Protecting the health and safety of health care workers is vital to the health of each of us. Preparing for and responding to a future influenza pandemic or to a sustained outbreak of an airborne transmissible disease requires a high-level commitment to respiratory protection for health care workers across the wide range of settings in which they work and the jobs that they perform. Keeping health care workers healthy is an ethical commitment both in terms of addressing the occupational risks faced by health care workers and of providing for the continuity of patient care and services needed to maintain the health of individuals and communities. During a public health emergency, challenges will arise concerning the availability of respiratory protective devices (i.e., respirators). In response to respirator shortages during the 2009 influenza pandemic, the Strategic National Stockpile distributed more than 85.1 million disposable filtering facepiece respirators (sometimes referred to as N95s), which was in addition to the inventory that hospitals and other health care facilities already had in stock or had acquired through normal supply chains. Reusable respirators (specifically, reusable half-facepiece elastomeric respirators) are the standard respiratory protection device used in many industries, and they provide an option for use in health care that has to date not been fully explored. The durability and reusability of elastomeric respirators make them desirable for stockpiling for emergencies, where the need for large volumes of respirators can be anticipated.
In 2017 the National Personal Protective Technology Laboratory and the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention requested that the National Academies of Sciences, Engineering, and Medicine conduct a study on the use of half-facepiece reusable elastomeric respirators in health care, which resulted in this report. The National Academies appointed a 16-member
committee that was tasked with exploring the potential for the use of elastomeric respirators in the U.S. health care system with a focus on the economic, policy, and implementation challenges and opportunities.
OVERVIEW OF RESPIRATORY PROTECTION AND ELASTOMERIC RESPIRATORS
Protecting health care workers from workplace risks involves a range of administrative, engineering, and environmental hazard controls designed to ensure workplace safety and to integrate into a larger system of accountability and enforcement. The overarching goals of these controls are to minimize the number of health care workers exposed, to limit the intensity of exposure, and to provide the best available protection. The correct selection and use of personal protective equipment (including respirators) is one component of the continuum of these safety efforts. Respirators are used in health care for a variety of reasons. The most prevalent reason is to protect health care staff from exposure to airborne transmissible diseases. Other uses in health care include protection from the chemical, biological, or radiological hazards associated with emergency response; maintenance activities (e.g., asbestos abatement, mold remediation); laboratory analysis (e.g., microbiology preparations, gross anatomy and tissue preparation); hazardous waste handling; and dealing with hazardous medication. The three types of respirators generally used in health care are
- Disposable filtering facepiece respirators: Often referred to by the health care community simply as N95s, this type of respirator is a half-facepiece respirator in which the facepiece is formed directly from a filter material (i.e., a filtering facepiece). The respirator is designed to be disposable after one use. These respirators may be made up of N95 filter media, but high-efficiency P100 media can also be used in this class of respirators. Fit testing is required.
- Reusable elastomeric respirators: This type of respirator is made from elastomeric materials (flexible polymer materials resembling rubber) and can be cleaned, disinfected, and reused. These respirators have replaceable filters or cartridges with the same filter media noted previously. Fit testing is required.
- Powered air-purifying respirators (PAPRs): The PAPR uses a battery-powered blower to push air through the filter and into a
hood or facepiece. The units are reusable after cleaning and disinfection. For loose-fitting PAPRs, fit testing is not required.
In routine health care, respirators are used relatively infrequently, with most of those uses occurring in emergency care and respiratory care situations. The majority of health care facilities in the United States have opted to provide their health care workers with disposable filtering facepiece respirators, or PAPRs, with some limited use of reusable elastomeric respirators. The committee is aware of only a few health care facilities in the United States that currently use reusable elastomeric respirators either exclusively or primarily. However, given recent concerns about pandemics and emergent diseases and given the potential for supply chain limitations, the options for reusable respirators are being explored.
This report examines two distinct circumstances in which half-facepiece reusable elastomeric respirators could be considered for use in health care settings—routine use and surge use. In routine use, respirators are employed in clinical scenarios—in the absence of notably increased clinical activity—that require the use of a respirator to protect health care workers from airborne contaminants. In surge use, a health care system manages a sudden or rapidly progressive influx of patients at a given point in time. A health care system’s ability to handle such surges is a critical aspect of its ability to provide a safe working environment, and, unfortunately, is often an area of weakness when responding to public health emergencies or other disasters. During a public health emergency response, protecting health care workers from infectious disease transmission is essential, given that these workers provide clinical care to those who fall ill, have a high risk of exposure, are limited in number, and need to be assured of workplace safety.
