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Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers
1
Introduction
During an influenza pandemic, healthcare workers will be on the front lines delivering care to patients and preventing further spread of the disease. Protecting these workers from illness or from infecting their families or the patients in their care is critical to managing pandemic influenza and limiting morbidity and mortality. Pandemic influenza will place enormous demands on the healthcare system that include protecting healthcare workers at the center of these efforts.
As the nation prepares for pandemic influenza, multiple avenues for protecting the health of the public are being carefully considered, ranging from rapid deployment of appropriate vaccines to quarantine plans should the need arise for their implementation. One vital aspect of pandemic influenza planning is the use of personal protective equipment (PPE)1—the respirators, gowns, gloves, face shields, eye protection, and other equipment that will be used by healthcare workers and others in their day-to-day patient care responsibilities. However, efforts to appropriately protect healthcare workers and their families and patients are greatly hindered by the paucity of data on the transmission of influenza and the challenges associated with training and equipping healthcare workers with effective PPE. Due to this lack of information on influenza transmission, it is not possible at the present time to definitively inform
1
This report defines the term personal protective equipment (PPE) as the equipment that is designed and worn to protect the wearer from exposure to hazardous agents. The term encompasses respirators, gowns, gloves, faceshields, and eye protective equipment as well as some head and shoe coverings. As discussed later in the chapter, the committee does not include medical masks (surgical or procedure masks) as PPE because they are not designed to be used to protect the wearer from hazardous exposures.
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healthcare workers about what PPE is critical and what level of protection this equipment will provide in a pandemic.
Prior to the 1980s, the use of healthcare PPE was largely confined to surgical settings and was primarily intended to protect patients rather than healthcare workers. Although infectious exposures to healthcare workers had long been recognized, with the emergence of HIV/AIDS and the resurgence of tuberculosis in the 1980s, emphasis was refocused on PPE for the protection of healthcare workers in all settings. Standard infection control precautions, advanced by the Centers for Disease Control and Prevention (CDC) in the late 1980s, first defined the spectrum of barrier precautions for the protection of healthcare workers (CDC, 1988). The Occupational Safety and Health Administration (OSHA) bloodborne pathogens standard, finalized in 1991, made these protections mandatory (OSHA, 1991). Most recently, the outbreaks of severe acute respiratory syndrome (SARS) in 2003 have underscored the importance of protecting healthcare workers from infectious agents. The surge capacity that will be required to reduce mortality from a pandemic cannot be met if healthcare workers are themselves ill or are absent due to concerns about PPE efficacy. The increased emphasis on healthcare PPE and the related challenges that are anticipated during an influenza pandemic necessitate prompt attention to ensuring the safety and efficacy of PPE products and their use.
In 2000, the Institute of Medicine (IOM) report To Err Is Human: Building a Safer Health System provided a call to action for building safer healthcare systems and raising the bar for patient safety. In recent years, many healthcare systems have begun extensive efforts to improve the patient safety infrastructure by combating medication and other medical errors as well as incorporating information technology into their management structures. The increased emphasis on patient safety is a strong foundation that should be coupled with an equally strong emphasis on the safety of healthcare workers, including the use of PPE. Ensuring the safety of the healthcare workforce will have additive benefits in reducing the risk of disease transmission to patients and preserving the quality of patient care.
In 2005, the National Personal Protective Technology Laboratory (NPPTL) at the National Institute for Occupational Safety and Health (NIOSH) asked the IOM to form a standing committee to provide strategic guidance in addressing PPE issues for a wide range of workers. One issue that the IOM standing committee and NPPTL deemed of high importance is the topic of this report—enhancing the PPE for healthcare
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workers in the event of pandemic influenza. This report is the result of a 12-month study begun in 2006 and conducted by an ad hoc IOM committee composed of experts in the fields of infectious disease, infection control, public health, occupational safety and health, emergency medicine, emergency response and preparedness, community health, industrial hygiene, internal medicine, and materials engineering.
