Summary

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)1 (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 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

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 protection as well as some head and shoe coverings. As discussed in the report, 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.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 1
Summary 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 Pro- tective Technology Laboratory asked the Institute of Medicine (IOM) to conduct a study on the personal protective equipment (PPE)1 (respira- tors, 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 ad- dress the lack of preparedness regarding effective PPE for use in an influenza pandemic. Three critical areas were identified that require ex- peditious 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 appropri- ate 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 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 protection as well as some head and shoe coverings. As discussed in the report, 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. 1

OCR for page 1
2 PREPARING FOR AN INFLUENZA PANDEMIC and utilize innovative materials and technologies to create the next gen- eration of PPE capable of meeting these needs. Increasing the use of field testing in the pre-market phase and conducting thorough post- marketing 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 trans- mission 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 hin- dered 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 knowl- edge 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 infec- tious 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 empha- sis 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.

OCR for page 1
3 SUMMARY 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 re- garding 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 is- sues 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 hazard- ous exposures because they are ubiquitous measures that affect a large number of workers and patients and do not depend on individual adher- ence. 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 effec- tive 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 medi- cal 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

OCR for page 1
4 PREPARING FOR AN INFLUENZA PANDEMIC infection control precautions, advanced by the Centers for Disease Con- trol and Prevention (CDC) in the late 1980s, first defined the spectrum of barrier precautions for the protection of healthcare workers. The Occupa- tional Safety and Health Administration (OSHA) bloodborne pathogens standard, finalized in 1991, made these precautions mandatory. The re- cent SARS outbreaks have emphasized the importance of attention to worker safety and PPE. Standard infection control precautions now stipu- late specific PPE and other measures for protection against contact, droplet, and aerosol transmission of hazardous agents. PPE for healthcare workers involves respiratory and dermal protec- tion 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 oper- ate 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 leak- age. 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 en- compass 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

OCR for page 1
5 SUMMARY 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 intuba- tion. 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 pro- tection. 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 re- quiring 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 dis- covered and despite the recognition that it can cause yearly epidemics 2 The full details of the recommendations are provided in the body of the report.

OCR for page 1
6 PREPARING FOR AN INFLUENZA PANDEMIC worldwide resulting in severe illness and death, little is known about the mechanisms by which the virus is transmitted between individuals. De- bate 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 contami- nated 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 trans- mission, 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 in- fluenza 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 in- fluenza. 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 num- ber of research efforts are under way to examine prevention interventions,

OCR for page 1
7 SUMMARY including the effectiveness of PPE and hand hygiene, as related to sea- sonal 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 pre- vention and intervention strategies. A global research effort focused on influenza transmission and pre- vention could provide much needed answers in a relatively short time frame. Equally important is the development of the technology and ex- pertise 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 exper- tise 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 collabo- ration with U.S. and global partners through the World Health Organization, should lead a multination, multicity, and multicenter focused research effort to facilitate under- standing 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 sug- gested 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.

OCR for page 1
8 PREPARING FOR AN INFLUENZA PANDEMIC COMMIT TO WORKER SAFETY AND APPROPRIATE USE OF PPE Because PPE works by acting as a barrier to hazardous agents, healthcare workers face challenges in wearing PPE that include difficul- ties in verbal communications and interactions with patients and family members, maintaining tactile sensitivity through gloves, and physiologi- cal burdens such as difficulties in breathing while wearing a respirator. For healthcare workers this may affect their work and the quality of in- terpersonal relationships with patients and family members. Despite expert recommendations and high-risk conditions, healthcare workers often do not wear PPE in situations that warrant its use. Al- though the use of PPE is often examined by observational studies or survey questionnaires of individual workers, assessments of the explana- tions for noncompliance and the solutions to these issues need to focus beyond the individual and address the institutional issues that prevent, allow, or even favor noncompliance. Improving worker safety necessi- tates an organization-wide dedication to the creation, implementation, evaluation, and maintenance of effective and current safety practices—a culture of safety. An institutional commitment to a culture of safety es- tablishes systems, policies, and practices to ensure that safety is the highest priority of the organization. The purpose of developing and in- stilling a culture of safety in the workplace is to promote habitual safety practice. Employees should feel uncomfortable when not wearing PPE during appropriate situations, and supervisors should reinforce the im- portance of PPE and enforce policies so that noncompliance is the rare exception and not the rule. Safety protocols should be mandatory and exceptionless. A positive work safety culture has been described as a just culture, a learning culture, a reporting culture, and a flexible culture. Each health- care employer should assume responsibility for taking an active role in facilitating, promoting, and requiring safety actions. Healthcare facilities need to foster and promote a strong culture of safety that includes a commitment to worker safety, adequate access to safety equipment, and extensive training efforts that utilize protocols requiring specific safety actions and detailing the consequences for noncompliance. For a culture of safety to work effectively and completely, all members of the health- care facility should participate in its maintenance. The focus on fostering and promoting a culture of worker safety in the healthcare workplace and the intersections of patient and worker safety are areas currently being

OCR for page 1
9 SUMMARY explored and emphasized, and further research is needed as is the dis- semination of best practices. Key components in promoting a culture of safety in healthcare facili- ties include providing leadership and commitment to worker safety; emphasizing education and training; improving feedback and enforce- ment of PPE policies and use; and clarifying work practices and policies. A concerted effort is needed to identify best practices in infection control and disseminate this information to all sites where health care is provided. These best practices could increase worker and patient safety and have positive ramifications well beyond preparedness for an influenza pandemic. Recommendations: Emphasize Appropriate PPE Use in Patient Care and in Healthcare Management, Accreditation, and Training Appropriate PPE use and healthcare worker safety should be a priority for healthcare organizations and healthcare work- ers, and in accreditation, regulatory policy, and training. Identify and Disseminate Best Practices for Improving PPE Compliance and Use CDC and the Agency for Healthcare Research and Quality (AHRQ) should support and evaluate demonstration projects on improving PPE compliance and use. This effort would identify and disseminate relevant best practices that are be- ing used by hospitals and other healthcare facilities. Increase Research and Research Translation Efforts Relevant to PPE Compliance NIOSH, the National Institutes of Health, AHRQ, and other relevant agencies and organizations should support research on improving the human factors and behavioral issues re- lated to ease and effectiveness of PPE use for extended periods and in patient care-interactive work environments.

OCR for page 1
10 PREPARING FOR AN INFLUENZA PANDEMIC INNOVATE AND STRENGTHEN PPE DESIGN, TESTING, AND CERTIFICATION An integrated life-cycle approach is needed for healthcare PPE prod- ucts. From the design of PPE that takes functionality, wearability, and other factors into account, to pre-market testing that examines the types of wear and tear and use of PPE in the workplace, through post- marketing evaluations of actual use in healthcare facilities, healthcare PPE needs to be considered an essential component of worker safety with concomitant resources devoted to the research and development efforts essential for the comprehensive protection of healthcare workers. The design and development of PPE are influenced by four key fac- tors: regulation, degree of protection, comfort, and cost. Since meeting the regulatory standards is mandatory and not optional, the design and development of PPE often involve major compromises while attempting to simultaneously achieve a maximal degree of protection with the high- est level of comfort and at the lowest possible cost. For example, the degree of protection provided by protective clothing, such as a gown, can be considerably enhanced by the use of polyethylene film without sub- stantial additional expense, but at a significant loss of comfort for the user. On the other hand, a high degree of protection and comfort can be achieved, but at a much higher cost, by using a breathable, impervious, nonwoven material. Thus, although materials and manufacturing tech- nologies exist that can maximize any one design factor, designing a product to achieve the appropriate balance is ultimately dictated by the requirements of the end user (Figure S-1). In developing evidence-based performance requirements, the ideal data acquisition process would involve use of the PPE component in the field and assessing the requirements; however, in the event this is not feasible, the data acquisition process should, at the very least, simulate the real-world usage of the specific component of the PPE ensemble. Effective PPE will save lives, just as other critical medical devices such as pacemakers or defibrillators do. In this era of working toward preparedness for a pandemic, it is important to examine the level of rigor employed to ensure that all forms of PPE are deemed to be safe and ef- fective medical devices. The committee believes that more rigorous pre- market testing is needed to ensure that healthcare PPE products demon- strate functionality and usability in the clinical setting for which they are designed. These products should undergo testing to meet evidence-based

OCR for page 1
11 SUMMARY Evidence-Based Performance Requirements Functionality Usability Comfort and Wearability Durability • Protect against • Maintain biomechanical • Comfortable—no skin • Adequate wear life • Strength—tear, influenza virus efficiency and sense of touch irritation or pressure • Guard against and feel points tensile, burst • Odor-free • Abrasion resistance • Prolonged use contact with • Hypoallergenic • Corrosion contaminated without discomfort • Accommodate wide range of • Breathable—air resistance fluids and aerosols users (face and body profiles) permeable • Compatability across various • Moisture absorbent— elements of the PPE wickability • Low bulk and weight ensemble and with other • Dimensional stabiltiy equipment (e.g., stethoscope) • Non-startling to patients and • Easy to put on and families take off (don and doff) • Facilitates communication with others (verbal, facial) Cost • Product cost Maintenance and Aesthetics • Total life-cycle Reuse • Variety of styles cost • Easy to • Minimal environ- and colors • Customizable decontaminate and mental impact discard disposable elements • Easy to clean and replace parts in reusable PPE FIGURE S-1 A structured approach to evidence-based performance requirements. performance requirements under conditions of normal clinical use; issues to be examined include acceptability to workers and usability along with specific performance testing (e.g., fit testing, protection factor testing). Post-marketing evaluation of healthcare PPE products should be carried out through a range of approaches in multiple types of healthcare settings and including workers performing a full range of common high-exposure tasks. Comparison studies or ratings systems are needed to provide in- formation to purchasers on the effectiveness and wearability ratings of PPE products. Studies should be conducted that evaluate the effective- ness of PPE products in the workplace. Of particular importance are studies of the effectiveness of PPE use during outbreaks and epidemics of seasonal influenza. The varied regulatory, certification, and evaluation requirements for healthcare PPE have largely evolved in a fragmented manner and without a focus on exposures of healthcare workers to infectious agents. Respira- tors have a long history in NIOSH certification efforts, and much of the focus for those efforts has been on industrial exposures, particularly to

