A Retrospective Analysis of the Technological Characteristics of Pediatric Facemasks Marketed within U.S.

Ali Hasani, Bryan Ibarra, Magdalene Fogarasi, Kirstie Snodderly, Dana Rottach, Daniel Porter, SUVAJYOTI GUHA, Center for Devices and Radiological Health, US FDA

     Abstract Number: 414
     Working Group: Aerosol Science of Infectious Diseases: Lessons and Open Questions on Models, Transmission and Mitigation

Abstract
Pediatric facemasks, like N95 respirators, are intended to provide some degree of respiratory protection. However, the technological characteristics for pediatric masks are different from that of adult N95 respirators because of the lower breathing resistance needed, the higher risk of asphyxiation, misuse, or injury, and because the pediatric facemasks need to be appropriate for smaller faces. While N95 respirators have been heavily characterized, pediatric facemasks have received little attention. Given the universal need for respiratory protection during COVID-19 pandemic, this field requires more research. Like respirators, filtration efficiency, breathability and fit-tests using anthropometric studies of pediatric facemasks are extremely important attributes. To date very little research has been performed that has compared the filtration efficiency, pressure drop and fit testing across multiple legally marketed pediatric facemask brands. In this presentation we will characterize the filtration efficiency, and breathability of four brands of pediatric facemasks that are currently marketed in the U.S. using in vitro testing. We will also assess the adequacy and appropriateness of current test methods that medical device manufacturers use to characterize pediatric facemasks.