Integration Of Fda And Niosh Proces

National Academies Of Sciences, Engineering, And Medicine; Health And Medicine Division; Board On Health Sciences Policy

ISBN 10: 0309451272 / ISBN 13: 9780309451277

Published by National Academies Press, 2017

About this Item

Seller Inventory # V9780309451277

Bibliographic Details

• Title: Integration Of Fda And Niosh Proces
• Publisher: National Academies Press
• Publication Date: 2017
• Language: English
• ISBN 10: 0309451272
• ISBN 13: 9780309451277
• Binding: Soft cover
• Condition: New

About this title

Synopsis

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.