The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. Based on the increased domestic supply of new respirators approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) currently available to facilitate this transition, the FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems.
Recommendations
The FDA recommends that health care personnel and facilities:
Limit decontamination of disposable respirators. Decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new FFRs or if you are unable to obtain any new respirators.
Transition away from a crisis capacity strategy for respirators, such as decontamination of N95 and other FFRs.
Increase inventory of available NIOSH-approved respirators—including N95s and other FFRs, elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in the operating room, and powered air-purifying respirators (PAPRs). Even if you are unable to obtain the respirator model that you would prefer, the FDA recommends that you obtain and use a new respirator before decontaminating or bioburden reducing a preferred disposable respirator.
Background
The FDA continues to work closely with other government partners, including CDC/NIOSH and Occupational Safety and Health Administration (OSHA), in a whole-of-government approach to help make available critical respiratory protection to address the needs of health care personnel.
If a reusable respirator is needed, organizations should first try to acquire respirators like elastomeric respirators and PAPRs, which are designed to be reusable. For more information on reusing FFRs in workplaces in which workers need respirators to protect against exposure to infectious agents that could be inhaled into the respiratory system, please see OSHA’s Enforcement Guidance on Decontamination of Filtering Facepiece Respirators in Healthcare During the COVID-19 Pandemic.
During the COVID-19 public health emergency, NIOSH-approved respirators, including N95 respirators, are authorized on a continual basis under the FDA emergency use authorization (EUA) for NIOSH-Approved air purifying respirators (includes single-use respirators and those designed to be reusable) until the U.S. Department of Health and Human Services (HHS) Secretary’s declaration that circumstances exist justifying authorization is terminated or the EUA is revoked. Once a respirator receives NIOSH approval, it is automatically authorized under this umbrella EUA. From January 2020 through April 2021, NIOSH has approved over 875 respirator models or configurations with some of these manufactured by approximately 20 new, domestic NIOSH approval holders. In addition, as of today, there are over 6,400 total respirator models or configurations on the NIOSH certified equipment list which met the NIOSH-Approved EUA criteria and thus had been FDA-authorized, including:
