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However, efforts to appropriately protect healthcare workers from illness or from infecting their families and their 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 personal protective equipment. Due to this lack of knowledge on influenza transmission, it is not possible at the present time to definitively inform healthcare workers about what PPE is critical and what level of protection this equipment will provide in a pandemic. 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 IOM committee determined that there is an urgent need to address the lack of preparedness regarding effective PPE for use in an influenza pandemic. Preparing for an Influenza Pandemic : Personal Protective Equipment for Healthcare Workers identifies that require expeditious research and policy action: (1) Influenza transmission research should become an immediate and short-term research priority so that effective prevention and control strategies can be developed and refined. The current paucity of knowledge significantly hinders prevention efforts. (2) Employer and employee commitment to worker safety and appropriate use of PPE should be strengthened. Healthcare facilities should establish and promote a culture of safety. (3) An integrated effort is needed to understand the PPE requirements of the worker and to develop and utilize innovative materials and technologies to create the next generation of PPE capable of meeting these needs.
Personal Protective Equipment for Healthcare Workers
Copyright © 2008 National Academy of Sciences
All right reserved.
ABSTRACT During an influenza pandemic, healthcare workers will be on the front lines delivering care to patients and preventing further spread of the disease. Protecting the more than 13 million healthcare workers in the United States from illness or from infecting their families or the patients in their care is critical to limiting morbidity and mortality and preventing progression of a pandemic. The National Personal Protective Technology Laboratory asked the Institute of Medicine (IOM) to conduct a study on the personal protective equipment (PPE) (respirators, gloves, gowns, eye protection, and other equipment) needed by healthcare workers in the event of an influenza pandemic.
The IOM committee determined that there is an urgent need to address the lack of preparedness regarding effective PPE for use in an influenza pandemic. Three critical areas were identified that require expeditious research and policy action: (1) Influenza transmission research should become an immediate and short-term research priority so that effective prevention and control strategies can be developed and refined. The current paucity of knowledge significantly hinders preventionefforts. (2) Employer and employee commitment to worker safety and appropriate use of PPE should be strengthened. Healthcare facilities should establish and promote a culture of safety. (3) An integrated effort is needed to understand the PPE requirements of the worker and to develop and utilize innovative materials and technologies to create the next generation of PPE capable of meeting these needs. Increasing the use of field testing in the pre-market phase and conducting thorough postmarketing evaluations are vital to producing effective equipment, as is the creation of rigorous federal regulatory and testing requirements. The committee believes that improvements can be made so that healthcare workers will have PPE that provides protection against influenza transmission based on a rigorous risk assessment with solid scientific evidence. The recommendations provided in this report are intended to serve as a framework and catalyst for a national PPE action plan that is an integral part of the overall national plan for an influenza pandemic.
During an influenza pandemic, healthcare workers will be on the front lines delivering care to patients and preventing further spread of the disease. As the nation prepares for pandemic influenza, multiple avenues for protecting the health of the public are being carefully considered, ranging from rapid development 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)-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 from illness or from infecting their families and their 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 personal protective equipment. Due to this lack of knowledge on influenza transmission, it is not possible at the present time to definitively inform healthcare workers about what PPE is critical and what level of protection this equipment will provide in a pandemic. 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 anticipated during an influenza pandemic necessitate prompt attention to ensuring the safety and efficacy of PPE products and their use.
In 2006, the National Personal Protective Technology Laboratory (NPPTL) at the National Institute for Occupational Safety and Health (NIOSH) asked the Institute of Medicine (IOM) to examine issues regarding PPE for healthcare workers in the event of pandemic influenza. 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.
PPE AND HEALTHCARE WORKERS
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 adherence. 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.
More than 13 million workers in the United States (approximately 10 percent of the U.S. workforce) are employed in the healthcare field. 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 the fields of home health care and emergency medical services. 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.
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. The Occupational Safety and Health Administration (OSHA) bloodborne pathogens standard, finalized in 1991, made these precautions mandatory. The recent SARS outbreaks have emphasized the importance of attention to worker safety and PPE. Standard infection control precautions now stipulate specific PPE and other measures for protection against contact, droplet, and aerosol transmission of hazardous agents.
PPE for healthcare workers involves respiratory and dermal protection as well as protection of mucous membranes (e.g., eye protection). Respirators are personal protective devices that cover the nose and mouth (or in some cases, more of the face and head) and are used to reduce the wearer's risk of inhaling hazardous airborne particles. Respirators operate either by purifying the air inhaled by the wearer through filtering materials or by independently supplying breathable air to the wearer. 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 does not permit inward leakage. 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. Respirators worn by healthcare workers not only will protect them, but also may reduce the spread of disease from one patient to another (via the healthcare worker) or from an infected but asymptomatic healthcare worker.
One of the challenges for the healthcare field is to clearly understand the differences between respirators and medical masks as well as their appropriate uses. Medical masks (the term is used in this report to encompass surgical masks and procedure masks) are loose-fitting coverings of the nose and mouth designed to protect the patient from the cough or exhaled secretions of the physician, nurse, or other healthcare worker. Medical masks are not designed or certified to protect the wearer from exposure to airborne hazards. They may offer some limited, as yet largely undefined, protection as a barrier to splashes and large droplets. However, because of the loose-fitting design of medical masks and their lack of protective engineering, medical masks are not considered PPE.
A terminology issue has further confused and blurred the boundary between medical masks and respirators. The term respirator is used in the healthcare field to refer to two different medical devices: (1) the PPE discussed in this report that is used to reduce the wearer's risk of inhaling hazardous substances and (2) the mechanical ventilator device that is used to maintain the patient's respiration following endotracheal intubation. This dual (medical and occupational) use of the term respirator has prompted many healthcare workers to refer to PPE respirators as masks, thereby confounding the important distinctions between medical masks and respirators.
