Testing and modelling decontamination, microbial exposure, and performance with a Repertoire of N95 respirators and surgical masks

Principle Investigator: Enusha Karunasena, PhD
FDA Center: Center for Devices and Radiological Health (OSEL/DBCMS)
Project Start Date: February 2023
Project Description: 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 Goals: The goal for this project is to assess microbial penetration and respirator/mask efficiency in close collaboration with CDC/NIOSH/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 MCMi, and subsequently provide the ‘PPE Risk Calculator’ as a free publicly accessible tool to allow product developers and users to assess PPE materials.
Project Outcomes: Submitting publications for review
Contact: ORES@fda.hhs.gov