The nature of health care work, relevant policies and practices, and the current design of reusable elastomeric respirators result in a number of implementation issues that the committee explored, including
- User comfort and tolerability;
- Storage, cleaning, disinfection, and maintenance;
- Medical clearance, fit testing, and respirator issuance;
- Training and education;
- Procurement and supply logistics and emergency stockpiles;
- Safety culture and risk perception; and
- Other issues, particularly respiratory protection in out-of-hospital settings (e.g., home health care, nursing homes), regulatory and policy considerations, and guidelines.
Health care workers spend large percentages of their work hours caring for and interacting with multiple patients who have varying health conditions and who are in a number of separate rooms or other settings. The vast majority of these interactions do not require the use of a respirator, except in the case of workers in specific units (such as a pulmonary unit) or specialized facilities (such as a tuberculosis hospital).
The selection of respiratory protection for use in the workplace considers the type of exposure, the level of protection needed, how the respirator will be used, the materials with which it is constructed, fit characteristics, and the ambient environmental conditions. User-focused considerations, such as the perception of risk and protection and acceptability, are equally critical, as user acceptance is a key determinant of compliance. Understanding the unique perceptions and experiences of the health care user includes consideration of communication and comfort with issues involving temperature discomfort, skin irritation, work of breathing, and carbon dioxide buildup.
A health care facility that decides to use elastomeric respirators would have several options for how those respirators could be distributed to the staff members who need them. An elastomeric respirator could be assigned to an individual, or could be available for the health care worker to select each day from a cart or other central location. Either option poses challenges. From a warehousing perspective (storage prior to use), elastomeric respirators have both advantages and disadvantages. While the elastomeric respirators are bulkier and take up more space per unit in storage than the filtering facepiece respirators, far fewer of the elastomerics are required to meet pandemic needs. In addition, in a surge situation education and training about the need for and use of reusable elastomeric respirators would have to be rapidly implemented, as would just-in-time fit-testing processes.
Key challenges in transitioning to elastomeric respirators would be their cleaning, disinfection, maintenance, and storage. Health care workers are currently accustomed to disposing of filtering facepiece respirators between patients, so the initial implementation of cleaning and disinfection protocols would be challenging. If the cleaning and disinfection is to be done by individual health care workers on their units, there will be chal-
lenges in finding the space for these efforts and also in setting up and maintaining the cleaning and disinfecting stations. If the cleaning and disinfection are to be done in a centralized reprocessing facility, challenges can arise in transporting the respirators to the central location and in storing the clean respirators, as noted in a 2013 study in British Columbia. Issues to take into consideration include cleaning and disinfection solutions and procedures and their compatibility with respirator materials (including straps and filters), the safety and availability of the disinfecting products, the ease and the time requirements of the procedure, and the space needs for the reprocessing procedure.
Only a few studies have examined the costs of stockpiling respirators for a surge event and have found that elastomeric respirators have the lowest costs when considering acquisition and warehousing costs. However, implementation costs, including the cleaning and disinfection of elastomeric respirators or staff training, have not been factored into those analyses. More work needs to be done to determine the total comparative costs of the various types of respirators, including elastomeric respirators, that could be used in a pandemic or other surge situation. The biggest unknown costs are data-driven policy development, staff education and training time, and staff time and supply costs for cleaning, disinfection, and maintenance. However, given the wide cost differences in the estimates that have been done, the stockpiling and use of elastomeric respirators could be a cost-effective option with further economic analyses needed of total costs.
