Workshop Proceedings Address Processes for Evaluating N95s in Healthcare
The proceedings of an August 2016 workshop on the integration of two federal agencies’ processes to certify and approve N95 respirators for healthcare settings are now available from the National Academies of Sciences, Engineering, and Medicine. Both NIOSH and the Food and Drug Administration (FDA) have responsibilities to evaluate and regulate respiratory protective devices (RPDs) for healthcare workers. As described in the proceedings, the distinction between NIOSH approval and FDA clearance creates confusion among healthcare professionals and others. For example, an internal NIOSH survey report published in January 2014 showed that NIOSH-approved RPDs that are not FDA-cleared medical devices were being used to protect healthcare workers from inhalation hazards. The agencies are examining ways to streamline the approach for regulatory oversight and approvals for N95 respirators used in healthcare.
Participants in the workshop discussed the strengths and limitations of current test methods for N95 respirators and next steps in research for improving test methods. Other discussions focused on priorities for research and standards development for filtration performance and fluid resistance, and for flammability and biocompatibility/usability.
The workshop proceedings are available from the National Academies