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 […]
Sterilucent Inc.
FDA restricts re-use of certain respirators for COVID-19
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 […]
FDA issues EUA for Sterilucent N95 hydrogen peroxide sterilization
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 […]
Medical device sterilization firm Sterilucent plans new investment round
Sterilucent Inc., a medical device sterilization company focused on serving the military, is looking to raise $2 million in sales of debt securities, according to a federal regulatory filing.
This looks to be the company’s first large private investment round.
