Amid nationwide personal protective equipment (PPE) shortages, the Food and Drug Administration (FDA) announced it will not levy penalties for distributing and using improvised face masks when FDA-cleared masks or respirators are unavailable. This guidance comes as volunteers offer to create face masks for health care providers.
FDA also has issued 16 emergency use authorizations (EUAs) during the COVID-19 public health emergency, enabling the use of unapproved medical products or unapproved uses of approved medical products. Notably, FDA authorized the emergency use of ventilators, anesthesia gas machines modified for use as ventilators, ventilator tubing connectors, and ventilator accessories. Another EUA authorizes the use of respirators not approved by the National Institute for Occupational Safety and Health (NIOSH). The agency issued a frequently asked questions document about using respirators not approved by NIOSH.
To help health care providers optimize PPE, the Centers for Disease Control and Prevention developed a PPE burn rate calculator. The tool prompts users to enter the number of full boxes of each type of PPE in stock and calculates the average consumption rate.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the outbreak.
Contact Senior Director of Policy Erin O’Malley at firstname.lastname@example.org or 202.585.0127 with questions.