The Use and Effectiveness of Powered Air Purifying Respirators in Health Care: Workshop Summary (2015)
Chapter: 1 Introduction
Protecting 18 million U.S. health care workers from infectious agents—known and unknown—involves a range of occupational safety and health measures2 that include identifying and using appropriate protective equipment (CDC, 2014a). The 2009 H1N1 influenza pandemic and the 2014 Ebola virus outbreak in West Africa have called attention to the importance of personal protective equipment (PPE)3 in different health care settings and have raised questions about how best to ensure appropriate and effective use of different kinds of PPE (such as respirators), not only to promote occupational safety but also to reduce disease transmission in general.
Since 2005, the National Personal Protective Technology Laboratory (NPPTL) at the National Institute for Occupational Safety and Health (NIOSH) has sponsored the Institute of Medicine (IOM) Standing Committee on Personal Protective Equipment for Workplace Safety and Health.4
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1The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the Institute of Medicine, and they should not be construed as reflecting any group consensus.
2Occupational safety and health programs rely on a well-established hierarchy of control measures aimed at eliminating a hazard or limiting exposures and related risks. This is done through engineering and environmental controls, administrative measures, and personal protective equipment (PPE) and work practices.
3PPE includes respirators, gloves, gowns, eye protection, and face shields.
4This committee provides a forum for discussion of scientific and technical issues relevant to the development, certification, deployment, and use of PPE, PPE standards, and related systems used to ensure workplace safety and health.
Additionally, NPPTL has sponsored multiple IOM reports on PPE, several of which focused on PPE for health care workers in the event of pandemic influenza (IOM, 2008, 2011). In mid-2014, NPPTL asked the IOM to convene a workshop, “The Use and Effectiveness of Powered Air Purifying Respirators in Health Care,” to help prioritize and accelerate NIOSH activities to update certification requirements for powered air purifying respirators (PAPRs). Box 1-1 provides the statement of task for this workshop. A separate planning committee was appointed to organize the workshop, which brought together representatives from federal, state, regional, and local government agencies; health care institutions (including clinics and hospitals); professional associations; device manufacturers; and health worker unions.5
BOX 1-1
The Use and Effectiveness of Powered Air Purifying Respirators in Health Care: A Workshop Statement of Task
An ad hoc committee will plan and conduct a workshop to explore the current state of practices and research related to powered air purifying respirators (PAPRs) and potential updates to PAPR performance requirements in 42 CFR Part 84. Presentations and discussions will highlight current health care practices using PAPRs and outline the research to date on the use and effectiveness of PAPRs in health care settings with a focus on the performance requirements. Research focus will include efficacy, current training, maintenance, supplies, and possible enhancements and barriers to use. Settings will include inpatient, clinic, nursing home, and community (home) settings. The workshop will also explore the strengths and weaknesses of using various approaches to health care PAPR standards (i.e., current standards, the International Organization for Standardization (ISO) respiratory protective device standards, or a consensus standard that could be incorporated by reference or introduced). Workshop participants will:
- Present information on
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- why, where, and how PAPRs are being used in health care;
- the measures and protections that need to be addressed to reduce exposures in health care;
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5The planning committee attempted to include representatives of small and rural hospitals, nursing homes, and home health agencies in the workshop, but those they contacted reported that their institution is not currently using PAPRs.
- actions that need to be taken to ensure PAPRs are properly used in the health care setting, especially as part of the national pandemic preparedness;
- the real and perceived barriers to the use of PAPRs in the health care setting; and
- the benefits of PAPRs in health care settings.
- Explore research and policy directions, including
- Research and/or policy activities with potential for removing or reducing the barriers (real and perceived) that may hamper the use of PAPRs in the health care setting. Include a focus on the option for a lower flow rate unit for health care workers and/or the option for a shorter life battery (e.g., 1-hour or 2-hour unit).
- Comments submitted on the review responses to the National Institute for Occupational Safety and Health (NIOSH) request for information (Federal Register Vol. 79, No. 50, pp. 14515-14517, CDC-2014-0005, Docket number NIOSH-272) and other pertinent information to discuss approaches to remove barriers to the use of PAPRs in health care.
- Strengths and weaknesses of various approaches to modifying the PAPR certification requirements, through
- Use of current NIOSH standards and certification processes
- Potential enhancements to the PAPR certification standard that could be incorporated in 42 CFR 84 to provide improved health care worker protection
- Use of the ISO standards for the certification of health care PAPRs. Specific questions to be discussed regarding the ISO standards include
- If the ISO standards can be incorporated by reference, what scientific studies are available to support the incorporation of the standards as currently drafted?
- What scientific studies are needed to validate the draft standards to address these requirements?
- What safeguards would be necessary to ensure the intended work rates are not exceeded?
The committee will plan and organize the workshop, select and invite speakers and discussants, and moderate the discussions. An individually authored summary of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.
This workshop summary describes the presentations given and the topics discussed. Generally, all text included under a specific presentation is attributable to the individual presenter listed. The workshop discussions with the audience have also been captured throughout this summary. Some material has been rearranged to provide a better flow for readers.
Following this introductory chapter, Chapter 2 summarizes the discussion on current standards and regulations related to PAPRs—the NIOSH standards that must be met for devices to be certified for use in the United States and the standards of the International Organization for Standardization (ISO). The experience of California’s Division of Occupational Safety and Health Administration (Cal/OSHA) also is included. Chapter 3 describes presentations about the experiences of health care and emergency response workers that are relevant to PAPRs as well as the perspectives of employers. The design and research needs for PAPRs intended for use by health care workers are discussed in Chapter 4. The workshop summary concludes in Chapter 5 with a synopsis of the workshop’s major themes and discussions:
- Improve PAPR design and standards by assessing risks and protective factors, identifying desired design attributes, and driving the market to meet health care needs;
- Increase education and training; and
- Strengthen implementation and use of PAPRs in health care.
OPENING REMARKS
In his welcome and introductory remarks, James Johnson, chair of the IOM workshop planning committee and a consultant for JSJ and Associates, noted that the workshop was focused on the health care workplace and challenged the participants to focus on improving PAPRs for use by health care workers by addressing four questions:
- How can PAPRs be better utilized?
- What is preventing them from being utilized?
- How do they need to be changed?
- How might the current PAPR certification standards followed by NPPTL be revised to help improve the equipment and make it more useful to health care?
Linda Hawes Clever, chair of the IOM Standing Committee on Personal Protective Equipment for Workplace Safety and Health and a senior physician at California Pacific Medical Center, said the workshop was meant to be practical, taking into account such considerations as equipment cost and the personnel time needed for respirator fitting and training. She said she hoped the workshop would present information that, when disseminated, could change how PAPRs and other protective respiratory equipment could be used to assure the health and safety of all those who provide health care.
Maryann D’Alessandro, NPPTL, stated that NIOSH anticipated that more information from end users and manufacturers could lead to revised NIOSH certification standards, which could support the development of improved product design and capabilities to meet user needs.6 D’Alessandro further explained that the 1995 National Technology Transfer and Advancement Act (Public Law 104-113) directs federal agencies to work with consensus standards and not to rely solely on existing federal standards in updating regulations. One of the issues the workshop is to address is whether and how to tie respirator certification standards (42 CFR Part 84) to ISO consensus standards.
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6In addition to the IOM workshop, NPPTL sought comments on PAPR standards for health care workers through the Federal Register docket, and some of the workshop presenters noted these comments in their remarks (CDC, 2014b).
