EUAs and Their Challenges
In 2020, responding to the COVID-19 pandemic, the US Secretary of Health and Human Services (HHS) declared a public health emergency and issued Emergency Use Authorization (EUA) declarations; in turn, FDA granted EUAs for certain in-demand medical devices. An EUA temporarily authorizes the use of either an unapproved medical device or an approved medical device for a previously unapproved application (we refer to both as "EUA devices" for simplicity). When all EUA declarations are terminated by the HHS Secretary, or if FDA revokes a specific EUA—which can happen at any time—EUA devices revert to their prior status. At that time, the legal protections that support the use of EUA devices on new patients are terminated.
Managing EUA devices is not simple. In fact, the number one topic on ECRI's Top 10 Health Technology Hazards list in 2021 was the Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization. We encourage you to read that report before reviewing the guidance that we present below; it contains comprehensive information and actionable recommendations to support healthcare facilities in managing EUA devices.
To reduce the risk of using a device on new patients after its EUA has been revoked or terminated, it is important that healthcare facilities monitor specific FDA websites to determine whether EUA devices in inventory still have active EUAs.
Here's a guide to the relevant FDA EUA websites, along with a list of best practices for monitoring those websites to determine EUA device status (i.e., active, revised, revoked, or terminated), and a discussion of how ECRI can help healthcare facilities carry out this work.
FDA EUA Websites
Emergency Use Authorization─This website for general EUA information contains links to FDA's important EUA guidance, Public Readiness and Emergency Preparedness Act (PREP Act) information, and general COVID-19 EUA information for medical devices, vaccines, convalescent plasma, drugs, and non-vaccine biological products.
Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices─This website contains information about, and links to, specific sites for all of the EUA medical devices associated with COVID-19 EUA declarations. Each of those sites provides current information about active EUA device names/models, dates of EUA issue/update, authorized settings (if applicable), and documents such as Healthcare Provider Fact Sheets, Patient Fact Sheets, and device instructions for use (IFU). Following are links to those sites:
1. Blood Purification Devices EUAs
2. Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
3. In Vitro Diagnostics (IVD) EUAs
4. Infusion Pump EUAs
5. Personal Protective Equipment EUAs
6. Remote or Wearable Patient Monitoring Devices EUAs
7. Respiratory Assist Devices EUAs
8. Ventilators and Ventilator Accessories EUAs
9. Other Medical Device EUAs
Historical Information about Device Emergency Use Authorizations—This website is dedicated to revoked or terminated COVID-19 EUA medical devices. It contains product information; dates when product EUAs were issued, revoked, amended, or reissued; links to EUA authorization and revocation letters; and links to documents such as Healthcare Provider Fact Sheets, Patient Fact Sheets, and device IFU.
Coronavirus Disease 2019 (COVID-19) EUA—Archived Information (Drug & Biological Products)—This website is dedicated to terminated or revoked EUAs for COVID-19 drugs and biological products. It contains product information; dates when product EUAs were issued, revoked, amended, or reissued; links to EUA authorization and revocation letters; and links to documents such as Healthcare Provider Fact Sheets and Patient/Parent/Caregiver Fact Sheets.
Best Practices for Monitoring FDA EUA Websites
1. Subscribe to FDA's EUA Email Feed
FDA's Center for Devices and Radiological Health (CDRH) distributes a daily email that summarizes and links to any changes in their authorizations. This email contains links to revised, reissued, revoked, and terminated EUAs. Users can subscribe to this email feed at https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrhnew-news-and-updates.
When you receive a notification that an EUA device in inventory has changed EUA status, proceed to best practice number 2.
2. Confirm the EUA Device Status and Take Appropriate Action
When the status of an EUA model in inventory changes, we recommend checking the relevant EUA device website as soon as possible to confirm the current EUA status. Next, complete the required steps to address the change in EUA status (see the decision tree below):
1. If the relevant EUA device list has been removed from the website or the specific model has been removed from the EUA device list, the EUA has been revoked or terminated. Follow our recommendations for EUA revocations in our Top 10 Hazard report.
2. If the EUA has a new date of issue/update, follow our recommendations for EUA revisions in the same report.
How ECRI Can Help Your Facility
To support our members in managing the substantial number of COVID-19 medical device EUAs, ECRI is monitoring the evolving situation and providing EUA device resources such as this article and our Top 10 Hazards piece. These provide specific recommendations on monitoring FDA's EUA websites and tackling any EUA device changes that are listed there.
ECRI will be posting any substantial changes to EUAs as reports in the ECRI Alerts database. That database also includes already-published alerts such as the following:
In addition, ECRI analysts are available if you have questions regarding the EUA status of specific devices, including those currently being used at your facility. Please contact deviceevaluation@ecri.org with any concerns or questions.
Finally, if you have experienced difficulty in managing the COVID-19 EUA process, or have specific processes that have worked well for your facility, we ask that you please share your experience with us at deviceevaluation@ecri.org. If appropriate, we will share these experiences and best practices with the rest of our membership.
