On March 26, 2020, the U.S. Food and Drug Administration (FDA) issued guidance surrounding the use of 3D printing on medical devices, accessories, components, and parts during the COVID-19 pandemic. The official guidance can be located here.

This alert provides an overview of the guidance.

General Recommendations

The FDA has previously published guidance on general recommendations for 3D printing in 2017, which outlines the FDA recommendations for the 3D-printed devices. That guidance can be located here.

Can 3D printing be used to make personal protective equipment (PPE) such as gowns, masks, and respirators?

While the 3D printed PPE may look similar to FDA-approved PPE, it does not provide the same level of protection. You may use a 3D printed PPE to provide a physical barrier, but it will likely be unable to provide the same fluid barrier, air filtration protection, and infection control as FDA-cleared masks and N95 respirators.

The Centers for Disease Control and Prevention (CDC) issued strategies for optimizing your supply of face masks. That guidance can be located here.

What should a healthcare provider do if they are to use a 3D-printed mask?

If you are using a 3D-printed mask, you should:

• Check the 3D-printed mask's seal for leaks.
• Confirm that the mask wearer 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 enough air filtration to prevent transmission of infectious agents.
• Safely dispose of infectious materials and disinfect any part the mask wearer intends to reuse.

Can accessories, components, or parts for medical devices be 3D printed?

Whenever possible, the original parts (or those with the same specifications, dimensions, and performance) for medical devices should be used. While it is feasible to 3D-print certain accessories and components, more complex parts (such as working pumps and electronics) cannot be 3D printed as easily.

For 3D printing parts, the FDA believes that it would be useful to use the plans from original parts when available, and to verify that any 3D printed parts will work as intended before using them in any clinical setting. Entities which print 3D devices should reach out and work with the relevant medical device manufacturer.

Can whole medical devices be 3D printed?

The FDA acknowledges that some devices are more easily 3D printed than others. The FDA will discuss printing medical devices with manufacturers and facilities. Entities interested in 3D printing medical devices should email cbsershortage@fda.hhs.gov.

How is the FDA working to mitigate PPE and component, part, and accessory shortages?

The FDA acknowledges that when the traditional medical devices or equipment are unavailable, entities are weighing printing medical devices or purchasing 3D-printed medical devices. The FDA is working closely with government, industry, and healthcare facility stakeholders on this and on the broader public health emergency.

The FDA recently authorized an Emergency Use Authorization (EUA) for ventilators, ventilator tubing connectors, and ventilator accessories, which may include 3D-printed accessories such as tubing connectors for multiplexing ventilator use.

If you have any questions about 3D printing to meet demand during the COVID-19 pandemic, email cbsershortage@fda.hhs.gov. If you have general questions, email DICE@fda.hhs.gov.