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Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers - Proceedings of a Workshop (Paperback)
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Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers - Proceedings of a Workshop (Paperback)
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Both the Food and Drug Administration (FDA) and the National
Institute for Occupational Safety and Health (NIOSH) have
responsibilities for evaluating and regulating respiratory
protective devices ("respirators") for health care workers.
Respirators protect the user from respiratory hazards by either
removing contaminants from the air (air-purifying respirators) or
by supplying clean air from another source (air-supplying
respirators). Respirators that are used in workplaces in the United
States must be approved by NIOSH and meet standards and test
results specified by regulation. Respirators used by health care
workers are air-purifying respirators that generally fall into
three types: (1) disposable particulate filtering facepiece
respirators (also termed N95s); (2) elastomeric respirators, also
known as reusable respirators because they use a replaceable
filter; or (3) powered air-purifying air respirators. To provide
input to NIOSH and FDA and to discuss potential next steps to
integrate the two agencies' processes to certify and approve N95
respirators for use in health care settings, a workshop was held by
the National Academies of Sciences, Engineering, and Medicine in
August 2016. The workshop was focused on exploring the strengths
and limitations of several current test methods for N95 respirators
as well as identifying ongoing research and research needs. This
publication summarizes the presentations and discussions from the
workshop. Table of Contents Front Matter 1 Introduction 2
Perspectives from Users, Manufacturers, and Distributors 3
Exploring the State of the Science and Potential Priorities for
Research and Standards Development 4 Options for Post-Market
Surveillance 5 Potential Next Steps and Priorities References
Appendix A: Workshop Agenda Appendix B: Workshop Participants
General
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