SCOPE OF THIS REPORT
The IOM committee was charged with examining research directions, certification and the establishment of standards, and risk assessment issues specific to PPE for healthcare workers during an influenza pandemic. The committee was specifically asked to focus on
research needed to understand and improve the efficacy and effectiveness of PPE, particularly respirators, for an influenza pandemic, with attention to improving functionality and addressing human factors such as wearability, compliance, and communications;
necessary certification, testing, and standards development requirements, with attention to clarifying the roles of NIOSH, NPPTL, the Food and Drug Administration (FDA), OSHA, and nongovernmental standards-setting organizations; and
priorities and resources for research and certification efforts.
To accomplish its charge, the committee held three meetings and gathered information through a scientific workshop (Appendix A) that included a public comment session, through discussions with numerous individuals in the infection control and occupational safety and health fields, and by conducting a review of the relevant literature. This report also benefits from the work of prior IOM committees and workshops that have examined issues related to PPE and to pandemic influenza (IOM, 2005a,b, 2006, 2007). Many of the issues related to PPE for healthcare workers are directly relevant to the PPE needs of workers in other occupations, as well as the general public. The committee believes that the recommendations in this report will have a broad impact on improving the quality, relevance, and use of PPE while enhancing the culture of safety in diverse occupations.
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Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers
PPE IN PERSPECTIVE: PANDEMIC INFLUENZA PLANNING
In the United States and across the globe, plans are being developed and investments are being made for a rapid response to an influenza pandemic (DHHS, 2005, 2006a,b, 2007; WHO, 2005; OSHA, 2007b). In part, this has been spurred by increases in avian-to-human transmission of influenza and by concerns—in light of past pandemics, particularly those of 1918, 1957, and 1968—about current underpreparation for the next influenza pandemic. Strategies being implemented include improvements in surveillance and monitoring efforts, enhancements in vaccine production capacity, an analysis of the safety and efficacy of antiviral medications, stockpiling of antiviral medications and other supplies (including PPE), and enhancing medical surge capacity and state and local preparedness, including extensive community planning efforts (Barnett et al., 2005; DHHS, 2006a,b, 2007). Resources necessary for pandemic influenza planning are drawn from local, state, federal, nonprofit, and for-profit organizations and agencies. Extensive training exercises and educational and communications programs have been initiated.
Investment in PPE, particularly respirators, is one area of focus in national planning for an influenza pandemic. The U.S. national planning for medical preparedness stockpiles called for purchases totaling $162 million in 2006 for medical supplies including 50 million medical masks and 50 million N95 respirators (DHHS, 2006a). States and local areas are also purchasing PPE in anticipation of a pandemic. However, because of the prolonged nature of a pandemic, research and development innovations are needed to address issues of equipment reusability and disinfection (IOM, 2006). Further, the challenges involved in the manufacturing surge and the logistics for delivery of PPE to healthcare facilities2 need to be addressed.
Ethical Considerations
In an influenza pandemic, ethical quandaries are likely to be faced, especially as needed supplies become scarce. In addition, priorities will have to be determined regarding the use and distribution of vaccines and
2
The term healthcare facilities is used in this report to encompass all sites of healthcare delivery including hospitals, long-term care facilities, pre-hospital facilities, home care, and private medical and dental offices.
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antiviral medications or the implementation of quarantines. The more that can be done to address issues of priorities for supplies (including PPE) and to anticipate the ethical challenges and the needs of healthcare employers and workers, the better prepared the nation will be for an influenza pandemic.
One ethical issue being discussed in this pre-pandemic planning period is the assessment of risks for healthcare workers.3 The expertise of healthcare workers is an integral and principal component of the response to a pandemic. Heightened work demands and increased chance of exposure to infectious agents will necessitate that healthcare workers and employers evaluate responsibilities with regard to the personal safety of the worker, his or her duty to work, and the safety and care of the employee’s family members. Discussions of these responsibilities point to the need for an ethical framework for pandemic planning that considers the balance of reciprocity, beneficence, and autonomy in decision making.
For employers, and society more broadly, reciprocity includes the responsibility to actively support healthcare workers by providing up-to-date training, equipment, communication measures, and other tools needed to effectively educate, protect, and communicate with workers as they perform their duties to ensure the lowest possible level of risk (Kotalik, 2005). Healthcare organizations should dedicate sufficient resources to ensure that these measures are easily accessible, maintained, and supported by healthcare management. Equal access and culturally competent training are needed for all workers at healthcare facilities who will be expected to come to work and keep the facility running smoothly during a pandemic. Plans should be developed, implemented, and evaluated with substantial input from workers at all levels so that not only direct patient care, but also all aspects of healthcare support efforts that may result in potential opportunities for exposure to infection, are considered.
