1
Introduction
When you purchase a product, you expect it to work. Construction workers on high-rise buildings need to be confident that their safety harnesses will arrest a fall. Firefighters need to know that their gloves and other protective turnout gear can withstand high temperatures. Healthcare workers administering highly toxic chemotherapy agents need to know that their gloves will withstand penetration. For personal protective technologies (PPT)—where the major purpose of the product is to protect the wearer against a hazard—a deficit in product effectiveness can mean injury, illness, or death. Examining the extent to which products meet specific performance or design criteria is the focus of conformity assessment efforts. For PPT conformity assessment, the ultimate goal is preventing worker illness, injury, or death from hazardous working conditions.
Personal protective technologies, including respirators, gloves, protective clothing, protective eyewear, and hearing protection, are used by workers in many types of worksites. An estimated 5 million workers are required to wear respirators in 1.3 million workplaces in the United States (OSHA, 2010). The U.S. market for personal protective equipment was estimated at approximately $6.4 billion in 2007 (SBI Reports, 2008).
Currently, product testing and conformity assessment requirements in the United States vary considerably among the various types of PPT. This report details the different approaches, examines the various roles that government agencies play in all phases of conformity assessment, and provides the committee’s recommendations for future conformity assessment efforts for PPT products.
SCOPE OF THIS REPORT
In 2009, the National Institute for Occupational Safety and Health (NIOSH) requested that the Institute of Medicine (IOM) convene an expert committee to assess the certification or conformity assessment mechanisms needed to ensure the efficacy and effectiveness1 of non-respirator PPT. The IOM committee was tasked with examining various approaches to conformity assessment and with making recommendations on conformity assessment processes for non-respirator PPT (Box 1-1). As part of its data-gathering efforts, the committee was asked to plan and conduct a public workshop to examine the conformity assessment approaches used for a range of products used for protection (e.g., bullet-proof vests, personal flotation devices) as well as to examine the benefits of certification to worker safety. The committee’s task also focused on PPT for healthcare workers during an influenza pandemic with the recognition of the broader implications for modifying conformity assessment processes for PPT.
The committee’s task did not focus on respirator certification because that is a well-established process codified in federal regulations and conducted by the NIOSH National Personal Protective Technology Laboratory (NPPTL). Additionally, the committee was not asked to examine the certification of personnel. Although PPT products are used by the general public in settings that range from hobbies to home repair and maintenance to protection against infectious disease, this report focuses on occupational use and does not specifically address PPT for use by the general public.
The committee held three meetings from January to July 2010. Two of those meetings included public sessions with input from many perspectives, including NIOSH staff, other federal agency staff, PPT manufacturers, professional association and labor union representatives, standards-setting organizations, third-party testing and certifying organizations, and other stakeholders (Appendixes A and B). The public sessions (one of which was organized as a workshop) provided background information to the committee; information gained in the presentations is referenced in the report.
This study follows up on a recommendation of a 2008 IOM and National Research Council report that called for “an assessment of the certification mechanisms needed to ensure the efficacy of all types of PPT” (IOM and NRC, 2008, p. 117). Specifically, that report called for an assessment of NPPTL’s role in conformity assessment for non-respirator PPT and that is one of the areas of focus of this report.
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BOX 1-1 Committee on the Certification of Personal Protective Technologies Statement of Task The Institute of Medicine (IOM) will convene an expert committee to assess the certification* mechanisms needed to ensure the efficacy of non-respirator personal protective technologies (PPT). National Institute for Occupational Safety and Health certification of respirators has had a significant positive impact on the quality of respirators available in the workplace; however, there is no analogous federal process for ensuring certification of the efficacy of non-respirator PPT (e.g., eye protection, hearing protection, medical masks, protective clothing). The IOM committee will examine various approaches to certification (e.g., federal laboratory certification, third-party certification, federal certification of nongovernmental laboratories) and will make recommendations on certifying non-respirator PPT. As part of its data-gathering efforts, the committee will plan and conduct a public workshop to examine the various approaches used to certify the efficacy of other types of products used for protection (e.g., bullet-proof vests, personal flotation devices) as well as to examine relevant standards and regulations and the benefits of certification to worker safety. The context for the study will emphasize efforts to certify personal protective technologies (other than respirators) for healthcare workers during an influenza pandemic, although the effort will be relevant to other types and uses of PPT. A report will be issued that includes the committee’s recommendations on mechanisms for certifying and ensuring the efficacy of non-respirator PPT. |
PERSONAL PROTECTIVE TECHNOLOGIES
PPT are defined as the specialized clothing or equipment worn by workers for protection against health and safety hazards, as well as the technical methods, processes, techniques, tools, and materials that support their development, evaluation, and use (OSHA, 2002; NIOSH, 2007). The broad umbrella term of PPT is used in this report as it includes a wide range of protective products and technologies, including the personal protective equipment (PPE) worn by workers (e.g., hearing protection, gloves, protective clothing, respiratory protection, protective eyewear, and fall arrest harnesses) as well as technologies such as service life indicators and filtration. PPE is a subset of PPT and refers specifically to the various types of gear worn to prevent injury, illness, or death.
