On January 21, 2021, the Food and Drug Administration (FDA) reissued the following updates to the Emergency Use Authorizations (EUA) for systems used in decontaminating compatible N95 respirators during the COVID-19 pandemic.  For purposes of the following EUA, the FDA defines compatible N95 respirators as any non-cellulose containing respirators that do not have an exhalation valve, antimicrobial agents, or a duck-billed design, and that are either authorized in the NIOSH-Approved Air Purifying Respirators EUA or authorized and identified in Exhibit 1 (updated February 1, 2021) of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. Compatible N95 respirators for the STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers are identified as the 3M 1860, 3M 1860S, 3M 1804, and 3M 8210 NIOSH-approved N95 respirators only. Per the FDA, compatibility of other N95 or N95-equivalent respirators with the STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers has not yet been demonstrated.

In addition to the following EUAs, the FDA has added Conditions of Authorization (Section IV.P) in which post-authorization studies verify compatibility of N95 respirators to maintain adequate performance following decontamination cycles. For all systems, the maximum quantity of decontamination cycles currently listed may be increased following submission and review of real-world evidence (RWE) to support a greater number of decontamination cycles. The post-authorization studies must be completed within 60 days of the date of the letters or before 1500 compatible N95 respirators have been decontaminated using your system, whichever occurs later. Extensions to complete the study require agreement with the FDA and results must be submitted for review within 15 days of the study completion.

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Overview

The FDA is revising the authorization of the SSS VHP N95 Respirator Decontamination System to include:

  • Limitation of the respirator features that are considered compatible N95 respirators in which this decontamination system is authorized to decontaminate. The product is no longer authorized to decontaminate compatible N95 respirators with antimicrobial/antiviral agents or a duck-bill design.
  • Limitation of the maximum number of decontamination cycles to four (4) cycles per compatible N95 respirator with the option to increase the maximum cycles with the submission of, and subject to review and concurrence with, real-world evidence (RWE) for more than four (4) cycles.
  • Incorporation of a post-authorization study to collect RWE to verify that compatible N95 respirators are capable of adequate reuse after four (4) decontamination cycles.
  • Incorporation of a Condition of Authorization that requires healthcare facilities to ensure that HCP receive the same model of decontaminated compatible N95 respirator for which they have been fit tested. If such model of respirator is unavailable, then healthcare facilities must provide HCP with fit testing prior to using an alternative model of decontaminated compatible N95 respirator.
  • The product is no longer authorized to decontaminate compatible N95 respirators up to 20 cycles and is now authorized to perform such decontamination for a maximum of four (4) times per respirator.
  • Condition of Authorization (Section IV.R) has been added in which you must conduct a post-authorization study to verify that compatible N95 respirators are adequate for reuse following four (4) decontamination cycles. The maximum number of cycles can be increased following submission and review of RWE for greater than four (4) decontamination cycles (see Section IV.S).

For details, see the Battelle Decontamination System Emergency Use Authorization letter (reissued January 21, 2021) in addition to the following:

The FDA is revising the authorization of the SSS VHP N95 Respirator Decontamination System to include:

  • Limitation of the respirator features that are considered compatible N95 respirators in which this decontamination system is authorized to decontaminate. The product is no longer authorized to decontaminate compatible N95 respirators with antimicrobial agents or a duck-billed design.
  • Limitation of the maximum number of decontamination cycles to four (4) cycles per compatible N95 respirator with the option to increase the maximum cycles with the submission of, and subject to review and concurrence with, real-world evidence (RWE) for more than four (4) cycles.
  • Incorporation of a post-authorization study to collect RWE to verify that compatible N95 respirators are capable of adequate reuse after four (4) decontamination cycles.
  • The product is no longer authorized to decontaminate compatible N95 respirators up to 10 cycles and is now authorized to perform decontamination for a maximum of four (4) times per respirator.
  • Condition of Authorization (Section IV.L) has been added in which you must conduct a post-authorization study to verify that compatible N95 respirators are adequate for reuse following four (4) decontamination cycles. The maximum number of cycles can be increased following submission and review of RWE for greater than four (4) decontamination cycles (see Section IV.M).

