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SARS-CoV 2 (COVID-19) related questions submitted via this link or the button below are reviewed by our Medical Affairs team on a regular basis. Our Medical Affairs team will be able to answer your questions and provide substantiated and up-to-date information as available.

Due to the volume of inquiries during this time, our Medical Affairs team will respond as quickly as possible. Please fill out the form fully so that our team is able to answer your questions quickly and appropriately.

Thank you for your patience and we are happy to help support your need for information during this critical time.

Frequently Asked Questions


The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

The EUA for the ASP STERRAD Sterilization System for decontamination of compatible N95 respirators is in effect for the duration of the COVID-19 declaration justifying emergency use of medical devices, unless terminated or revoked by FDA (after which the products may no longer be used).

Potential benefits include:
  • May help prevent exposure to airborne pathogens
  • Extends the usability of compatible N95 respirators by allowing for decontamination and single-user reuse
  • Availability of N95 respirators is critical to healthcare workers in the diagnosis and treatment of patients with COVID-19
Potential risks include:
  • Failure of filtration efficiency
  • Reduced breathability
  • Strap failure and ineffective face-fit
  • Reused respirators may not have been effectively decontaminated of SARS-CoV-2 or other pathogens
Yes. Functionality testing completed with N95 or N95-equivalent respirators indicated that compatible N95 or N95-equivalent respirators tested met filtration requirements after two cycles.
Yes. Testing found after 60 minutes in an open pouch, H2O2 residuals were 1ppm or less, a generally accepted exposure limit (OSHA Standard Number 1910.1000 Table Z-1).
Please notify your local ASP Account Manager or complete the Contact Us form.

Compatible N95 Respirators may be decontaminated a maximum of 2 times using STERRAD Sterilizers in the following cycles.

ASP System

Cycle

Cycle Time

Placement

STERRAD 100S System

-

55 Minutes

Both shelves

STERRAD NX System

Standard

28 Minutes

Both shelves

STERRAD 100NX System

Express

24 Minutes

Bottom shelf only

 

N95 or N95-equivalent respirators containing cellulose-based materials are not compatible with the ASP STERRAD Sterilization Systems.
Each cycle can decontaminate ten (10) N95 compatible respirators and sterilization pouches per sterilizer load.
Place a tick mark on your compatible N95 respirator each time to maintain the decontamination cycle count. Your respirator may be decontaminated no more than 2 times.
Yes, once the ALLClear Technology feature has been disabled. ASP completed testing with the ALLClear Technology disabled. Please reach out to your Account Manager or contact us for more information on how to disable and enable ALLClear Technology.
FDA has specified that decontaminated N95 respirators are for single-user reuse to minimize any risk of cross-contamination and also to ensure proper fit post reprocessing. Once the nosepiece has been molded to the original user’s anatomy, it may be difficult for a second user to achieve proper fit and thus it could negatively impact function. To assure form, fit, and function are intact for 2 reprocessing cycles, masks should be returned to the original user.
No. A full cycle must be successfully completed for decontamination.
Cancelled cycles count as a cycle and masks cannot be decontaminated more than 2 times. If you are experiencing cancelled cycles, please notify your local ASP Account Manager or contact us.
The compatible N95 or N95-equivalent respirators cannot be cleaned prior to putting them into the STERRAD Sterilizer. Compatible N95 or N95-equivalent respirators that are visibly soiled (e.g., blood, dried sputum, makeup, soil, bodily fluids) or damaged must be discarded.

ASP System

Cycle

Cycle Time

Placement

STERRAD 100S System

-

55 Minutes

Both shelves

STERRAD NX System

Standard

28 Minutes

Both shelves

STERRAD 100NX System

Express

24 Minutes

Bottom shelf only

 

If you have a STERRAD 100NX Sterilizer and do not have Express Cycle, please reach out to your local ASP Account Manager or contact us.

The hydrogen peroxide concentration in the STERRAD System cassettes is 59%. Select STERRAD Sterilizer cycles use altered concentration levels during diffusion phases within the cycles to achieve device performance. STERRAD Systems also use gas plasma technology to breakdown hydrogen peroxide into water and oxygen, minimizing toxic residue.
STERRAD Systems do not require a wait time between cycles. This has not changed with the reprocessing of N95 respirators.
A specific orientation of the respirator in the sterilization pouch or pouches in the sterilizer is not required. Pouches should not overlap or cover other pouches.
ASP is currently evaluating the most critical PPE for reprocessing and is working with the PPE manufacturers. ASP will provide additional information when available.

The ASP STERRAD Sterilization Systems have neither been cleared or approved for the prevention of the COVID-19 infection;

The ASP STERRAD Sterilization Systems have been authorized by FDA under an EUA;

The ASP STERRAD Sterilization Systems are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the ASP STERRAD Sterilization Systems under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

If your facility plans to use STERRAD Sterilization Systems for emergency use, please notify us by reaching out to your Account Manager or contact us.