Advising the nation / Improving health

For more information visit www.iom.edu/certifyingppt

REPORT BRIEF NOVEMBER 2010

Certifying Personal Protective TechnologiesImproving Worker Safety

Millions of workers in worksites across the United States rely on personal protective technologies (PPT) to guard them against injury, illness, or death. 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 protective turnout gear can withstand high temperatures, and healthcare workers administering highly toxic chemotherapy agents need to know that their gloves will withstand penetration. The term PPT encompasses a wide range of specialized clothing and equipment including respirators, gloves, hearing protection, fall arrest harnesses, and eye protection. To ensure that PPT will perform as intended, government agencies, man-ufacturers, purchasers, testing laboratories, certifying organizations, workers, and other stakeholders participate in an array of activities that are referred to collectively as conformity assessment. Conformity assessment processes include testing to ensure that the product meets specific design or perfor-mance criteria, examining the test results to declare conformity to the speci-fications, inspecting manufacturing sites, and conducting post-market evalua-tions. Currently, the nature and rigor of the conformity assessment processes that PPT products are required to meet in the United States vary widely. The National Institute for Occupational Safety and Health (NIOSH) asked the Institute of Medicine (IOM) to convene an expert committee to study con-formity assessment of personal protective technologies other than respirators. (Respirators were excluded because processes to assess their performance are already covered under a variety of federal regulations and certification pro-cesses.) The committee was asked to examine the various approaches cur-rently used to certify the effectiveness of PPT used by workers, to review the

Conformity assessment processes include testing to ensure that the product meets specific design or performance criteria, examining the test results to declare confor-mity to the specifications, inspect-ing manufacturing sites, and con-ducting post-market evaluations.

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implementing conformity assessment pro-cesses.

use, and testing need to be clearly specified and serve as a precursor to conformity assess-ment.

-ment processes need to be considered.

includes postmarketing testing, evaluation, and surveillance, as well as an effective recall system.

promote and not inhibit innovation.

The report recommends that the National Personal Protective Technology Laboratory (NPPTL), which is part of NIOSH, work with other relevant government agencies, certifying and accrediting organizations, manufacturers, and end users to develop, implement, and support conformity assessment processes for PPT used in specific applications. The framework should be based, in large measure, on the degree of risk to the safety and health of the user. In this type of tiered framework, risks would be rated as high, medium, or low, with each cat-egory requiring different levels of conformity assessment. When risks are low, manufactur-ers would only need to attest that their products meet certain standards recognized by the federal government. When risks are determined to be “medium,” products would need to be tested and assessed by an independent testing laboratory and certifying organization. Federal agencies would specify the required standards and require third-party testing and declaration of product confor-mity by accredited entities. When risks are high, third-party testing and certification would be required, coupled with government involvement to provide oversight and assist in enforcement. In such cases, the process would include the speci-fication of design and performance standards,

standards and regulations that cover PPT, and to assess the benefits of certification to worker safety.

examine PPT that healthcare workers would use during an influenza pandemic.

Develop a Comprehensive Risk-based FrameworkThe committee’s report, Certifying Personal Pro-tective Technologies, Improving Worker Safety, concludes that current approaches to evaluating occupational PPT, often by job sector, are frag-mented and vary in the extent to which third-party independent assessments are conducted.

-tion in the evaluation of PPT ranges from an all- encompassing role in each phase of conformity assessment to more of an oversight role in setting product standards. Therefore, the report recom-mends as a first step the establishment of a com-prehensive framework for PPT conformity assess-ment. This framework will categorize products based on the health or safety hazards that workers would encounter due to product failure, while also considering various pragmatic factors, such as the cost or feasibility of developing a new product and the size of the intended target population. Having such a system in place would identify gaps in con-formity assessment, prioritize resources, deter-mine and direct conformity assessment efforts, and ensure consistent approaches for products protecting against comparable risks. Developing such a framework should involve the following guiding principles:

be focused on reducing or eliminating the risks of worker injury, illness, or death; there-fore, the framework should be risk-based.

