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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1 Introduction
1 Introduction
Pages 1-6
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have responsibilities for evaluating and regulating respiratory protective devices (termed "respirators" for this proceedings) for health care workers.
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The workshop resulted from discussions between FDA and NIOSH and from discussions of the National Academies' Standing Committee on Personal Protective Equipment for Workplace Safety and Health. This workshop provided the opportunity to exchange knowledge and ideas between health care professionals, policy makers, and manufacturers involved in the field of personal protective equipment for health care workers.
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This workshop participants will examine the following issues re garding the current processes and next steps toward the integra tion of federal processes for respiratory protective devices for use in health care settings: • Test methods -- The workshop will discuss tests and test ing requirements to be considered in a unified process for evaluating N95 respiratory protective devices for use in health care settings. Specifically, the following test meth ods and associated requirements will be discussed: o Filtration performance -- The workshop will provide an overview of current test methods and identify any is sues that need to be resolved.
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Following this introductory chapter, Chapter 2 presents user, manufacturer, and distributor perspectives on several issues related to N95 respirators, including how they should be tested to ensure worker safety and health and if there are challenges arising from having surgical and standard N95 respirators. Chapter 3 discusses the state of the science and potential priorities for research and standards development for filtration performance, fluid resistance, flammability, biocompatibility, and usability.
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Today, she said, both NIOSH and FDA have authorities over a subset of N95 respirators designated as surgical N95 respirators, and these concurrent authorities have resulted in confusion in the marketplace and challenges for health care institutions. Among these, said D'Alessandro, is the duplication of efforts by the two agencies in requiring similar processes, multiple and sometimes overlapping processes for manufacturers, and confusion in the marketplace with regard to whether NIOSH, FDA, or both must approve a particular product.
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Toward that end, she stated that from her perspective the goals for the workshop were to obtain input from stakeholders on • Test methods and other features of approval/clearance process, • Approaches to reduce conflicting and duplicative steps, • Pre-approval and post-approval activities, and • Additional approaches to improve workplace safety and health. Aftin Ross, senior project manager at FDA's Center for Devices and Radiological Health, welcomed the workshop participants and noted that the shared goal of the workshop is to "ensure that health care workers have the respiratory protective devices they need both in their day-to-day work as well as in the event of an airborne infectious disease pandemic such as H1N1 influenza in 2009." She explained that because surgical N95s fall under the authorities of both FDA and NIOSH that the agencies have been looking at ways of increasing information sharing and integrating processes and activities regarding the approvals of these respirators.
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