For healthcare workers the principle of beneficence involves providing care to patients and the obligation on the part of healthcare workers to further the welfare of patients and to advance patients’ well-being. The principle of beneficence is generally accepted as a basic foundation of the patient-provider relationship (Ruderman et al., 2006).
3
The term healthcare workers is broadly defined (as discussed later in the chapter) to include all workers in healthcare offices and facilities including individuals responsible for patient care, food services, facilities maintenance, and administration and those individuals working in home health care and emergency medical services.
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The principle of autonomy in decision making is a substantial factor in risk assessment. This principle implies that when the healthcare organization provides adequate safety and protective measures, the decision to provide patient care should be considered as minimal or low risk for infectious agent transmission and resulting illness. On the other hand, if adequate protective measures are not secured, providing patient care may be considered high risk and should be questioned. In this instance, it is the obligation of the healthcare organization to provide adequate protective measures to safeguard the healthcare worker and workforce. Recommendations have been made to strengthen the ethical codes of healthcare workers to provide guidance as to their responsibilities and rights during high-risk situations (Joint Centre for Bioethics, 2005).
Occupational Safety and Health Context
PPE is an important component in the continuum of safety efforts. Occupational safety and health measures have traditionally followed a hierarchy of controls. Engineering and environmental controls, such as air exchanges or negative-pressure rooms that can isolate the hazard or reduce exposure, are considered the first line of defense against hazardous exposures because they are ubiquitous measures that affect a large number of workers and patients and do not depend on individual compliance (Table 1-1; Thorne et al., 2004; Ulrich et al., 2004). Administrative controls include the policies, standards, and procedures set within an organization to limit hazardous exposures and improve worker safety, including the provision of appropriate and effective protective equipment. At the individual level, responsibilities incumbent on the healthcare worker include appropriate use of PPE as well as adherence to work safety practices.
The selection of specific PPE options for a given task must be determined within the context of the multiple layers of controls. The contribution to disease prevention provided by each of these layers of exposure control (including PPE) is likely to vary considerably based on task and local conditions. All relevant work situations with the potential for infection risk (such as cleaning patient rooms, delivery of food) must be considered in addition to direct patient care. The goal is to develop a
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TABLE 1-1 Examples of Occupational Safety and Health Controls
Engineering and Environmental Controls
Administrative Controls
Personal Protective Equipment and Work Practices
Ventilation—air exchanges
Negative-pressure rooms
Isolation rooms
Anterooms
Filtration
Waste disposal
Cleaning
PPE design
Culture of safety
Availability of PPE
Patient access restrictions
Source control
Policies regarding PPE, vaccination, etc.
Education and training
Enforcement, Supervision
Hand hygiene
Wearing PPE
Vaccination
Antivirals
Adhering to other safety precautions
Encouraging peers to follow safety precautions
continuum of effective safety actions that can be implemented concurrently by healthcare institutions, administrative units, and healthcare workers to protect against workplace hazards.
Although there are research opportunities in each of these areas of controls, it is the purview of this report to focus on PPE and to provide recommendations for improving PPE and its utilization.
HEALTHCARE WORKERS: DEFINING THE SCOPE
More than 13 million workers in the United States (approximately 10 percent of the U.S. workforce) are employed in the healthcare field (Table 1-2; BLS, 2006). The committee broadly defines healthcare workers to encompass all workers employed by private and public healthcare offices and facilities as well as those working in home health care and emergency medical services. The definition would also include health professional students who are working at or receiving instruction in healthcare facilities. As indicated in Tables 1-2 and 1-3, the breadth of the term healthcare workers encompasses professional and support services; includes individuals involved in administration, patient care, and facilities care; and represents individuals working for private- and
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public-sector employers as well as those who are self-employed. The healthcare workforce in the United States is culturally diverse and encompasses a spectrum of educational levels. Further, the employment of many temporary and part-time workers also adds to the challenges and complexity of disseminating information within this job sector.
