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

Workshop

You must be logged in to download this publication.

Select Book Type

Paperback - $36.00
Ebook - $29.69

Request an exam or desk copy

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.

Import this citation to:

Bibtext
EndNote
Reference manager

First Name
Last Name
Email (required)
I agree to receive emails from the National Academies (required)

We respect your privacy and will never share your information.

Search this publication

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

Log In

Former MyNAP users: You'll need to reset your password on your first login to MyAcademies. Click "Forgot password" below to receive a reset link via email. Having trouble? Visit our FAQ page to contact support.

Members of the National Academy of Sciences, National Academy of Engineering, or National Academy of Medicine should log in through their respective Academy portals.

Email (required)
Password (required)

Don't have an account?

Register

Email (required)
New password (required)
Retype password (required) Password must be at least 8 characters
I accept the terms of use
terms of use

Thank You

Thank you for creating a MyAcademies account!

Enjoy free access to thousands of National Academies' publications, a 10% discount off every purchase, and build your personal library.

Forgot Password

Enter the email address for your MyAcademies (formerly MyNAP) account to receive password reset instructions.

Email (required)

Reset Requested

We sent password reset instructions to your email . Follow the link in that email to create a new password. Didn't receive it? Check your spam folder or contact us for assistance.

Reset Password

New password (required)
Retype password (required) Password must be at least 8 characters

Reset Password

Your password has been reset.

Verify email

Verify Your Email Address

We sent a verification link to your email. Please check your inbox (and spam folder) and follow the link to verify your email address. If you did not receive the email, you can request a new verification link below

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

Chapter: 2 Perspectives from Users, Manufacturers, and Distributors

Publication information

Suggested citation

My Academies

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

Chapter: 2 Perspectives from Users, Manufacturers, and Distributors