Respiratory Protective Devices Used in Healthcare

Respiratory protective devices (RPDs) approved by the National Institute for Occupational Safety and Health (NIOSH), and also cleared by the Food and Drug Administration (FDA) as medical devices, are widely used in surgical and non-surgical healthcare environments. There were reports that other NIOSH-approved RPDs, not FDA-cleared as medical devices, were also used to protect healthcare workers from inhalation hazards. The desirability of NIOSH incorporating additional requirements and tests in its 42 CFR Part 84 respirator approval process to parallel the protections in the FDA clearance process for Surgical N95 Respirators in surgical and non-surgical healthcare environments had been mentioned during broad-based and cross-agency discussions for future pandemic events as well as day-to-day use in healthcare settings.

NIOSH considered augmenting the requirements and tests of the 42 CFR Part 84 conformity assessment process to incorporate requirements included in the FDA clearance process, such as fluid resistance and flammability. Both FDA and NIOSH required demonstration of filtration performance. The NIOSH filtration testing requirements used non-biological aerosol based on the assumption that all particles, biological or non-biological, behave according to the same principles of aerosol physics for filtration: that is, by impaction, interception, diffusion, and electrostatic attraction. NIOSH sought public comment with available supporting data that either validated or disproved this assumption.

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Background Information

Federal Register Notice

Federal Register Notice - Comment Period Extended