Agencies Step Up Their 3D-Printing Efforts
The Energy Department’s labs will primarily focus “on the development of dies and molds that can be rapidly and broadly distributed to private companies experienced in the manufacturing” of healthcare supplies and equipment, Dabbar says, using protocols that meet regulated healthcare standards.
However, the Food and Drug Administration urges caution for healthcare workers who may consider using 3D-printed PPE. “While it is possible to use 3D printing to make certain PPE, there are technical challenges that have to be overcome to be effective enough,” the agency notes in a FAQ post on the topic. “For example, 3D-printed PPE may provide a physical barrier, but 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators.”
The FDA also says that it “understands that 3D printing may occur to provide wider availability of devices during the COVID-19 public health emergency,” but that “some devices are more amenable to 3D printing than others.”
If healthcare providers are using 3D-printed masks, they should check the masks’ seals for leaks, confirm that personnel can breathe through any makeshift filter materials, exercise caution in surgical environments where the need for liquid barrier protection and flammability is a concern, recognize that the mask may not provide air filtration enough to prevent transmission of infectious agents, and safely dispose of infectious materials and disinfect any part they intend to reuse.
The FDA says it recently approved an Emergency Use Authorization for ventilators, ventilator tubing connectors and ventilator accessories, “which could include items such as 3D-printed tubing connectors for multiplexing ventilator use.”
The FDA is working with the Department of Veterans Affairs’ Innovation Ecosystem, the America Makes public-private partnership, and the National Institutes of Health’s 3D Print Exchange, a resource from the National Institute of Allergy and Infectious Diseases at the NIH.
America Makes says its online repository is “gathering the needs of healthcare providers, 3D printing capabilities of U.S. manufacturers, and 3D print designs.” It is connecting manufacturers with printable designs that can produce the supplies needed by healthcare providers.