Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers: Proceedings of a Workshop
2017

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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.

Publication information

76 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-45127-2
ISBN Ebook: 0-309-45128-0
DOI: https://doi.org/10.17226/23679

Suggested citation

National Academies of Sciences, Engineering, and Medicine. 2017. Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers: Proceedings of a Workshop. Washington, DC: The National Academies Press.

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Front Matter i-xii
1 Introduction 1-6
2 Perspectives from Users, Manufacturers, and Distributors 7-16
3 Exploring the State of the Science and Potential Priorities for Research and Standards Development 17-34
4 Options for Post-Market Surveillance 35-40
5 Potential Next Steps and Priorities 41-48
References 49-50
Appendix A: Workshop Agenda 51-56
Appendix B: Workshop Participants 57-64

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Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers: Proceedings of a Workshop (2017)

Chapter: 4 Options for Post-Market Surveillance

Publication information

Suggested citation

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Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers: Proceedings of a Workshop (2017)

Chapter: 4 Options for Post-Market Surveillance