The use of PPT is a key element of the standard hierarchy of hazard control approaches that aims first to eliminate or minimize the risk in the work environment, then to modify the work environment or processes, and as needed to provide individual protective equipment to workers:
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Substitution—changing the environment to reduce or eliminate the hazard;
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Engineering or environmental controls—modifying the work environment (e.g., ventilation fans, negative pressure rooms);
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Administrative controls—changing the work processes and practices (e.g., limiting the number of hours worked in a specific area); and
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Personal protective technologies—use of equipment by individuals to provide protection from work hazards.
Although PPT is generally considered a last line of defense in the hierarchy of protective controls because it relies on the correct individual use and fit of protective equipment, in some jobs, such as firefighting, PPT is the only means available to minimize exposure to serious hazards.
Effective use of PPT requires proper selection, use, care, and maintenance of the product. For PPT products such as respirators, testing to ensure the proper fit (i.e., fit testing) is a critical element of ensuring worker safety and is a required component of the comprehensive respirator protection programs required by the Occupational Safety and Health Administration (OSHA) for workplaces with respiratory hazards.
BASICS OF CONFORMITY ASSESSMENT
The International Organization for Standardization defines conformity assessment as the “demonstration that specified requirements relating to a product, process, system, person, or body are fulfilled” (ISO/IEC, 2004). Conformity assessment is thus a broad term that encompasses an array of activities conducted by manufacturers, distributors, purchasers, end users, testing laboratories, certifying organizations, accrediting organizations, and government agencies. In discussions on product conformity assessment, the term first party refers to the manufacturer, second party to the purchaser, and third party to an independent entity, which is neither the seller nor the buyer (Breitenberg, 1997a; Gillerman, 2004).
What’s Involved in Conformity Assessment?
Conformity assessment for products in the marketplace is focused on product effectiveness—verifying and ensuring that a product meets specific criteria for use in workplaces and other locations. To make this happen, conformity assessment involves the following components:
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Standards—A prerequisite to conformity assessment, well-defined criteria must be in place so that there is a measure against which to assess the product.
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Testing or inspection—The product is subjected to the required assessments.
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Accreditation—Accreditation ensures that testing and certifying procedures are being carried out properly and that testing laboratories, certifying organizations, and other entities are evaluated.
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Attesting to conformity assessment—An entity has the responsibility for examining the test results and attesting to whether the product meets the requirements or standards.
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Communication—Purchasers need to be able to identify which products meet the test criteria.
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Post-marketing testing and evaluation, and health surveillance—Post-marketing testing and evaluation involves the ongoing process of monitoring product manufacturing and products used in the workplace to ensure consistency in the quality and effectiveness of the products and recall of defective products from the work-
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place. Health surveillance includes collecting and analyzing data on the impacts of PPT use on the health and safety of workers.
Each of these components in conformity assessment is discussed in Chapter 2, and the various roles that federal agencies and other organizations play in each of these areas is explored with specific consideration as to what is needed to improve conformity assessment processes for non-respirator PPT.
WHY CERTIFY? WHY CONFORM?
Certification as a Public Health Function
In the 1988 IOM report The Future of Public Health, the mission of public health was described as fulfilling society’s interest in assuring the conditions in which people can be healthy (IOM, 1988). Three core functions of public health agencies were described—assessment, policy development, and assurance—as means toward achieving that goal. Each function has a role in the focus of this current report, certifying PPT.
