Surgical Mask Particle Filtration Efficiency (PFE)

The particle filtration efficiency (PFE) of surgical (procedure) masks is a key differentiator of its classification and therefore, its use by healthcare workers.  Surgical masks are regulated by the Food and Drug Administration (FDA).  The FDA Guidance document has adopted a number of ASTM standards for establishing the criteria for the classification of masks.  ASTM F2299 is recommended for the measurement of PFE with minor modifications. Both ASTM F2299 and the FDA Guidance Document fail however to establish standard test procedures and therefore, it is possible to attain diverging results.  This creates a major problem in one’s ability to be able to relate the measured performance across different masks on the market.  In this paper, we outline the deficiencies of these test methods and discuss the challenges that need to be addressed by FDA and other regulatory agencies.