Performer: Battelle Memorial Institute
Project leader: William Richter
Contract value: $435,285
Project dates: August 2014 - July 2016
While everyone else exits, they rush in. Protecting the health and safety of first responders and health care workers is an essential part of planning for public health emergencies. Personal protective equipment (PPE) items such as respirators, protective clothing, and eye protection are standard supplies.
One of many preparedness and response challenges is ensuring adequate supplies of this protective equipment during an emergency, when responders may need to don additional protective gear or replace used equipment more rapidly as they treat an increased number of patients.
One type of respirator routinely used to protect workers from biological hazards is known as an N95 filtering facepiece respirator (FFR, pictured). These respirators protect the wearer by filtering contaminants from the air. Currently, these respirators must be discarded after one use, but in emergency response circumstances such as an emerging infectious disease (pandemic influenza, for example) or intentional release of a biological threat agent, reuse of these respirators may be necessary to maintain adequate supplies.
To investigate the potential for reusing respirators in emergency situations, FDA awarded an 18-month contract to Battelle Memorial Institute. Battelle conducted tests to evaluate the feasibility of using a commercially available hydrogen peroxide vapor technology to decontaminate N95 respirators.
Based on recommendations from an interagency respirator equipment working group known as Project BREATHE, this pilot-scale testing evaluated respirators during and after as many as 50 decontamination cycles. The testing examined the ability of hydrogen peroxide vapor to decontaminate respirators, and it determined whether the respirators maintained their structure and function after multiple decontamination cycles.
The project addressed three areas related to decontamination of N95 respirators:
- Optimizing decontamination parameters
- Evaluating the impact of repeated decontamination cycles on functional performance of the respirators
- Assessing efficacy of repeated decontamination for up to 50 cycles
This project demonstrated the feasibility of FFR decontamination and reuse, and established testing methods for future investigation of additional decontamination technologies—important steps in ensuring continued and sustainable protection of our nation’s health workers, responders and patients during public health emergencies.
This project offered a comprehensive pilot-scale study that evaluated the efficacy of hydrogen peroxide vapor (HPV) for decontamination of N95 respirators against a single organism using the Bioquell Clarus C HPV decontamination system. The study measured filter efficiency, fit, and differential pressure after exposure to up to 50 decontamination cycles. This study:
- Established the parameters of the HPV decontamination cycle to ensure a 6-log reduction in organism viability
- Evaluated the mechanical integrity and performance of the N95 FFR following exposure to up to 50 cycles of HPV decontamination
- Confirmed that decontamination was still achieved even after 50 repeated cycles of biological aerosol exposure/HPV decontamination
The project successfully demonstrated the feasibility of a test approach to evaluate FFR reuse and establish testing methods for future investigation of additional decontamination technologies. This information is being used to support development of decontamination systems for the COVID-19 response.
For example, on March 28, 2020, FDA issued an Emergency Use Authorization (EUA) for the Battelle CCDS Critical Care Decontamination System for use in decontaminating compatible N95 respirators during the COVID-19 public health emergency. This EUA is an important step forward in helping to reduce shortages in critical N95 respirators by authorizing these important devices, when decontaminated, to be reused by medical professionals on the front lines of the COVID-19 pandemic.
- Final Report for the Bioquell Hydrogen Peroxide Vapor (HPV) Decontamination for Reuse of N95 Respirators (PDF, 1.14 MB) [ARCHIVED], provided by Battelle
This project was funded through the MCMi Regulatory Science Extramural Research program.
- Masks and N95 Respirators
- Coronavirus Disease 2019 (COVID-19)
- About MCMi
- CDC NIOSH: More information on respirators
- CDC NIOSH: Respiratory protection research