Advanced Sterilization Products Granted FDA EUA Allowing Decontamination of Millions of Compatible N95 Respirators to Help Protect Against COVID-19

04/14/2020

- STERRAD® Systems already available onsite in many US hospitals could collectively decontaminate millions of masks daily –

- Instructions for use available for immediate implementation –

IRVINE, Calif. April 13, 2020 – Advanced Sterilization Products (ASP), a Fortive (NYSE:FTV) company and global leader in infection prevention, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the use of STERRAD® Systems to decontaminate compatible N95 respirators.1 Utilizing equipment already available onsite in many US hospitals, STERRAD Systems could collectively reprocess millions of compatible N95 respirators daily.

 

Advanced Sterilization Products Granted FDA EUA Allowing Decontamination of Millions of Compatible N95 Respirators to Help Protect Against COVID-19

The EUA designation was granted based on ASP’s reprocessing protocol that allows single-use compatible N95 respirators to be decontaminated and reused twice after initial use.  The FDA-authorized fact sheet, healthcare facility and healthcare professional instructions for use (IFU) are available on the company’s COVID-19 resource hub to ensure the efficient implementation of the reprocessing protocol amid the COVID-19 crisis.

In addition to the US, emergency use status has been obtained for the use of STERRAD Systems to decontaminate compatible N95 respirators and equivalents in the European Union, New Zealand, Canada and Japan.

“We are pleased to have received EUA for the use of STERRAD Systems – a technology that is readily available across many sites throughout the country and provides an effective solution to the PPE shortages that our healthcare providers are facing,” said Dominic Ivankovich, President of ASP. “Our hope is that this will make an immediate impact for all our heroes at the frontline of this pandemic.”

ASP sterilization systems and disinfectant solutions have been tested against enveloped viruses, the family of viruses that includes coronavirus, and have been demonstrated to be efficacious against those viruses. To determine whether compatible N95 masks/respirators can be reprocessed in STERRAD Systems and maintain their functionality, while remaining safe for use after hydrogen peroxide vapor exposure2, ASP (in partnership with key N95 respirator manufacturers) initiated testing on functionality (filtration plus form/fit) and to ensure H2O2 residuals did not pose risk to the wearer after decontamination.  Those results indicated form, fit and function of tested N95 respirators was maintained through two (2) cycles of reprocessing in STERRAD Systems and cycles.3

Healthcare professionals struggling with PPE shortages may already have access to STERRAD Systems each capable of reprocessing over 400 compatible N95 respirators per day.  Millions of compatible respirators could be decontaminated onsite at US healthcare facilities each day to help healthcare professionals combat the spread of COVID-19.

Visit asp.com for complete and up-to-date information on PPE reprocessing, including an updated list of compatible masks and instructions for use of the compatible N95 respirators reprocessing protocol. 

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About Advanced Sterilization Products (ASP)

Advanced Sterilization Products (ASP) has a long track record of designing and delivering innovative infection prevention solutions that dramatically raise the level of health care and safety for those who matter most. Our pioneering technology, global distribution and established leadership position enable us to simplify the process of buying and operating infection prevention products and services every day for thousands of medical facilities around the world. This enables our customers to focus on what they do best – preventing infection and saving lives. For more information, please visit www.asp.com.

 

About Fortive

Fortive is a diversified industrial technology growth company comprised of Professional Instrumentation and Industrial Technologies businesses that are recognized leaders in attractive markets. Fortive’s well-known brands hold leading positions in field solutions, product realization, sensing technologies, transportation technologies, and franchise distribution. Fortive is headquartered in Everett, Washington and employs a team of more than 25,000 research and development, manufacturing, sales, distribution, service and administrative employees in more than 50 countries around the world. With a culture rooted in continuous improvement, the core of our company’s operating model is the Fortive Business System. For more information please visit: www.fortive.com.

About Emergency Use Authorization (EUA)

Emergency Use Authorization (EUA)  allows the United States Food and Drug Administration (FDA) to help strengthen the nation’s public health protections against chemical, biological, radiological and nuclear defense (CBRN) 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.

  1. ASP STERRAD Sterilization Systems have neither been cleared or approved for the prevention of COVID-19 infection. ASP STERRAD Sterilization Systems have been authorized by FDA under an EUA. 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.
  2. Testing showed after 60 minutes in an open pouch, H2O2 residuals were <1ppm, a generally accepted exposure limit (OSHA Standard Number 1910.1000 Table Z-1 and NIOSH Pocket Guide to Chemical Hazards). 
  3. https://multimedia.3m.com/mws/media/1824869O/decontamination-methods-for-3m-n95-respirators-technical-bulletin.pdf

 

Media Contact:

Glenn Silver

[email protected]

M: 973-818-8198

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