OCR for page 1
12 PREPARING FOR AN INFLUENZA PANDEMIC dusts and chemicals. PPE regulations by the Food and Drug Administra- tion (FDA) and OSHA specifically related to healthcare settings are largely focused on protection against bloodborne pathogens or on splash and body fluid protection appropriate for the surgical setting. While each of the federal agencies has a distinct and vital role in en- suring the use of effective PPE, there is a strong need for a coordinated effort to ensure harmonization of requirements and to focus on coordinat- ing the entire process from product design to use in the workplace. NIOSH, through NPPTL, is well suited to ensuring this integrated ap- proach. NPPTL has the specialized expertise relevant to PPE. Additional resources are needed to extend its partnering initiatives with other agen- cies and organizations and with academia and manufacturers. In working on its charge to examine PPE for healthcare workers in the event of an influenza pandemic, the committee became aware of sub- stantial gaps in knowledge regarding the design and implementation of PPE for family members and others who will provide care to influenza patients during a pandemic or who wish to use preventive measures to avoid influenza transmission. For example, challenges and considera- tions for the next generation of respiratory protection appropriate for use by the general public will need to take into account the benefits of mini- mizing or negating the need for fit testing, the issues involved in protecting people with a range of face sizes (including children), as well as issues regarding respiratory protection for individuals with respiratory diseases or impairment. Further, the committee recognized the limited oversight of PPE sold in the retail marketplace, which is often the loca- tion for purchases by home healthcare workers in addition to the general public. The need for coordinated and focused efforts to address these gaps is critical to moving forward in planning for an influenza pandemic. Although it is beyond the purview of this report to provide recommenda- tions on these issues, the committee wishes to express its view that further attention to these issues is needed. Opportunities to improve the effectiveness of PPE products for the healthcare workplace, particularly regarding an influenza pandemic, will involve addressing several critical issues: • meeting the unique needs of the healthcare industry, • filling the gaps regarding PPE sold in the retail marketplace, • strengthening and coordinating testing and regulatory efforts, and

OCR for page 1
13 SUMMARY • promoting innovative approaches to the design and development of healthcare PPE. Recommendations: Define Evidence-Based Performance Requirements (Prescrip- tive Standards) for PPE NIOSH, through the NPPTL, in collaboration with extramu- ral researchers, manufacturers, and regulatory agencies, should define a set of evidence-based performance require- ments or prescriptive standards for PPE to facilitate their design and development that optimally balances the cost, comfort, and degree of protection of PPE and enhances the compliance with their use in the field. Adopt a Systems Approach to the Design and Development of PPE NIOSH should promote a systems approach to the design, development, testing, and certification of PPE using evidence-based performance requirements or prescriptive standards and fostering closer collaboration between users, manufacturers, and research and regulatory agencies. Increase Research on the Design and Engineering of the Next Generation of PPE NIOSH, the Department of Homeland Security, the Depart- ment of Defense, manufacturers, and other relevant organizations and agencies should fund research directed at the design and development of the next generation of respira- tors, gowns, gloves, and eye protection for healthcare workers that would enhance their safety and comfort. Establish Measures to Assess and Compare the Effectiveness of PPE NIOSH, through NPPTL, should develop and promote a vali- dated set of measures for comparing the effectiveness of PPE products. The goal is a set of measures that would allow us- ers to compare and select appropriate PPE commensurate with the assessed risk and desired level of protection. Par- ticular attention should be paid to disseminating information

