Summary

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 equipment 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.

In 2009, the National Institute for Occupational Safety and Health (NIOSH) requested that the Institute of Medicine convene an expert committee to assess the certification or conformity assessment mechanisms needed to ensure the efficacy and effectiveness of non-respirator PPT (Box S-1).

WHY CERTIFY? WHY CONFORM?

Although safety and health professionals rank it low on the hierarchy of hazard controls, personal protective technologies continue to provide the primary means of risk reduction in workplace settings where risks or exposures change rapidly, where process change or engineering controls



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Summary When you purchase a product, you expect it to work. Construction workers on high-rise buildings need to be confident that their safety har- nesses will arrest a fall. Firefighters need to know that their gloves and other protective equipment can withstand high temperatures. Healthcare workers administering highly toxic chemotherapy agents need to know that their gloves will withstand penetration. For personal protective tech- nologies (PPT)—where the major purpose of the product is to protect the wearer against a hazard—a deficit in product effectiveness can mean in- jury, illness, or death. Examining the extent to which products meet spe- cific 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. In 2009, the National Institute for Occupational Safety and Health (NIOSH) requested that the Institute of Medicine convene an expert committee to assess the certification or conformity assessment mechan- isms needed to ensure the efficacy and effectiveness of non-respirator PPT (Box S-1). WHY CERTIFY? WHY CONFORM? Although safety and health professionals rank it low on the hierarchy of hazard controls, personal protective technologies continue to provide the primary means of risk reduction in workplace settings where risks or exposures change rapidly, where process change or engineering controls 1

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2 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES BOX S-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 im- pact 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, pro- tective clothing). The IOM committee will examine various approaches to certification (e.g., fed- eral laboratory certification, third-party certification, federal certification of non- governmental 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 stan- dards and regulations and the benefits of certification to worker safety. The context for the study will emphasize efforts to certify personal protec- tive technologies (other than respirators) for healthcare workers during an in- fluenza 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 me- chanisms for certifying and ensuring the efficacy of non-respirator PPT. ______________________ *Defined broadly to encompass conformity assessment. are deemed to be impractical (e.g., construction, maritime), or where ex- posures are poorly characterized (e.g., spill response, hazardous waste remediation, firefighting). Approximately 5 million U.S. workers are required to wear respirators in 1.3 million U.S. workplaces. In some oc- cupations, such as construction and firefighting, PPT is the primary or only line of defense against hazardous exposure. PPT effectiveness can be seen every day in the survival and lack of harm experienced by most firefighters. In 2008, U.S. firefighters responded to 1,451,500 calls and suffered 36,595 injuries and 29 deaths on scene at fire incidents.

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3 SUMMARY Conformity assessment in the arena of occupational health has sever- al advantages for the various stakeholders involved, from the manufac- turer who designs and builds the product, to the consumer comparing features of the product to make a decision to purchase, and to the regula- tor who must assess claims about product design or performance. 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. WHAT’S INVOLVED IN CONFORMITY ASSESSMENT? Conformity assessment is defined as the “demonstration that speci- fied requirements relating to a product, process, system, person, or body are fulfilled.” The broad array of conformity assessment activities in- volves manufacturers, distributors, purchasers, end users, testing laborato- ries, 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. Conformity assessment processes for products in the marketplace are focused on product effectiveness—verifying and ensuring that a product meets specific criteria. To make this happen, conformity assessment in- volves the following components: • 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. • Testing or inspection—The product is subjected to the required assessments. • Accreditation—Accreditation ensures that testing and certifying procedures are being carried out properly and that testing labora- tories, certifying organizations, and other entities are evaluated. • Attesting to conformity assessment—An entity has the responsi- bility for examining the test results and attesting to whether the product met the requirements or standards.

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4 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES • Communication—Purchasers need to be able to identify which products meet the test criteria. • 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 effec- tiveness of the products and recall defective products from the workplace. Health surveillance includes collecting and analyzing data on the impacts of PPT use on the health and safety of workers. THE ROLE OF FEDERAL AGENCIES IN CONFORMITY ASSESSMENT Many U.S. government agencies have been and continue to be active in ensuring the consistency and safety of products and services through a wide range of activities. The committee explored the range of possible roles for federal agencies by examining the current conformity assess- ment processes for respirators, healthcare worker PPT, firefighter and emergency responder PPT, ballistic-resistant body armor, hearing protec- tive devices, and personal flotation devices (Table S-1). The role of federal government agencies ranged from an all- encompassing role in each phase of conformity assessment (e.g., respira- tors) to more specific roles such as standardized labeling (e.g., Noise Re- duction Rating labels for hearing protection devices). Many of the variations had multiple roles for government agencies, including specify- ing or accrediting testing laboratories and certifying organizations. Prod- ucts that have extensive conformity assessment processes often are those whose failure could significantly impact the health or safety of the worker. A COMPREHENSIVE RISK-BASED FRAMEWORK FOR PPT CONFORMITY ASSESSMENT Given the wide range of current approaches used to conduct confor- mity assessment for PPT products, the committee saw the need for a structured framework to evaluate products protecting against comparable risks. This framework can be used to identify gaps, prioritize resources,