Manufacturing and Supply Chain
Health care is one sector of a much larger—primarily, industrial—market for respirators. It is estimated that more than 5 million workers are required to wear respirators in 1.3 million U.S. workplaces. The production capacity for respirators, particularly the U.S.-based capacity, will be a major concern in a public health crisis, particularly a crisis in which there is global demand for respiratory protection. As noted by the authors of a review of lessons learned from recent public crises:
A significant proportion of the respiratory protective device supply chain is produced offshore and may not be available to
the U.S. market during a public health response because of export restrictions to the United States or the nationalization of manufacturing facilities, which may favor in-country rather than foreign demands. (Patel et al., 2017, p. 245)
Thus, in a global emergency situation, respirator supplies might be quite limited, and it will take time for U.S.-based manufacturing to gear up to meet the demands. Additionally, global suppliers play a role in the supply of the raw materials needed to manufacture respirators.
Adding to the supply concerns is the lean supply management approach used by many health care facilities, which rely on just-in-time supply chains that deliver products, including respirators, when needed, resulting in little excess inventory to deal with an emergency situation. Health care facilities often do not have the capacity to store large quantities of supplies, and the storage space they do have is needed for a wide variety of products and devices. In the 2009 pandemic, the manufacturing and supply chain limitations quickly became apparent when orders for disposable filtering facepiece respirators rapidly spiked and created a 2- to 3-year backlog.
One of the challenges in emergency planning has been the lack of clarity on the nature and extent of the responsibilities that private-sector health care organizations and federal and state government agencies each have regarding the stockpiling of respirators and other personal protective equipment (PPE). Additionally, health care systems and facilities do not have information on the specific makes, models, and sizes of the respirators that are in the federal stockpile—information that would be helpful to better plan for transitions during surge situations. If it became possible to know the types of respirators and the specific models in the stockpiles, staff could be fit tested and trained on those specific respirators, and the transition would be expedited. Finding out this information in the midst of a pandemic or other crisis puts additional strains on what will be an already heavily burdened workforce.
The committee explored a wide range of scientific and implementation issues regarding reusable elastomeric respirators and carefully examined
the challenges and benefits of these respirators (see Table S-1), including consideration of the
- Demonstrated efficacy of reusable elastomeric respirators, and
- Extent of feasibility of clinical implementation, particularly regarding
- User comfort and tolerability;
- Patient perceptions;
- Cleaning, disinfection and maintenance;
- Fit and fit testing;
- Value analysis (cost, storage, etc.);
- Contribution to a culture of safety; and
- Potential for incorporation into education and training programs.
The adoption of reusable elastomeric respirators in routine use—even in selected settings—could increase institutional and staff familiarity with the devices and facilitate successful adoption during a surge event. Respiratory protection programs would be able to use the existing fit-testing process to fit test employees for both disposable filtering facepiece respirators and reusable elastomeric respirators. Existing training materials would be in place and could be expanded to all affected employees. Cleaning and disinfection protocols would need to be refined and standardized. This may prove to be the largest hurdle, but it is one that could be overcome with some sustained research and standardization efforts.
Based on the decision factors listed above, the committee carefully considered the evidence and offers the following conclusions:
Conclusion 1: Efficacy of Reusable Elastomeric Respirators
The committee concludes that research studies in controlled laboratory settings have demonstrated the efficacy of reusable elastomeric respirators.
Conclusion 2: Routine Use of Elastomeric Respirators
The committee concludes that reusable elastomeric respirators could be a viable option for respiratory protection programs for routine use in health care when logistic and implementation challenges are addressed, including education, training, cleaning, disinfection, and storage challenges. Advantages of integrating reusable elastomeric respirators into day-to-day practice and regular training would include the increased familiarity of staff with these respirators and the implementation and continued improvement of policies and practices for
cleaning, disinfection, and maintenance, leading to better preparedness in the event of the need for broader use during an emergency or pandemic situation.
Conclusion 3: Surge Use of Elastomeric Respirators
The committee concludes that reusable elastomeric respirators could be a viable option for use as needed in surge situations (e.g., influenza pandemic, airborne transmissible disease outbreak, unknown hazard) when logistic and implementation challenges are addressed, including challenges related to cleaning, disinfection, and storage, as well as just-in-time fit testing and training for staff unfamiliar or untested for these respirators. A smooth transition to surge use would be expedited and enhanced if reusable elastomeric respirators were a part of the health care facilities’ day-to-day respiratory protection program.
