Image credits: Dr. Beth Ripley and Timothy Prestero.

COVID-19 collection icon

COVID-19 Supply Chain Response: Essential Information

Curated by NIH/NIAID in collaboration with the U.S. Food and Drug Administration, the Veterans Healthcare Administration, and America Makes

This collection is intended to support innovation and informed decision-making during the COVID-19 pandemic, while critical safety and medical equipment are unavailable through traditional supply chains.

Designs have been assessed by the Veterans Healthcare Administration for appropriate use in clinical or community settings, but they are not approved by the NIH, FDA, VA, or other authority. The inclusion of a design in this collection does not imply endorsement by the NIH, FDA, VA, or America Makes.

The FDA has issued Emergency Use Authorizations (EUAs) that waive manufacturing and labeling requirements for some, but not all, PPE and devices. When the EUAs are lifted, manufacturers - whether industry or individuals - must cease operations if they are unable to meet those requirements.

Read the device category guide

DESIGNERS

Designers have a responsibility to:

  • Test the design and the printer settings to ensure the product is robust as possible to meet its purpose
  • Give a clear description of the device, its purpose, and its limitations
  • Provide thorough instructions to help others reproduce it accurately
  • Avoid using language that may misrepresent the level of protection, for example, putting “N95” or “surgical mask” in the title of a device that not fully meet the specifications.

Prototype designs can be uploaded here. We encourage that you use the template to provide an Instructions For Use document that you can upload with your entry: [MS Word] or [PDF]

PRODUCERS

Manufacturers and Makers have a responsibility to:

  • Carefully read the description and instructions for printing or otherwise manufacturing the design
  • Test the product and optimize your own production method if you are not confident in the results
  • When distributing devices, be sure to provide the necessary and appropriate information and provide the user with the IFU document if one is available
  • Keep in mind that a device failure or design flaw could be detrimental when the end product is used as a barrier to an infectious pathogen

It is essential that you check that the materials you are using are appropriate for the type of device and if it has skin contact.

Clinically Reviewed entries will have an IFU, and some designs will have either an IFU or a TDP. Commercial manufacturers should follow guidelines in the TDP when possible.

Download the Surgical Mask Production Checklist

USERS

When acquiring open source PPE and related equipment - whether purchased or donated - the end user should:

  • Review the IFU or any other documentation provided by the manufacturer and request written instructions or other guidance if none is provided you
  • Understand the limitations of the device and the settings in which is should and should not be used.
  • Conduct your own testing for fit and comfort, and confirm that you can see clearly and breath comfortably
  • Safely dispose of devices if they are not indicated as single-use only, and disinfect any reusable items in a manner that is appropriate for the materials used