-cal input into the types of equipment needed to protect against job hazards and should be involved in all aspects of developing and

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periodic unannounced inspection of production facilities, evaluation of quality control techniques and standards in the manufacturing plants, prod-uct audits, and postmarketing surveillance. The IOM report calls on the NPPTL to work with other relevant federal agencies, manufactur-ers, organizations, and end users to identify gaps and priorities in conformity assessment, espe-cially for medium- and high-risk PPT use, and to engage in developing and implementing processes to improve assessments. In addition, to help foster adoption of improved PPT, government contracts should specify that PPT must meet the requisite level of conformity assessment based on the com-prehensive risk-based PPT framework.

Improve Research and Communication The fragmented nature of current PPT conformity assessment has resulted in multiple and diverse sources of information that employers, workers, and others need to consult in order to identify effective equipment or find independent infor-mation on PPT. The NPPTL currently maintains

-rators and respirator components the agency has determined to be effective. The committee recom-mends that NPPTL expand its efforts to become a national clearinghouse for information on all types of PPT. NPPTL should continue its involve-ment in standards-setting processes and commit-tees and should facilitate the participation of end

. . . the report recommends as a first step the establishment of a comprehensive framework for PPT conformity assessment. This framework will categorize products based on the health or safety haz-ards that workers would encounter due to product failure, while also considering various pragmatic fac-tors . . .

users in voluntary, performance-based standards. NPPTL also should expand its research efforts on non-respirator PPT (based on risk assessment and opportunities) to help establish standards and develop test methods, and NPPTL should maintain a website resource that provides access to listings of all non-respirator PPT products that meet third-party conformity assessment require-ments.

Expand SurveillanceSurveillance data on PPT use in the workplace are limited, including data on the extent and nature of 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

the current information gap, the committee rec-ommends that NIOSH work with other relevant government agencies to establish an electronic PPT and Occupational Safety and Health Surveil-lance System that includes data on PPT product effectiveness in the workplace. The new surveil-lance system would collect data from across the lifecycle of PPT products used in the workplace, from production to worker use and maintenance. The data would cover, among other things, fail-ures of PPT and adverse outcomes such as injury, illness, and death that may occur while workers are wearing personal protective equipment or devices.

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Advising the nation / Improving health

Howard J. Cohen (Chair) Professor of Occupational Safety and Health, Emeritus, University of New Haven Roger L. Barker Professor, North Carolina State University Janice Comer Bradley Executive Vice President, Waste Equipment Technology Association, Washington, DCBarbara Burgel Clinical Professor of Occu-pational and Environmental Health Nursing, University of California, San Francisco Michael Easterbrook Professor of Ophthalmology, University of Toronto Christina Egan Director, Biodefense Labora-tory, Wadsworth Center, New York State Department of Health, Albany Alexander Isakov Executive Director, Office of Critical Event Preparedness and Response, Emory University, Atlanta, Georgia

Sundaresan Jayaraman Professor, Georgia Institute of Technology, Atlanta James S. Johnson Consultant, JSJ and Associates, Pleasanton, California Melissa A. McDiarmid Director, Occupational Health Program, University of Mary-land, Baltimore County James W. Platner Associate Director, CPWR– Center for Construction Research and Training, Silver Spring, Maryland Anugrah Shaw Professor, University of Mary-land, Eastern Shore Tanya Wanchek Health Economist, Center for Economic and Policy Studies, University of Virginia, Charlot-tesville Samuel E. Wehr Consultant in Survival and Flotation Technology, Standards and Regulations Manager, Mustang Survival Cor-poration, Woodbridge, Virginia

Committee on Personal Protective Technologies Conclusion To ensure that workers are using PPT that meets required standards, PPT products need to be con-sistently assessed with products used in high-risk workplaces undergoing rigorous testing and certi-fication processes. What will it take to make the recommended changes happen? Significant input will be needed from end users. Professional organizations spe-cific to various occupations can reinforce the req-

resources and staffing will be required of govern-ment agencies, labor and manufacturing organi-zations, standards-setting organizations, third-party testing laboratories, and others. Regulatory requirements for third-party testing and certifica-tion, where applicable, will provide the impetus for change that will result in a more consistent, com-prehensive risk-based approach to PPT conformity assessment. The goal is ensuring and maintaining a safe and healthy workforce. f

Catharyn T. Liverman Study DirectorAndrew M. Pope Director, Board on Health Sciences Policy

Sarah L. Hanson Associate Program Officer (through July 2010)Judith L. Estep Program Associate

Study Staff

Study Sponsor

The National Institute for Occupational Safety and Health