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Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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Integration of

FDA and NIOSH Processes

Used to Evaluate Respiratory
Protective Devices for

Health Care Workers

Proceedings of a Workshop

Catharyn T. Liverman and Joe Alper, Rapporteurs

Board on Health Sciences Policy

Health and Medicine Division

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by Award #10002969 between the National Academy of Sciences and the Department of Health and Human Services’ Centers for Disease Control and Prevention. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-45127-7
International Standard Book Number-10: 0-309-45127-2
Digital Object Identifier: 10.17226/23679

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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. doi: 10.17226/23679.

Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

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Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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Reports document the evidence-based consensus of an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and committee deliberations. Reports are peer reviewed and are approved by the National Academies of Sciences, Engineering, and Medicine.

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Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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PLANNING COMMITTEE FOR THE WORKSHOP ON THE INTEGRATION OF FDA AND NIOSH PROCESSES USED TO EVALUATE RESPIRATORY PROTECTIVE DEVICES FOR HEALTH CARE WORKERS1

LINDA HAWES CLEVER (Chair), California Pacific Medical Center

HOWARD J. COHEN, Yale University

BARBARA DEBAUN, Cynosure Health

JAMES S. JOHNSON, JSJ and Associates

CECILE S. ROSE, Department of Medicine, University of Colorado Denver

KERRI L. RUPE, College of Nursing, University of Iowa

DANIEL K. SHIPP, International Safety Equipment Association

MARK SHIRLEY, Sutter Health

Project Staff

CATHARYN T. LIVERMAN, Program Director

JUDY ESTEP, Program Associate

ANDREW M. POPE, Director, Board on Health Sciences Policy

Consultant

JOE ALPER, Writer

___________________

1The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing this workshop, identifying topics, and choosing speakers. The responsibility for this published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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STANDING COMMITTEE ON PERSONAL PROTECTIVE EQUIPMENT FOR WORKPLACE SAFETY AND HEALTH1

LINDA HAWES CLEVER (Chair), California Pacific Medical Center

HOWARD J. COHEN, Yale University

BARBARA DEBAUN, Cynosure Health

DAVID M. DEJOY, University of Georgia

EMIEL A. DENHARTOG, North Carolina State University

WILLIAM H. KOJOLA, AFL-CIO, retired

HERNANDO PEREZ, Department of Homeland Security

DAVID PREZANT, New York City Fire Department

CECILE S. ROSE, Department of Medicine, University of Colorado Denver

KERRI L. RUPE, College of Nursing, University of Iowa

ANUGRAH SHAW, University of Maryland, Eastern Shore

DANIEL K. SHIPP, International Safety Equipment Association

MARK SHIRLEY, Sutter Health

JAMES P. ZEIGLER, J.P. Zeigler, LLC

___________________

1The National Academies of Sciences, Engineering, and Medicine’s standing committees do not issue, review, or approve individual documents. The responsibility for this published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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This page intentionally left blank.

Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
×

Reviewers

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published Proceedings of a Workshop as sound as possible and to ensure that this Proceedings of a Workshop meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain privileged to protect the integrity of the process. We wish to thank the following individuals for their review of this Proceedings of a Workshop:

LISA BROSSEAU, University of Illinois, Chicago

JAMES CHANG, University of Maryland Medical Center

LINDA ROUSE O’NEILL, Health Industry Distributors Association

MARK SHIRLEY, Sutter Health

GEETA SOOD, Johns Hopkins University

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the Proceedings of a Workshop before its release. The review of this Proceedings of a Workshop was overseen by BONNIE ROGERS, University of North Carolina at Chapel Hill. She was responsible for making certain that an independent examination of this Proceedings of a Workshop was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the Proceedings of a Workshop rests entirely with the rapporteurs and the institution.

Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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This page intentionally left blank.

Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
×
Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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This page intentionally left blank.

Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
×
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Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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Page R5
Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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Page R6
Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
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Page R7
Page viii Cite
Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
×
Page R8
Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
×
Page R9
Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
×
Page R10
Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
×
Page R11
Suggested Citation:"Front Matter." 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. doi: 10.17226/23679.
×
Page R12
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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.

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