Assessment entails gathering data through case reviews or surveillance systems to determine the status of health and safety in specific industries and occupations. Examples include hazard identification and exposure assessment in specific work environments.
The second public health function, policy development, is the response crafted to address threats to safety and health identified in the assessment stage. For example, public health policy might be drafted to include use of PPE to minimize hazardous exposure and to prescribe certain performance criteria for that equipment.
The assurance function includes activities that assure adopted policies are implemented. Examples include OSHA enforcing the requirement of respirator use for workers exposed to an inhalation hazard or the use of gloves for workers exposed to blood-borne pathogens. The assurance function also includes requiring documentation of conformity to specified performance standards for a respirator or glove type.
Although this report has a focus on PPT with applications in occupational health, and the assurance of standards is a recognized function of the public health system, conformity assessment issues arise in part from the international trade community.
Conformity Assessment and the Global Economy
With the advancement of international free trade agreements in the past several decades, the growth of emerging economies, and the removal of many historical geographic and political trade barriers, the marketplace has become global, permitting commercial activity among new and diverse partners. Both the number and diversity of new trading partners has imposed the need for a common international language with which to discuss the buying and selling of goods and services in this increasingly global marketplace. Central to this common language is the development and implementation of standards and descriptors of those goods and services that allow comparison of products and assist in judging product value. The elements of standards may describe both design and performance criteria, other requirements against which a product can be assessed, and test methods. The challenge for manufacturers may arise when varying conformity assessment processes and criteria are required to enter the marketplace in different countries and regions.
Benefits of Conformity Assessment to Manufacturers, Consumers, and Regulators
Conformity assessment in the arena of occupational health has several advantages for the various stakeholders involved. Conformity assessment provides benefits to any party encountering a product throughout its life cycle, from the manufacturer who designs and builds the product, to the consumer comparing features of the product to make a decision to purchase, and to the regulator who must assess claims about product design or performance.
Manufacturers may gain valuable quality control feedback by having their products assessed for conformity to performance standards, which can enable consistency in maintaining product effectiveness. Such activities may also validate marketing claims for their products. This may differentiate their product from a competitor’s, providing a marketing advantage.
For the consumer, conformity assessment provides confidence in the claims made about the product by the manufacturer and may assist the consumer with purchasing decisions in determining the fitness of a product for its intended use. Conformity assessment may also allow the consumer or worker to differentiate among product choices with confidence
in the labeling claims, have confidence a product meets a specific performance standard, and understand the limitations of its use or benefit.
The regulator benefits from the conformity assessment processes by having a designated pathway to follow to perform the assurance function to determine that product claims are valid and to verify the circumstances under which products were manufactured. This process also provides the platform from which to enforce health, safety, and environmental regulations pertaining to the product performance and manufacture.
Benefits to Worker Safety and Health
Although standards may be an important communication tool in the marketplace, providing a common language to discuss a product, in the public health arena demonstrating a product’s conformity to a standard may be the regulatory “floor” on which a minimum level of protection from hazardous work is built. Conformity to the critical performance characteristics of PPT literally has “life or death” consequences for the firefighter, for example.
In considering the need for and benefits of conformity testing for PPT, it is helpful to review the rationale for the current requirements for such testing for respiratory protection equipment. OSHA, in its 1998 Respiratory Protection Standard Final Rule, made reference in the Preamble to the meaning and benefits of a certification “mark,” specifically that of NIOSH (OSHA, 1998). Having examined the existing requirements of the National Fire Protection Association’s (NFPA’s) standards that required NIOSH certification for respirators used in firefighting (NFPA 1981, Standard on Open-Circuit Self-Contained Breathing Apparatus for Emergency Services), the agency went on to more broadly require NIOSH certification for compliance with the OSHA respirator standard (29 CFR §1910.134).
Selected quotes from the Preamble (OSHA, 1998) describe the agency’s rationale for this decision as informed by the comments received from the affected parties, also referenced:
Paragraph (d)(1)(ii) requires the employer to select a NIOSH-certified respirator and to use the respirator only in ways that comply with the conditions of its certification. There was little controversy about this requirement, and there is no disagreement that respirators must be
tested and found to be effective before they can be marketed. NIOSH has performed this function in the past and has begun to revise its certification requirements to ensure that its procedures continue to define the performance capabilities of acceptable respirator models, and to identify unacceptable models. The ISEA [International Safety Equipment Association] (Ex. 65–363), the trade association that represents most major respirator manufacturers, urged OSHA to require that only NIOSH-certified respirators be used to comply with this standard, and other commenters agreed (Exs. 54–187, 54–213, 54–387, 54–428).