Offices of physicians, dentists, or other healthcare professionals accounted for approximately 75 percent of the estimated total of 545,000 healthcare establishments in 2004. Those offices employed approximately 25 percent of the 2004 healthcare workforce (BLS, 2006). Hospitals, constituting about 2 percent of the total number of healthcare facilities in 2004, were the largest healthcare employers, employing 41.3 percent of healthcare workers. Nursing and residential care facilities employed 21.3 percent and home health care employed 5.8 percent of the healthcare workforce.
TABLE 1-2 U.S. Healthcare Workers, Location of Employment
2004 Employment (thousands)
Projected Change (% increase) 2004-2014
Hospitals, public and private
5,301
13.1
Nursing and residential care Facilities
2,815
27.8
Offices of physicians
2,054
37.0
Home healthcare services
773
69.5
Offices of dentists
760
31.7
Offices of other healthcare practitioners
524
42.7
Outpatient care centers
446
44.2
Other ambulatory healthcare services
201
37.7
Medical and diagnostic laboratories
189
27.1
Total
13,063
27.3
SOURCE: BLS, 2006.
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TABLE 1-3 Employment of U.S. Healthcare Workers by Occupation, 2004
Occupation
Number (thousands)
Percentage
Total, all healthcare occupations
13,062
100.0
Management, business, and financial occupations
574
4.4
Professional and related occupations
5,657
43.3
Registered nurses
1,988
15.2
Licensed practical and licensed vocational nurses
586
4.5
Physicians and surgeons
417
3.2
Therapists
358
2.7
Diagnostic-related technologists and technicians
269
2.1
Clinical laboratory technologists and technicians
257
2.0
Health diagnosing and treating practitioner support technicians
226
1.7
Social workers
169
1.3
Dental hygienists
153
1.2
Counselors
152
1.2
Emergency medical technicians and paramedics
122
0.9
Dentists
95
0.7
Physician assistants
53
0.4
Service occupations
4,152
31.8
Nursing aides, orderlies, and attendants
1,230
9.4
Food preparation and serving-related occupations
462
3.5
Home health aides
458
3.5
Building cleaning workers
365
2.8
Medical assistants
361
2.8
Personal and home care aides
312
2.4
Dental assistants
257
2.0
Physical therapist assistants and aides
95
0.7
Medical transcriptionists
81
0.6
Office and administrative support occupations
2,379
18.2
NOTE: This table does not list all specific occupations within each category; therefore, totals do not achieve 100 percent.
SOURCE: BLS, 2006.
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The committee acknowledges that in the midst of an influenza pandemic many people outside of the healthcare workforce will become caregivers, including many family members. It is hoped that improvements in PPE for healthcare workers will result in improvements in PPE for other caregiving adults as well.
PERSONAL PROTECTIVE EQUIPMENT FOR HEALTHCARE WORKERS: AN OVERVIEW
The unique characteristics of the healthcare industry regarding use of PPE are important to consider throughout this report. With the goal or “product” of the healthcare industry being human health and well-being, healthcare jobs and exposures involve working with or acting upon another living human being as distinct from an inanimate object or production process. Split-second actions in some healthcare situations can have major consequences and exposure monitoring is not a routine facet of protecting healthcare workers. Thus, although the usual barriers and encumbrances associated with PPE usage (such as communication interference and physical discomfort) are operative, they are compounded by the unique features of patient interaction. Further, there is a strong tradition among healthcare workers and healthcare institutions that the patient’s needs come first. Thus, opportunities are available to incorporate an emphasis on worker safety and to integrate worker and patient safety efforts.
For many healthcare workers, the use of some type of PPE, particularly medical gloves, occurs on a daily basis as part of infection control precautions that are designed to protect both the healthcare worker and the patient from disease acquisition. Varying types of PPE are recommended. The first of the two tiers of infection precautions developed by CDC’s Hospital Infection Control Practices Advisory Committee (Box 1-1; Garner and HICPAC, 1996; Siegel et al., 2007) consists of the standard precautions4 and is designed to protect healthcare workers from
4
Standard precautions apply to the care of all patients and synthesize the major features of universal precautions (designed to reduce the risk of transmission of bloodborne pathogens) and body substance isolation recommendations (designed to reduce the risk of transmission of pathogens from moist body substances) (Garner and HICPAC, 1996). These guidelines apply to potential contact with blood; all body fluids, secretions, and excretions except sweat, regardless of whether or not they contain visible blood; nonintact skin; and mucous membranes.
