April 15, 2021

FDA Recommends Healthcare Facilities Limit Use of Decontaminated Disposable Respirators

Healthcare workers and facilities should move away from using decontaminated disposable respirators, the U.S. Food and Drug Administration (FDA) says in a letter dated April 9. FDA, together with CDC, “[believes] there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems,” the letter states. These systems have been used to support the reuse of respirators in healthcare settings in response to respirator shortages stemming from the COVID-19 public health emergency.

FDA’s letter states that healthcare facilities should only use decontaminated respirators and respirators that have undergone bioburden reduction when there are insufficient supplies of new filtering facepiece respirators (FFRs) or if facilities are unable to obtain new respirators. The agency also urges facilities to increase their inventory of available NIOSH-approved respirators, including N95s and other FFRs, elastomeric respirators, and powered air-purifying respirators (PAPRs). If reusable respirators are needed, FDA recommends that healthcare facilities first try to acquire respirators that are designed to be reusable, like elastomeric respirators and PAPRs, before decontaminating or reducing the bioburden of disposable respirators.

Bioburden reduction systems use dry heat to support single-person reuse of certain FFRs. Last April, NIOSH identified three decontamination methods that showed “the most promise” for the reuse of FFRs: ultraviolet germicidal irradiation, vaporous hydrogen peroxide, and moist heat. A previous FDA press release clarifies that bioburden reduction, which achieves a certain level of microbial reduction on a device, is not the same as decontamination, which results in a higher level of microbial reduction.

FDA is not yet revoking its emergency use authorizations (EUAs) for decontamination and bioburden reduction systems and will “continue to monitor supply and demand to assess respirator availability as facilities systematically transition away from the most extreme measures of respirator conservation.” FDA’s EUAs for decontamination systems for personal protective equipment are collected on the administration’s website.

For more information, see FDA’s letter to healthcare personnel and facilities.