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Dear CCDS™ Customer,
We are writing to let you know the Food and Drug Administration (FDA) re-issued an Emergency Use Authorization (EUA) for the Battelle CCDS Critical Care Decontamination System™ dated January 21, 2021. This EUA is in effect immediately.
As a result, Battelle is providing you with the following FDA EUA literature related to the CCDS™ program:
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Instructions
for Healthcare Personnel: Preparation of Compatible N95 Respirators for Decontamination by the Battelle Memorial Institute Using the Battelle Decontamination System for Return to the Same Healthcare Facility (“Instructions for Healthcare Personnel-Closed
System”)
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Instructions for
Healthcare Facilities: Preparation and Collection of Compatible N95 Respirators for Decontamination by the Battelle Memorial Institute Using the Battelle Decontamination System for Return to the Same Healthcare Facility (“Instructions for Healthcare
Facilities-Closed System”); and
As the authorized labeling may change from time to time, please refer to Battelle’s website for the current version of the
EUA and authorized labeling.
The January 21, 2021 EUA changes include:
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CCDS™ is not authorized for use in decontaminating incompatible N95 respirators. N95 respirators containing cellulose-based materials, respirators that have exhalation valves, antimicrobial agents,
and duck-billed design are not compatible with the Battelle CCDS™.
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This system is also not authorized to decontaminate respirators authorized by the non-NIOSH-approved Disposable Filtering Facepiece Respirators Manufactured in China EUA.
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The maximum number of decontamination cycles has been decreased from twenty (20) to four (4) cycles per compatible N95 respirator, and any decontaminated, compatible
N95 respirator that has exceeded 4 decontamination cycles must be discarded.
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All healthcare facilities must ensure that HCP receive the same model of decontaminated compatible N95 respirator for which they have been fit tested. If such model of respirator is unavailable,
then healthcare facilities must provide HCP with fit testing prior to using an alternative model of decontaminated compatible N95 respirator.
Additionally, HCFs are responsible to report any adverse events associated with decontaminated respirators and must report to FDA and Battelle adverse events of which it becomes aware
related to compatible N95 respirators that have undergone decontamination using CCDS™. This includes, but is not limited to, monitoring HCP using the decontaminated, compatible N95 respirators for signs and symptoms of potential infection with SARS-CoV-2 or
other respiratory infection and reporting such infections, and monitoring HCP handling contaminated, compatible N95 respirators. Other examples of reportable events that may be relevant to the authorized product include, but are not limited to: allergic reactions
or eye, mouth, or nose irritation, evidence that a decontaminated, compatible N95 respirator is unable to perform its essential function, events related to residuals or user contact with residuals (if applicable), infection in decontaminated, compatible N95
respirator wearers, or concerns with the process control or malfunctions of the authorized product used to decontaminate the compatible N95 respirators.
If you have any questions about the EUA or labeling amendments, or do not wish to continue participating in the CCDS program, please contact Battelle at
ccdscustomerservice@battelle.org.
We are honored to continue serving you during this critical time.
Sincerely,
The Battelle CCDS™ Team
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