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BOX 1-1
Overview of PPE Use in Infection Control Precautions
Tier 1—Standard Precautions
Designed as the primary strategy for the prevention of healthcare-associated transmission of infectious agents among patients and healthcare personnel.
Gloves—Wear when touching blood, body fluids, secretions, excretions, mucous membranes, nonintact skin, and contaminated items. Remove gloves promptly after use and follow hand hygiene guidelines.
Mask,5 Eye Protection, Face Shield—Wear to protect mucous membranes of the eyes, nose, and mouth during procedures and patient-care activities that are likely to generate splashes or sprays of blood, body fluids, secretions, and excretions.
Gown—Wear a gown appropriate to the task to protect skin and avoid soiling or contamination of clothing when contact with blood, body fluids, secretions, and excretions is anticipated. Remove gown and perform hand hygiene before leaving the patient’s environment.
Other areas addressed include hand hygiene, cleaning of patient-care equipment and the environment, care and disposal of soiled linens, occupational health protections regarding bloodborne pathogens, and patient placement.
Tier 2—Transmission-Based Precautions
Used in addition to standard precautions. Transmission-based precautions may be combined for protection from diseases with multiple modes of transmission.
Contact Precautions—Intended to prevent the transmission of infectious agents spread by direct or indirect contact with the patient or the patient’s environment. In addition to standard precautions, contact precautions require the following:
Gloves—Wear gloves whenever touching the patient’s intact skin or surfaces and articles in close proximity to the patient. Don gloves upon entry into the room.
Gown—Wear a gown whenever anticipating that clothing will have direct contact with the patient or potentially contaminated environ
5
In discussing the literature on respiratory protection, this report uses the terminology (masks or respirators) employed by the investigators or authors of the cited journal article or report. In some cases, it is not possible to determine whether the authors’ use of the term masks refers to medical masks, respirators, or both.
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formance of a wide range of jobs (e.g., firefighting, automobile painting); as a result, a broad portfolio of respirators have been designed and marketed to meet job specifications. Respirators operate either by purifying the air inhaled by the wearer through filtering materials or by independently supplying breathable air to the wearer. Respirators are also categorized by their basic design, type of filter, resistance to oil, and degree of filtering efficiency (Box 1-2).
The two major issues related to air-purifying respirators are the filter and the fit—the effectiveness of the filter and the extent to which the respirator has a tight seal with the wearer’s face that restricts inward leakage. In addition, for air-purifying respirators the pressure drop is an important factor regarding the wearability of the respirator. Current filters generally work through electrostatically enhanced filtering media
BOX 1-2
Categorizing Respirators
Type of Respirators
Air purifying
Nonpowered—Depend on the wearer drawing air in through filters or cartridges
Powered air-purifying respirators—Use a blower to draw air through the filter and deliver it to the wearer
Air supplying
Self-contained breathing apparatus
Type of Filters
Particulate filters
P (oilproof; can survive oil exposure for more than one work shift)
R (oil resistant; can be used for oil exposure in one shift)
N (not oil resistant; used for oil-free environments)
Gas-vapor respirator
Combination particulate and gas-vapor
Filtering Efficiency
Certified for a range of efficiency classes (e.g., 95, 99, 100 percent)
Type of Facepiece
Filtering facepieces
Replaceable filter components—half-mask and full-mask elastomeric respirators
Loose-fitting facepieces
Use or nonuse of an exhalation valve
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and are tested to determine the percentage of the challenge aerosol concentration that penetrates the filter. To effectively wear most types of air-purifying respirators, prospective wearers must undergo annual fit testing (using qualitative and/or quantitative tests), and they are asked to perform a fit check with each use of the device (see Chapter 3).
