With the Coronavirus (COVID-19) pandemic that is affecting millions of people around the world, Advanced Sterilization Products is committed as a leader in protecting patients and healthcare workers with infection prevention solutions.
We designed this Coronavirus Resource Center to help our global healthcare communities navigate the significant challenges they are facing in this time of great uncertainty. With important facts and information that is updated, we want to become a resource for you in combatting COVID-19 and other infections.
June 8 - The U.S. Food and Drug Administration has provided an updated Fact Sheet and IFUs for the emergency use of the Advanced Sterilization Products (ASP) STERRAD® Sterilization Systems for use in decontaminating compatible N95 respirators for single-user reuse by healthcare personnel in healthcare facilities. Read it here »
April 16 - Advanced Sterilization Products Granted FDA EUA Allowing Decontamination of Millions of Compatible N95 Respirators to Help Protect Against COVID-19. Read it here »
April 13 - The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the emergency use of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems for use in decontaminating compatible N95 respirators for single-user reuse by healthcare personnel in healthcare facilities. Learn more »
April 9 - Added letters of efficacy for select CIDEX® Solutions against coronavirus.
April 3 - Updated Ask-An-Expert page with latest FAQ and information about our Medical Information Request form. See here »
March 27 - Beyond Clean and Dr. Ryan Lewis, Sr. Director of Medical Affairs at ASP, answer some of the questions for sterile processing professionals in this Beyond Clean podcast. Read more »
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 to decontaminate compatible N95 and N95-equivalent respirators, please notify us by reaching out to your Account Manager or contact us.