OCR for page 1
14 PREPARING FOR AN INFLUENZA PANDEMIC to healthcare workers on PPE effectiveness relevant to influenza. Ensure Balance and Transparency of Standards-Setting Processes Federal agencies (e.g., FDA, NIOSH, OSHA) should use stan- dards developed through a consensus-based transparent process that sets specific and clearly defined limits regarding conflicts of interest (financial or other) and involves broad representation of all affected parties. Strengthen Pre-market Testing of PPE for Healthcare Workers FDA, NIOSH, and other relevant agencies and organizations should strengthen pre-market testing requirements for healthcare PPE by requiring field testing of PPE prior to ap- proval and by reevaluating the FDA medical device classification for healthcare PPE. Testing requirements should use rigorous standards while also providing expedi- tious review of innovative approaches. Strengthen Post-market Evaluation of PPE for Healthcare Workers NIOSH, FDA, and other relevant agencies and organizations should support and strengthen adverse event reporting and post-market evaluation studies and surveillance regarding the effectiveness of PPE used by healthcare workers. Coordinate Efforts and Expand Resources for Research and Approval of PPE Congress should expand the resources provided to NIOSH to further research efforts on the next generation of PPE and to coordinate and expedite the approval of effective PPE. Ef- forts to coordinate PPE testing, certification, and approval across all relevant federal agencies should include developing evidence-based performance standards for all types of PPE for healthcare workers.

OCR for page 1
15 SUMMARY MOVING FORWARD WITH URGENCY If an influenza pandemic were to occur within the next 6 months or in the near future, it is likely that many of the healthcare challenges faced in addressing SARS would be repeated—this report emphasizes the cur- rent lack of preparedness for effective use of PPE. In the event of a pandemic, healthcare institutions and healthcare workers would face de- cisions about what types of PPE would offer effective prevention; many healthcare workers would not have received recent training on the appro- priate use of PPE; and questions about the effectiveness of PPE in preventing influenza transmission would raise concerns. As a result, the surge capacity to treat ill patients could be severely impaired. This report provides a set of recommendations aimed at improving PPE for healthcare workers (Box S-1). In addition, the committee high- lights throughout the report a set of actions and research questions that could be addressed in the next 6 to 12 months and have the potential to significantly improve the nation’s readiness for pandemic influenza. These recommendations provide a framework for a national PPE action plan that is an integral part of the overall national plan for an influenza pandemic. The committee believes that improvements should be made so that healthcare workers have PPE that provides protection against influenza transmission based on a rigorous risk assessment with solid scientific evidence. However, this level of protection will require increased re- sources dedicated to answering the critical questions that remain regarding the transmission, prevention, and mitigation of influenza. Con- sideration should be given to the range of healthcare workplaces (including home care, nursing homes, private practices, and hospitals), the multiple types of healthcare workers who come in contact with patients or face exposure to influenza (e.g., administrative and house- keeping staff, physicians, nurses), the diverse tasks they perform with varying degrees of exposure risk, their diverse educational and cultural backgrounds, and their diverse work environments (some of which have engineering or other controls, such as ventilation, in place). In 2000, the 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

OCR for page 1
16 PREPARING FOR AN INFLUENZA PANDEMIC BOX S-1 Overview of the Report Recommendations Understand Influenza Transmission • Initiate and Support a Global Influenza Research Network Commit to Worker Safety and Appropriate Use of PPE • Emphasize Appropriate PPE Use in Patient Care and in Healthcare Management, Accreditation, and Training • Identify and Disseminate Best Practices for Improving PPE Compli- ance and Use • Increase Research and Research Translation Efforts Relevant to PPE Compliance Innovate and Strengthen PPE Design, Testing, and Certification • Define Evidence-Based Performance Requirements (Prescriptive Standards) for PPE • Adopt a Systems Approach to the Design and Development of PPE • Increase Research on the Design and Engineering of the Next Gen- eration of PPE • Establish Measures to Assess and Compare the Effectiveness of PPE • Ensure Balance and Transparency of Standards-Setting Processes • Strengthen Pre-market Testing of PPE for Healthcare Workers • Strengthen Post-market Evaluation of PPE for Healthcare Workers • Coordinate Efforts and Expand Resources for Research and Ap- proval of PPE infrastructure by combating medication and other medical errors as well as incorporating information technology into their management struc- tures. 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. Until more is known about influenza transmission, it will be critical to follow current infection control practices, to ensure that all forms of pro- tections are available to healthcare workers, and to heighten their knowledge of PPE and its use, while also obtaining the input of health- care workers in designing, testing, and developing the next generation of PPE. It is hoped that this report will catalyze initiatives to promote a strong emphasis on the safety of healthcare workers.

OCR for page 1
17 SUMMARY Being ready for an influenza pandemic—having the necessary re- sources to minimize morbidity and mortality—is the goal of ongoing global efforts in many areas of endeavor. Because healthcare workers are essential for providing patient care during a pandemic, the PPE that can protect these workers from becoming infected or from transmitting infec- tion is a vital part of these efforts. Healthcare worker safety is essential for patient safety and patient care. Being prepared for an influenza pan- demic places a priority on protecting the healthcare workforce.

OCR for page 1