Conclusion 4: Health Care Needs Regarding Respirator Protection The committee concludes that addressing the respiratory health needs of health care workers—across their wide range of settings and jobs (including home health caregivers, rural clinic personnel, outpatient emergency medical personnel, food and custodial staff, nursing home staff, and hospital staff)—will require the design of innovative reusable respirators and the implementation of robust respiratory protection programs. These needs include taking into account the distinctive characteristics of the health care workplace, including patient care responsibilities (i.e., multiple patients with varying health conditions); sudden and non-routine need for respiratory protection; and the possibility of needing to address unknown, potentially lethal, and highly transmissible infectious agents.
Conclusion 5: Implementation Gaps
The committee concludes that urgent action is needed to resolve gaps in knowledge and leadership on reusable respiratory protection in order to protect the health and safety of health care workers, particularly in an influenza pandemic or an epidemic of an airborne transmissible disease. The gaps include the
- Need for innovation and design of reusable respirators for use by health care workers, with attention given to communication, comfort, and wearability concerns, and ease of maintenance;
- Lack of standardized processes for the cleaning and disinfection of reusable respirators;
- General lack of knowledge among health care workers and leaders about the transmission of airborne infectious diseases and about protective equipment (e.g., droplet versus aerosol pathways for airborne transmission, differences between respirators and medical masks);
- Need for estimates of the total costs of using reusable elastomeric respirators including costs of training, cleaning, disinfection, and maintenance and comparisons of total costs of using other types of respiratory protection;
- Paucity of education programs, training materials, and strategies for change that focus on both basic routine use and transitions from routine to surge situations for respiratory protection;
- Need for harmonized and consistent guidance and standards by regulatory and policy-making authorities that include clear direction on the level of respiratory protection needed and on the stockpiling responsibilities of government and private-sector organizations;
- Need for collaborative efforts by health care management and workers to considerably improve the monitoring and championing of respiratory protection in clinical care across the wide range of health care settings and professions in routine health care and surge situations;
- Need for well-integrated and comprehensively evaluated implementation plans for transitioning between regular and surge use of respirators and between types of respirators;
- Need for established accountability policies for each facility’s respiratory protection program that include responsibilities of health care leaders, including administrators and managers, health care workers, infection prevention and control specialists, and occupational health and safety professionals; and
- Incomplete information for health care facilities concerning stockpiling expectations and the make and model of respirators stored in state and federal stockpiles.
NEXT STEPS AND RECOMMENDATIONS
The committee sees potential long-term value in the use of elastomeric respirators both during routine use and during public health emergencies; therefore, it has developed the following set of recommendations to promote their use and protect health care workers and, as a result, improve patient care. The committee reaffirms the recommendations in the 2008 Institute of Medicine study covering all types of PPE and presents the following recommendations. The committee’s conclusions and recommendations focus on reusable elastomeric respirators, but given the task of exploring the feasibility of these respirators in health care settings, broader issues of respiratory protection for health care workers are integral to these discussions and are also addressed.
Incentivize and Conduct Research
Respiratory protection and its implementation in the health care field continue to evolve and will require extensive research and development efforts. Currently there is a dearth of knowledge on many aspects of respiratory protection for health care workers. Lessons learned and research done to support respiratory protection in a number of industries (see Chapter 2) have helped inform the use of respirators in health care, but much remains to be learned about how to address the unique circumstances found in health care. As noted earlier, the nature of health care work includes providers being responsible for multiple patients with varying health conditions and therefore needing to prevent transmission between and among patients and providers; the sudden and non-routine need for respiratory protection; the possibility of needing to address unknown and potentially lethal and highly transmissible infectious agents; and the absence of an “industry standard” protocol ensuring that health care workers are allowed to perform their jobs only if they conform to the safety requirements associated with the job. There are currently gaps in knowledge in a number of areas, ranging from the basic science of the transmission of many airborne diseases to design and technology innovations in respirators, especially reusable elastomeric respirators, and to improved fit, degree of protection, and ease of use. Incentives to innovate and move beyond current technologies and designs are critical for increasing compliance with the use of these devices and thereby enhancing the health and safety of health care workers at all times and in all health care settings. This work could be conducted effectively and efficiently through a national
collaboration of health care facilities working with university partners, government agencies, and other relevant organizations.
