Intrepid 3D printing companies and individuals who want to print masks, gowns and other personal protective equipment (PPE) to fight the coronavirus pandemic might want to take a look at the FDA’s new frequently asked questions page on the topic.
While it says it welcomes coronavirus-fighting efforts, the agency said that 3D-printed masks are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators, which are in very short supply.
University research teams and others have been racing to develop DIY ventilators to help patients whose breathing is restricted by COVID-19. Those seeking to 3D-print accessories or parts for medical devices should use original parts or those with the same specifications, dimensions and performance, if available, the FDA advised. The agency encouraged using plans from original parts and working with relevant medtech manufacturers for guidance.
Atlanta-based Global Center for Medical Innovation (GCMI) announced this week that it is entering into a collaboration with multiple entities to provide designs — free of charge and with necessary regulatory guidance — for any Good Manufacturing Practice (GMP)-compliant facility to use in the production and distribution of face shields to healthcare workers.
The FDA recently issued an emergency use authorization (EUA) for ventilators, ventilator tubing connectors and ventilator accessories, which could include items such as 3D-printed tubing connectors for multiplexing ventilator use. The agency is also collaborating with the Department of Veterans Affairs (VA) Innovation Ecosystem, America Makes public-private partnership, and the National Institutes of Health (NIH) 3D Print Exchange, a resource from the National Institute of Allergy and Infectious Diseases at the NIH.
The FDA’s FAQ on 3D-printed devices for the coronavirus can be found here.