Not only does NIOSH respirator certification pertain to the original selection and purchase of new equipment, but it also addresses the repair and maintenance of respirator equipment, according to OSHA (1998):
The final provision of paragraph (h) deals with respirator repairs and adjustments. Final paragraph (h)(4) provides that respirators that fail inspections, or are otherwise defective, are to be removed from service and discarded, repaired, or adjusted according to the specified procedures. In addition, the employer shall ensure that repairs or adjustments to respirators are made only by persons appropriately trained to do so, and that they use only the respirator manufacturer’s NIOSH-approved parts that are designed for the particular respirator. The repairs also must be made in accordance with the manufacturer’s recommendations and specifications. Because components such as reducing and admission valves, regulators, and alarms are complex and essential to the safe functioning of the respirator, they are required to be adjusted and repaired only by the manufacturer or a technician trained by the manufacturer.
Paragraph (j)—Identification of Filters, Cartridges, and Canisters. The Final Rule provides that the employer only use filter cartridges and canisters that are labeled and color coded with the NIOSH approval label and that the label not be removed or made illegible. This is similar to
the parallel requirement in the proposal, which was supported by commenters (Exs. 54–361, 54–428, 54–455). OSHA has modified the proposed language in certain respects to add compliance flexibility while retaining the original objective, that is, assurance that these elements meet NIOSH’s stringent requirements. These comments and modifications are discussed below.
Further endorsing the importance of having confidence in the meaning of a manufacturer’s labeling, the agency remarked (OSHA, 1998):
The changes from the previous standard recognize that employers who use respirators should be able to rely on labeling and color coding by respirator manufacturers for assurance that the respirators meet NIOSH requirements. This position is consistent with that taken by many commenters, who noted that the labeling and color coding of filters are the responsibility of the respirator manufacturer (Exs. 54–208, 54–218, 54–219, 54–278, 54–289) and are required by NIOSH for certification.
Expounding on the benefits that labeling provides in ensuring conformity to a standard, OSHA (1998) commented further:
The NIOSH label serves several purposes. It ensures selection of appropriate filters for the contaminants encountered in the workplace and permits the employee using the respirator to check and confirm that the respirator has the appropriate filters before the respirator is used…. However, the employee is not the only one who uses the color coding and label. Color coding and labeling also allow fellow employees, supervisors, and the respirator program administrator to readily determine that the appropriate filters are being used by the employee. Cartridges that are appropriate for one operation may be inappropriate for another, and color coding and labeling allow respirator users with inappropriate filters to be identified in the workplace and potential respiratory hazards to be avoided.
OSHA makes the case that reliance on the meaning and assurance of a certification mark benefits both workers and employers where respiratory protection is used. These comments are also applicable to other types of PPT. The progression of conformity assessment efforts in response to injuries is illustrated in the efforts made to prevent eye injuries to ice hockey players (Box 1-2).