Recommendation 1: Expand Research to Improve Respiratory Protection
The National Institute for Occupational Safety and Health and the National Center for Immunization and Respiratory Diseases of the Centers for Disease Control and Prevention, and the Biomedical Advanced Research and Development Authority—working in collaboration with manufacturers, researchers, infection prevention and occupational safety and health professional organizations, and other relevant agencies and organizations—should expand their support for and conduct of research on respiratory protection and reusable elastomeric respirators in the following areas for the ongoing improvement of respiratory protection for health care workers. This research should involve the collaborative efforts of a nationwide network of health care facilities that can address the research gaps, expand and refine the results for underserved health care settings, and share lessons learned and best practices.
Infection Risk Research for Hazard Assessment
- Determine and better understand the relative contribution of the routes of transmission for potentially airborne transmissible pathogens to underpin and improve hazard assessment in health care to ensure proper respiratory protection;
Cleaning and Disinfection Research
- Identify and disseminate guidance and standards for cleaning and disinfecting reusable respirators (including cleaning and disinfection agents that are mycobacterial, viral, and sporicidal) without damaging the integrity of the devices and degrading their performance;
- Develop and evaluate practical and effective cleaning, disinfection, and maintenance processes, systems, and equipment for reusable respirators that could be implemented for routine use and could be
rapidly deployed for emergency use in health care environments;
Respirator Research and Development
- Develop the next generation of reusable respirators to meet the needs of health care workers as informed by prior research (e.g., Project BREATHE), including but not limited to innovative materials and designs to enhance comfort (including the weight of the device, CO2 buildup, temperature, work of breathing); ease of cleaning and disinfection; communication intelligibility while speaking; attention to visual aesthetics to enhance patient perceptions and interpersonal interactions; individual fit customization; sensors to detect breaches and provide notifications concerning end of service life; and potentially disposable pre-filters to minimize cross-contamination;
- Develop and evaluate rapid fit-test methods and new user seal-check training methods for reusable respirators, including exploring new technologies that provide an indicator of the quality of the fit;
- Standardize respirator sizing parameters among manufacturers to facilitate fit testing, with attention to seamless and rapid transitions to products from different manufacturers during a health care crisis;
- Conduct research to understand the barriers to market entry for a health care–specific, reusable respirator;
- Develop robust value-analysis processes for decisions on respirator purchases that include inter-professional decision making and input from manufacturers and product distributors;
- Develop total cost estimates for reusable elastomeric respirators (including purchase, storage, cleaning, training, fitting, use) to compare with total cost estimates of other types of respirators;
Behavior and Safety Culture Research
- Evaluate clinical programs that use reusable elastomeric respirators to more fully understand their processes and identify effective practices;
- Using implementation science methods and information, develop and evaluate best practices to improve adherence to respiratory protection by health care workers (this should include collaborative leadership, management, worker, and union decision making; practice champions) during routine use across the range of health care settings and jobs;
- Develop, implement, and evaluate best practices, implementation strategies, and integrated transition plans to ensure the health and effectiveness of the health care workforce through rapid transitions to new products and proper use of respirators during emergencies (rapid fit testing, just-in-time training, etc.);
- Build on existing research about health care worker attitudes, knowledge, and perceptions on the use of respirators with a focus on the use of elastomeric respirators in various work settings.
Effective Respiratory Protection Programs, Training, and Education
The primary goal of a respiratory protection program is to ensure the safety of the health care worker either during the routine care of patients or during a public health emergency triggered by a pandemic or other airborne transmissible disease outbreak. An effective respiratory protection program should be viewed as a continuum of safety that begins with engineering/environmental controls and administrative controls and ends with the individual’s personal protective equipment. What makes respiratory protection efforts effective is a function of the efficacy of the respirator; the compliance by health care workers including organizational monitoring, which is driven by the culture of safety in the organization and its leadership; and the organization’s commitment, which is driven by the logistics and economics of the program. All these facets must come together for the successful protection of health care workers in clinical settings both
during regular operations and during public health emergencies. There has been little attention paid to reusable elastomeric respirators or to exploration about how to engage the health care workforce in respiratory protection education and training. Such engagement is critical to ensure the health and safety of health care workers at all times, especially in the event of a public health emergency.
