Certifying Personal Protective Technologies: Improving Worker Safety (2011)

Although safety and health professionals rank it low on the hierarchy of hazard controls, personal protective technologies (PPT) continue to provide the primary means of risk reduction in workplace settings where risks or exposures change rapidly, where process change or engineering controls are deemed to be impractical (e.g., construction, maritime), or where exposures are poorly characterized (e.g., spill response, hazardous waste remediation, firefighting). Reliable risk reduction using PPT requires an often complex web of tasks performed by product designers or engineers, manufacturers, employers, safety and health professionals, supervisors, and trained workers. Assessing the conformity assessment of PPT products is one part of the efforts needed across the life cycle of the product to ensure effectiveness; these efforts also encompass careful attention to design, quality manufacturing practices, end-user training, and evaluation of product performance in real-world use. For PPT to provide effective risk reduction, several criteria must be met:

• PPT standard test methods must consistently reflect field conditions and technology performance;

• Standards must include an adequate margin of safety to accommodate exposure variation in the work process and expected misuse;

• Manufacturing systems standards such as quality control must be adequate to assure each PPT item performs at least to minimum standards;

• Selection of PPT for specific work practices must conform to expected use;

• Potential interference of PPT with the functions of other ensemble components or planned work tasks needs to be characterized and potential adverse impacts of PPT examined;

• Use instructions, training, and supervision regarding PPT to ensure proper work practices must be addressed;

• Replacement cycles, field checks, maintenance, cleaning, storage, packaging, and durability standards must assure continued field performance over the normal lifetime of the PPT;

• Product labeling must be accurate;

• Consumers need to be aware of any recalls due to product failure; and

• Post-marketing testing and recalls must be used to correct process issues, be timely and comprehensive, and be a mechanism for continuous performance improvement.

Standards development and conformity assessment efforts may address selected aspects of these criteria in order to increase the likelihood of effective implementation and risk reduction.

This chapter explores the limited types of data that are available on the impact of PPT conformity assessment on worker safety and health. The chapter also explores issues that pose particularly challenging questions for implementing and sustaining conformity assessment processes for PPT products.

Assessing the impact of PPT use on reductions in worker injury or death can be challenging, particularly in occupations where multiple safety measures are implemented, where exposures are intermittent or variable, or where risks are poorly characterized. A greater challenge is finding data to assess the impact of PPT conformity assessment on worker safety and health. To address the question regarding the impact of con-

formity assessment posed in the committee’s charge, the committee first took a broader look at the impact of PPT.

What is clear throughout the many successes in the fields of public health and occupational health and safety is that reducing or eliminating hazardous exposures leads to reductions in injuries and deaths. Examples include reductions in cigarette smoking and increases in seat belt use (IOM, 2003). PPT products are designed to reduce hazardous exposures. Improvements in the effectiveness of PPT products—including those resulting from conformity assessment testing and certification—should lead to a greater beneficial impact on worker safety and health.

As noted in the Institute of Medicine and National Research Council report (2008, p. 81), which assessed the National Institute for Occupational Safety and Health (NIOSH) PPT Program,

Approximately 5 million U.S. workers are required to wear respirators in 1.3 million U.S. workplaces (OSHA, 2010). In some occupations, 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 (NFPA, 2010).

Researchers have found that individual firefighters not wearing PPT had an increased risk of respiratory health problems. For example, a study of New York firefighters found that individuals who did not wear protective respiratory equipment had statistically significant decrements in acute pulmonary function (Brandt-Rauf et al., 1989). Similar results were found in a study of the effectiveness of respiratory protection for coal miners in West Virginia (Li et al., 2002). In New York City, Prezant and colleagues (1999) found an 85 percent reduction in lower extremity burn injuries, a 65 percent reduction in upper extremity burn injuries, and a significant reduction in head burn injuries in firefighters who used more protective uniforms and hoods.