Gowns, Gloves, Eye Protection, and Other PPE
Protection of the healthcare worker against infectious disease can also involve gloves,6 eye protection, face shields, gowns, and other protection. For the most part, these products are designed to provide a barrier to microbial transfer with particular attention to protecting the wearer’s mucous membranes. The extent of liquid penetration (or strike-through) is a major issue with gowns and gloves. Comfort and wearability issues include the breathability of the fabric or material and biocompatibility or sensitivity to avoid contact dermatitis and other skin irritations (see Chapters 3 and 4). Issues related to viral survival, penetrance, and reusability remain to be explored as do considerations about how best to integrate the various types of protective equipment to ensure that they work as ensembles (e.g., the respirator and eye protection).
Prevention Strategies for Influenza
The CDC has developed interim safety recommendations for healthcare workers who treat patients in the United States with known or suspected avian influenza (CDC, 2004) and has outlined infection control guidelines for the prevention and control of influenza in acute care and other healthcare facilities (CDC, 2007a,b). As additional information becomes available regarding the mechanisms of influenza transmission (Chapter 2), the guidelines will continue to be refined. Until more is known about this issue, all PPE precautions assuming the highest risk level are urged and should be fully supported by healthcare facilities.
Influenza precautions emphasize the need for healthcare workers to be vaccinated with the most recent seasonal human influenza vaccine. In addition to providing protection against human influenza, vaccination
6
Hand hygiene is another important and effective component of infection control of respiratory diseases (Ryan et al., 2001; White et al., 2003), but is not in the direct purview of this report.
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also avoids the potential for healthcare workers to be co-infected with both human and avian viruses leading to the potential for viral genetic rearrangement and the emergence of a pandemic strain.
CDC recommends that healthcare workers practice standard and droplet infection control precautions for the care of patients infected with human influenza. However, those in contact with patients suspected of having avian influenza are instructed to use additional precautions (such as used for SARS, including airborne precautions and eye protection) because of uncertainty of how the virus may be transmitted between humans. The reasons for additional precautions for avian influenza include the following:
the potential for highly pathogenic avian influenza to cause serious disease and higher death rates may be significantly greater than from human influenza;
each time avian influenza is transmitted to humans, there is an increased chance for the strain to adapt and gain the ability to be transferred more easily to other humans; and
the emergence of a possible pandemic strain could be linked with human-to-human transmission of avian influenza.
OVERVIEW OF RELEVANT AGENCIES AND ORGANIZATIONS
The testing, regulation, and use of PPE for healthcare workers involves a number of government and nongovernmental agencies and organizations. This brief overview is meant to set the context for the report; more details are provided throughout the report, particularly in Chapter 5. In the federal government, occupational health and safety is the responsibility of both the Department of Health and Human Services (DHHS) and the Department of Labor (DoL). The Occupational Safety and Health Act of 1970 created two federal agencies to address worker safety and health: NIOSH (in DHHS) was designated with responsibilities for relevant research, training, and education, and OSHA (in DoL) was designated with responsibilities for developing and enforcing workplace safety and health regulations.
The NPPTL, created as part of NIOSH in 2000, tests and certifies respirators, and conducts and funds research on improvements in PPE and ensembles used in a variety of occupations. NPPTL also plays an
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integral role in standards-setting efforts relevant to PPE. Respirators used by workers in OSHA-regulated workplaces, including healthcare workplaces, must be NIOSH certified. The criteria used by NIOSH to certify respirators are specified in federal regulations (42 CFR 84); certification testing includes laboratory tests of the filter efficiency of respirators. In addition to work on fit testing, NIOSH is working to address issues regarding respirator effectiveness through efforts to establish measures of total inward leakage.
OSHA regulates the use of PPE products in the workplace. For the most part, OSHA regulations relevant to the use of PPE in healthcare workplaces are the same as those that apply to other industries. The one area of regulation that is particularly pertinent to healthcare workers is the OSHA bloodborne pathogens standard (29 CFR 1910.1030). In addition to requiring that respiratory protection be NIOSH certified, OSHA respirator regulations (29 CFR 1910.134) detail employer responsibilities for establishing and maintaining a comprehensive respiratory protection program, including requirements for a risk assessment to be performed to select the proper respirator, users to be fit tested when tight-fitting facepieces are selected, annual training, users to be medically cleared to wear the device, and a program of inspection, cleaning, and disinfection. OSHA also has a general regulatory standard (29 CFR 1910.132) that governs all other forms of PPE. This regulation details requirements for PPE regarding selection of equipment based on the hazard, proper fit of the equipment, and training for workers as to the hazards present and the safe use of the PPE selected. The federal Occupational Safety and Health Act of 1970 encourages states to develop and operate their own job safety and health programs. Currently 22 states and jurisdictions operate plans that cover both private-sector and state and local government employees, while 4 states and jurisdictions cover public employees only (OSHA, 2007a).
