Executive Summary

The number one topic on ECRI's Top 10 Health Technology Hazards list for 2021 addresses the complexity of managing medical devices with FDA Emergency Use Authorization (EUA) during and after the COVID-19 public health emergency. (Read the Top 10 article.) EUA devices are unapproved medical devices or unapproved applications of approved medical devices that FDA has authorized for temporary use during a health emergency. Once all EUAs have terminated at the end of the health emergency, 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.

To reduce the risk of using a device on new patients after its EUA has been revoked or terminated, it is important that healthcare facilities monitor specific FDA websites to determine whether EUA devices in inventory still have active EUAs.

This article describes the relevant FDA EUA websites, provides best practices for monitoring those websites to determine EUA device status (i.e., active, revised, revoked, or terminated), and discusses how ECRI can aid healthcare facilities in carrying out this work.

Who Should Read This

Table of Contents

​EUAs and Their Challenges

In response to the COVID-19 pandemic, FDA has granted Emergency Use Authorizations (EUAs) for certain in-demand medical devices. EUA devices are either unapproved medical devices or unapproved applications of approved medical devices that FDA has authorized for temporary use during a health emergency. When all EUAs terminate at the end of the declared health emergency, 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 2021 Top 10 Health Technology Hazards list is the Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization. We encourage you to read that Hazard Report before reviewing the guidance that we present below. The report 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To reduce the risk of using a device on new patients after its EUA has been revoked or terminated, it is important that healthcare facilities monitor specific FDA websites to determine whether EUA devices in inventory still have active EUAs.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, COVID-19 Public Readiness and Emergency Preparedness Act (PREP Act) information, and general COVID-19 EUA information for medical devices, drugs, and biological products, as well as specific information for some EUA medical devices.

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 the COVID-19 public health emergency. 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 (current as of the publication date of this article):

1. Blood Purification Devices EUAs

2. Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs

3. In Vitro Diagnostics (IVD) EUAs

a) Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2     

b) Umbrella EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests

c) Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2

d) Individual EUAs for Serology Tests for SARS-CoV-2

e) Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2

f) Individual EUAs for IVDs for Management of COVID-19 Patients

4. Decontamination Systems for Personal Protective Equipment EUAs

5. Infusion Pump EUAs

6. Personal Protective Equipment EUAs

a) Umbrella EUA for Surgical Masks

b) N95 and Other Respirators EUAs

c) Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China

d) Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)

e) Face Shields and Other Barrier EUAs

7. Remote or Wearable Patient Monitoring Devices EUAs

8. Other Medical Device EUAs

9. Respiratory Assist Devices EUAs  

10. Umbrella EUA for Ventilators and Ventilator Accessories

a) Authorized Ventilators

b) Authorized Ventilator Tubing Connectors

c) Authorized Ventilator Accessories

Coronavirus Disease 2019 (COVID-19) EUA—Archived Information—This website is dedicated to revoked or terminated COVID-19 EUA medical devices, 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, Patient Fact Sheets, and device IFU.
 

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 daily email contains links to revised, reissued, revoked, and terminated EUAs. Users can subscribe to this email feed at https://www.fda.gov/medical-devices/news-events-medical-devices/cdrhnew-news-and-updates?utm_medium=email&utm_source=govdelivery#subscribe.

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 (listed below and illustrated in the decision tree beneath):

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, such as revoked EUAs or revisions to umbrella EUAs, as reports in Health Devices 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 HealthDevices@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 HealthDevices@ecri.org. If  appropriate, we will share these experiences and best practices with the rest of our membership. 

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Topics

Administrative and Support Services; Bariatric Medicine; Biomedical Engineering; Culture of Safety; Emergency Preparedness; Equipment and Facility Planning; Hazard and Recall Management; Implants; Incident Reporting and Management; Infection Control; Infusion Therapy; Laws, Regulations, Standards; Long-term Care; Occupational Health; Patient Transport; Pharmacy; Procurement Trends; Quality Assurance/Risk Management; Service and Maintenance; Sterilization and Reprocessing; Physician Preference Items; Technology Management; Technology Selection; Inventory Management

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