In successful outcomes to some disaster situations, wearing PPT has played a major role. In 2006, miners in West Virginia used NIOSH/Mine Safety and Health Administration-certified self-contained, self-rescuer respirators, which chemically generate breathable oxygen, in their successful escape from a hazardous mixture of dense smoke and deadly concentrations of carbon monoxide after a mine fire (MSHA, 2006).

In the committee’s efforts to identify data on the impact of conformity assessment efforts, the data from falls by construction workers were examined. Data collection for evaluating a reduction in fatality rates associated with certification of fall prevention and arrest PPT systems is limited. Falls are the leading cause of U.S. construction worker deaths with on average 363 deaths due to falls annually from the period 1992 to 2005 (CPWR, 2008). Falls are also the second most frequent cause of non-fatal injuries in this industry (CPWR, 2008).

Fall arrest technology has changed rapidly, and Occupational Safety and Health Administration (OSHA) regulations and voluntary consensus

standards have played, and continue to play, an important role in risk reduction. OSHA regulations (29 CFR §1926.502d) prohibiting the use of body belts for fall arrest and requiring full-body harnesses went into effect on January 1, 1998. However, there is no government mandate for the testing or certification of these products. The first American National Standards Institute (ANSI) standard (ANSI Z359) was approved in 1992 and was an important driver in the process that led to the eventual OSHA regulatory change in 1998. NIOSH research (e.g., whole body anthropometry for informing design of fall arrest harness sizing) has been instrumental in informing the regulatory changes and is outpacing changes in practice, such that more aggressive research to practice and standards/certification development efforts are needed.

The impact of regulatory and standards changes regarding fall prevention and fall arrest PPT is difficult to quantify. Recent data on construction worker deaths do not show a change in fatalities due to falls from height. Although the overall death rate of construction workers declined between 1992 and 2005, the number of fatal falls in construction increased (CPWR, 2008). Information on PPT use is often unreported on injury logs and fatality records. In general, assessing the impact of a preventive intervention, that is, proving that a negative outcome did not occur because a preventive measure is taken, is difficult. For that reason, quantifying the impact of PPT is challenging as the goals for using PPT are that a hazardous exposure or event will not occur and that workers will remain safe and healthy.

Estimates of the occupational health and safety risks due to hazardous exposures can be quantified based on knowledge about the exposure. However, health surveillance data on PPT use in the workplace are limited 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. These types of data are needed to focus PPT standards development and conformity assessment efforts in areas that will significantly improve worker health and safety.

Several issues regarding testing and certifying PPT products are worth highlighting including PPT interfaces and ensembles, user training, varied work tasks, unintended consequences of wearing PPT, contractual requirements for PPT, and risk assessment.

Workers wear items of protective equipment to protect against varied workplace hazards, including noise, falling objects, projectiles, dust, fumes, liquid aerosols, and chemical, thermal, radiological, and biological exposure. In many cases workers are provided with individual items of PPT equipment that do not work together or fit together and do not have a seamless interface or seal between pieces of equipment to provide adequate total protection. The cumbersome or ineffective interface among multiple items can often prevent the combination from providing the optimum level of protection. Examples of these problems include wearing both ear muff-style protectors and safety glasses (due to the temples of the glasses) or a half-mask respirators and safety glasses. Similarly, interfaces between coverall sleeves and gloves or between coverall cuffs and boots may result in gaps, overlap, or unprotected areas. The ability of the ensemble to protect the worker depends on the following factors:

• Proper design, manufacturing, and testing of the individual components and the interfaces among components to meet appropriate design specifications and performance standards;

• Ensuring that the combination of individual personal protective equipment items does not degrade the performance of any of the items in the ensemble; and

• Properly training the worker about the workplace hazards and how to assemble, evaluate, wear, clean, store, maintain, and replace the ensemble or any of the items and their components.

A few examples point to the possibilities of developing and implementing ensemble specifications or standards: the National Aeronautics and Space Administration specifications for a propellant handler’s ensemble (Stull et al., 1996); the National Fire Protection Association

(NFPA) standard for protective ensembles for structural firefighting (NFPA 1971); the NFPA standard on protective ensembles for first responders to CBRN (chemical, biological, radiological, nuclear) terrorism incidents (NFPA 1994); and the recent National Institute of Justice’s CBRN protective ensemble standard for law enforcement (NIJ 0116.00).

