3D printer company Formlabs reports that it is now using its 250+ in-house 3D printers at its Ohio-based printing facility to produce up to 150,000 COVID-19 test swabs per day. The swabs are being used on patients at hospitals and healthcare providers across the country experiencing test kit shortages, including New York’s largest hospital system, Northwell Health, and Tampa General Hospital.
Over the span of one weekend, Formlabs, Northwell Health, and University of South Florida (USF) Health worked together to develop and test a nasal swab prototype, said Formlabs. In just two days, USF Health and Northwell, using Formlabs’ 3D printers and autoclavable resins, developed prototypes that received a variety of hospital approvals, and have now received FDA Class I Exempt status and are in compliance with new guidelines from the Centers for Disease Control, said Formlabs. The nasopharyngeal swabs will be provided to patients at Northwell Health and USF Health, and the design will be shared with other institutions across the country via Formlabs COVID-19 Response page.
|3D-printed nasal swabs. Image courtesy Formlabs/University of South Florida Health.|
"This is a prime example of the incredible impact we can have on human lives when teams of experts across academia, healthcare delivery, and the tech industry come together," said Charles J. Lockwood, MD, MHCM, Senior Vice President for USF Health and Dean of the USF Health Morsani College of Medicine. "During this current COVID-19 outbreak, there is little time for delay, and the swift, agile, and adept action of everyone on this effort will greatly improve this nation's ability to test patients,” Lockwood said in a prepared statement.
"When we were notified of the shortage of swabs by Dr. Lockwood, we immediately began working as a team to create a novel design in a printed material that was proven safe for patients, as is Formlabs' surgical-grade resin," said Summer Decker, PhD, Associate Professor in the USF Health Morsani College of Medicine and Director for 3D Clinical Applications in USF Health's Department of Radiology. "We reached out to Northwell Health and Formlabs to work with us on this response initiative. With 3D-printed swabs, we will be able to add thousands of swabs a day to testing kits developed here at USF Health, and treat more patients safely and effectively. We look forward to continuing to work with Northwell Health and Formlabs to further combat the COVID-19 pandemic."
"Northwell Health is proud to collaborate with Formlabs and USF to address the global health crisis of COVID-19," said Todd Goldstein, PhD, Director of Northwell Health 3D Design and Innovation. "When we saw that the testing kits were limited in supply, our 3D-printing lab immediately changed focus from creating materials for surgeries to designing and creating materials that help our frontline healthcare providers treating COVID-19 patients. In one weekend, we worked together to develop a nasal swab prototype and test it in the lab. After our positive testing results, we then immediately went to work and have already started producing 1,000 to 1,500 swabs per day. Not only will these swabs be provided to Northwell Health patients, we are also proud to be sharing the design with other institutions that can 3D print so that patients across the country can benefit from our work."
Formlabs' CEO and co-founder, Max Lobovsky, said: "Formlabs has been working around the clock to provide assistance in the wake of the COVID-19 pandemic, and we're hopeful that our efforts will help patients get the care they need. It is important that the medical devices we supply to medical professionals on the frontlines battling this disease are safe and work effectively so as not to put workers or their patients at risk. By working hand-in-hand with Northwell Health and USF Health to design and safely produce these swabs, Formlabs is providing a viable solution to the current shortage of nasopharyngeal (NP) swabs and can now produce them at scale to help hospitals better treat patients."
It is worth noting that the "FDA believes that a nasopharyngeal specimen is the preferred choice for swab-based SARS-CoV-2 testing," and that "collection should be conducted with a sterile swab," said Formlabs in a press release. With years of experience in the medical industry and hundreds of hospitals already using its technology to develop tools for surgery on-premises, Formlabs stressed that it adheres to a range of required sterilization, regulatory, safety, biocompatibility, and manufacturing standards. The company produces sterilizable, surgical-grade plastics for use in medical and dental applications, and its FDA-registered manufacturing site has an ISO 13485 certification. By turning to proven 3D-printing technology to improve production processes, shorten supply chains and localize manufacturing, healthcare providers can quickly and efficiently gain better access to the supplies they need to combat COVID-19, added Formlabs.
The company recently launched the Formlabs Support Network for COVID-19 Response, an initiative that matches healthcare organizations and providers with Formlabs customers who are willing to use their printers and volunteer their time to help address critical supply-chain shortages and other healthcare needs. Formlabs said that it is working closely with health systems, government agencies, and its network of more than 1,500 volunteers to help design, prototype, and produce parts to be tested and potentially adopted by clinicians.
In addition to the nasal swabs, Formlabs has launched projects to print components for ventilators, face masks, and respirators. The clinical steps that have been completed and the current status of these projects is posted on the Formlabs website.