UPDATE: FDA Recommends Transition from Use of Decontaminated Disposable Respirators
On April 9, 2021, the U.S. Food and Drug Administration (FDA) recommended health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. An 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) and authorized for health care personnel use by the FDA are now currently available to facilitate this transition. For more information, see FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities.
Decontamination and bioburden reduction systems are devices intended to decontaminate or reduce bioburden of certain medical devices (such as compatible respirators) so that they can be reused by healthcare personnel. The FDA has issued EUAs authorizing the emergency use of some decontamination systems to decontaminate certain respirators as well as a bioburden reduction system, recognizing that availability of PPE is an integral part of routine patient care during the COVID-19 pandemic.
This table below includes authorization information for the use of bioburden reduction and decontamination systems to decontaminate certain PPE devices during the COVID-19 public health emergency.
On April 30, 2021, the FDA revoked the emergency use authorization (EUA) of the Battelle CCDS Critical Care Decontamination System, which was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by healthcare personnel. The FDA revoked the EUA in response to Battelle's request for voluntary withdrawal of the authorization. In response to changing customer needs, as of March 31, 2021, Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities.
- FDA Guidance: Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency