CPAC Equipment system meets FDA guideline for dry heat decontamination of N95 masks

Dec. 8, 2020

The RH-N95 Mask Decontamination System manufactured by CPAC Equipment, Inc. meets all of the U.S. Food and Drug Administration (FDA) guidance requirements for reprocessing FDA acceptable N95 respirator masks, reported the company.

The FDA recently issued an Enforcement Policy Guideline allowing dry heat to be used in decontaminating N95 masks. Through the convenience of on-site reprocessing using the RH-N95 tabletop decontamination system, healthcare providers can decontaminate their N95 respirators for single-user reuse up to 20 cycles while maintaining mask performance and integrity. CPAC uses their FDA-Cleared RapidHeat sterilization technology in their manufacture of the RH-N95 Mask Decontamination System.

The principal safety advantage in using RapidHeat technology to decontaminate N95 masks is that there are no chemicals or steam used, which would require complete aeration or drying before mask reuse. The RH-N95 t comes with a dual USB flash drive allowing the practitioner to switch back and forth from a mask decontamination system to a sterilizer that can process wrapped or unwrapped instruments in minutes. The software download takes less than five minutes. For example, a practitioner could start the day with a mask decontamination cycle and then using the conversion flash drive switch to the higher-temperature RapidHeat sterilization of instruments for the rest of the day.

CPAC Equipment, Inc. has the release.