The FDA has issued an Emergency Use Authorization to STERIS for N95 or equivalent respirator decontamination
STERIS has announced that the US FDA has issued an Emergency Use Authorization (EUA) for respirator decontamination. The EUA enables healthcare providers to decontaminate N95 Respirators on-site by utilising certain STERIS V-PRO Low Temperature Sterilisation Systems.
The EUA allows STERIS to temporarily provide a solution for decontaminating compatible N95 or N95-equivalent respirators using the 28-minute Non-Lumen Cycle available on most V-PRO models.
STERIS recommends decontaminating masks after each use, up to a maximum of ten times. Ten masks can be decontaminated per cycle.
"Healthcare providers are on the front lines of this pandemic and are in desperate need of personal protective equipment," said Walt Rosebrough, President and CEO of STERIS. "We are pleased to be able to offer a partial solution for healthcare providers during this crisis, and hope that this temporary authorisation will provide some relief to them"
"This would not have been possible without around the clock work from STERIS's technical people and testing support from 3M, and we deeply appreciate their involvement," Rosebrough added. "In addition, we appreciate the diligence, responsiveness and suggestions from the FDA reviewers. We are working on additional potential solutions and look forward to continuing to work with the Agency."