3-D Printed Face Masks Aren’t Foolproof, FDA Warns

Face masks created through 3-D printing might not be as effective in blocking fluids or filtering the air as typical masks the FDA authorized for health workers, the agency warned.

The Food and Drug Administration is working with the Department of Veterans Affairs, the National Institutes of Health, and manufacturers to print “crucial medical devices for veterans & civilians” during the coronavirus pandemic, Food and Drug Administration Commissioner Stephen Hahn said Friday. The FDA also is working with companies and federal agencies to print parts for medical devices in short supply, like ventilators, but advises companies to be cautious.

Shortages of face masks, certain medical devices, and other protective equipment like surgical gowns are pushing doctors and nurses around the country to reuse equipment or improvise their own when there’s nothing else available. 3-D printing could help stem shortages, the FDA hopes, but it has limitations.

Machines can create three dimensional solid objects by using a digital file and gradually adding layers of materials in a process commonly known as 3-D printing.

“While the FDA understands that 3D printing may occur to provide wider availability of devices during the COVID-19 public health emergency, some devices are more amenable to 3D printing than others,” the agency said.

Those limitations also extend to protective equipment. “They may not provide the same level of barrier protection, fluid resistance, filtration, and infection control,” the agency warned.

When using printed masks, workers should check for leaks and “exercise caution in surgical environments where the need for liquid barrier protection and flammability is a concern,” it said.