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  1. MCM Regulatory Science

Optimizing Respirator Decontamination to Ensure Supplies for Emergency Preparedness

Image
A CDC microbiologist conducts an influenza experiment in a biological safety cabinet. She is wearing a powered air purifying respirator (PAPR), which filters the air she breathes. (CDC/Greg Knobloch)
Caption
A CDC microbiologist conducts an influenza experiment in a biological safety cabinet. She is wearing a powered air purifying respirator (PAPR), which filters the air she breathes. (CDC/Greg Knobloch)

Background | Project Description | Project Outcomes | Updates | Publications  

Performer: Applied Research Associates, Inc. disclaimer icon

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

Background

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.

Project Description

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.

Updates

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.

Project Outcomes

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. 

This project was funded through the MCMi Regulatory Science Extramural Research program.

Publications

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