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Advanced Sterilization Products

FDA says to limit mask decontamination to 4 cycles

January 22, 2021 By Nancy Crotti

Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times. The FDA began issuing emergency use authorizations (EUAs) for FFR decontamination systems with a range of allowable cycles and major media […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Regulatory/Compliance, Sterilization / Calibration Tagged With: Advanced Sterilization Products, Battelle, Duke University, FDA, Michigan State University, Sterilucent Inc., Steris Corp., Stryker, Technical Safety Services

FDA restricts re-use of certain respirators for COVID-19

June 8, 2020 By Nancy Crotti

Certain respirators made in China and respirators with exhalation valves should not be decontaminated for re-use by healthcare workers, the FDA announced today. The agency revised these respirators’ emergency use authorizations (EUAs) to reflect the changes. The particular respirators from China “may vary in their design and performance,” the FDA said, basing its decision on […]

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory, Sterilization / Calibration Tagged With: Advanced Sterilization Products, Battelle, COVID-19, Duke University, FDA, Sterilucent Inc., Steris Corp., Stryker

FDA issues EUA for Sterilucent N95 hydrogen peroxide sterilization

April 22, 2020 By Sean Whooley

The FDA has granted Sterilucent emergency use authorization (EUA) for its hydrogen peroxide sterilizer for use with N95 and N95-equivalent respirators — the latest in a string of mask sterilizers receiving EUAs amid the coronavirus pandemic. Minneapolis-based Sterilucent’s HC 80TT vaporized hydrogen peroxide sterilizer may now be used to decontaminate the single-use compatible respirators that […]

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory, Sterilization / Calibration Tagged With: Advanced Sterilization Products, Battelle, coronavirus, FDA, Fresenius, Sterilucent Inc., Steris Corp., Stryker

Stryker gains emergency nod for respirator decontamination

April 16, 2020 By Nancy Crotti

The FDA has granted Stryker (NYSE:SYK) an emergency use authorization to decontaminate used N95 respirators using the company’s Sterizone VP4 sterilizer during the coronavirus outbreak. The Sterizone VP4 uses vaporized hydrogen peroxide to sterilize up to 20 of the masks in one cycle, according to the FDA. Stryker’s sterilizer is the fourth that uses vaporized hydrogen […]

Filed Under: Blog, Featured, News Well, Respiratory Tagged With: Advanced Sterilization Products, Battelle, coronavirus, COVID-19, FDA, National Institutes of Health (NIH), Steris Corp., Stryker

Advanced Sterilization wins FDA nod for emergency mask decontamination

April 13, 2020 By Nancy Crotti

Advanced Sterilization Products has won FDA emergency use authorization (EUA) for hospitals to use its Sterrad Sterilization Cycles systems to decontaminate N95 or N95-equivalent respirators for reuse by healthcare workers treating COVID-19 patients. The EUA will enable decontamination of approximately 4 million respirators per day, according to the FDA. It covers the Sterrad 100S cycle, Sterrad […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Hospital Care, Regulatory/Compliance, Respiratory Tagged With: Advanced Sterilization Products, coronavirus, COVID-19, FDA, Testing and Sterilization

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