Recommendation 2: Ensure Robust Respiratory Protection Programs and Training
The leadership of health care facilities, professional associations, professional schools (including continuing education programs), and accrediting and credentialing organizations (working in collaboration with the National Institute for Occupational Safety and Health and other parts of the Centers for Disease Control and Prevention [CDC], the Occupational Safety and Health Administration [OSHA], the Joint Commission, health care workers, and other relevant stakeholders) should ensure that ongoing education and training for robust respiratory protection programs, including on the use of elastomeric respirators for health care workers, are a high priority for health care workers, managers, and leaders; that compliance is actively monitored; and that respiratory protection is championed and financially well supported across the range of health care institutions and settings. To implement this recommendation,
- Health care professional associations, professional schools (including continuing education programs), and accrediting and credentialing organizations (in collaboration with infection prevention and occupational health and safety professional organizations) should adopt, implement, and evaluate a set of core competencies in respiratory protection that include reusable respirators as an integral component of new and updated respiratory protection curricula and should ensure that training and education programs, at all levels and across work settings, equip health care workers to meet those competencies;
- Health care employers, managers, and workers—working with CDC, OSHA, the Joint Commission, and
- professional associations—should champion the importance of respiratory protection programs, especially involving the use of reusable elastomeric respirators, and support the use of new models for building a workplace safety culture, such as the use of practice champions, to normalize the use of respiratory protection;
- CDC, relevant professional associations, health care employers, and clinical leadership should develop appropriate mechanisms, including a network of health care respiratory protection program managers and other leaders, to share best practices in respiratory protection within facilities, across regions, and across the nation, with the goal of ensuring the health and safety of health care workers across all settings including currently underserved settings (e.g., home health care, some rural facilities, nursing homes).
Ensure Rapid and Seamless Implementation
In examining the use of reusable elastomeric respirators the committee noted not only the potential benefits that these respirators could bring to the health care field but also the current challenges for implementation, including cleaning, disinfection, and maintenance, and the disparities in preparedness among hospitals. With a focus on public health preparedness and on the health and safety of all health care workers, efforts are needed to improve the adoption and implementation of reusable respirators by reducing the variances and harmonizing the standards and guidelines. Without attention to this issue, facilities may be ill prepared to respond to a respiratory disease pandemic that exhausts respirator supplies and could put the safety of health care workers and the care of patients at risk.
Recommendation 3: Harmonize Standards and Clarify Guidelines and Responsibilities
The Centers for Disease Control and Prevention, including the National Institute for Occupational Safety and Health and the National Center for Immunization and Respiratory Diseases, Occupational Safety and Health Administration, the U.S. Food and Drug Administration, staff of the Strategic National Stockpile, and state-level regulatory and stockpile entities—in
conjunction with manufacturers, standards-setting organizations, health care facilities, health care professional associations, and other relevant stakeholders—should support the harmonization of guidance and operating procedures for the use of elastomeric respirators in the health care setting. To implement this recommendation,
- Standardize and clearly communicate respiratory protection and infection prevention guidance from international, national, state, and local public health authorities in the event of an influenza pandemic or other public health crisis (i.e., who in the health care facility should use respiratory protection and in what circumstances and what level of protection is to be used) for all types of workers in health care facilities;
- Provide clear, practical, and standardized guidance on effective cleaning and disinfection processes for reusable respirators, including harmonizing manufacturers’ recommendations for cleaning and disinfection without damaging the integrity of the device; and
- Clarify and broadly communicate the expectations and responsibilities for emergency preparedness stockpiling of respirators among federal, state, and private-sector agencies and entities and provide health care facilities with information as to the makes and models of respirators in stockpiles.
Although this report is focused on one type of respiratory protective device—half-facepiece reusable elastomeric respirators—the paramount issues are much broader and center on ensuring the safety and health of health care workers and the continuity of high-quality patient care. Health care has long been acknowledged as a profession with potential dangerous and life-threatening risks. Therefore, there is an ethical imperative to improve and ensure health care worker safety and health.
Patel, A., M. M. D’Alessandro, K. J. Ireland, W. G. Burel, E. B. Wencil, and S. A. Rasmussen. 2017. Personal protective equipment supply chain: Lessons learned from recent public health emergency responses. Health Security 15(3):244–252.