Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers

Proceedings of a Workshop

Engineering National Academies of Sciences and Medicine, Health and Medicine Division, Board on Health Sciences Policy (Autoren)

Joe Alper, Catharyn T. Liverman (Herausgeber)

Buch | Softcover

76 Seiten

2017
National Academies Press (Verlag)
9780309451277 (ISBN)

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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

1 Front Matter; 2 1 Introduction; 3 2 Perspectives from Users, Manufacturers, and Distributors; 4 3 Exploring the State of the Science and Potential Priorities for Research and Standards Development; 5 4 Options for Post-Market Surveillance; 6 5 Potential Next Steps and Priorities; 7 References; 8 Appendix A: Workshop Agenda; 9 Appendix B: Workshop Participants

Erscheinungsdatum	03.06.2017
Verlagsort	Washington
Sprache	englisch
Maße	152 x 229 mm
Themenwelt	Studium ► Querschnittsbereiche ► Prävention / Gesundheitsförderung
Themenwelt	Sozialwissenschaften ► Pädagogik ► Erwachsenenbildung
ISBN-13	9780309451277 / 9780309451277
Zustand	Neuware