Charleston VA seeks FDA approval for 3D-printed medical devices
CHARLESTON, S.C. (WCSC) - The Ralph H. Johnson VA Medical Center says it can produce tens of thousands of medical devices each year once federal regulators gives it a green light.
Its 3D Innovation Center is seeking approval from the FDA to make that goal a reality. The hospital says its center’s 17 3D printers place the Charleston VA at the forefront of this emerging technology.
The hospital is the first VA hospital in the country to receive compassionate use approval from the FDA on a 3D printed medical device.
“This isn’t something you can go and get on the market,” Charleston VA Supervisory Biomedical Engineer Nikki Beitenman said.
The approval is for a hearing device designed specifically for one local veteran.
“The patient actually had the idea to insert plastic drinking straws into his ears to try to open that cartilage up,” Beitenman said. “So the audiologist came to us and asked if we could 3-D print an option for him.”
But Beitenman says this is only the beginning.
“Without this technology we wouldn’t have been able to offer this patient something that he could just buy or that we could order for him. So this is something that you’re never going to find anywhere else.”
Beitenman says what makes this technology so important is how quickly and cheaply they can make these medical devices.
From hearing aids, to dentures, to a 3D print of someone’s heart valve, she says these are things that often take months and thousands of dollars to make. But the 3D Innovation Center can make them in a matter of minutes for less than $10.
The center is working on getting FDA approval to be able to expand this technology and get these devices to anyone who needs them.
Beitenman says based on data within the VA, the hearing device alone could help 8,000 veterans with hearing impairments.
“When you can turn around and tell the doctor, ‘Hey, I can make this for you right away,’ or not only the fact that we can do it so quick is I can make it exactly how you want it,” she says.
With the technology and equipment in place, Beitenman says they hope to be able to start distributing more medical devices in the next six months once they receive FDA approval.
Copyright 2021 WCSC. All rights reserved.