FDA issues Emergency Use Authorization allowing for emergency use of certain anesthesia ventilators
TUESDAY, March 31, 2020 (HealthDay News) — Although U.S. Food and Drug Administration-approved labeling does not provide for use of anesthesia ventilators for long-term ventilator support, they can be repurposed during the coronavirus disease 2019 (COVID-19) pandemic, according to a statement from the American Society of Anesthesiologists and the Anesthesia Patient Safety Foundation.
During the COVID-19 pandemic, anesthesia ventilators that are not currently being used may represent a first-line backup. Safe and effective use requires consideration of guidance from manufacturers and other clinical issues.
The statement provides key points to consider when preparing to use anesthesia ventilators as intensive care unit (ICU) ventilators. These include the need for FDA and manufacturer approval for use of ventilators; the need for an anesthesia professional to be available at all times; and consideration of whether the machines should be used in the ICU or operating room. Use of inhaled anesthetics for sedation is not recommended. The statement also addresses equipment considerations, including guidance for machine set-up, managing the self-test, delivering a desired inspired oxygen concentration, total fresh gas flow settings, strategies for conserving oxygen, humidification considerations, monitoring ventilation, providing potent anesthetic agents, and processing between patients.
The FDA has issued an Emergency Use Authorization (EUA) to allow for emergency use of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators in health care settings. With this EUA, the FDA said it aims to provide maximum regulatory flexibility while helping to increase the U.S. ventilator inventory.
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