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TABLE S-1 Summary of Standards and Conformity Assessment Approaches for Selected Examples of Personal Protective Technologies (PPT) Hearing Personal Healthcare Body Firefighter Protection Flotation Respirators Worker PPT Armor PPT Devices Devices STANDARDS Voluntary consensus a Government standards TESTING f First party b Third party DECLARATION OF CONFORMITY ASSESSMENT First party—Manufacturer’s declaration e b Third-party certification—Optionalc d Third-party certification—Mandated NOTE: Second-party processes were not used in the examples described in this report. a Environmental Protection Agency standards for noise reduction ratings. b Not federally mandated, but required to meet National Fire Protection Association criteria. c Optional is used to denote that third-party certification is not mandated by Occupational Safety and Health Administration or other federal regulatory agencies. d Food and Drug Administration clearance or approval. e Not federally mandated, but required for inclusion on the National Institute of Justice Compliant Products List. f Third-party oversight of testing. 5

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6 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES determine and direct conformity assessment efforts, and ensure consis- tent conformity assessment approaches. The necessary starting premise for PPT conformity assessment is that well-defined and adequate design specifications and performance standards with pass–fail criteria are in place for these products. Developing and designing a framework for PPT conformity assess- ment should involve the following guiding principles: • Conformity assessment efforts for PPT should be focused on re- ducing or eliminating the risks of worker injury, illness, or death; therefore the framework should be risk based. • End users can provide realistic and practical input into the types of equipment needed to protect against job hazards and should be involved in developing and implementing conformity assessment processes. • Adequate standards for product performance, use, and testing need to be clearly specified and serve as a prerequisite to con- formity assessment. • The burden and cost of conformity assessment processes need to be considered. • A total life cycle approach is needed that includes postmarketing testing, evaluation, and surveillance, as well as an effective recall system. • The conformity assessment process should promote and not in- hibit product innovation. The degree of potential risk to the user from the failure of a PPT product during use in a specific task should determine the rigor of the conformity assessment process, particularly decisions regarding whether the process calls for first-, second-, or third-party declaration of confor- mity. The potential risk is a function of the probability of product failure and the impact on user health and safety due to the failure, assuming proper use of the product. For instance, if a bullet-proof vest is pene- trated by a projectile, the impact can be fatal for the user; therefore, the degree of potential risk due to failure is high. The probability of occur- rence of failure will depend on the task in which the worker is engaged. Thus, the potential risk to the safety and health of the worker should be the key factor in determining the type of conformity assessment process that should be adopted; the greater the risk to the end user in the event of product failure, the greater should be the rigor of the conformity assess-

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7 SUMMARY ment process. This could be implemented for PPT used in medium and high-risk work environments through independent third-party testing and certifying processes. Estimates of the occupational health and safety risks due to hazard- ous exposures can be quantified based on knowledge about the exposure. However, health surveillance data on PPT use in the workplace are li- mited or missing, including data on the extent and nature of PPT use and on adverse outcomes that occur related to PPT use (those that occur due to PPT failures, while wearing PPT, and when not wearing PPT in work situations requiring PPT use). Without these types of data, there are no drivers to draw attention to PPT performance, use, failures, and interface problems that could be harmful to workers. The proposed framework developed by the committee (Table S-2) emphasizes the risk to worker safety and health that would be encoun- tered if the PPT were not working effectively. It also considers economic and other pragmatic factors (e.g., cost of conformance, impediments to innovation, risk to manufacturer’s reputation due to poor product quality and/or product failure). RECOMMENDATIONS A Comprehensive Risk-Based Framework for PPT Conformity Assessment The committee documented the wide range of approaches to PPT conformity assessment and the varied nature of government agency in- volvement in these processes. Current U.S. approaches to occupational PPT are fragmented, often by job sector. Little has been done to classify PPT products based on a comprehensive risk-based framework. There- fore, the first step needed for conformity assessment of non-respirator PPT products is to establish a framework that will categorize products based on the level of risk (low, medium, or high) to the health or safety of the worker that could result from failure of the product (equivalent to not using PPT), while also considering feasibility, cost, and other prag- matic factors. Conformity assessment requirements would be detailed for each category of products in the framework. Efforts will be needed to identify the gaps and inconsistencies in current approaches for specific types of PPT, particularly for those in the medium- and high-risk categories.

