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  5. Intramural Challenge Grant Project: Testing and modelling decontamination, microbial exposure, and performance with a repertoire of N95 respirators and surgical masks  
  1. Innovative Technologies

Intramural Challenge Grant Project: Testing and modelling decontamination, microbial exposure, and performance with a repertoire of N95 respirators and surgical masks  

An ORES Advanced Manufacturing Funded Project

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Personal Protective Equipment (PPE) Calculator Output

Principal Investigator: Enusha Karunasena, PhD 

FDA Center: Center for Devices and Radiological Health (CDRH/OSEL/Division of Biology, Chemistry, and Materials Science)

Project Dates:  February 2023 - March 2024 

Regulatory Science Challenge 

Personal protective equipment (PPE) is critical to minimizing exposure to hazardous conditions and limiting the spread of infectious disease. The global scale of the COVID-19 pandemic led to a significant and rapid increase in the demand for PPE. Demand for PPE outside of healthcare settings remains higher than traditional levels of use for both medical and occupational purposes. A tenuous and long supply chain that included shortages in PPE materials, led to difficulties in procuring appropriate PPE, and identified gaps in regulatory assessments for public use.

The importance of PPE availability on a national scale, including surgical N95 respirators and masks, from secure supply chains was appreciably demonstrated during the pandemic. To promote coordination on PPE availability across the U.S. government, the U.S. Department of Health and Human Services is supporting improvements in inter- and intra- agency alignment, including developing tools and research to advance the regulatory review of PPE. The “PPE Risk Calculator “is a computational tool developed using data from current research and previously developed PPE test standards which can be applied to regulatory assessments.   

Project Goal

The goal for this project is to assess microbial penetration and respirator/mask efficiency in close collaboration with the Centers for Disease Control and Prevention (CDC)/National Institute for Occupational Safety and Health (NIOSH)/National Personal Protective Technology Laboratory (NPPTL) (research and regulatory body for PPE testing at CDC). The outcome of this work will support FDA efforts on product assessment, assist with regulatory priorities important to Medical Countermeasures (MCMs), and subsequently provide the ‘PPE Risk Calculator’ as a free publicly accessible tool to allow product developers and users to assess PPE materials.    

Project Aims

  • Examine respirator and surgical mask porosity and material tensile strength to determine material characteristics of these materials. 
  • Introduce three methods for decontamination—two methods commonly proposed in Emergency Use Authorizations (EUAs) for PPE and one novel method.
  • Examine PPE using appropriate standards and novel protocols to measure fitness, performance, and microbial penetration following decontamination and stress-train testing.

Project Outcomes

  • Creating a refined model of PPE efficacy that includes air permeability and material density.
  • Characterizing materials through stress testing, scanning electron microscopy, bacterial filtration efficiency testing and cross-sectional measurements.
  • Planning additional testing with collaborators.
  • Exploring further collaborations to extend computational models.

Contact the Office of Regulatory and Emerging Science: ORES@fda.hhs.gov

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