FDA MedWatch - STERRAD Sterilization Systems: Letter to Health Care Providers

June 1, 2020

A MedWatch Safety Alert was added to the FDA Medical Device Safety webpage.

TOPIC: STERRAD Sterilization Systems: Letter to Health Care Providers - Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators

AUDIENCE: Health Professional, Risk Manager

ISSUE: Health care facilities alerted the FDA of the potential for reprocessing staff that decontaminate respirators to use an incorrect decontamination cycle and incompatible respirator when using ASP STERRAD Sterilization Systems.

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.

There have been no injuries reported to the FDA associated with the use of an incorrect decontamination cycle with the ASP STERRAD Sterilization Systems for decontaminating compatible N95 or N95-equivalent respirators for single-user reuse.

BACKGROUND: During the COVID-19 pandemic, health care facilities are rapidly adopting conservation practices such as decontaminating compatible N95 or N95-equivalent respirators for single-user reuse.

RECOMMENDATIONS:

  • 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.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Read Letter to Health Care Providers