For the most part, performance specifications and voluntary consensus standards have been developed to assess the performance of specific personal protective equipment items and do not address issues regarding the interface with other protective equipment or interchange of parts. PPT products are generally manufactured and marketed as individual stand-alone items, and there are no marketplace drivers to incentivize or address interface concerns. Additionally, current marketing and purchasing practices often focus on individual products. NIOSH certification of respirators requires that all components be tested and evaluated, and replacing a component with an aftermarket substitute from a different manufacturer can void the approval.

OSHA has attempted to address the interface issues relevant to respirators by requiring that during mandatory respirator fit testing, the employee also wear other types of PPT (e.g., head protection, hearing protection, eye protection) that could affect respirator performance. Appendix A to OSHA 29 CFR §1910.134 states, “The fit test shall be performed while the test subject is wearing any applicable safety equipment that may be worn during actual respirator use which could interfere with respirator fit.” However, many respirators are used in the workplace without fit testing, making this requirement generally ineffective at identifying and addressing PPT interface issues.

NIOSH and its National Personal Protective Technology Laboratory (NPPTL), working with manufacturers, users, and other stakeholders, can play an important leadership role in efforts to move toward performance standards and test methods for protective ensembles and individual PPT items that address interface issues. Because there are no economic or market incentives for the private sector to develop ensemble or interface standards, it is incumbent on federal agencies, in particular, NPPTL, to expand work on PPT ensembles and interface development. NPPTL’s participation in the collaborative approach used to develop a new firefighter’s ensemble, Project HEROES (Homeland Emergency Response Operational and Equipment Systems) can be used as a model to develop other PPT ensembles. Specific ensemble performance standards will need to be developed to overcome the current focus on individual PPT items. Given the numerous possible combinations of protective equip-

ment that individual workers could assemble, it is likely that ensembles will need to be designed and used for specific job requirements or that the design of interfaces will need to be standardized so that parts from different manufacturers are interchangeable, although the latter presents numerous challenges.

The healthcare sector is one work sector among many that would benefit from work on protective ensemble standards development and conformity assessment. The committee was asked to address conformity assessment issues relevant to preparing healthcare workers for an influenza pandemic. The issues relevant to conformity assessment for healthcare worker PPT are similar to those for PPT for other occupations; improvements in these processes will result in protective equipment in the marketplace that meets the specified criteria. The one specific issue relevant to this area would be efforts to develop and certify infection control PPT ensembles. Further research clarifying the mode(s) of influenza transmission will inform the development and selection of appropriate PPT ensembles.

Research on protective ensembles for healthcare workers should address infection control precautions at each level of use from standard precautions to the three levels of transmission-based precautions (contact, droplet, and airborne) (Siegel et al., 2007). Healthcare workers face issues of donning and doffing gowns, gloves, medical masks or respirators, shoe and hair covers, and in some cases face shields or other protective equipment. This is especially challenging in emergency situations.

Another challenge with PPT products is that full protective capabilities of the product are only realized when they are made available by the employer and correctly fitted and used. Respiratory protection programs are mandated by OSHA to ensure that employees are fit tested and go through the training to know how to use respirators (29 CFR §1910.132). Because an effective product is only one component of correct use, greater attention may need to be paid to certifications of trainers and training materials. Personnel certification is addressed separately from product certification in voluntary standards, such as ANSI/ISO/IEC (International Organization for Standardization/International Electrotechnical Commission) 17024, General Requirements for Bodies Operating Certification of Persons. In addition, greater attention should be paid to

the manufacturer user instructions that come with the PPT product, with criteria incorporated as part of the standards development and conformity assessment process. These criteria need to be more comprehensive and reflect the use of the individual PPT products with other types of PPT that, when used together, create an ensemble as well as addressing potential interface issues. Easy to read and culturally relevant documents on the selection, care, use, and maintenance of PPT are also critical for worker health and safety training.