Because respirators, gloves, and gowns used by healthcare workers are considered medical devices (as are medical masks), the FDA (in DHHS) has regulatory authority to provide manufacturers with the approval or clearance to market PPE products for use in health care. Manufacturer’s data are reviewed by FDA staff to verify that the product does what it claims to do effectively and is not a safety hazard. For most medical devices, the requirements and processes for medical devices to obtain FDA clearance or approval differ considerably from the FDA drug approval process. Pharmaceutical manufacturers are required to submit data from three phases of preclinical and clinical testing prior to consid-
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eration of any drug for FDA approval. Medical devices are categorized into one of three classes of devices that are subject to differing levels of regulation (see details in Chapter 5). Only the Class III approval process requires the submission of clinical testing data similar to the drug approval process.
Other departments, agencies, and organizations also have a role in testing and improving PPE. The Department of Defense is actively involved in testing and developing PPE for military applications, including health care. The Department of Homeland Security focuses on emergency response PPE and works to coordinate and improve standards and equipment-related issues. The Environmental Protection Agency addresses PPE issues relevant to pesticide exposures and emergency response readiness.
The Consumer Product Safety Commission has oversight responsibilities for products sold in the commercial marketplace including PPE. PPE products that assert protection against a specific health hazard must have FDA approval or market clearance. For any other PPE products sold in the commercial marketplace, there are no requirements stipulating pre-market or other testing prior to their sale to the public. For those products that assert NIOSH certification, NIOSH has the authority to act against mislabeled products.
FDA, OSHA, and other agencies utilize testing methods and performance requirements for PPE that are based on consensus standards developed by voluntary standards-setting organizations such as the International Organization for Standardization, the American National Standards Institute, and ASTM International (see Chapter 5).
FROM CHALLENGES TO OPPORTUNITIES
Preparations for an influenza pandemic have heightened the realization that much remains to be done in order to be adequately prepared to meet this pending public health emergency. Although significant national and worldwide investments have been made in pandemic planning and research, many basic and critical questions remain to be answered.
This report focuses on opportunities for answering the questions relevant to providing protection against potential infection of healthcare workers during an influenza pandemic. Technological advances now available can be applied to influenza research and to research on the design and engineering of PPE in order to better meet the needs of the
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healthcare worker. The three key components of this effort are discussed in depth in this report:
Understanding influenza transmission—Current knowledge is rudimentary regarding the mechanisms and routes of human-to-human influenza transmission (Chapter 2), but with dedicated resources and new technologies, more can be known about the extent of droplet, aerosol, and contact transmission and the optimum ways to prevent transmission.
Making the commitment to worker safety and appropriate use of PPE—Healthcare workers often do not wear the protective equipment needed to ensure that they are adequately protected from exposure to hazardous agents including infectious disease. Strengthening the commitment of healthcare employers to worker safety and enhancing the culture of safety in the workplace involve both an organizational and an individual commitment to the appropriate use of PPE (Chapter 4).
Designing, testing, and certifying effective PPE for the healthcare workforce—Using PPE in a healthcare workplace places specific demands on the design and engineering of these products that are particularly focused on interactions with patients and ensuring that healthcare workers do not become infected and do not transmit infection. An integrated effort is needed to further understand the requirements of healthcare workers and to develop innovative materials and technologies that can meet these needs (Chapter 3). Issues regarding the responsibilities of federal agencies and organizations have to be clarified. Further, increasing the use of the field testing in the pre-market phase and conducting thorough post-marketing evaluations are vital to the development of effective products (Chapter 5).
REFERENCES
Agah, R., J. D. Cherry, A. J. Garakian, and M. Chapin. 1987. Respiratory syncytial virus (RSV) infection rate in personnel caring for children with RSV infections. Routine isolation procedure vs routine procedure supplemented by use of masks and goggles. American Journal of Diseases of Children 141(6):695-697.
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