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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5 Potential Next Steps and Priorities
5 Potential Next Steps and Priorities
Pages 41-48
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From page 41... ...
as relevant to N95s used in health care settings o Identify priorities and delineate potential next steps for com pleting the integration of the evaluation processes • Breakout 3 -- Priorities for Health Care Workers o Discuss whether the attributes needed for respiratory protec tion for health care workers differ from the attributes needed for respiratory protection for other workers (e.g., agriculture, industry) o Identify priorities for improving N95s for use by health care workers 41
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He noted that more information is needed on the fluid hazards that health care workers deal with and to inform decisions regarding the utility of the ASTM test method. "It is unknown whether this jet of synthetic blood is appropriate for testing the hazards," said Cohen.
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Participants differed in their views of whether surgical N95s are intended only for use in surgical suites and similar health care settings or if they are intended to be used throughout all health care environments. Rupe noted that, in general, the group agreed that the respirators should continue to be certified by NIOSH and felt that flammability and biocompatibility testing could be done by the manufacturers with data provided to NIOSH, similar to what is done now with the FDA clearance process.
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From page 44... ...
The priorities that individual participants in the breakout group identified for improving N95s for use by health care workers included a need to improve comfort, fit, and usability and to finalize a total inward leakage test. There was strong support in this breakout group to improve training and education on the proper use of N95s, which will require management commitment to respiratory protection and worker involvement, and for addressing the issues raised earlier in the workshop around fit testing, particularly its time-consuming nature.
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From page 45... ...
Jonathan Rosen noted that the stockpiling issue goes beyond supplying the needs of health care workers as evidenced by the problems with mold exposure that homeowners and volunteers experienced after Hurricane Katrina. Anugrah Shaw from the University of Maryland, Eastern Shore, said that comfort and fit are universal issues for all respirators, regardless of whether they are for use in health care or by pesticide applicators.
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Risk assessment could point to protective needs that would not mean the need for new respirators or respirator requirements but for different protective ensembles to protect health care workers and different tests to assess performance of the ensembles. The discussion raised a few additional points.
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From page 47... ...
• Harmonization and integration are needed, and it will take goodwill and intent on the part of FDA and NIOSH to make that happen. • Major challenges include respirator comfort, fit, faceseal integri ty, contamination, effectiveness, stockpiling, expiration dates, supply lines, and hazard assessment.
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