Prehospital Use of the Critical Care Decontamination System (CCDS) for N95 Respirators Download as PDF PURPOSE: Use of personal protective equipment (PPE) during the COVID-19 pandemic response is at unprecedented levels. In order to slow usage rates and maintain supply chain stability, the U.S. Food and Drug Administration (FDA) has authorized an Emergency Use Authorization (EUA) for the emergency use of an N95 respirator decontamination system. This is one of several EUAs for decontamination technologies granted by the FDA. This document is intended to provide basic information on the Critical Care Decontamination System (CCDS) for pre-hospital use. MANUFACTURER SYSTEM REQUIREMENTS Method: vapor phase hydrogen-peroxide (VPHP) For use in decontaminating N95 or N95-equivalent respirators Respirators can undergo up to 20 decontamination cycles with the CCDS. Due to incompatibility, the CCDS is not authorized for use with respirators containing cellulose-based materials. All compatible N95 respirators provided to CCDS must be free of any visual soiling or contamination (e.g., blood, bodily fluids, makeup). If N95 respirators are soiled or damaged, they will be disposed of and not returned after decontamination. Healthcare personnel should follow the instructions provided by the CCDS program in Instructions for Healthcare Personnel There is not a cost for use…

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