Further work into standards that address the selection, use, maintenance, and care of PPT products are needed. For example, for fall arrest technologies to be effective, they must be integrated into practice or programs and must consider other components at the work site (anchorage points, guard rails, personnel nets, etc.). An example of a practice standard is ANSI/ASSE (American Society of Safety Engineers) A10.32, Fall Protection Systems for Construction and Demolition Operations. An example of a recent federal effort regarding guidelines is the NIJ Law Enforcement CBRN Protective Ensemble Selection and Application Guide, which will soon be released as a companion document to the product performance standard and the certification program requirements document (NIJ, 2010).

As highlighted in Chapters 2 and 3, conformity assessment for PPT products involves a number of government agencies and private-sector organizations. The organizations and agencies vary depending on the type of PPT or in some cases its purpose. One of the constants is that all respirators used in occupational settings are required to be certified by NIOSH. Requirements for protective clothing, on the other hand, vary depending on the use (e.g., healthcare worker gowns need Food and Drug Administration [FDA] clearance; protective clothing for firefighters must be certified by third-party organizations to meet NFPA standards; construction hard hats, fall arrest harnesses, and arc flash protective clothing can be voluntarily assessed to meet ANSI-related standards by third-party laboratories and certifying organizations; and protective clothing products for agricultural workers are just beginning to enter the conformity assessment process).

One challenge that will need to be faced in determining the appropriate type and level of rigor needed for PPT conformity assessment

processes is the level of specificity needed for the same or similar products that are used in widely varying work tasks. For example, gloves for healthcare workers are being used for a variety of tasks, some of which place the user at much higher risk of injury, illness, or death if the PPT does not perform effectively. Specific requirements have been put in place that work toward addressing some of these issues, such as the voluntary consensus standards that are incorporated into the FDA guidance for gloves used to administer chemotherapy agents. Finding the appropriate level of differentiation among products for specific work tasks poses challenges to conformity assessment processes for non-respirator PPT.

Although PPT products are designed to protect the worker from various hazards, the use of PPT may affect the worker’s productivity or ability to perform tasks due to physical discomfort or impaired senses. These unintended consequences include reduced peripheral vision or visibility, claustrophobia, breathing difficulty, impaired communication, reduced dexterity, increased slip and trip hazards, increased exertion or workload, overheating, static charge risks in explosive atmospheres, and skin abrasion and contact dermatitis. PPT requirements can make simple tasks such as climbing a ladder quite cumbersome. For healthcare workers, wearing respirators or face masks can interfere with communications with patients and their families. Wearing PPT may also give the worker a false sense of security, altering work behavior and thus presenting an increased risk of injury. When setting performance standards and outlining conformity assessment requirements for PPT, consideration needs to be given to reducing or eliminating unintended consequences of wearing PPT.

In addition to regulatory requirements mandating that employers provide appropriate PPT to protect their employees, contracts and subcontracts for services or for the purchase of PPT products may impose performance standards. To the extent that customers and regulators evaluate conformance with contractual standards, this provides market in-

centives to participate in various voluntary assurance and conformity assessment processes.

Federal contracts for PPT, or for construction or services, often impose safety and health or quality assurance requirements that extend beyond minimal OSHA compliance, where deemed to be advantageous. The contracts may incorporate additional testing protocols and performance standards (e.g., military specifications); contracts may refer directly to specific consensus standards (e.g., compliance with specific NFPA or ANSI-related standards); or they may incorporate PPT performance requirements by reference to more comprehensive documents such as the U.S. Army Corps of Engineers Safety and Health Requirements Manual (U.S. Army Corps of Engineers, 2005). Including specific standards or performance requirements by reference in a federal or federally funded contract is described or authorized under the Federal Acquisition Regulations (FAR 52.233-1 Accident Prevention). This incorporation by reference into contracts helps in simplifying and standardizing contract language across projects and over time, but publicly accessible data on compliance is very limited. Research evaluating the effectiveness of contract requirements or third-party audits of conformance would be valuable in determining whether PPT failures contributed to injury or illness. A research program similar to NPPTL’s evaluation of PPT in firefighter fatalities but targeting federal contracts could guide improved public procurement policies.