For details, see the STERIS Sterilization Systems for Decontamination of N95 Respirators Emergency Use Authorization letter (reissued January 21, 2021) in addition to the following:

The FDA is revising the authorization of the SSS VHP N95 Respirator Decontamination System to include:

  • Revise the scope of the EUA to include one additional model of compatible N95 respirator to additionally include the 3M 8210 model of N95 respirator for this product.
  • Limitation of the maximum number of decontamination cycles to four (4) cycles per compatible N95 respirator with the option to increase the maximum cycles with the submission of, and subject to review and concurrence with RWE for more than four (4) cycles.
  • Incorporation of a post-authorization study to collect RWE to verify that compatible N95 respirators are capable of adequate reuse after four (4) decontamination cycles.
  • The product is no longer authorized to decontaminate compatible N95 respirators up to ten (10) cycles and is now authorized to perform such decontamination for a maximum of four (4) times per respirator.
  • Condition of Authorization (Section IV.M) has been added in which you must conduct a post-authorization study to verify that compatible N95 respirators are adequate for reuse following four (4) decontamination cycles. The maximum number of cycles can be increased following submission and review of RWE for greater than four (4) decontamination cycles (see Section IV.N).

For details, see the STERIS STEAM Decontamination Cycle in AMSCO Medium Steam Sterilizers Emergency Use Authorization letter (reissued January 21, 2021) in addition to the following:

The FDA is revising the authorization of the SSS VHP N95 Respirator Decontamination System to include:

  • Limitation of the respirator features that are considered compatible N95 respirators in which this decontamination system is authorized to decontaminate. The ASP STERRAD Sterilization Systems are no longer authorized to decontaminate compatible N95 respirators with antimicrobial agents or a duck-billed design.
  • Incorporation of a post-authorization study to collect RWE to verify that compatible N95 respirators are capable of adequate reuse after two (2) decontamination cycles.
  • Condition of Authorization (Section IV.L) has been added in which you must conduct a post-authorization study to verify that compatible N95 respirators are adequate for reuse following two (2) decontamination cycles. The maximum number of cycles can be increased following submission and review of RWE for greater than two (2) decontamination cycles (see Section IV.M).

For details, see the Advanced Sterilization Products (ASP) STERRAD Sterilization System Emergency Use Authorization letter (reissued January 21, 2021) in addition to the following:

The FDA is revising the authorization of the SSS VHP N95 Respirator Decontamination System to include:

  • Limitation of the respirator features that are considered compatible N95 respirators in which this decontamination system is authorized to decontaminate. The STERIZONE VP4 Sterilizer is no longer authorized to decontaminate compatible N95 respirators with antimicrobial agents or a duck-billed design.
  • Incorporation of a post-authorization study to collect RWE to verify that compatible N95 respirators are capable of adequate reuse after two (2) decontamination cycles.
  • Condition of Authorization (Section IV.L) has been added in which you must conduct a post-authorization study to verify that compatible N95 respirators are adequate for reuse following two (2) decontamination cycles. The maximum number of cycles can be increased following submission and review of RWE for greater than two (2) decontamination cycles (see Section IV.M).

For details, see the Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle Emergency Use Authorization letter (reissued January 21, 2021) in addition to the following:

The FDA is revising the authorization of the SSS VHP N95 Respirator Decontamination System to include:

  • Limitation of the respirator features that are considered compatible N95 respirators in which this decontamination system is authorized to decontaminate. The product is no longer authorized to decontaminate compatible N95 respirators with antimicrobial agents or a duck-billed design.
  • Limitation of the maximum number of decontamination cycles to four (4) cycles per compatible N95 respirator with the option to increase the maximum cycles with the submission of, and subject to review and concurrence with RWE
    for more than four (4) cycles.
  • Incorporation of a post-authorization study to collect RWE to verify that compatible N95 respirators are capable of adequate reuse after four (4) decontamination cycles.
  • The product is no longer authorized to decontaminate compatible N95 respirators up to 10 cycles and is now authorized to perform such decontamination for a maximum of 4 times per respirator.
  • Condition of Authorization (Section IV.L) has been added in which you must conduct a post-authorization study to verify that compatible N95 respirators are adequate for reuse following four (4) decontamination cycles. The maximum number of cycles can be increased following submission and review of RWE for greater than four (4) decontamination cycles (see Section IV.M).

For details, see the Sterilucent, Inc. Sterilization System Emergency Use Authorization letter (reissued January 21, 2021) in addition to the following:

The FDA is revising the authorization of the SSS VHP N95 Respirator Decontamination System to include:

