Critical Care Decontamination System (CCDS) for N95 Respirators

Prehospital Use of the Critical Care Decontamination System (CCDS) for
N95 Respirators

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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 of the system
  • First responders will have access to the system(s) in their region
  • Healthcare facilities and first responder agencies need to request a Site Location Code from the CCDS program.
  • The Site Location Code must be placed by the healthcare facility or first responder agency on each of their N-95 respirators.
  • This is not a one-for-one exchange program –if the N95 cannot be disinfected, it will not be replaced. Decontaminated N95s will be returned to the healthcare facility with the designated facility code and chain-of-custody forms.

LOCATIONS
The CCDS location for your area can be found by contacting your state or local EMS agency/public health agency / Emergency Operations Center (EOC).

NOTE: If there is not one in your area, a request can be submitted through your local EOC to
utilize others.

Further information can be found on the CCDS Site

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coronavirus, Coronavirus Aid Relief and Economic Security Act (CARES Act), COVID-19, Families First Coronavirus Response Act (FFCRA)