Integration of FDA and NIOSH processes used to evaluate respiratory protective devices for health care workers: proceedings of a workshop

Details

• Personal Author:
  Alper J ; Liverman, Catharyn T.
• Description:
  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 (termed "respirators" for this proceedings) 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) (NIOSH, 2016). Respirators that are used in workplaces in the United States must be approved by NIOSH and meet standards and test results specified by regulation (42 Code of Federal Regulations [CFR] Part 84). 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 (that can either be washable and able to be cleaned and disinfected or have a "disposable (rubber-like) facepiece"; or (3) powered air-purifying air respirators (PAPRs) in which a battery-powered blower moves the air through the filters (NIOSH, 2016). This Proceedings of a Workshop focused on N95 respirators. As noted above, NIOSH certifies all N95 respirators. A subset of N95 respirators termed "surgical N95 respirators" (also termed "surgical N95s") is designated and cleared by FDA. This subset differs from standard N95s (also termed "nonsurgical N95s") in that surgical N95s are products that have been submitted for FDA clearance and have met FDA's additional requirements related to flammability, fluid resistance, and biocompatibility. The distinction between NIOSH approval and FDA clearance has created confusion among health care delivery organizations, health care professionals, and other end users. To improve clarity and increase efficiency, NIOSH and FDA are considering streamlining the approach for regulatory oversight and approvals for N95 respirators intended for use in health care settings. Under a streamlined approach, it is anticipated that NIOSH would determine whether the N95 filtering facepiece respirator receives approval based on specific criteria agreed upon by the two agencies. However, the evaluation of flammability, fluid resistance, and biocompatibility for N95 filtering facepiece respirators are new assessments for NIOSH as they have historically been performed by manufacturers and submitted for FDA review as a part of the agency's 510(k) premarket notification. 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 (the National Academies) in Washington, DC, on August 1, 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. The workshop resulted from discussions between FDA and NIOSH and from discussions of the National Academies' Standing Committee on Personal Protective Equipment for Workplace Safety and Health. This workshop provided the opportunity to exchange knowledge and ideas between health care professionals, policy makers, and manufacturers involved in the field of personal protective equipment for health care workers. Box 1-1 provides the statement of task for this workshop. A planning committee was appointed to organize the workshop, which brought together representatives from the user, manufacturer, distributor, and research communities, as well as from federal regulatory agencies, to discuss the topic at hand. This Proceedings of a Workshop describes the presentations given and the topics discussed. Text included under a specific presentation is attributable to the individual presenter listed unless otherwise noted. Following this introductory chapter, Chapter 2 presents user, manufacturer, and distributor perspectives on several issues related to N95 respirators, including how they should be tested to ensure worker safety and health and if there are challenges arising from having surgical and standard N95 respirators. Chapter 3 discusses the state of the science and potential priorities for research and standards development for filtration performance, fluid resistance, flammability, biocompatibility, and usability. Chapter 4 recounts the discussions about options for post-market surveillance. The workshop proceedings concludes in Chapter 5 with a summary of three breakout group discussions and a synopsis of the workshop's major themes and discussions. [Description provided by NIOSH]
• Subjects:
  Filtration Health Personnel Occupational Health Personal Protective Equipment Quality Control Respiratory Protective Devices Respiratory System Safety
• Keywords:
  Biological Factors Equipment Reliability Equipment Testing Fluids Health Care Personnel Health Care Workers N95 Filtering Facepiece Respirators Performance Capability Performance Tests Personal Protective Equipment Quality Assurance Quality Control Quality Standards Regulations Respirator Certification Respirator Testing Respiratory Equipment Respiratory Protective Equipment Safety Research Standards Surgical Masks Surveillance Testing Equipment

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• ISBN:
  9780309451277
• Publisher:
  The National Academies Press
• Document Type:
  Text
• Funding:
  Contract
• Genre:
  Book
• Place as Subject:
  District of Columbia ; Ohio ; OSHA Region 3 ; OSHA Region 5 ; Pennsylvania
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  NPPTL - National Personal Protective Technology Laboratory ; OD - Office of the Director
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  1-63
• NIOSHTIC Number:
  nn:20049298
• Citation:
  Washington, DC: The National Academies Press, 2017 Feb; :1-63
• Contact Point Address:
  The National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001
• Federal Fiscal Year:
  2017
• Peer Reviewed:
  False
• Source Full Name:
  Integration of FDA and NIOSH processes used to evaluate respiratory protective devices for health care workers: proceedings of a workshop
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:2bff690e13e4b593cd565b118c2cc52b9dd21684b598ac867c39dc14debea5a3f05dd94c315f2e1aef85b1e9a2c451827a62d2d2b599346ce16b05357dae3b57
• Download URL:
  https://stacks.cdc.gov/view/cdc/203773/cdc_203773_DS1.pdf
• File Type:
  [PDF - 829.50 KB ]