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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
- 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
9:55 – 10:20 Discussion |
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Issues for Presentations and Discussion:
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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
11:05 – 11:35 Fluid Resistance
11:35 – 12:00 Discussion |
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Issues for Presentations and Discussion:
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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? |
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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
1:20 – 1:35 Biocompatibility/Usability
1:35 – 2:00 Discussion |
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Issues for Presentations and Discussion:
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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
2:20 – 2:45 Discussion |
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Issues for Presentations and Discussion:
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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 |
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Tasks for the breakout group:
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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 |
Tasks for the breakout group:
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Breakout #3—Priorities for Health Care Workers (Room 106) Facilitator: Cecile Rose |
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Tasks for the breakout group:
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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 |