  • Limitation of the respirator features that are considered compatible N95 respirators in which this decontamination system is authorized to decontaminate. The product is no longer authorized to decontaminate compatible N95 respirators with antimicrobial agents or a duck-billed design.
  • Limitation of the maximum number of decontamination cycles to four (4) cycles per compatible N95 respirator with the option to increase the maximum cycles with the submission of, and subject to review and concurrence with RWE
    for more than four (4) cycles.
  • Incorporation of a post-authorization study to collect RWE to verify that compatible N95 respirators are capable of adequate reuse after four (4) decontamination cycles.
  • Incorporation of a Condition of Authorization that requires healthcare facilities to ensure that HCP receive the same model of decontaminated compatible N95 respirator for which they have been fit tested. If such model of respirator is unavailable, then Duke must provide HCP with fit testing prior to using an alternative model of decontaminated compatible N95 respirator.
  • The product is no longer authorized to decontaminate compatible N95 respirators up to 20 cycles and is now authorized to perform such decontamination for a maximum of four (4) times per respirator.
  • Condition of Authorization (Section IV.S) has been added in which you must conduct a post-authorization study to verify that compatible N95 respirators are adequate for reuse following four (4) decontamination cycles. The maximum number of cycles can be increased following submission and review of RWE to support greater than four (4) decontamination cycles (see Section IV.T).

For details, see the Duke Decontamination System Emergency Use Authorization letter (reissued January 21, 2021) in addition to the following:

The FDA is revising the authorization of the SSS VHP N95 Respirator Decontamination System to include:

  • Limitation of the respirator features that are considered compatible N95 respirators in which this decontamination system is authorized to decontaminate: The product is no longer authorized to decontaminate compatible N95 respirators with antimicrobial agents or a duck-billed design.
  • Incorporation of a post-authorization study to collect RWE to verify that compatible N95 respirators are capable of adequate reuse after three (3) decontamination cycles, with the option to increase the maximum cycles with the submission of, and subject to review and concurrence with, RWE for more than three (3) cycles.
  • Incorporation of a Condition of Authorization that requires healthcare facilities ensure that HCP receive the same model of decontaminated compatible N95 respirator for which they have been fit tested. If such model of respirator is unavailable, then healthcare facilities must provide HCP with fit testing prior to using an alternative model of decontaminated compatible N95 respirator.
  • Condition of Authorization (Section IV.Q) has been added in which you must conduct a post-authorization study to verify that compatible N95 respirators are adequate for reuse following three (3) decontamination cycles. The maximum number of cycles can be increased following submission and review of RWE for greater than three (3) decontamination cycles per respirator (see Section IV.R).

For details, see the Stryker Sustainability Solutions VHP Decontamination System Emergency Use Authorization letter (reissued January 21, 2021) in addition to the following:

The FDA revised the Scope of Authorization for Michigan State University Decontamination System to:

  • Limitation of the respirator features that are considered compatible N95 respirators in which this decontamination system is authorized to decontaminate: The product is no longer authorized to decontaminate N95 respirators with antimicrobial agents or a duck-billed design.
  • Incorporation of a post-authorization study to collect real-world evidence (RWE) to verify that compatible N95 respirators are capable of adequate reuse after three (3) decontamination cycles.
  • Condition of Authorization (Section IV.P) has been added in which you must conduct a post-authorization study to verify that compatible N95 respirators maintain adequate performance following three (3) decontamination cycles. The maximum number of decontamination cycles can be increased following submission and review of RWE to support greater than three (3) decontamination cycles (Section IV.Q).

For details, see the Michigan State University Decontamination System Emergency Use Authorization letter (reissued January 21, 2021) in addition to the following:

The FDA is revising the authorization of the 20-CS Decontamination System to:

  • Limitation of the respirator features that are considered compatible N95 respirators in which this decontamination system is authorized to decontaminate: The product is no longer authorized to decontaminate compatible N95 respirators with antimicrobial agents or a duck-billed design.
  • Limitation of the maximum number of decontamination cycles to four (4) cycles per compatible N95 respirator.  The option to increase the maximum cycles with the submission of, is subject to review, and concurrent with RWE for more than four (4) cycles.
  • Incorporation of a post-authorization study to collect RWE to verify that compatible N95 respirators are capable for adequate reuse after four (4) decontamination cycles.
  • Incorporation of a Condition of Authorization that requires healthcare facilities to ensure that HCP receive the same model of decontaminated compatible N95 respirator for which they have been fit tested. If such model of respirator is unavailable, then healthcare facilities must provide HCP with fit testing prior to using an alternative model of decontaminated compatible N95 respirator.
  • The product is no longer authorized to decontaminate compatible N95 respirators up to 20 cycles and is now authorized to perform decontamination for a maximum of (four) 4 times per respirator.
  • Condition of Authorization (Section IV.S) has been added in which conduction of a post-authorization study to verify that compatible N95 respirators are adequate for reuse following four (4) decontamination cycles. The maximum number of cycles can be increased following submission and review of RWE for greater than four (4) decontamination cycles (see Section IV.T).

For details, see the Technical Safety Services VHP Decontamination System Emergency Use Authorization letter (reissued January 21, 2021) in addition to the following: