Battelle CCDS Critical Care Decontamination System for PPE Decontamination

DELIVERING CRITICAL EQUIPMENT TO HOSPITAL SYSTEMS

The Battelle CCDS Critical Care Decontamination System™ addresses the current shortage of critical Personal Protective Equipment (PPE) across the United States. Battelle CCDS™ is designed to work on N95 respirators for the removal of the novel coronavirus (SARS-CoV-2).

Image of N95 Mask Decontamination Solution at Battelle

How does it work?

Battelle CCDS™ can decontaminate thousands of N95 respirators using concentrated, vapor phase hydrogen peroxide. The respirators are exposed at the validated concentration level to decontaminate biological contaminants, including the SARS-CoV-2. Battelle CCDS™ can decontaminate the same respirator multiple times without degrading N95 respirator performance.

Based on Proven Science

Battelle CCDS™ draws on decades of research and is grounded on an FDA study Battelle completed following a 2016 contagion. NIOSH has tested and verified the CCDS methodology through multiple decontamination cycles per respirator.

How do healthcare systems use Battelle CCDS™?

Healthcare systems will collect worn N95 respirators each day in accordance with an approved procedure, and the PPE will be labeled with a barcoded serial number for tracking the chain-of-custody throughout the decontamination process. This procedure ensures that the hospital system receives its own respirators back.

Questions?

You'll find many of the most common questions on the
CCDS FAQ Page

And if you still have questions, feel free to
CONTACT CCDS CUSTOMER SERVICE

CCDS™ Information & Instructions

Check out the documents below for information on how your healthcare system or personnel can use the Battelle CCDS Critical Care Decontamination System™

Instructions for Healthcare Facilities

Click on the image of the document to the left for information about the preparation and collection of compatible N95 respirators for decontamination by Battelle using the Battelle CCDS Critical Care Decontamination System™.

Instructions for Healthcare Personnel

Click on the image of the document to the left for information about the preparation of compatible N95 respirators for decontamination by Battelle using the Battelle CCDS Critical Care Decontamination System™

Fact Sheet for Healthcare Personnel

Click on the image of the document to the left to review this fact sheet. The fact sheet informs you of the significant known and potential risks and benefits of the emergency use of decontaminated N95 or N95-equivalent respirators. These respirators have been decontaminated using the Battelle CCDS Critical Care Decontamination System™

Emergency Use Authorization for Battelle CCDS™

Click on the image of the document to the left to review the U.S. Food and Drug Administration's Emergency Use Authorization (EUA) for the use of the Battelle CCDS Critical Care Decontamination System™ in decontaminating compatible N95 or N95-equivalent respirators for reuse by healthcare personnel to prevent exposure to pathogenic biological airborne during the COVID-19 pandemic.

Overview and Reports

Per the Emergency Use Authorization for Battelle CCDS™:
- The Battelle Decontamination System has neither been cleared or approved for the decontamination of compatible N95 respirators for multiple-user reuse by HCP to prevent exposure to SARS-CoV-2 and other pathogenic biological airborne particulates;
- The Battelle Decontamination System has been authorized by FDA under an EUA;
- The Battelle Decontamination System is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices during the COVID-19 outbreak, under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.