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.
ASP STERRAD Sterilization Systems use vaporized hydrogen peroxide to decontaminate medical devices. Only the combination of certain models of the ASP STERRAD Sterilization System and their associated STERRAD Decontamination Cycle listed in the FDA's Emergency Use Authorization (EUA), and shown in the table below, are authorized for the decontamination of compatible N95 respirators.
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The FDA recommends that reprocessing staff in health care facilities:
- Recognize that new N95 and N95-equivalent respirators, when available, are always the first choice for health care personnel.
- Confirm the N95 or N95-equivalent respirators you are decontaminating do not contain cellulose (i.e., paper-based materials). Respirators that contain cellulose are incompatible with vaporized hydrogen peroxide decontamination.
- Use only the Express cycle for the STERRAD 100NX System. Do not use other cycles available on the STERRAD 100NX System to decontaminate compatible N95 respirators.
- If your system currently does not have the Express cycle, consider the software upgrade available from the manufacturer to add this cycle to the STERRAD 100NX System at your facility.
- Use only the 100S cycle to decontaminate compatible N95 respirators with the STERRAD 100S System.
- Use only the Standard cycle to decontaminate compatible N95 respirators with the STERRAD NX System.
- Review the Fact Sheet and Instructions associated with the Emergency Use Authorization.
The complete instruction sheets and guidelines are available on the FDA website.