On June 6, the Food and Drug Administration (FDA) issued updates to Emergency Use Authorizations (EUA) for systems used in decontaminating compatible N95 respirators during the COVID-19 pandemic. For purposes of the following EUAs, the FDA defines compatible N95 respirators as those that are non-cellulose containing respirators that do not have an exhalation valve that are either:

  • Authorized in the National Institute for Occupational Safety and Health (NIOSH)-Approved Air Purifying Respirators EUA; or
  • Authorized and identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators

Batelle Decontamination System

The FDA revised the Scope of Authorization for Battelle Decontamination System to:

  • Allow Battelle to distribute decontaminated, compatible N95 respirators to a different health care facility (Open System), in addition to the previously authorized distribution to the health care facility from which the compatible N95 respirators were collected (Closed System)
  • Clarify which respirators may be decontaminated using this decontamination system by adding respirators that have exhalation valves to the description of incompatible respirators.

For details, see the Battelle Emergency Use Authorization letter (reissued June 6) in addition to the following resources:

STERIS Sterilization Systems for Decontamination of N95 Respirators

The FDA revised the Scope of Authorization (Section II) for STERIS Decontamination Systems to:

  • Add the STERIS V-PRO 60 and V-PRO s2 Low Temperature Sterilization Systems to your authorized products for use in decontaminating compatible N95 respirators for single-user reuse by health care personnel as additional authorized products under this EUA
  • Modify which respirators may be decontaminated using this decontamination system. The STERIS Sterilization Systems are no longer authorized to decontaminate respirators that are authorized under the Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA nor is the device authorized to decontaminate respirators that have exhalation valves

For details, please see the STERIS Sterilizations Systems Emergency Use Authorization letter (reissued June 6) in addition to the following resources:

Advanced Sterilization Systems (ASP) STERRAD Sterilization System

The FDA reissued a letter to ASP to:

  • Revise the compatible N95 respirators this decontamination system is authorized to decontaminate. As described in the Scope of Authorization (Section II), the ASP STERRAD Sterilization Systems are no longer authorized to decontaminate respirators that are authorized under the Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA.
  • Clarify that the ASP System is no longer authorized to decontaminate respirators that have exhalation valves

For details, see the ASP Sterilization Systems Emergency Use Authorization letter (reissued June 6) in addition to the following resources:

Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle

The FDA reissued a letter to Stryker to:

  • Revise which compatible N95 respirators this decontamination system is authorized to decontaminate. As described in the Scope of Authorization (Section II), the STERIZONE VP4 N95 Respirator Decontamination Cycle is no longer authorized to decontaminate respirators that are authorized under the Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA
  • Clarify that the Stryker STERIZONE System is no longer authorized to decontaminate respirators that have exhalation valves

For details, see the Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle Emergency Use Authorization letter (reissued June 6) in addition to the following resources:

Sterilucent Sterilization System

The FDA reissued a letter to Sterilucent:

  • In order to revise the compatible N95 respirators this decontamination system is authorized to decontaminate. As described in the Scope of Authorization (Section II), the Sterilucent Sterilization System is no longer authorized to decontaminate respirators that are authorized under the Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA.
  • The Sterilucent System is no longer authorized to decontaminate respirators that have exhalation valves.

For details, see the Sterilucent Sterilization System Emergency Use Authorization letter (Reissued June 6) in addition to the following resources:

Duke Decontamination System

The FDA reissued a letter to Duke:

  • To revise which compatible N95 respirators this decontamination system is authorized to decontaminate. As described in the revised Scope of Authorization (Section II), the Duke Decontamination System is no longer authorized to decontaminate respirators that are authorized under the NonNIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA
  • To clarify that the Duke Decontamination System is no longer authorized to decontaminate respirators that have exhalation valves

For details, see the Duke Decontamination System Emergency Use Authorization letter (reissued June 6) in addition to the following resources:

Stryker Sustainability Solutions VHP Decontamination System

The FDA reissued a letter to Stryker to:

  • Revise the Scope of Authorization with respect to which compatible N95 respirators this decontamination system is authorized to decontaminate. The SSS VHP N95 Respirator Decontamination System is no longer authorized to decontaminate authorized respirators that have exhalation valves.

For details, see the Stryker Sustainability Solutions VHP Decontamination System Emergency Use Authorization letter (reissued June 6) in addition to the following resources:

Visit the COVID-19 Resources for more information.