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5 A General Framework for Respiratory Protection Oversight and Guidance
Pages 269-294

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From page 269...
... and for the general population. Many of the challenges highlighted in these for the Public chapters relate to the fragmented regulatory landscape and the lack of a cohesive national strategy for addressing the respiratory protection needs of these two populations.
From page 270...
... Figure 5-2, first published in that report, outlines a set of overarching performance requirements to guide the design and development of PPE in a manner that prioritizes functional characteristics, such as filtration efficiency, and usercentric needs. From this broad set of design requirements, more specific requirements can be identified for specific use scenarios, considering the hazard and the intended users, including challenges faced by vulnerable groups in terms of gaining access to respiratory protective devices.
From page 271...
... hazards Lifecycle learning and continuous improvement FIGURE 5-1  Processes needed to deliver respiratory protection from design and manufacturing to use, with continuous improvement through learning cycles at every step.
From page 272...
... NOTE: PPE = personal protective equipment.
From page 273...
... For example, an employer that has instituted an RPP may purchase respiratory protective devices and provide them to employees to protect them against inhalation hazards in the workplace. Or a family might choose to purchase and store such devices because of potential risks from wildfire smoke or airborne infectious agents.
From page 274...
... In the sections below, the committee introduces its approach to addressing the element of its charge concerned with making recommendations for the requested framework. The committee's proposed framework extends from the design, manufacturing, and testing of respiratory protective devices to their delivery to users who need to be prepared to use them in a way that will provide the desired level of protection, as depicted in Figure 5-1.
From page 275...
... The Core Functions Figure 5-3 shows the core, high-level functions that must be carried out as part of the framework: • Function F0: Develop and approve respiratory protective devices; • Function F1: Assess hazard and determine need for respiratory protection; • Function F2: Determine the necessary respiratory protective devices; • Function F3: Ensure availability and access pathways for respiratory protective devices; • Function F4: Engage, inform, and ensure access for the target community; • Function F5: Incorporate lifecycle learning and continuous improve ment; and • Function F6: Coordination These core functions make up a comprehensive framework that builds on the experience reviewed in Chapters 2 through 4 and addresses the identified gaps. For example, the eighth conclusion in Chapter 4 states that the public does not know where, which, and when respiratory protective devices should be used.
From page 276...
... Function F0 (see Figure 5-4) encompasses the continuous development and approval of respiratory protective devices as technologies evolve and needs and standards change.
From page 277...
... Activities Postevent Activities F0. Develop • Definition of respiratory protection • See F2 and Approve requirements for different hazard use Respiratory scenarios Protective • Development of performance standards Devices • Design and manufacturing of respiratory protective devices • Conformity assessment and approval F1.
From page 278...
... Development Population) to Identify Requirements YES F0.2 F0.5 New Product Product Conformity Development Assessment and Approval FIGURE 5-4  Function F0: subfunctions related to ongoing development and approval of respiratory protective devices.
From page 279...
... . By enabling approved respiratory protective devices to be identified and ordered directly from their manufacturers, this function will also limit use of the counterfeits currently plaguing the supply chain and adversely affecting both manufacturers and users.
From page 280...
... YES NO F1.3 Quantify Hazard Using Specific Metrics F1.6 Employ Engineering Controls FIGURE 5-5  Function F1: subfunctions related to assessing a hazard and determining the need for respiratory protection.
From page 281...
... FIGURE 5-6  Function F2: subfunctions related to determining the necessary respiratory protective devices.
From page 282...
... This issue can be addressed by such measures as that adopted for some respiratory protective devices during the COVID-19 pandemic -- extension of liability protection to manufacturers and distributors by invoking and including such devices as covered countermeasures under the 2005 Public Readiness and Emergency Preparedness (PREP)
From page 283...
... 283 NOTE: DPA = Defense Production Act; SNS = Strategic National Stockpile.
From page 284...
