STERIS Decontamination Solutions for compatible N95 Respirators for Healthcare Facilities outside the U.S.
The SARS-CoV-2 Coronavirus pandemic has created unprecedented challenges for patient care and staff safety. To provide an immediate, short term solution to the shortage of Personal Protective Equipment (PPE), STERIS is pleased to announce the following:
The U.S. FDA has granted STERIS an Emergency Use Authorization (EUA). This allows STERIS to temporarily provide a distinct option to effectively decontaminate compatible N95 Respirators up to 10-times using the Non-Lumen Cycle of the V-PRO® Low Temperature Sterilization System (Models: 1 Plus, maX, maX 2, 60 and s2).
Although the FFP2 respirator testing was not part of the U.S. FDA Emergency Use Authorization (EUA) submission or approval, respirators equivalent in design and construction to FFP2 respirators were tested under the same conditions using the Non-Lumen Cycle of the V-PRO® Low Temperature Sterilization System (Models: 1 Plus, maX,maX 2, 60 and s2) up to 10 times and with results consistent with those for the N95 Respirators. This testing was done with the support of 3M to support use in regions outside of the United States.