Battelle CCDS™ FAQ
Answers to frequently asked questions and up-to-date information about the Battelle CCDS Critical Care Decontamination System™ that's headed your way.
Welcome to the Battelle CCDS Critical Care Decontamination System™ FAQ. This FAQ provides the most current information about the technology, who can use it, how to sign up, and more.
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 decontamination of the novel coronavirus (SARS-CoV-2).
We have deployed the Battelle CCDS™ to multiple sites across the country and are actively building more systems to increase coverage.
We post updates on this page as site status changes.
Battelle’s EUA allows us to provide N95 decontamination services to healthcare personnel (HCP). The EUA defines healthcare personnel as follows:
HCP refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These HCP include, but are not limited to emergency medical service personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, dentists and dental hygienists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel).”
Non-medical personnel who are participating in an emergency response to COVID-19 may qualify as HCP under the EUA.
Battelle was awarded a contract by the Defense Logistics Agency (DLA) on behalf of the U.S Department of Health and Human Services (HHS) and the Federal Emergency Management Agency (FEMA) to provide N95 decontamination at no charge to HCP as defined in the EUA.
Detailed information on the Battelle CCDS™ collection process and how to prep N95s can be found in the following documentation:
Healthcare providers can begin to stockpile used N95s immediately. Our operation sites will accept shipments once enrollment is finalized, so getting equipment ready to send now will speed the process.
Marking each individual N95 and packing per the instructions is vitally important to comply with Battelle’s FDA EUA and protect the safety of our staff.
Contact Battelle to enroll and obtain the 3-digit site code(s) needed to label your N95 respirators. Without these 3-digit site codes we will not be able to return your processed N95s to you.
Our FDA EUA is for N95 respirators. It covers any N95s (healthcare and industrial) that are not cellulose based, and that do not contain exhalation valves. Respirators must be certified by NIOSH as an N95. If NIOSH hasn’t certified it, Battelle does not recommend decontamination via our process.
To help assist you in determining if your N95 respirator contains cellulose, we have created a N95 Guidance document for your reference.
Battelle’s EUA does not cover decontamination of PAPR hoods, face shields or other types of PPE and we are not processing these at this time. We are conducting studies to determine other items that would be suitable for decontamination with this process, and what data would be required to achieve FDA authorization for use.
End-to-end logistics support is available to enrolled organizations at no cost through FedEx.
You may choose to use your current or another preferred shipping company/courier of choice. In this instance, you will be responsible for the cost of shipping your N95 respirators to and from the Battelle CCDS site.
For the delivery of N95s to Battelle, healthcare providers must use a carrier that can transport biohazardous materials. For the return of decontaminated N95s, any carrier may be used. The materials are no longer biohazardous.
Depending on your choice of transportation option, you will coordinate drop off and pick up of N95 respirators with your logistics provider or the appropriate Battelle site POC. We will provide contact information and directions for mask transfer to your specific site.
Battelle’s goal is to have decontaminated N95 respirators ready for shipment back to the originating healthcare provider within 72 hours of receipt. Processing and turnaround time will depend on the volume of incoming respirators.
Once the shipment arrives at Battelle, we will log and barcode the received respirators received according to your assigned site code labeled on each mask. We track all the production lot information including healthcare provider and number of masks processed.
We visually inspect all N95s for damage and soiling from blood, bodily fluids, or makeup. Any soiled or damaged masks will be discarded appropriately and not returned to the healthcare provider.
After decontamination, the masks are marked to keep track of the number of times they have been decontaminated. They are placed into a clean box that is labeled with the healthcare provider code so it can be returned to the originating healthcare provider. About 120 – 150 decontaminated N95s can fit into a box.
We generate a shipment form that is included with every return shipment, which includes the number of N95s successfully decontaminated.
The point of contact you provide during enrollment will be notified that masks have been decontaminated and are ready for transport back to you via your chosen transport method.
Battelle is accepting N95s seven days a week at most active sites. At full capacity, the Battelle CCDS™ system can be run 24/7.
Battelle CCDS™ can decontaminate thousands of N95 respirators using concentrated, Vapor Phase Hydrogen Peroxide (VPHP). The respirators are exposed at the validated concentration level to decontaminate biological contaminants, including the SARS-CoV-2.
Battelle CCDS™ can decontaminate the same N95 respirator multiple times without degrading N95 respirator performance.
To validate VPHP to decontaminate SARS-CoV-2, Battelle spiked N95 respirator masks and exposed these to our VPHP process. The results showed that VPHP renders SARS-CoV-2 non-infectious for filtering facial respirators (FFRs) and other healthcare-related PPE. In fact, zero viable SARS-CoV-2 was recovered in our test samples post VPHP decontamination. For routine decontamination runs, Battelle uses a standard chemical indicator to confirm that the appropriate levels of VPHP were achieved during the process to achieve decontamination.
Battelle has demonstrated the VPHP process penetrates all filter layers using two methods that simulate real-world contamination scenarios: a large droplet inoculation to simulate a splash contamination, and an aerosol inoculation to simulate contamination by airborne route. Using the industry-standard biological indicator organism for hydrogen peroxide-based decontamination (Geobacillus stearothermophilus, or G. stearo), Battelle achieved a 6-log inactivation of the organism. FDA recognizes and requires this 6-log spore inactivation threshold to prove sterilization of medical devices, as it ensures decontamination of both viruses and other nosocomial pathogens.
We confirm that the hydrogen peroxide is removed from N95s prior to re-use using handheld monitors. Battelle tests masks from each run to ensure they are below the permissible exposure limit (PEL) of 1 ppm.
Battelle CCDS™ can decontaminate the same N95 respirator multiple times without degrading performance. The CDC shared the test results for the Battelle CCDS VPHP process on N95s that confirmed performance and fit are maintained.
Contact Battelle to enroll in our decontamination program, receive your site codes for labeling, and determine your preferred transportation method.
Check out the documents below for information on how your healthcare system or personnel can use the Battelle CCDS Critical Care Decontamination System™
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™.
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™
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™
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.
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.