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BOX 1-2 Eye Protection for Ice Hockey Players Eye Injuries The progression of conformity assessment efforts is illustrated in the history of eye guards and face protection in ice hockey. In Canada, a prospective study during the 1974–1975 ice hockey season identified 253 amateur players with eye injuries, 37 of whom were legally blinded in one eye due to participation in the sport (Pashby et al., 1975). By comparison, a study in the 1983–1984 ice hockey season found the incidence of eye injuries in amateur players had declined to 124 cases, with no face injuries in those wearing certified face protectors (Pashby, 1985). In the intervening years several changes had been put in place including changes in the penalties for stick infractions and mandatory requirements for certified face protectors to be worn by young hockey players. The average age of players with eye injuries was 14 in 1974–1975, and rose to 24 in 1983–1984 (Pashby, 1985). Standards and Certification After the early study and other reports (e.g., Horns, 1976; Vinger, 1976), the Canadian Standards Association (CSA) and ASTM International developed standards specific to eye and face protection in sports in an attempt to reduce injuries and prevent inadequate products from being purchased by the consumer. The standards committees consisted of consumers, manufacturers, sports organizations, and public officials who helped formulate standards for sports eye protection in the United States and Canada. International standards for head and face protection in ice hockey have been developed by the International Organization for Standardization (ISO 10256, Head and Face Protection for Use in Ice Hockey, 2003). Development of standards has been followed in the United States and Canada by the implementation of third-party testing and certification requirements for some uses of eye-protective equipment for ice hockey. In Canada, CSA International (an arm of CSA Group) is responsible for the testing and certification of a number of products, including eye protectors. Upon successful completion of the testing and certification of the product, the product receives a CSA certification mark. Canada’s Hazardous Products Act prohibits the sale or importation of ice hockey helmets and face protectors that do not meet the requirements of the relevant standards (CAN/CSA-Z262.1-M90 and CAN 3-Z262.2-M78) (Health Canada, |
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2010). Beginning in 1981, the Canadian Amateur Hockey Association made certified CSA face protection a mandatory requirement for all of its minor players (Pashby, 1985). In the United States, amateur ice hockey equipment is certified by the Hockey Equipment Certification Council (HECC), an independent, nonprofit organization established in 1978. HECC works through the third-party validating laboratory, Intertek Testing Services, to verify that helmets, goal-tenders headgear, full-face protectors, and visors meet ASTM or CSA standards (HECC, 2010a). The HECC label is affixed to products that meet the required standards. An online listing of certified products is available through the HECC website (HECC, 2010b). HECC-certified equipment is required by USA Hockey, the National Federation of State High School Associations, and the National Collegiate Athletic Association (facemasks only) (HECC, 2010c). |
U.S. Approach to Standards Development and Conformity Assessment
In the United States, many marketplace transactions rely on the manufacturer’s declaration of product conformity (Breitenberg, 1997b)—in which the interaction is between the buyer and seller with no third-party involvement required by the government or private sector. However, varying levels of oversight are used for products that may significantly impact the health and safety of the consumer (e.g., pharmaceuticals, respirators, personal flotation devices). The use of a manufacturer’s self-declaration is generally effective in the United States because of several factors: competition among manufacturers, the size of the U.S. market, laws regarding truth in labeling and advertising, the abundance of product comparison information available to the consumer, and the potential for penalties to be imposed by the judicial system for products found to be defective (Breitenberg, 1997b).
Federal legislation, in particular the National Technology Transfer and Advancement Act (NTTAA), Public Law 104-113, emphasizes the government’s use of voluntary consensus standards and encourages the participation of government agency staff in the work of standards development organizations in the United States and globally. Specific to conformity assessment, the NTTAA specifies that the National Institute of Standards and Technology (NIST) is charged with coordinating federal, state, and local conformity assessment efforts with private-sector activi-
ties to eliminate duplication and reduce the complexities of the processes (OMB, 1998).
Drivers of Conformity Assessment
Not all products have extensive conformity assessment requirements. But for those that do, what drives the considerable investment of time, funds, staffing, and other resources necessary to ensure that products go through required procedures before reaching the marketplace?
Spurring the investment are the incentives for conformity assessment. Reputable manufacturers aim to grow their share of the market by striving to maintain and enhance the company’s reputation for producing quality products. Taking an active role in developing standards and adhering to conformity assessment procedures can be a major part of quality assurance efforts. For some products, consumer or purchaser demand for certified products is a strong incentive. This demand can translate into financial incentives when the requirements for certified products are written into purchasing contracts. For example, a number of law enforcement departments write specifications into their contracts that they will purchase only body armor certified by the National Institute of Justice and therefore listed on the Body Armor Compliant Products List. Grants or contracts that specify that funds can only be awarded if they are used to purchase certified equipment are another strong incentive (e.g., the Bulletproof Vest Partnership, see Chapter 3). Additionally, a competitive market can motivate manufacturers to ensure that their product line meets the required conformity assessment procedures and can therefore be marketed with the relevant certification mark or label.
Beyond incentives, the drivers for conformity assessment include requirements for compliance as well as disincentives for noncompliance. For example, OSHA regulations stipulate that employers provide NIOSH-certified respirators in workplaces with respiratory hazards. Penalties and regulations are in place for a number of conformity assessment processes that provide the legal and/or financial ramifications for noncompliance. However, the use of fraudulent certification marks or misrepresentations of conformity assessment continue to be reported by third-party certifying organizations.
