Overview of the University of Louisville N95 Decontamination Program
**At this time, the UofL N95 Decontamination Program is not accepting new organization registrations or volunteers/participants**
The Battelle Critical Care Decontamination System is now available in Kentucky and is also offering respirator decontamination. In light of the Battelle Critical Care Decontamination System’s availability, as well as the University of Louisville’s phased transition back to campus, we have decided to commence close out of the N95 Decontamination Project, with a planned end date of July 31, 2020. We will continue operations until that time to allow participating organizations time to transition to Battelle.
The SARS-CoV-2 pandemic has resulted in a nationwide shortage of N95 respirators available for the protection of healthcare providers, first responders, and for community organizations (nursing homes, long-term care and public health). In order to aid in the alleviation of the N95 respirator shortage and to conserve this critical resource, a process using vaporized hydrogen peroxide (VHP) to decontaminate/sterilize used (potentially contaminated) respirators is being initiated at the University of Louisville (UofL) for area healthcare facilities and first responders. This VHP decontamination process was originally developed at Battelle after the 2014 Ebola crisis as a way to conserve PPE in the event of a pandemic-related shortage. This decontamination process is currently being used at other institutions, including Duke University in North Carolina. The UofL N95 Decontamination Program is modeled largely on the Batelle report to the Food and Drug Administration (FDA) and the Duke University process. In a March 29, 2020 letter, the Chief Scientist of the FDA issued an Emergency Use Authorization (EUA) for the emergency use of the Battelle CCDS Critical Care Decontamination System™ for use in decontaminating compatible N95 respirators for reuse by healthcare personnel, which is similar to the process that will be used at UofL. This decontamination process is also in accordance with the Center for Disease Control’s (CDC) National Institute for Occupational Safety and Health (NIOSH) optimization of Personal Protective Equipment (PPE) supply. The manufacturer of our VHP equipment has filed for an FDA EUA. Once approved, we will follow the protocol approved in their EUA for the decontamination of used N95s. The VHP decontamination process involves many safeguards to protect volunteers/participants who handle potentially contaminated respirators prior to decontamination as well as those healthcare professionals, first responders and other community organizations who will be using decontaminated respirators following the VHP decontamination process.
This decontamination process has been validated for up to 20 decontamination cycles of the same respirator, both for sterility and post decontamination integrity of the respirators (structural and filtering). Decontamination of the respirators will be confirmed utilizing biological indicators. Quality Assurance (QA) checks will be performed on all decontaminated N95s prior to redistribution. This will include checking respirators to assure that hydrogen peroxide levels of the mask are <0.1 ppm prior to packaging for redistribution, checking for obvious signs of deformities, makeup, staining, or other problems which would prevent reuse. Decontaminated respirators will be marked with a hashmark on the elastic portion of the respirator to track how many times an individual respirator has been through the decontamination process, and they will be discarded following 20 decontamination cycles.
Note: Due to incompatibility, the VHP Decontamination Process is not authorized for use with respirators containing cellulose-based materials.
The UofL N95 Decontamination Program will be performed on the UofL Health Sciences Center (HSC) campus. UofL’s School of Medicine Research Resources Facilities (RRF) and the Office of Research Services (ORS) is providing the VHP generator, facilities, and equipment to decontaminate large numbers of respirators daily (~7,000/day). The Office of the Executive Vice President for Research & Innovation (EVPRI) is facilitating this effort with coordination from the Department of Environmental Health & Safety (DEHS), RRF and ORS.
The UofL N95 Decon Program will collect used (potentially contaminated) N95s from participating organizations and return the same, now decontaminated respirators back to the organizations.
For organizations in the Louisville Metro or Southern Indiana area UofL will provide participating organizations with site specific, labelled dedicated containers, instructions, and signage for you to establish used N95 collection points within your organization. UofL will pick up the containers of used (potentially contaminated) N95s for decontamination on the UofL HSC campus. In a separate vehicle, decontaminated N95s will be returned in clean, packaged containers following QA check and batched according to the type and size of N95. The expected turnaround time from collection of used N95s to return of decontaminated N95s is expected to be approximately 48hrs until UofL reaches the daily capacity of ~7,000 N95s/day. For organizations outside of the Louisville Metro or Southern Indiana area, UofL will decontaminate respirators, but will ask the organization to provide their own collection containers with lids and transportation (or shipping) of the containers to and from the decontamination facility. Shipping instructions will be provided for organizations choosing this method. This community service is being provided by UofL at no cost to participating organizations.
Local participating organizations will be asked to provide UofL with a pickup location for used N95s and a delivery location for decontaminated N95s. We also ask that you surface disinfect all SIX sides of used N95 collection containers with an FDA approved disinfectant with efficacy against SARS-CoV-2 virus prior to placing them in the designated pickup location. To decrease the costs of this program, we request that any containers we provide to you that contain decontaminated respirators be surface decontaminated and returned to us when we are collecting used N95s. These containers will be undergo VHP decontamination prior to reuse.
If you are a Healthcare, First Responder or Community Organization and would like to participate in this program, please complete the form for Healthcare, First Responder and Community Organizations (i.e.nursing homes), and we will contact you to finalize arrangements to provide you with the necessary materials.
If you are a UofL employee or PostDoctoral scholar and would like to volunteer to participate in the decontamination program, please complete the Volunteer/Participant Application and Questionnaire, and we will contact you once your application has been reviewed.
For more information or questions, please contact Tegan Tulloch, (502) 852-7307.