... The guidelines developed under Function F2 with hazard-specific recommendations for a respiratory protective device serve as the foundation for the development of guidance for target audiences. The approach taken to this step needs to address the technical aspects of the recommended protection (e.g., which device, when and why to use it)
From page 285...
... Figure 5-8 (formerly Figure 6-9) F5 Incorporate Lifecycle Learning and Continuous Improvement F4.1 Employer Develop Guidance and Produce • Update Policy Manual • Educate and Train Employees Documents for Various Target Groups • Procure and Make Device Available • Ensure Compliance with Use • Technical • Operational Worker Organizations • Tailor Materials to Target Worker Groups • Communicate and Measure Response • Educate and Train Workers F4.2 Identify Individuals/Organizations to Public Health Agencies • Determine Communication Mode and Conduct Outreach and Engage Target • Tailor Materials to Target Population Modify Materials Groups • Communicate and Measure Response Medical Professionals • Tailor Materials to Target Population • Communicate and Measure Response F4.3 Develop and Implement Feedback Direct to Individuals • Determine Communication Mode and Mechanisms to Improve Guidance Modify Materials • Tailor Materials to Target Population Documents and Outcomes • Communicate and Measure Response FIGURE 5-8 Function F4: subfunctions related to engaging, informing, and ensuring access for the target community via multiple 285 stakeholders and pathways.
From page 286...
... TABLE 5-2  Fragmentation of Governmental Stakeholder Responsibilities and Authorities Based on the Hazard Type and Exposure Context Workplace Exposures Nonoccupational Exposures Respirators Respiratory protective devices used for • National Institute for Occupational Safety medical purposes, including source control Requirements for Respiratory and Health (NIOSH) /National Personal • FDA Protective Technology Laboratory (NPPTL)
From page 287...
... This fragmentation and the lack of a cohesive national strategy for informing, educating, and providing guidance for workers without RPPs and the public as to how they can protect themselves from inhalation hazards highlight the need for a central, accountable entity to perform a coordinating function across the framework. Absent such an entity, the goal of providing respiratory protection for workers without RPPs and the public may not be met satisfactorily.
From page 288...
... For the public, it is a potential approach. The Interagency Task Force Model At the other end of the continuum of centralization, a coalition of stakeholders could be charged with working collaboratively to serve as the coordinating entity.
From page 289...
... The Hub-and-Spoke Model This model moves away from the interagency task force model toward an empowered coordinating entity. In the hub-and-spoke model, the coordinating entity serves as the hub that is empowered to harness and build on the expertise and experience of current stakeholders engaged in respiratory protection for carrying out all the activities within Functions F0 through F5 (the spokes)
From page 290...
... A coordinating structure with an architecture similar to that of the PHEMCE model could be well suited to drawing on the domain expertise, experience, and regulatory authority of the stakeholders enumerated in Table 5-2. Successful Realization and Operation of the Coordinating Entity: The Essential Attributes In considering the above three examples of potential architectures for a coordinating entity, the committee sought to identify essential attributes for the successful realization and operationalization of any such structure.
From page 291...
... First, it is essential to articulate clearly the policy goal or vision for the entity, which will need to be supported at the highest levels, potentially including the White House and the Congress, to empower and guide the coordinating entity in carrying out its activities. The success of the leadership for the coordinating entity would be defined by its ability to establish a strong culture of collaboration and partnerships with other stakeholders in the respiratory protection enterprise to harness their domain-specific expertise.
From page 292...
... Framework Requirements Concerning Diversity and Equity As stated in Chapter 1, the committee believes strongly that its framework must incorporate equity as an overarching principle. This principle needs to be considered and addressed by the coordinating entity and other participants in the framework enterprise across each of the functions, as follows: • Function F0: Develop and approve respiratory protective devices.
From page 293...
... 2020. Selecting controls for minimizing SARS CoV-2 aerosol transmission in workplaces and conserving respiratory protective equip ment supplies.
From page 294...
... . NIOSH (National Institute for Occupational Safety and Health)


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