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8 TABLE S-2 Risk-Based Framework for Non-Respirator Personal Protective Technologies (PPT) Conformity Assessment Conformity Assessment Responsibilities Degree of Conduct Provide Risk to the Post-Marketing Oversight to the User’s Declaration of Testing, Listing of Institute Conformity Safety and Product Accredit Product Evaluation, Recall Certified Tracking Assessment Healtha Productsb Testing Testing Labs Compliance Surveillance Products Label Process Low First party Voluntary First party Voluntary First party First party Medium Third party Third party Third party Third party Third party Federal govt. Third party agency High Third party Third party Third party Third party Third party Federal govt. Third party Federal govt. agency agency NOTE: The term third party is used to denote that the responsibility could be carried out by either private-sector organizations or federal government agencies that are independent of the product manufacturer. govt. = government. a Risk is based on the potential for illness and injury that would result from failure of the PPT product. b Listing could provide links to lists of certified products from third-party private-sector and government certifying organizations and agencies.

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9 SUMMARY Recommendation 1: Develop and Implement Risk-Based Con- formity Assessment Processes for Non-Respirator PPT The National Institute for Occupational Safety and Health (NIOSH) should work with other relevant government agencies, certifying and accrediting organizations, manufacturers, and end users to develop, implement, and support conformity assessment processes for non-respirator PPT. These conformity assessment processes should be commensurate with the level of risk of in- jury, illness, or death that could result from failure of the PPT to protect the user from workplace hazards. NIOSH’s National Personal Protective Technology Labora- tory (NPPTL) should serve in a leadership role and convene oth- er relevant government agencies, certifying and accrediting organizations, manufacturers, and end users to develop and im- plement a comprehensive, tiered risk-based framework for the classification and conformity assessment of PPT products for specific applications. This framework should be based on the de- gree of risk to the safety and health of the user and other factors affecting the feasibility of implementing the proposed conformity assessment processes. To develop this framework and implement the conformity assessment processes, the committee recommends that • Components of the tiered PPT conformity assessment framework include the following categories and actions: o Low risk—manufacturer’s attestation to meet relevant standards, o Medium risk—third-party testing and certification, and o High risk—third-party testing and certification with government involvement to provide oversight and to as- sist in enforcement; • Current processes and innovative models (e.g., probabilistic models) should be explored, where adequate data exist, for assessing the level of risk and incorporating other feasibility factors into categorizing PPT; • NIOSH NPPTL should work with other relevant federal agencies, manufacturers, organizations, and end users to identify current gaps and priorities in conformity assessment for medium- and high-risk PPT use, and to subsequently en- gage in developing and implementing the appropriate con- formity assessment processes;

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10 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES • NPPTL and other government agencies should have the ap- propriate level of engagement in the conformity assessment processes for non-respirator PPT depending on the risk lev- el; and • Government contracts should specify that PPT used in work to fulfill those contracts must meet the requisite level of con- formity assessment based on the comprehensive risk-based PPT framework. Research, Surveillance, and Communication NPPTL is already substantively involved in many aspects of confor- mity assessment for non-respirator PPT, particularly voluntary standards development and development of test methods. Continued efforts in standards setting would be enhanced with NPPTL working with other government agencies and stakeholder organizations to encourage and promote end-user involvement in the development of voluntary stan- dards. As a research agency, NPPTL is well suited to furthering its ongo- ing efforts to develop test methods and conduct research that contributes to the development of voluntary consensus standards and other conformi- ty assessment efforts for improving PPT. In particular, the committee emphasizes protective ensembles and believes that NPPTL should focus efforts on PPT interface and related issues that are important in ensuring the effective use of multiple types of PPT or integrated ensembles. A new area for exploration could be the development and evaluation of the effectiveness of integrated ensembles for healthcare worker infection con- trol precautions. Increased postmarket testing, evaluation, and surveillance are key factors in enhancing PPT products for worker use. The limited availabili- ty of data on product effectiveness across the life cycle of PPT products, and in particular on PPT use in the workplace (including use of PPT in emergency conditions), are currently hindering improvements in PPT and PPT conformity assessment processes. A surveillance network that draws on and expands current surveillance systems already in place could provide information needed to identify workplace tasks where in- juries, illnesses, or deaths are occurring because of noncompliant and/or poorly manufactured PPT, inadequately or incorrectly labeled PPT, PPT not being provided by the employer, and/or any end-user performance

