A retrospective characterization of pediatric facemasks marketed in the United States and implications for future...

Device manufacturers who seek to market their pediatric facemasks in the United States (U.S.), as part of anthropometric data requirement, need to demonstrate their mask designs are expected to fit the intended user population. However, currently there are no well accepted test methodologies for pediatric facemasks. In addition, unlike N95 respirators, the expected maximum flow rate, and the pressure drop at that expected maximum flow rate for pediatric facemasks have not been established.

The objective of this article is three-fold; use a literature survey to determine the worst-case flow rate, and an acceptable breathing resistance; and come up with a bench-test based protocol for assessing fit of pediatric facemasks.

The worst-case breathing flow rate for mask testing in the pediatric population is 45-60 Liters/minute (LPM), and the acceptable pressure drop at the worst-case flow rate is 2.0 mmH2O. A retrospective assessment of all the four brands of legally marketed facemasks in the U.S. that could be purchased, revealed that majority of the brands have high filtration efficiency (>95%) at low flow rate 5 LPM which reduces to ~ 80% at 45 LPM. At 5 LPM, the pressure drop ranges from 0.3-0.6 mmH2O, remaining below the 2.0 mmH2O. However, at higher flow rates, (representing strenuous activities, or older children (> 12 years)), most masks exhibited a pressure drop within the range of 2.9 to 6.0 mmH2O. Furthermore, opening the pleats of the facemasks completely results in a notable reduction in pressure drop (a 6.6-fold decrease, p = 0.03). To assess fit of these same brands of facemasks, we then updated our previous validated adult manikin fit-test method and used it in manikins in the age group of 2 to 14 years. Either poor nose-clip adherence to the manikin, low filtration efficiency of the pediatric facemasks, or off-label use (i.e. when donned on manikins representing 2 years to 14 years) contributed to low fit.

A new bench-top tool to evaluate quantitative fit of pediatric facemasks was developed. In addition, based on the research reported here, we provide practical implications for the members of the community: users, academia and medical device manufacturers.