To meet the unprecedented need for medical equipment and supplies during the COVID-19 public health emergency, the FDA issued Emergency Use Authorizations (EUAs) to temporarily permit the use of hundreds of products. For health care providers, the resulting need to manage large numbers of devices that are authorized only for temporary use poses a unique technology management and patient safety challenge. The scope and complexity of that challenge prompted ECRI to place EUA device management at the top of its list of the Top 10 Health Technology Hazards for 2021.
FDA’s Emergency Use Authorization authority allows the agency to designate previously unapproved products as acceptable for use during an emergency or to permit the temporary use of an approved product for a previously unapproved application. With an EUA designation, a product that has not otherwise received FDA clearance can be deployed to meet emergency needs.
When determining whether to issue an EUA for a product, the FDA must find that: (1) An emergency exists involving an agent that is capable of causing a serious or life-threatening disease or condition. (2) Evidence demonstrates that the product “may be effective” to prevent, diagnose or treat that serious or life-threatening disease or condition. (3) A risk-benefit analysis concludes that the known and potential benefits of the product outweigh the known and potential risks. (4) Approved alternatives do not exist or, for example, are not available in sufficient quantities to fully meet the emergency need.
Once an EUA has been issued, the product can be deployed much like any other medical device, but only for the period of time that the EUA is active. That last phrase is key: this authorization is temporary. All device EUAs issued in response to the COVID-19 public health emergency will terminate when the Secretary of Health and Human Services (HHS) ends the medical device EUA declaration. Additionally, even before that time the FDA may revoke or revise an EUA if it determines that the criteria supporting the EUA are no longer met or if it otherwise determines that the action is needed to protect public health or safety.
When a pertinent EUA ends, the EUA device reverts to unapproved status. At that time, the legal protections that support the use of the product on new patients are terminated. The FDA consults with the manufacturers about appropriate disposition of the device, which may include disposing of the product, modifying the device or its instructions for use, returning the product to the manufacturer or some other action, depending on the circumstances (e.g., the nature of the EUA, the type of product).
EUAs are not new. What’s different now, though, is the scale. The FDA has granted EUAs for more than 600 products to help address the COVID-19 pandemic. The need to manage large numbers of medical devices and supplies that have been authorized only for temporary use is a challenge that is unique to this moment, and one that requires careful planning on the part of health care providers.
ECRI’s coverage of this topic for its 2021 list of the “Top 10 Health Technology Hazards” focuses on two concerns, according to Amanda Sivek, Ph.D., a principal project officer in ECRI’s device evaluation group:
“The first is that EUA devices may not be safe or effective.” the FDA can issue an EUA if it determines that the device may be effective for the specified use, and if it assesses that the benefits outweigh the risks. “But note the wording – may be effective; that’s a lower standard for checking safety and effectiveness than the FDA uses for its normal clearance process,” Sivek explains. Thus, health care facilities that use EUA devices must be mindful of the potential for problems with these devices.
“Second – and this is the main reason that facilities need to pay attention – is that EUAs are temporary.” Sivek cautions. “FDA can revise or revoke an EUA at any time. When that happens, health care facilities need to be prepared to act. They need to know what EUA devices they have, where they are in the facility and what needs to be done with them.”
In practice, that means health care facilities must have measures in place to manage inventories of EUA devices and their documentation, to monitor the safety and effectiveness of those devices, to track each device’s EUA status (daily) to determine whether the EUA remains active and unchanged, and to determine what to do with these devices when the EUA status changes. Specific plans are needed for when an EUA for a device in inventory has been revised, revoked or terminated. ECRI’s 2021 “Top 10 Health Technology Hazards” report, specifically the article “Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization,” provides step-by-step recommendations for each of these scenarios.
“The bottom line is that health care facilities that are using EUA devices need to be proactive,” advises Tom Toczylowski, assistant director of the ECRI’s Alerts service. FDA’s COVID-19 medical device EUA websites include the information you need, but you need to know where to look, and when. “EUAs have been modified quite frequently, so you need to have a system for monitoring all those changes.”
As a first step, ECRI recommends that health care facilities subscribe to the email feed distributed by the FDA’s Center for Devices and Radiological Health (CDRH). These daily emails summarize and link to any changes in EUA authorizations. To subscribe to this email feed, visit https://www.fda.gov/medical-devices/news-events-medical-devices/cdrhnew-news-and-updates#subscribe.
When you receive a notification that the EUA status has changed for a device in inventory, ECRI recommends checking the relevant EUA device website as soon as possible to confirm the current EUA status. Then complete the required steps to address the change: If the EUA has a new date of issue/update, activate your plans for an EUA that has been revised. If, on the other hand, the relevant EUA device list has been removed from the website or the specific model has been removed from the EUA device list, activate your plans for an EUA that has been revoked or terminated.
This article is adapted from ECRI’s “Top 10 Health Technology Hazards for 2021” and related content, including ECRI’s February 2021 webcast “Top 10 Health Technology Hazards 2021: An In-Depth Look at Managing Medical Devices with COVID-19 Emergency Use Authorization.” Each year, ECRI produces its “Top 10 Health Technology Hazards” report to help hospitals direct their time and energy toward technology management activities that can have the greatest impact on patient safety. An executive brief version of the report is available for complimentary download at www.ecri.org/2021hazards. The full report, accessible to ECRI members, provides in-depth discussion of each hazard, including detailed steps that organizations can take to prevent adverse incidents. To learn more, contact ECRI at 610-825-6000, ext. 5891, or by email at email@example.com.
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