RELEVANT AGENCIES AND ORGANIZATIONS
In the United States, the testing, regulation, and use of PPT involve a number of government and nongovernmental agencies and organizations. In the federal government, oversight responsibilities for the safety of consumer products fall under agencies different from those responsible for worker health and safety. The Occupational Safety and Health Act of 1970 created two federal agencies to address civilian worker safety and health: NIOSH (in the Department of Health and Human Services, or HHS) was designated with responsibilities for relevant research, training, and education, and OSHA (within the Department of Labor) for developing and enforcing workplace safety and health regulations. The Occupational Safety and Health Act also included the general duty clause regarding the duty of employers to ensure safe workplaces.
NIOSH conducts and funds research in PPT and plays an integral role in the development of relevant voluntary consensus standards for many types of PPT. In 2001, the congressional mandate to expand NIOSH’s research included a directive for NIOSH to establish NPPTL. The congressional intent, which resulted in the inception of NPPTL in 2001, was outlined in Senate Report 106-293:
[I]t has been brought to the Committee’s attention the need for design, testing and state-of-the-art equipment for this nation’s 50 million miners, firefighters, healthcare, agricultural, and industrial workers…. The Committee encourages NIOSH to carry out research, testing, and related activities aimed at protecting workers, who respond to public health needs in the event of a terrorist incident. The Committee encourages CDC [the Centers for Disease Control and Prevention] to organize and implement a national personal protective equipment laboratory.
This comprehensive approach to PPT has been an ongoing goal for NPPTL, although a large percentage of NPPTL’s current efforts and budget are necessary to meet their mandated task of testing and certifying respirators (IOM and NRC, 2008). NPPTL also conducts and funds research in non-respirator PPT and is the only federal entity focused solely on PPT.
OSHA regulates the use of PPT products in most U.S. workplaces; the Mine Safety and Health Administration (MSHA) regulates PPT use in the mining industry. As part of the requirements for a comprehensive respiratory protection program, OSHA and MSHA require that respirators used by workers must be certified by NIOSH to meet specific performance criteria (29 CFR §1910.134). OSHA also has a general regulatory standard (29 CFR §1910.132) and related regulations for the maritime, construction, and mining industries that govern all other forms of PPT. Several regulatory standards include requirements that occupational PPT must meet specific voluntary consensus standards. MSHA and NIOSH jointly certify respirators for mining applications.
Other federal agencies also have a role in testing and improving PPT for specific worker groups and the general public. The Consumer Product Safety Commission has oversight responsibilities for PPT products sold in the consumer retail marketplace. The Department of Defense develops and tests PPT for military applications. The Department of Homeland Security focuses on emergency response PPT and works to coordinate and improve standards and equipment-related issues. The National Institute of Justice has responsibilities for certifying body armor and other protective technologies for law enforcement officers. The Environmental Protection Agency addresses PPT issues relevant to hearing protection, pesticide exposures, and emergency response readiness. The Food and Drug Administration (in HHS) has federal regulatory authority to provide manufacturers with the approval or clearance to market personal protective devices used in health care. NIST, within the Department of Commerce, is designated to coordinate and assist with standards and conformity assessment efforts throughout the government.
OVERVIEW OF THIS REPORT
In the remaining chapters of this report the committee discusses issues related to conformity assessment of PPT and provides its recommendations. Chapter 2 takes a step-by-step approach through each of the components of conformity assessment and discusses potential roles for government agencies in conformity assessment efforts for non-respirator PPT. Chapter 3 provides examples of current approaches to conformity assessment for PPT by highlighting the range of diverse approaches currently in use, including those used for certification of healthcare PPT, respirator certification, and certification of body armor for law enforce-
ment personnel. Chapter 4 examines the limited data available on the impact of conformity assessment processes, and then delves into issues specific to PPT, including the complexities of certifying protective ensembles, user training, and risk assessment. In outlining an approach to conformity assessment for non-respirator PPT, the committee provides its framework in Chapter 5, and in Chapter 6 outlines its findings and recommendations. The report concludes in Chapter 7 with the commit-tee’s thoughts on opportunities for moving forward in improving conformity assessment for non-respirator PPT with the goal of improving worker safety and health.
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