innovation and transform the industry status quo.”
Noel Laing, health science product manager for the U.S. Army Medical Materiel Development Activity, emphasized that N95s are not normally considered medical devices, but that during the pandemic, they were “called into action to support care through Enforcement Discretion by the Food and Drug Administration.”
Webster said the team was “pretty happy” with its progress on the mask. “It was amazing to see our team come together and develop masks at such a rapid pace during the pandemic,” he added.
The team obtained five patents—four design patents and one utility patent for an injection molded design—and made its design files available for free online so that others could produce the mask themselves.
Hawk underscored the historic significance of the mask exhibit: "This is probably the first time additive manufacturing was suddenly used on a wide scale for dealing with shortages in the medical supply and attempting to develop medical devices," he said.
Hawk added that NUWC Division, Keyport’s masks stood out from the others due to their advanced design and practicality.
"It seemed like Keyport was the group that went the furthest along with its mask design," said Hawk, adding that its masks "came the closest to being practical."
The "Military Medical Innovation” exhibit runs through Sept. 30.
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NUWC Division, Keyport provides advanced technical capabilities for test and evaluation, in-service engineering, maintenance and industrial base support, fleet material readiness, and obsolescence management for undersea warfare to expand America’s undersea dominance.
Date Taken: | 09.25.2024 |
Date Posted: | 09.25.2024 16:38 |
Story ID: | 481789 |
Location: | KEYPORT, WASHINGTON, US |
Web Views: | 221 |
Downloads: | 1 |
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