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Introduction¹

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 (termed “respirators” for this proceedings) 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) (NIOSH, 2016). Respirators that are used in workplaces in the United States must be approved by NIOSH and meet standards and test results specified by regulation (42 Code of Federal Regulations [CFR] Part 84).

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 (2) elastomeric respirators, also known as reusable respirators because they use a replaceable filter (that can either be washable and able to be cleaned and disinfected or have a “disposable (rubber-like) facepiece”; or (3) powered air-purifying air respirators (PAPRs) in which a battery-powered blower moves the air through the filters (NIOSH, 2016).

This Proceedings of a Workshop focused on N95 respirators. As noted above, NIOSH certifies all N95 respirators. A subset of N95 respira-

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¹The planning committee’s role was limited to planning the workshop, and the Proceedings of a Workshop was prepared by the workshop rapporteurs as a factual account of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They should not be construed as reflecting any group consensus.

²The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. This product filters at least 95 percent of airborne particles but is not resistant to oil.

tors termed “surgical N95 respirators” (also termed “surgical N95s”) is designated and cleared by FDA. This subset differs from standard N95s (also termed “nonsurgical N95s”) in that surgical N95s are products that have been submitted for FDA clearance and have met FDA’s additional requirements related to flammability, fluid resistance, and biocompatibility.

The distinction between NIOSH approval and FDA clearance has created confusion among health care delivery organizations, health care professionals, and other end users. To improve clarity and increase efficiency, NIOSH and FDA are considering streamlining the approach for regulatory oversight and approvals for N95 respirators intended for use in health care settings. Under a streamlined approach, it is anticipated that NIOSH would determine whether the N95 filtering facepiece respirator receives approval based on specific criteria agreed upon by the two agencies. However, the evaluation of flammability, fluid resistance, and biocompatibility for N95 filtering facepiece respirators are new assessments for NIOSH as they have historically been performed by manufacturers and submitted for FDA review as a part of the agency’s 510(k) pre-market notification.

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 (the National Academies) in Washington, DC, on August 1, 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. 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. Box 1-1 provides the statement of task for this workshop. A planning committee was appointed to organize the workshop, which brought together representatives from the user, manufacturer, distributor, and research communities, as well as from federal regulatory agencies, to discuss the topic at hand.

This Proceedings of a Workshop describes the presentations given and the topics discussed. Text included under a specific presentation is attributable to the individual presenter listed unless otherwise noted. The

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. Chapter 4 recounts the discussions about options for post-market surveillance. The workshop proceedings concludes in Chapter 5 with a summary of three breakout group discussions and a synopsis of the workshop’s major themes and discussions.

OPENING REMARKS

In her welcome and introductory remarks, Linda Hawes Clever, chair of the National Academies’ workshop planning committee and a senior physician at the California Pacific Medical Center, noted that the most important part of the workshop’s objective was to ensure health care worker safety, health, and productivity. Doing so, she explained, may require surmounting barriers to the integration of federal processes regarding personal protective equipment for health care workers, and those specific to N95 respirators would be discussed at the workshop.

Maryann D’Alessandro, director of NIOSH’s National Personal Protective Technology Laboratory (NPPTL), estimated that some 20 million workers use personal protective equipment, including N95 respirators, on a regular basis to protect themselves from job hazards. NPPTL, which sponsored this workshop, is charged with conducting the research and the surveillance necessary for the development and refinement of personal protective equipment standards and conformity assessment processes, and with post-market surveillance of respirators and other protective equipment.

NPPTL is also charged with conducting the certification testing on N95 and other respirators. The authority to certify respirators, she explained, dates back to the early 1900s and the Bureau of Mines, with subsequent evolutions through the 1969 Federal Coal Mine Safety and Health Act (Public Law 91-173) and the Occupational Safety and Health Act of 1970 (Public Law 91-596). NIOSH’s charge is now detailed in Title 42, Part 84 of the CFR.

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. The approval process as it stands becomes even more complex, she added, when these products are intended for use by emergency responders because of requirements in the Public Readiness and Emergency Preparedness Act (Public Law 109-148).

As a response to these issues, NIOSH and FDA are putting together a Memorandum of Understanding (MOU) through which the two agencies will develop a process to reduce the conflicting and duplicative steps that manufacturers have to go through to obtain approval for a surgical N95

respirator. It is her hope, said D’Alessandro, that the input from this workshop will move the MOU forward. She noted that the Secretary of Health and Human Services, the FDA Commissioner, and the director of the Centers for Disease Control and Prevention (CDC) are all interested in seeing the MOU finalized and work begin on the harmonization process.

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. Toward that end, she noted that the goals of the workshop are to

• Hear perspectives from stakeholders regarding their experiences with N95 respirators in the health care setting,
• Examine the test methods used to evaluate N95s, and
• Discuss the opportunities and challenges of integrating the NIOSH and FDA processes that aim to ensure the safety of health care workers.