FDA Guidance Fails to Ensure Security of 3D-Printed Masks and PPE

New Brunswick, N.J. (Sept. 16, 2020) – FDA guidelines for making 3D-printed masks, face shields and other personal protective equipment (PPE) in the COVID-19 era fail to defend against cyberattacks, according to Rutgers and Georgia Tech engineers.

Due to the shortage of medical PPE, 3D printing has become a good way to produce masks, face shields and other equipment. To ensure the security and safety of PPE, FDA guidelines should be expanded to guard against cyberattacks during the design of PPE, when printing is underway and after printing has ended, according to the engineers’ white paper.

For example, a rogue operator could design a 3D-printed mask with a malicious embedded part that connects an air filter to the mask. After the mask is printed, a cyberattack could change the structure of the part to let air bypass the air filter. Cyberattack detection tools such as artificial intelligence could be implemented to detect and thwart such attacks.

“Typically, the designer generates PPE design files and shares them on a cloud service and the 3D printing operator downloads and starts the manufacturing process,” said co-author Saman Aliari Zonouz, an associate professor in the Department of Electrical and Computer Engineering in the School of Engineering at Rutgers University–New Brunswick. “Potentially, a malicious designer could generate a malicious design file and start the printing process himself before distributing 3D printed objects to users.”

The white paper: https://drive.google.com/file/d/1-mdqIDOgB8w9_7402IlRZtOWTe_Qunl1/view

To interview Zonouz, contact Todd Bates at [email protected]

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