This partnership will ensure the test swabs are safe and effective for use by qualified medical professionals to support the ongoing testing efforts, officials said. The goal is that with Food and Drug Administration enforcement discretion, these swabs, once sterilized, can be used by the Defense Department in conjunction with COVID-19 testing kits that have received emergency use authorization.
“Before the pandemic hit, Portsmouth’s Innovation Project was working with Naval Information Warfare Center Pacific to develop additive manufacturing of parts for use on submarines,” said Joe Murphy, the innovation project’s superintendent. “Through these partnerships, we were able to emulate the process of 3D printing [nasopharyngeal test swabs] to assist in the response to this virus.”
Naval Sea Systems Command originally introduced Portsmouth Naval Shipyard to USAMMDA to produce a manufacturer’s label for 3D-printed face shields being produced at Portsmouth. Now, the shipyard’s additive manufacturing community will continue to contribute to the Defense Department’s response to COVID-19 by 3D printing the nasal 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, the 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. The 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 of a testing medium, capped, and delivered to a laboratory for COVID-19 testing.
The global pandemic has resulted in a shortage of critical testing supplies. The shipyard has the infrastructure to produce up to 10,000 swabs per day. Portsmouth has used its full spectrum of in-house support, officials noted, 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 COVID-19, the accelerated learning on this particular type of 3D printing can only come from the pressure of a crisis of this magnitude,” said Navy Capt. Daniel Ettlich, the commander of Portsmouth Naval Shipyard. “This experience will benefit Portsmouth Naval Shipyard for many years to come as we move forward in developing 3D-printed submarine parts.”
During the COVID-19 response, U.S. Army Medical Research and Development Command stood up an entire process to assist all Defense Department 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 pandemic. Swabs are the tip of the iceberg, officials said, and Portsmouth Naval Shipyard was the first group to go through the working group process.
BY CAREY PHILLIPS
(Carey Phillips is assigned to the U.S. Army Medical Research and Development Command.)