Emergency Use Authorization granted to ASP STERRAD® Systems to Enable Re-Use of N95 respirator


Dear Valued Customer, 

First, I want to personally thank all of you, your staff and your institution for everything you are doing at the forefront of this battle against COVID-19. 

I am pleased to share news that holds promise in addressing the severe shortage of PPE for healthcare professionals as you focus on treating those in need. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the ASP STERRAD® 100S Sterilizer, STERRAD NX® Sterilizer, and STERRAD® 100NX Sterilization Systems1 for use in decontaminating compatible N95 or N95-equivalent2 respirators3 for single-user4 reuse by healthcare personnel (HCP)5 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of N95 respirators resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.6

ASP's qualified reprocessing protocol for select N95 respirators can effectively triple the lifespan of these otherwise-single-use masks utilizing STERRAD® Sterilizer Systems already available in most US hospitals and globally. As a leader in Hydrogen Peroxide Gas Plasma (HPGP) technology, ASP STERRAD Sterilizer Systems can reprocess approximately 400 masks per day.*

Instructions for use, fact sheets for both healthcare facilities and personnel, and other helpful information to guide you in the implementation of this protocol are available on our COVID-19 web hub

Again, thank you for everything you do for our communities and loved ones needing medical assistance, and please know that all of us at ASP remain fully committed to doing all we can to help you in the fight against this pandemic. Our focus, as always, is to help improve outcomes by reducing HAIs. 

Sincerely, 

Dominic lvankovich 
President, ASP 

 


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 the 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 to decontaminate compatible N95 and N95-equivalent respirators, please notify us by reaching out to your Account Manager or contact us.


Important information: Prior to use, refer to the instructions for use supplied with the STERRAD Sterilization Systems for standard indications, contraindications, warnings, and precautions. 

*Testing included 10 masks per cycle. Cycle times range from 24 minutes - 55 minutes, depending on the sterilizer model. Reprocess up to 480 masks per machine daily (24 hour period) on models with cycle times less than 30 minutes.

1 This EUA includes the emergency use of the ASP STERRAD 100S Sterilizer, NX Sterilizer, and 100NX Sterilization Systems in the STERRAD 100S Sterilizer, NX Standard Sterilizer, and 100NX Sterilizer Express Cycles, respectively, for decontamination of compatible N95 respirators (as defined in footnote 3). Use of the ASP STERRAD Sterilization Systems on other types of personal protective equipment is not authorized and would require a request for a separate EUA or marketing authorization and data supporting such other use.

2 For purposes of this EUA, “N95-equivalent respirators” refers to respirators identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators and in Appendix A of the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, which are available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

3 For purposes of this EUA, “compatible N95 respirators” means any N95 or N95-equivalent respirator that does not contain cellulose-based materials. Respirators containing cellulose-based materials are incompatible with the ASP STERRAD Sterilization Systems.

4 Single-user reuse means that the same HCP should use the mask following decontamination.

5 HCP refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These HCP include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, dentists and dental hygienists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering, and facilities management, administrative, billing, and volunteer personnel).

6 The ASP STERRAD Sterilization Systems are FDA cleared for use in the sterilization of certain metal and non-metal medical devices, which do not include N95 respirators (see K023290, K162007, and K160903 for the most recent clearances).

Capitalized product names and ALLClear® are trademarks of ASP Global Manufacturing, GmbH.

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