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This page applies to healthcare facilities outside the United States.

STERIS Decontamination Solutions for compatible N95 Respirators for Healthcare Facilities Outside the United States

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 US 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.

RESOURCES for Healthcare Facilities Outside the United States

STERIS V-PRO Decontamination Systems EUA

Instructions for Healthcare Facilities

Instructions for Healthcare Personnel

Compatible N95 V-PRO

Decontamination Fact Sheet

 

Customer Letter

Q & A

V-PRO Decontamination Protocol

Q & A

STERIS Infection Prevention Solutions

Operations Update

Media Fact Sheet

Contact STERIS – Non-US Healthcare Facilities

If you have a question regarding the appropriate use of a STERIS reprocessing product, please contact STERIS.