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11 SUMMARY issues associated with PPT (e.g., the incorrect use of PPT due to inade- quate or improper training that could shed light on PPT training needs). The fragmented nature of current PPT conformity assessment has re- sulted in multiple and diverse sources of information that employers, workers, and others need to consult in order to identify certified equip- ment or find independent information on non-respirator PPT. NPPTL currently administers its Certified Equipment List, which details the res- pirators and respirator components that meet certification criteria. A sin- gle reputable source for certified PPT products needs to exist for consumers (employers and end users) to make informed PPT choices. Recommendation 2: Enhance Research, Standards Development, and Communication NIOSH NPPTL should continue and expand its role in PPT conformity assessment. Specifically, NPPTL should • Continue its involvement in standards-setting processes and committees and facilitate end-user participation in voluntary consensus performance-based standards; • Expand research efforts on non-respirator PPT (based on risk assessment and opportunities) to include further efforts to establish standards and to develop test methods; • Develop and maintain an online resource (available through a website and other sources) that provides access to listings of all non-respirator PPT products that meet third-party conformity assessment requirements; • Expand its role and become the primary clearinghouse for reliable information on non-respirator PPT; • Fund research and support standards development necessary to test and certify protective ensembles, develop criteria for standardized interfaces, and flag non-conforming ensemble components; and • Expand its efforts in influenza pandemic-related research and conformity assessment for infection control ensembles.

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12 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES Recommendation 3: Establish a PPT and Occupational Safety and Health Surveillance System NIOSH should work with the Consumer Product Safety Commission (CPSC), Food and Drug Administration (FDA), Oc- cupational Safety and Health Administration (OSHA), third- party certifying organizations, and other relevant organizations to establish an electronic PPT and Occupational Safety and Health Surveillance System that includes data on PPT product effectiveness in the workplace. This system would involve the col- lection and analysis of data across the life cycle of PPT products (from design and production to worker use and maintenance) on the use of PPT, the failure of PPT, and adverse outcomes (injury, illness, fatality) that occur while wearing PPT in the workplace, including information on the performance standards assessed and adherence to labeling requirements. These efforts should collect and analyze data on PPT product effectiveness in the field by collaborating with existing surveillance programs and ex- panding where needed to incorporate data collection on PPT use across industries including product recall information. The sur- veillance system should link to the expanded Certified Equip- ment List. Potential sources of collaboration include • Other NIOSH surveillance and data collection systems, in- cluding the Fatality Assessment and Control Evaluation pro- gram, health hazard evaluations, and the Sentinel Event Notification System for Occupational Risk (SENSOR); • CPSC’s recall database, unsafe product reporting system, and the National Electronic Injury Surveillance System (NEISS); • FDA’s surveillance and adverse event reporting databases, such as the Medical Product Safety Network (MedSun), the FDA Safety Information and Adverse Event Reporting Pro- gram (MedWatch), and the Manufacturer and User Facility Device Experience (MAUDE) database; and • OSHA’s injury and fatality investigations and surveys to col- lect information about injuries or illnesses potentially due to the failure of PPT.

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13 SUMMARY TOWARD A COMPREHENSIVE APPROACH TO SAFE AND EFFECTIVE PPT FOR WORKERS To address the task of conformity assessment for non-respirator PPT, the committee has recommended a tiered risk-based approach that would categorize various types of PPT and apply consistent conformity assess- ment requirements. From the committee’s perspective, this tiered ap- proach has the advantage of addressing all types of non-respirator PPT and raising the quality of PPT conformity assessment. Although imple- menting this approach will be a major effort, it will incentivize non- respirator PPT developers and manufacturers to innovate and develop new products and technologies expeditiously to further enhance worker safety and health. What will it take to make this change happen? First, government agencies, employers, workers, and other stakeholders must recognize that improving the health and safety of workers is of critical importance and impacts both economic and national security. Second, adequate resources and staffing will be required of relevant government agencies, labor and manufacturing organizations, standards-setting organizations, third-party testing and certifying organizations, and others. Third, PPT end users must actively participate in the process by providing feedback based on experience in using PPT in work and emergency situations. Fourth, de- mand for certified products need to be made evident. Professional organ- izations specific to various occupations (e.g., Joint Commission) must reinforce the requisite conformity assessment processes. Government and private-sector contracts need to specify that PPT used in that work must meet performance criteria. Finally and most importantly, regulatory re- quirements will largely drive whether change occurs. OSHA and the Mine Safety and Health Administration regulations that stipulate re- quirements for third-party testing and certification, where applicable, can provide the impetus to drive the change that will result in a more consis- tent, comprehensive, and risk-based approach to PPT conformity assess- ment. This commitment to improve non-respirator PPT by strengthening the conformity assessment processes also necessitates an equally strong commitment to training and use of PPT. The goal is ensuring and main- taining a safe and healthy workforce.

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