PNSY Partners with USAMMDA on 3-D Printed Test Swabs
Point of Contact:
Public Affairs Specialist
U.S. Army Medical Materiel Development Activity
FOR IMMEDIATE RELEASE
PORTSMOUTH NAVAL SHIPYARD, Maine – Portsmouth Naval Shipyard and U.S. Army Medical Materiel Development Activity (USAMMDA) finalized a memorandum of agreement Thursday to support the production and delivery of 3-D printed nasopharyngeal swabs needed to support diagnostic testing for COVID-19.
This partnership will ensure the test swabs being produced are safe and effective for use by qualified medical professionals to support the ongoing testing efforts. The goal is with Food and Drug Administration enforcement discretion, these swabs, once sterilized, can be used by the Department of Defense in conjunction with COVID-19 testing kits that have received Emergency Use Authorization.
"Before the pandemic hit, Portsmouth's Innovation Project (IPx) was working with Naval Information Warfare Center - Pacific to develop additive manufacturing of parts for use on submarines," said IPx Superintendent Joe Murphy. "Through these partnerships, we were able to emulate the process of 3-D printing [nasopharyngeal test swabs] to assist in the response to this virus."
Introduction with USAMMDA was initially made by Naval Sea Systems Command (NAVSEA) in order to produce a manufacturer's label for 3-D printed face shields being produced at Portsmouth. Now the shipyard's additive manufacturing community will continue to contribute to the DoD's overall response to the COVID-19 pandemic by 3-D printing these swabs.
"The entire Department of Defense community has really stepped up to assist with meeting the critical medical equipment shortages experienced during the COVID-19 crisis," said Edward Brown, Product Manager for the Warfighter Expeditionary Medicine and Treatment Project Management Office at USAMMDA. "We are happy to partner with Portsmouth Naval Shipyard to help navigate the complex requirements and regulations needed to produce and distribute FDA-regulated medical products."
These nasopharyngeal swabs are 3-D printed using surgical grade resin specifically designed for Class I medical devices, and are similar in size to a coffee stirrer. Bristled ends on the swab are designed to collect a sample from the nasal cavity. After a sample is collected, the swab is placed into a sterile vial prefilled with a testing medium, capped, and delivered to a laboratory for active COVID-19 testing.
The global pandemic has resulted in a shortage of critical testing supplies. The shipyard currently has the infrastructure to produce up to 10,000 swabs per day. Portsmouth has utilized its full spectrum of in-house support, from production and quality assurance departments, to the people behind the scenes procuring material and forming partnerships.
"In addition to supporting the response effort to COVD-19, the accelerated learning on this particular type of 3-D printing can only come from the pressure of a crisis of this magnitude," said Shipyard Commander, Captain Daniel Ettlich. "This experience will benefit Portsmouth Naval Shipyard for many years to come as we move forward in developing 3-D printed submarine parts."
During the COVID-19 response, U.S. Army Medical Research and Development Command stood up an entire process to assist all DoD additive manufacturers who are interested in organically producing FDA regulated devices – dubbed the "USAMRDC Additive Manufacturing Working Group." USAMMDA, a subordinate command of USAMRDC, is the Army's medical materiel developer, responsible for medical research, development, acquisition and procurement of medical items. The USAMRDC Additive Manufacturing Working Group offers their unique regulatory, legal, programmatic, and clinical expertise, used in their daily mission, to the broader DoD community seeking to manufacture medical products to address the critical supply shortages during the COVID-19 pandemic. Swabs are the tip of the iceberg and Portsmouth Naval Shipyard was the first group to go through the Working Group process.
USAMMDA is a subordinate command of the U.S. Army Medical Research and Development Command, under the Army Futures Command. As the premier developer of world-class military medical capabilities, USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. USAMRDC is leading research to prevent, detect and treat COVID-19. USAMMDA is applying existing field-leading research capabilities, a global research network and established partnerships to support the Whole-of-Government response to COVID-19.
Portsmouth Naval Shipyard is America's leader in attack submarine maintenance, repair and modernization. As a field activity of the Naval Sea Systems Command, Portsmouth is committed to expanding our undersea advantage and maritime superiority by continuing to safely deliver first-time quality work, on time and on budget.