Because medical masks are readily available to healthcare workers and are lower in cost than respirators, but are not designed to provide respiratory protection, there is a need to clearly delineate the differences for healthcare management and workers and to consistently use standard terminology.
Protection of the healthcare worker against infectious disease can also involve gloves, 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 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. Issues related to viral survival on contaminated surfaces and objects, viral penetrance, and reusability remain to be explored as do considerations about how best to integrate the use of the various types of protective equipment to ensure that they work as ensembles (e.g., the respirator and eye protection).
The committee examined the range of issues relevant to healthcare PPE, particularly in planning for a potential influenza pandemic, and developed a set of recommendations2 focused on three major areas requiring action to ensure the safety of healthcare workers:
Understand influenza transmission. Commit to worker safety and appropriate use of PPE. Innovate and strengthen PPE design, testing, and certification.
UNDERSTANDING INFLUENZA TRANSMISSION
Although it has been 70 years since the influenza A virus was discovered and despite the recognition that it can cause yearly epidemics worldwide resulting in severe illness and death, little is known about the mechanisms by which the virus is transmitted between individuals. Debate continues about whether influenza transmission is primarily via the airborne or the droplet routes and the extent of the contribution of the contact route (including contact with blood, fecal matter, or contaminated surfaces). Further, the aerosol-droplet continuum needs to be clarified as soon as possible in order to develop and implement effective prevention strategies. Without knowing the contributions of each of the possible route(s) of transmission, all routes must be considered probable and consequential, and the resources needed for prevention and control strategies cannot be rationally focused to maximize preparedness efforts.
Most of the research on influenza transmission was conducted prior to the 1970s, and there has only recently been a renewed focus on transmission, primarily as a result of new pandemic threats. The ongoing outbreak of H5N1 (avian) influenza among poultry and other birds with occasional transmission to human beings is of major concern because of intriguing parallels between the H5N1 strain and the highly virulent 1918 influenza strain. Should H5N1 or another novel influenza strain acquire the capability of easy human-to-human transmissibility, conservative estimates project several hundred million emergency and outpatient visits, more than 25 million hospital admissions, and several million deaths worldwide. The next pandemic may come from a human or an avian influenza strain; the virulence of the strain will determine its impact on the healthcare system.
Influenza transmission research should become an immediate and short-term research priority so that effective prevention and control strategies can be developed and refined. Moving forward toward the goal of developing effective strategies to prevent the transmission and spread of influenza will require substantial investment in research and dedicated efforts by investigators throughout the world. Since much of the research in this field was conducted 40 to 60 years ago, opportunities abound for building on prior research and applying new technologies including air particle size analyzers (e.g., impactors) and polymerase chain reaction assays, as well as advances in research fields such as aerobiology and mathematical modeling, to the study of seasonal influenza and avian influenza. Knowledge of influenza transmission can be furthered through examinations of natural experiments (e.g., workplace or school closures) involving seasonal influenza outbreaks as well as by a variety of research efforts including challenge studies and volunteer studies. A limited number of research efforts are under way to examine prevention interventions, including the effectiveness of PPE and hand hygiene, as related to seasonal influenza. However, what is missing and needed is a concerted research effort that prioritizes research encompassing the continuum from basic science to epidemiologic investigations and is aimed at fully understanding influenza transmission and informing a wide range of prevention and intervention strategies.
A global research effort focused on influenza transmission and prevention could provide much needed answers in a relatively short time frame. Equally important is the development of the technology and expertise to study pandemic influenza when it occurs. In this time of preparation for an influenza pandemic, the realization of how little is known about critical aspects of the disease should prompt immediate action to coordinate multiple resources and a diversity of research expertise to address the unknowns regarding influenza transmission and prevention.
Recommendation: Initiate and Support a Global Influenza Research Network The Department of Health and Human Services, in collaboration with U.S. and global partners through the World Health Organization, should lead a multination, multicity, and multicenter focused research effort to facilitate understanding of the transmission and prevention of seasonal and pandemic influenza. A global research network of excellence should be developed and implemented that would
Identify and prioritize research questions with suggested possible study designs.
Provide priority funding to support short-term (1 to 3 years) laboratory and clinical studies of influenza transmission and prevention of seasonal influenza with particular focus on the effectiveness of types of PPE. Develop rigorous evidence-based research protocols and implementation plans for clinical studies during an influenza pandemic.
Excerpted from PREPARING FOR AN INFLUENZA PANDEMIC Copyright © 2008 by National Academy of Sciences. Excerpted by permission.
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2 UNDERSTANDING THE RISK OF INFLUENZA TO HEALTHCARE WORKERS....................47
3 DESIGNING AND ENGINEERING EFFECTIVE PPE....................77
4 USING PPE: INDIVIDUAL AND INSTITUTIONAL ISSUES....................113
5 CERTIFYING AND REGULATING HEALTHCARE PPE: DEFINING AN INTEGRATED SYSTEM....................147
6 MOVING FORWARD WITH URGENCY....................169
APPENDIXES A WORKSHOP AGENDA....................173
C PPE-RELATED STANDARDS AND REGULATIONS....................181
D STANDING COMMITTEE ON PERSONAL PROTECTIVE EQUIPMENT IN THE WORKPLACE AND BOARD ON HEALTH SCIENCES POLICY....................183
E COMMITTEE AND STAFF BIOGRAPHIES....................185