Background

The Centers for Disease Control and Prevention (CDC) released guidance on the decontamination and reuse of N95 FFRs as a crisis capacity strategy on March 31, 2020. Although there are currently no manufacturer authorized methods for FFRs decontamination prior to reuse, Battelle CCDS Critical Care Decontamination System^TM, a vapor phase hydrogen peroxide (H₂O₂) (VPHP) system, received emergency use authorization (EUA) (PDF) from the Food and Drug Administration (FDA) on March 29, 2020 for decontamination of N95 respirators. Facilities should continue to monitor the FDA website to determine if other EUAs have been issued.

The National Institute of Occupational Safety and Health (NIOSH) and other researchers have investigated the impact of various decontamination methods on filtration efficiency, facepiece fit, and the ability to reduce viable virus or bacteria on the respirator surface. VPHP, in addition to ultraviolet germicidal irradiation (UVGI), and moist heat, showed the most promise as potential methods to decontaminate FFRs.

Battelle continues to follow all FDA guidance regarding decontaminating masks and does not accept non-NIOSH-approved FFRs nor masks with exhalation valves. A list of approved masks for decontamination can be found in the following Guide for Identifying FDA EUA Authorized N95 Respirators for Battelle CCDS™ Processing – updated June 10, 2020 (PDF).

The State of California is working with Battelle Memorial Institute to deploy their FDA emergency use authorized decontamination systems in California. Hospitals regularly use VPHP for decontamination to inactivate highly resistant pathogens, including bacterial spores and viruses for terminal decontamination of hospital rooms, biosafety cabinets, and medical equipment and materials that are intolerant to heat or have diffusion-restricted space. A number of studies (Battelle 2016, 2020; Bergman 2010, Viscusi 2009) have demonstrated that certain N95 respirators can be safely decontaminated with proper use of VPHP.

Sign-up Process

Facilities are encouraged to participate in the N95 decontamination program. Please note, in order to use the Battelle CCDS Critical Care Decontamination System^TM, facilities must have a signed service agreement with Battelle. Once Battelle has received a signed agreement, Battelle will issue a three-digit site code ID to the medical facility.

For information on the sign-up process, refer to the Battelle CCDS Process flowchart (PDF).

Below is guidance for how to collect, properly package, and ship the used N95 FFRs to Battelle for decontamination. Even if your facility does not plan to reuse N95 respirators, we would recommend you collect used N95 respirators so that the State can decontaminate the respirators and allocate them to areas who have a need for such a resource.

On-Site Collection

1.     Your facility should create a N95 respirator collection station at the point of generation (i.e. hospital floor/unit).

• Any N95 or N95-equivalent respirator that does not contain cellulose-based materials is compatible with the Battelle Decontamination System.
• All compatible N95 respirators must be free of any visual soiling or contamination (e.g. blood, bodily fluids, makeup).
• Compatible N95 respirators that are visually soiled or damaged should not be collected for decontamination and will be disposed of and not returned after decontamination.

2.     Each station should have a bag provided by the facility to collect compatible N95 respirators.

• Bags are for compatible N95 respirators only. Do not put other personal protective equipment (such as gloves), paper towels, or waste in the collection bag. 

3.   With a permanent marker, each compatible N95 respirator should be labeled with a three-digit site code and a 2-digit location identifier (as shown below). The hospital three-digit site code can be found on the Battelle Hospital List. For all other facility types, the three-digit code is issued by Battelle after they receive a signed agreement from the facility (contact Battelle if you have not yet received your three-digit site code). Your organization may designate the location identifier to correspond to a specific location/floor/unit within your site.

            _______  _______  _______   --   _________  ___________
                                    Site Code ID                        Site Location ID
                  (Assigned by Battelle POC)        (Assigned by Facility)                                

Preparation for Shipment or Pick-up:

1.    Bags containing the contaminated compatible N95 respirators to be decontaminated ("primary collection bag") should be closed.

2.    Place the primary collection bag into another bag ("secondary collection bag") (provided by the hospital), which is then closed.

3.    Decontaminate the secondary collection bag with alcohol or other suitable decontaminant.

4.    Place the decontaminated bags into a rigid, closed box (supplied by the hospital) clearly labeled with a biohazard symbol, and tape the box securely shut.

5.    Label the outside of the box with the 3-digit site code and 2-digit location identifier.

Facility Shipping Information

Cardinal Health will provide weekly pick-up and return services to hospitals and hospital-associated clinics located within a 2-hour driving radius of a Battelle site free of charge. Hospitals and hospital-associated clinics can sign up for services with Cardinal Health when signing their service agreement with Battelle, or send an inquiry to gogreen@sustainabletechnologies.com if they have already signed their agreement but did not coordinate with Cardinal Health.

For all other facility types or hospitals and hospital-associated clinics not within a 2-hour driving radius of a Battelle site, FedEx will provide courier services free of charge. Battelle shipments should be sent to your local Battelle site:

Reuse Information
Following decontamination, each hospital will be provided the decontaminated N95 respirators they submitted. Each hospital should inspect each returned decontaminated N95 respirator for visible damage or soiling. If visually damaged or soiled, decontaminated N95 respirators should be discarded and not reused. 

Additionally, staff should be reminded of the following:

• Clean hands with soap and water or an alcohol-based hand sanitizer before and after touching or adjusting the N95 respirator.
• Avoid touching the inside of the N95 respirator.
• Use a pair of clean (non-sterile) gloves when donning and performing a user seal check.
• Visually inspect the N95 respirator to determine if its integrity has been compromised.
• Check that components such as the straps, nose bridge, and nose foam material did not degrade, which can affect the quality of the fit, and seal.
• If the integrity of any part of the N95 respirator is compromised, or if a successful user seal check cannot be performed, discard the N95 respirator.

Battelle Memorial Institute has developed a fact sheet (PDF) for health care providers who use the decontaminated N95 respirators.

If you have any questions about infection prevention and control of COVID-19, please contact the CDPH Healthcare-Associated Infections Program via email at HAIProgram@cdph.ca.gov or novelvirus@cdph.ca.gov.

Sincerely,

Original signed by Heidi W. Steinecker

Heidi W. Steinecker
Deputy Director

Resources

• CDC Decontamination and Reuse of Filtering Facepiece Respirators
• FDA Emergency Authorization of Battelle Decontamination System (PDF)
• FDA Emergency Use Authorization website
• How to Perform a User Seal Check with an N95 Respirator video
• Battelle Decontamination System Fact Sheet for Healthcare Personnel (PDF)
• Battelle Hospital List
• Battelle CCDS Process (PDF)
• Battelle Service Agreement
• Battelle CCDS Critical Care Decontamination System Safety Response (PDF)
• Battelle CCDS Critical Care Decontamination System Frequently Asked Questions (PDF)
• Guide for Identifying FDA EUA Authorized N95 Respirators for Battelle CCDS™ Processing – updated June 10, 2020 (PDF)
• Battelle Response to Cal/OSHA Guidance on Mask Labeling (PDF)