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Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers Proceedings of a Workshop (2017) / Chapter Skim
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Appendix A: Workshop Agenda
Pages 51-56

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From page 51...
... The workshop will focus on potential next steps and priorities for harmonization: o FDA -- Approval of surgical N95 respirators, which in addi tion to NIOSH certification also meet FDA requirements re garding flammability, fluid resistance, and biocompatibility 51
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From page 52...
... 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, flamma bility, fluid resistance, biocompatibility, others)
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From page 53...
... ? • In your opinion, what are the priorities for research, testing, and post-market surveil lance to improve N95s for health care work ers' safety and health?
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From page 54...
... • 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?
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From page 55...
... 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)
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From page 56...
... Facilitator: Cecile Rose Tasks for the breakout group: • Discuss whether the attributes needed for respiratory protection for health care work ers differ from the attributes needed for res piratory 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.
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Key Terms

  • care settings
  • fluid resistance
  • panel introductions
  • niosh evaluation
  • filtration performance

  • care workers
  • linda hawes
  • research gaps
  • worker safety
  • hawes clever

  • evaluation processes
  • respiratory protection
  • garding flammability
  • maryland medical
  • materials outlining

  • identify research
  • workers safety
  • technology laboratory
  • meet fda
  • niosh certification

  • grating fda
  • care worker
  • improving test
  • fda requirements
  • identify priorities

  • background materials
  • five research
  • assure worker
  • method development
  • protective technology


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