Current Issues in the Assessment of Respiratory Protective Devices for Occupational and Non-Occupational Uses Proceedings of a Workshop (2021) / Chapter Skim
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2 Lessons Learned from 100 Years of Respiratory Protection
2 Lessons Learned from 100 Years of Respiratory Protection
Pages 7-16
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From page 7... ...
, explored how the assessment and approval of respiratory protective devices (RPDs) have evolved over the past century to meet the needs of occupational users.
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ANSI facilitates the development of American national standards by accrediting more than 240 standards development organizations, such as ASTM International, the National Fire Protection Association, and the International Symposium on Computer Architecture. Effective Conformity Assessment for Respiratory Protective Devices RPD requirements are typically defined in American national standards developed by ANSI-accredited standards development organizations, Metzler said, but they may also be included in contracts and purchase agreements.
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However, he added that the current infrastructure lacks a centralized authority to provide oversight of nontraditional and public uses of RPDs. APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Metzler briefly traced the history of the approval process for RPDs (Spelce et al., 2019)
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The Occupational Safety and Health Administration (OSHA) implemented Respiratory Protection Standard 1910.1344 in 1971, and NIOSH began administering respirator quality control provisions in 1972 via the federal regulation 30 CFR 11.5 A major lesson learned from the past century, Metzler said, is that a respiratory protection program is necessary and should not be "short-circuited" for public protection.
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A NATIONAL STRATEGY FOR CONFORMITY ASSESSMENT Metzler explained that CA of RPDs is a component of a broader integrated system of requirements to ensure protections in the United States; this broader system includes national laws and regulations, the industrial hygiene infrastructure, the standardization infrastructure, the broader CA infrastructure, and federal and private research. Metzler suggested that a national strategy is needed for nontraditional RPD users, including the general public, a population for which there is no centralized, recognized authority currently providing oversight.
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Specifically, a nationally recognized authority could: • Establish and maintain protection requirements based on hazards and risks; • Investigate nonconformance and fraudulent CA declarations and remove nonconforming products; • Inform and provide the public with critical guidance when new or evolving hazards arise; and • Update processes and requirements to address new or evolving hazards, advances in technologies, and revised or new national consensus standards. Metzler concluded that the absence of these oversight functions weakens protection and reduces confidence in PPE conformance declarations; he said that Congress is best suited to act to fill this gap by identifying a centralized authority.
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Challenges to Nontraditional User Respirator Approval McDiarmid asked about the barriers that might be encountered in extending the "traditional"8 NIOSH approval process for occupational use products to products for nontraditional users. For example, there may be insufficient information about risk assessment for nontraditional users, including risks from the very hazards the products are designed to protect against.
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He added that it is unfortunate that some people believe that using conforming respirators makes a respiratory protection program for the public unnecessary, because history indicates otherwise. Planning committee member Howard Cohen of the Yale School of Medicine said that he gained an understanding from the opening session of the workshop that first a hazard should be identified, then the identified hazard should result in a standard, and finally, CA should be developed for that standard.
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Metzler added that, typically, NIOSH would approve a self-contained breathing apparatus and then NFPA also would have the product certified by a certification organization to ensure that the specific NFPA requirements are met. Role of Federal Agencies in Public Respiratory Protection Planning committee member John Balmes of the University of California, San Francisco, noted NIOSH's central role in CA, certification, and approval of respirators for occupational users and remarked that multiple agencies are currently involved in respiratory protection for the public, including FDA, the Environmental Protection Agency, and the Centers for Disease Control and Prevention.
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Role of NIOSH in Approving Respirators for Use in Health Care Settings A participant asked about FDA's role in the approval processes described by Metzler. Maryann D'Alessandro, the director of the NPPTL at NIOSH, explained that NIOSH approves all respirators that are used in occupational settings.
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