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FDA Updates Information on Respirator Decontamination Systems

The U.S. Food and Drug Administration (FDA) is reissuing the Emergency Use Authorizations for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological...

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FDA Letter: Use Correct Cycle When Decontaminating Respirators with STERRAD Sterilization Systems

The U.S. Food and Drug Administration (FDA) reminds reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the COVID-19 pandemic.

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The Letter to Health Care Providers includes important information about the use of ASP STERRAD Sterilization Systems to decontaminate compatible N95 respirators, including:

  • Details on the combination of certain models of the STERRAD Sterilization System to be used with their appropriate Respirators Decontamination Cycle listed in the FDA’s Emergency Use Authorization.
  • Recommendations for health care facilities and reprocessing staff.
  • Actions that the FDA has taken to address conserving supply of respirators during the COVID-19 pandemic in health care facilities.
  • Instructions for reporting problems with a device.

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