Topic: Charleston VA 3D Innovation Center Requests FDA Clearance For 3D Printed Medical Devices
Based in Charleston, South Carolina, the Ralph H. Johnson VA Medical Center is seeking approval from the US Food and Drug Administration (FDA) for its 3D printed hearing aids.
As reported by Live 5 News, the center believes it can produce tens of thousands of medical devices each year using its 17 3D printers, once it receives the go ahead. The hospital is also the first Veteran Affairs (VA) hospital in the US to receive compassionate use approval from the FDA for a 3D printed medical device – a custom-designed hearing aid for a local veteran.
Once approval is secured, Charleston VA hopes to start distributing more medical devices over the next six months, with the hearing aid alone potentially able to help some 8,000 veterans with hearing impairments.
Charleston VA’s 3D Innovation Center began printing face shields and masks at the start of the Covid-19 pandemic, when medical supplies were in high demand.
At the time, Biomedical Engineer at the center, Nikki Beitenman said: “The first thing we started printing was face shields because there was a shortage across the nation. When we initially tried to order them from a supplier, we were quoted a price of $4 per face shield. We can make them in-house for about 85 cents.”
In addition to 3D printing custom face shields for its staff, the center also uses the technology to produce attachable screens for optometry equipment used in examinations, education models for staff training, and swabs for Covid-19 tests. Ventilator splitters, wheelchair accessories, and patient specific assistive devices are also additively manufactured using the center’s 17 3D printers.
According to Bietenman, 3D printing has been vital to the hospital’s ability to produce medical devices quickly and at low-cost for its patients, in comparison to sourcing the products through a supplier.
Discussed: Charleston VA 3D Innovation Center Requests FDA Clearance For 3D Printed Medical Devices