FDA Recommends Transition Away from Processing Single-Use Respirators


By: Randolph Fillmore

Categories: AAMI News, Sterilization Professionals

The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) agree that the supply of new respirators, including N95s and National Institute for Occupational Safety and Health (NIOSH)-approved particulate filtering facepiece respirators (FFRs), is adequate and, in an letter to healthcare personnel, recommended transitioning away from decontaminating disposable respirators.

When the COVID-19 pandemic public health emergency emerged in 2020, a shortage of respirators led to decontaminating single-use respirators under an emergency use authorization (EUA). Since then, according to the FDA letter, NIOSH has approved and certified more than 875 N95 and FFR respirator models or configurations, in addition to elastomeric respirators and powered air-purifying respirators (PAPRs) for operating room use.

The letter also said that even if facilities are unable to obtain their preferred respirator models, the agency recommends obtaining new respirators before continuing to decontaminate preferred disposable respirators.

FDA added that it is not revoking the EUAs for decontamination in case a situation arises where a supply insufficiency re-occurs. In such a case, health care personnel could continue to use currently authorized decontamination or bioburden reducing efforts.

FDA said it would “continue to monitor the supply and demand” and to assess respirator availability as health care facilities systematically transition away from the most extreme measures of respirator conservation.”