With over 9 million unique patients, the Veterans Health Administration (VHA) is the largest integrated health care system in the United States. For each of those Veterans, VHA provides high-quality care. Recently, VHA has begun to use additive manufacturing capabilities to deliver this care.
“With our 3D printing and other advanced manufacturing capabilities, we are providing equitable access to patient-matched medical devices. We’re developing a set of products that can’t be bought off the shelf,” says Kathryn Sherrill, executive director of the VHA Office of Advanced Manufacturing. “We want to empower frontline clinicians to design and implement product-based solutions to serve our Veterans at the point of care and strengthen supply chain resiliency by providing ‘insourcing’ manufacturing capability.”1
According to Sherrill, the power of advanced manufacturing to transform health and patient care was demonstrated when a retired Veteran told his Department of Veterans Affairs (VA) doctor that when he began to lose his hearing, he developed a simple solution by using a drinking straw to prop open his collapsed ear canals. The medical and 3D printing team realized they could custom-build a device by digitally scanning the patient’s ear canal, and design and create a 3D-printed stent specifically for him. This personalized solution improved hearing for the patient without surgery. The medical device is named Giostent in honor of the Veteran’s grandson.2 The US Food and Drug Administration (FDA) granted compassionate-use authorization for this solution in February 2021. Product development is underway to produce a Class 1, 510(k) exempt device.3
Since the Giostent, the Office of Advanced Manufacturing has expanded its use of additive manufacturing. Currently, it’s using CT images to create 3D models of patients’ hearts, giving surgeons a true-to-life view before surgery. Examining the 3D models can reduce both the need for exploratory surgeries as well as the duration of hospital stays, infection risk, and potential complications. The number of applications for 3D-printed models is relatively small now, but Sherrill expects the portfolio to grow substantially in the next three to four years.
Quality control is a critical component of all medical manufacturing, both traditional and additive. Sherrill says one of the critical roles of the program office is to develop, educate, and implement quality standards and ensure that users at medical facilities throughout the country adhere to them.4 The Office of Advanced Manufacturing employs an FDA-compliant quality management system and follows VA policies to maintain safety and standardize production. The vision is for every VHA facility to be able to access additive manufacturing capacity so that every eligible Veteran has access to the same high-quality, personalized care.
“It’s about credibility and sustainability and being able to verify that what we’re doing is the best it can be,” Sherrill says. “You can’t just buy a 3D printer, plug it in, and print a device. There has to be continuous training, quality management, and safety testing.”
The VHA’s additive manufacturing program played an important role during the early days of the COVID-19 pandemic. Even though the capability was still in its early days, facilities could use 3D printing to produce face masks, face shields, and nasal swabs, items that were hard to acquire at that point throughout the US health care system.
Sherrill says this initiative heightened the importance of how additive manufacturing can be instrumental in supporting efficient, quality patient care. There will always be another disruption. Supply chains can break for a variety of reasons, and at the worst imaginable time, but having the capability to produce in-house materials blunts the effects of such disruptions.
“The ability to manufacture at the point of care brings device manufacturing to USA soil,” Sherrill says. “We’re not relying on any companies overseas, hence we mitigate supply chain challenges. Is there going to be another pandemic? The likelihood may be high. If so, VHA will be ready.”
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