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Suggested Citation:"References." 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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References

Chen, C. C., and K. Willeke. 1992. Characteristics of face seal leakage in filtering facepieces. American Industrial Hygiene Association Journal 53(9):533-539.

Eninger, R. M., T. Honda, T. Reponen, R. McKay, and S. A. Grinshpun. 2008. What does respirator certification tell us about filtration of ultrafine particles? Journal of Occupational and Environmental Hygiene 5(5):286-295.

FDA (Food and Drug Administration). 2004. Guidance for industry and FDA staff: Surgical masks—Premarket notification [510(k)] submissions; guidance for industry and FDA. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072549.htm (accessed September 20, 2016).

FDA. 2016. Use of International Standard ISO 10993-1, “Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process.” Guidance for industry and Food and Drug Administration staff.http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Documents/ucm348890.pdf (accessed September 20, 2016).

Grinshpun, S. A., H. Haruta, R. M. Eninger, T. Reponen, R. T. McKay, and S. A. Lee. 2009. Performance of an N95 filtering facepiece particulate respirator and a surgical mask during human breathing: Two pathways for particle penetration. Journal of Occupational and Environmental Hygiene 6(10):593-603.

Harnish, D. A., B. K. Heimbuch, M. Husband, A. E. Lumley, K. Kinney, R. E. Shaffer, and J. D. Wander. 2013. Challenge of N95 filtering facepiece respirators with viable H1N1 influenza aerosols. Infection Control and Hospital Epidemiology 34(5):494-499.

Harnish, D. A., B. K. Heimbuch, C. Balzli, M. Choe, A. E. Lumley, R. E. Shaffer, and J. D. Wander. 2016. Capture of 0.1-μm aerosol particles containing viable H1N1 influenza virus by N95 filtering facepiece respirators. Journal of Occupational and Environmental Hygiene 13(3):D46-D49.

Suggested Citation:"References." 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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HHS (Department of Health and Human Services. 2014. Respiratory protective devices used in healthcare. Federal Register 79(50):14515-14517.

Janssen, L., H. Ettinger, S. Graham, R. Shaffer, and Z. Zhuang. 2013. The use of respirators to reduce inhalation of airborne biological agents. Journal of Occupational and Environmental Hygiene 10(8):D97-D103.

Joint Commission. 2014. Implementing hospital respiratory protection programs: Strategies from the field. Oakbrook Terrace, IL: Joint Commission. https://www.jointcommission.org/assets/1/18/Implementing_Hospital_RPP_2-19-15.pdf (accessed September 15, 2016).

NIOSH (National Institute for Occupational Safety and Health). Respirator trusted-source information. http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource1quest3.html (accessed December 9, 2016).

Rengasamy, S., and B. C. Eimer. 2012. Nanoparticle penetration through filter media and leakage through face seal interface of N95 filtering facepiece respirators. Annals of Occupational Hygiene 56(5):568-580.

Rengasamy, S., R. BerryAnn, and J. Szalajda. 2013. Nanoparticle filtration performance of filtering facepiece respirators and canister/cartridge filters. Journal of Occupational and Environmental Hygiene 10(9):519-525.

Rengasamy, S., D. Sbarra, J. Nwoko, and R. Shaffer. 2015. Resistance to synthetic blood penetration of National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators and surgical N95 respirators. American Journal of Infection Control 43(11):1190-1196.

Rengasamy, S., R. Shaffer, B. Williams, and S. Smit. 2016. A comparison of facemask and respirator filtration test methods. Journal of Occupational and Environmental Hygiene 19.

USP (U.S. Pharmacopeial Convention). 2016. Hazardous drugs: Handling in health care settings. http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings (accessed December 9, 2016).

Suggested Citation:"References." 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 49
Suggested Citation:"References." 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 50
Next: Appendix A: Workshop Agenda »
Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers: Proceedings of a Workshop Get This Book
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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 (“respirators”) 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). Respirators that are used in workplaces in the United States must be approved by NIOSH and meet standards and test results specified by regulation.

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; or (3) powered air-purifying air respirators.

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 in August 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. This publication summarizes the presentations and discussions from the workshop.

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