Performer: Applied Research Associates, Inc.
Project leader: Brian Heimbuch
Initial contract value: $930,197
Contract modification: $1,030,637 (option exercised in August 2015, for a total contract value of $1,960,834)
Project dates: September 2014 - September 2019
Respiratory protective devices (RPDs) that protect first responders and workers from infectious disease outbreaks may be in short supply during public health emergency situations.
Some RPDs, including filtering facepiece respirators (FFRs), are currently designated as single-use devices. Others, including half-mask elastomeric respirators (HMERs) and powered air purifying respirators (PAPRs, pictured), are reusable and can be shared among multiple people.
In emergency response circumstances such as an influenza pandemic, decontamination and reuse of FFRs and more efficient decontamination processes for other types of respirators may be necessary to maintain adequate supplies.
To investigate FFR decontamination and reuse in emergency situations, and optimize cleaning and disinfection of certain reusable respirators, FDA has awarded a 22-month contract to Applied Research Associates, Inc. (ARA). This work will provide solutions to mitigate shortages of RPDs during public health emergencies.
During this project ARA will examine decontamination of 15 FFR models and the 3 most common HMER and PAPR models used in U.S. hospitals. Testing will use ultraviolet germicidal irradiation (UVGI) as a decontamination method; this method is simple, rapidly scalable, and commercially available.
In addition to testing durability of the respirators, ARA will develop a strategy for implementing UVGI decontamination in healthcare settings by working with U.S. hospitals.
FDA exercised a contract option in August 2015, expanding this contract to include:
- Evaluating washer-disinfectors for cleaning and disinfecting the RPDs being studied
- Conducting further evaluations following UVGI treatments
- Developing an American Society for Testing and Materials (ASTM) consensus standard for N95 FFR decontamination
- Performing a feasibility evaluation for implementing N95 FFR decontamination and reuse in hospitals
In 2018, ARA developed the first consensus standard for UV surface decontamination.
The project will test solutions to extend the life of FFRs and more efficiently clean HMERs and PAPRs in a hospital setting. ARA will:
- Investigate the durability of FFRs following multiple decontamination cycles
- Optimize UVGI cleaning and disinfecting methods for HMERs and PAPRs, and test durability following 100 decontamination cycles
- Explore risk elements and concerns related to implementation of RPD decontamination strategies
By exploring the potential for decontaminating a range of respiratory protection devices, this project will support sustainable protection of our nation’s health workers and first responders, an important part of public health emergency preparedness.
View the final project report.
This project was funded through the MCMi Regulatory Science Extramural Research program.
- Ultraviolet Germicidal Irradiation of Influenza-Contaminated N95 Filtering Facepiece Respirators - ASM Microbe Meeting - Boston, MA, June 16-20, 2016
- Assessment of Half-Mask Elastomeric Respirator and Powered Air-Purifying Respirator Reprocessing for an Influenza Pandemic - ASM Microbe Meeting - Boston, MA, June 16-20, 2016
- Lawrence C, Harnish DA, Sandoval-Powers M, et al. Assessment of half-mask elastomeric respirator and powered air-purifying respirator reprocessing for an influenza pandemic. Am J Infect Control. 2017 Aug 22. doi: 10.1016/j.ajic.2017.06.034
- Mills D, Harnish DA, Lawrence C, Sandoval-Powers M, Heimbuch BK, et al. Ultraviolet germicidal irradiation of influenza-contaminated N95 filtering facepiece respirators. Am J Infect Control. Am J Infect Control. 2018 Jul. pii: S0196-6553(18)30140-8. doi: 10.1016/j.ajic.2018.02.018.