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

Chapter: Appendix A: Workshop Agenda

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Suggested Citation: "Appendix A: Workshop Agenda." 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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A

Workshop Agenda

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

Keck Center of the National Academies
of Sciences, Engineering, and Medicine
500 Fifth Street, NW, Room 100
Washington, DC

August 1, 2016

Workshop Objective:

  • Ensure health care worker safety, health, and productivity by discussing potential next steps to integrate federal processes (FDA and NIOSH) used to certify and approve N95 respiratory protective devices for use in health care settings.

Starting Points:

  • All participants are familiar with the FDA and NIOSH approval and certification processes. Background materials outlining these processes have been provided to all workshop participants. The workshop will focus on potential next steps and priorities for harmonization:
    • FDA—Approval of surgical N95 respirators, which in addition to NIOSH certification also meet FDA requirements regarding flammability, fluid resistance, and biocompatibility
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Suggested Citation: "Appendix A: Workshop Agenda." 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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  • NIOSH—Certification of all N95 respirators with tests, including for filtration performance
7:45 – 8:30 a.m. Breakfast, Available in Keck Atrium, 3rd floor
8:30 – 8:40 a.m. Welcome and Introductions

Linda Hawes Clever, Chair, Workshop Planning Committee
8:40 – 9:00 a.m. Goals for the Workshop

Maryann D’Alessandro, National Personal Protective Technology Laboratory (NPPTL)

Aftin Ross, Food and Drug Administration (FDA)
Discussion
9:00 – 10:20 a.m. Panel 1: Perspectives from Users, Manufacturers, and Distributors

Facilitator: Barbara DeBaun
9:00 – 9:05 Panel Introductions
9:05 – 9:55 Presentations
  • Jeffrey Nesbitt, Mayo Clinic
  • Geeta Sood, Johns Hopkins University
  • James Chang, University of Maryland Medical Center
  • Craig Colton, 3M
  • Akhil Agrawal, American Medical Depot

9:55 – 10:20 Discussion
Issues for Presentations and Discussion:
  • What N95 respirator attributes need to be tested to assure worker safety and health in health care settings (e.g., filtration, flammability, fluid resistance, biocompatibility, others)?
Page 53 Cite Bookmark
Suggested Citation: "Appendix A: Workshop Agenda." 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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  • What, if any, are the current issues being faced with having two types of N95 respirators (surgical N95s and standard N95s)?
  • In your opinion, what are the priorities for research, testing, and post-market surveillance to improve N95s for health care workers’ safety and health? What are the priorities to be considered in the integration of FDA and NIOSH evaluation processes for N95s?
10:20 – 10:30 a.m. BREAK
10:30 a.m. – 12:00 p.m. Panel 2: State of the Science and Priorities for Research and Standards Development—Filtration Performance and Fluid Resistance
Facilitator: Jim Johnson

10:30 – 10:35 Panel Introductions

10:35 – 11:35 Presentations

10:35 – 11:05 Filtration Performance

  • Robert Eninger, Air Force Institute of Technology
  • Sergey Grinshpun, University of Cincinnati

11:05 – 11:35 Fluid Resistance

  • Brandon Williams, Nelson Laboratories
  • Steven Elliott, FDA

11:35 – 12:00 Discussion
Issues for Presentations and Discussion:
  • What improvements are needed to the tests and test methods? What efforts are under way to revise the standards?
  • What are the research gaps and priorities?
  • What are the priorities for research, test method development and refinement, and
Page 54 Cite Bookmark
Suggested Citation: "Appendix A: Workshop Agenda." 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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post-market surveillance of N95s to improve health care workers’ safety and health? What are the priorities to be considered in integrating FDA and NIOSH evaluation processes for N95s used in health care settings?
12:00 – 12:45 p.m. Lunch, Available in Keck Atrium, 3rd floor
12:45 – 2:00 p.m. Panel 3: State of the Science and Priorities for Research and Standards Development—Flammability and Biocompatibility/Usability
Facilitator: Mark Shirley

12:45 – 12:50 Panel Introductions

12:50 – 1:35 Presentations

12:50 – 1:20 Flammability

  • Samy Rengasamy, NPPTL
  • Roger Barker, North Carolina State University

1:20 – 1:35 Biocompatibility/Usability

  • BiFeng Qian, FDA

1:35 – 2:00 Discussion
Issues for Presentations and Discussion:
  • What improvements are needed to the tests and test methods? What efforts are under way to revise the standards?
  • What are the research gaps and priorities?
  • What are the priorities for research, test method development and refinement, and post-market surveillance of N95s to improve health care workers safety and health? What are the priorities to be considered in integrating FDA and NIOSH evaluation processes for N95s used in health care settings?
Page 55 Cite Bookmark
Suggested Citation: "Appendix A: Workshop Agenda." 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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2:00 – 2:45 p.m. Panel 4: Options for Post-Market Surveillance
Facilitator: Dan Shipp

2:00 – 2:05 Panel Introductions

2:05 – 2:20 Presentation

  • Jeffrey Peterson and James Harris, NPPTL

2:20 – 2:45 Discussion
Issues for Presentations and Discussion:
  • Overview of current processes for post-market surveillance of N95 respirators and other similar types of devices
  • Examples from other devices/processes
  • What are suggested considerations for improving post-market surveillance?
2:45 – 3:00 p.m. Break and Move to Breakout Sessions
3:00 – 4:15 p.m. Breakout Sessions
Breakout #1—Next Steps in Research for Improving Test Methods (Room 100)
Facilitator: Howard Cohen
Tasks for the breakout group:
  • Identify research gaps for test methods used to evaluate N95 respirators for use by health care workers
  • Identify three to five research priorities
  • Outline next steps for filling the research gaps
Breakout #2—Issues in Improving and Streamlining the Integration of FDA and NIOSH Processes for N95s Used in Health Care Settings (Room 103)
Facilitator: Kerri Rupe
Page 56 Cite Bookmark
Suggested Citation: "Appendix A: Workshop Agenda." 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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Tasks for the breakout group:
  • Identify outstanding issues in the integration of the FDA and NIOSH processes
  • Discuss the strengths and weaknesses of various approaches to testing (i.e., third-party testing, government lab testing, manufacturer attestation of testing) as relevant to N95s used in health care settings
  • Identify priorities and delineate potential next steps for completing the integration of the evaluation processes
Breakout #3—Priorities for Health Care Workers (Room 106)
Facilitator: Cecile Rose
Tasks for the breakout group:
  • Discuss whether the attributes needed for respiratory protection for health care workers differ from the attributes needed for respiratory protection for other workers (e.g., agriculture, industry)
  • Identify priorities for improving N95s for use by health care workers
4:15 – 4:30 p.m. Break and Move to Plenary Session
4:30 – 5:30 p.m. Plenary Session, Keck 100
Facilitator: Linda Hawes Clever
Reports on Potential Next Steps and Priorities
Public Comments
Closing Remarks
5:30 p.m. ADJOURN
Page 51 Cite Bookmark
Suggested Citation: "Appendix A: Workshop Agenda." 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 52 Cite Bookmark
Suggested Citation: "Appendix A: Workshop Agenda." 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 53 Cite Bookmark
Suggested Citation: "Appendix A: Workshop Agenda." 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 54 Cite Bookmark
Suggested Citation: "Appendix A: Workshop Agenda." 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 55 Cite Bookmark
Suggested Citation: "Appendix A: Workshop Agenda." 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 56 Cite Bookmark
Suggested Citation: "Appendix A: Workshop Agenda." 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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Next Chapter: Appendix B: Workshop Participants
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