Another example of incorporating PPT technical specifications by reference is the U.S. Department of Transportation’s Manual on Uniform Traffic Control Devices, which must be followed on every highway project using federal funds. The manual stipulates adherence to ANSI/ISEA (International Safety Equipment Association) 107, American National Standard for High-Visibility Safety Apparel and Headwear, which is a performance standard for high-visibility safety clothing used in work zones.

A similar process of incorporating technical PPT requirements into contracts by reference is also common practice in the private sector. For example, a requirement to conform to the ICC (International Code Council) or BOCA (Building Officials and Code Administrators International) building codes would incorporate by reference the requirements for clothing, gloves, face shield, and safety shoes aimed a protecting workers from arc flash injuries around high-voltage equipment as defined in ANSI/NFPA 70E, Standard for Electrical Safety in the Workplace. Arc flash PPT is frequently inadequate and would benefit from a systematic

research program to identify and evaluate enhancements. Consensus NFPA standards are complemented by OSHA requirements for arc flash PPT under 29 CFR §1910.335.

Although tying conformity assessment requirements to a contract may provide much greater financial incentives to comply than relatively small OSHA fines, there are limited quantitative research data supporting the adequacy of the systems in place to ensure that the pass–fail criteria for meeting the performance standards are actually being met. Currently, product testing may be done by manufacturers or importers, either with or without third-party verification and quality assurance. Federal contracts incorporating PPT performance standards and requiring third-party testing with stipulations for follow-up research may provide valuable baseline data to determine the effectiveness of such interventions, similar to Executive Orders that have set aside selected federal building projects to serve as test beds for evaluating innovative “green” and energy-efficiency technologies.

Unlike products that are designed for recreational, informational, computational, or other purposes, PPT products are designed to protect against and reduce hazardous exposures. As mentioned earlier, health risks from known hazardous exposures can be quantified for many work sites. However, categorizing PPT products by the level of risk against which they protect in multiple work sites and for various work tasks can pose challenges. Some current PPT conformity assessment approaches have attempted to categorize products by risk, while others have segmented the products by their use or other criteria.

NIOSH certification of respirators is not based on specific risk assessment. The certification test requirements vary with the type of respirator (e.g., air-purifying, self-contained breathing apparatus). NIOSH has a long-term field evaluation of self-contained, self-rescuer respirators used in mining environments. This may reflect the risk associated with mining environments, but other high-risk sectors (logging, fishing, construction) have an equivalent risk. Using a different approach, the Environmental Protection Agency’s labeling regulations for protective devices intended to prevent noise-induced hearing loss do not follow a risk assessment approach. The devices are tested and given a Noise Reduction Rating, and the worker and employer must ensure that equipment

is selected to address the level of noise in the workplace. This is a labeling requirement, but it does not restrict or place mandates on manufacturing, sale, or use.

The European Union uses a three-category system for conformity assessment of PPT (Chapter 3). EU’s Category III devices are described as “PPE of complex design intended to protect against mortal danger or against dangers that may seriously and irreversibly harm the health, the immediate effects of which the designer assumes the user cannot identify in sufficient time” (EC, 2010). FDA clearance processes for medical devices are based on a broad assessment of the risk to both the wearer and to the patient. In addition to other requirements, Class I products are defined as “not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness or injury” (21 CFR §860.3).

For personal flotation devices (PFDs), a probabilistic risk-based approach is being explored by the U.S. Coast Guard to categorize the devices based on the probability of a PFD saving the life of a user from drowning in a marine event (Chapter 3). This approach to standards and conformance assessment could be applied to the evaluation and design of conformance assessment programs for various kinds of PPT (Box 4-1).

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