6
Findings and Recommendations
A COMPREHENSIVE RISK-BASED FRAMEWORK FOR PPT CONFORMITY ASSESSMENT
In considering conformity assessment for personal protective technologies (PPT) used in the workplace, the committee recognized the broad array of PPT products and the wide range of job tasks that people perform while using this equipment. Within the same basic type of PPT, for example gloves, there are wide variations in requirements that must be met to protect workers—protecting construction workers from lacerations when handling sheet metal, healthcare workers handling chemotherapy agents, firefighters facing flames and hot surfaces, and agricultural workers applying pesticides. The lives or health of many members of the U.S. workforce depend on the proper selection and reliable performance of various types of PPT. Reliable conformance of these products to appropriate performance standards is critical.
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, which can then be used to identify gaps, prioritize resources, determine and direct conformity assessment efforts, and ensure consistent conformity assessment approaches for comparable products, with the goal of improving worker safety and health. In Chapter 5, the committee began the process toward a comprehensive framework by outlining the guiding principles and a risk-based approach that is needed to categorize PPT, and then outlining options for conformity assessment that could be associated with each category of PPT. Data on the occupational health risks of a specific job due to haz-
ardous exposures in the workplace can be estimated based on knowledge about the exposure; this information can be used to categorize PPT.
Throughout the report the committee documents a wide range of approaches to PPT conformity assessment and the varied nature of government agency involvement in these processes. The role of federal agencies ranged from an all-encompassing role in each phase of conformity assessment (e.g., respirators) to more specific roles such as standardized labeling (e.g., Noise Reduction Rating labels for hearing protection devices). Other roles for federal agencies include accrediting testing laboratories or specifying accreditation organizations. For some products, the government agency acts as the certifying organization. A unique government role in a voluntary third-party conformity assessment program is evidenced by the Bulletproof Vest Partnership Program, through which the Department of Justice provides a financial incentive through matching grants to law enforcement agencies to purchase compliant body armor. Government agencies also play key roles in the research needed to support standards development and conformity assessment processes, including the development and assessment of potential test methods. Health surveillance also can be facilitated through the work of federal, state, or local agencies.
The committee emphasizes that consistency in the level of rigor required for conformity assessment of PPT products used for tasks with comparable risks is a priority. Therefore, the first step is to establish a framework that will categorize similar 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 pragmatic factors described in Chapter 5 (e.g., cost of conformance, impediments to innovation, competition, comfort, durability, globalization, risk to manufacturer’s reputation due to poor product quality and/or product failure). 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. Regulations mandating that PPT products used in the workplace adhere to conformity assessment and certification processes will be critical to ensuring that more rigorous product testing and audit requirements are met. An increased role for third-party testing and conformity assessment is recommended for many types of PPT because of the value of independent assessments in increasing the rigor of the process. As noted throughout
this report, third-party testing and declaration of conformity assessment can and are being done largely by third-party private-sector organizations, which is consistent with the approach of the National Technology Transfer and Advancement Act (Public Law 104-113).
The recommendations provided in this chapter are focused on the role of the National Institute for Occupational Safety and Health (NIOSH), and specifically the National Personal Protective Technology Laboratory (NPPTL), as it is the only federal organization that is focused solely on PPT and therefore has a leadership role in addressing PPT issues. However, the actions that are recommended require coordination and cooperation with multiple federal agencies, private-sector corporations and organizations, workers, and other stakeholders. Box 6-1 summarizes the findings of the committee regarding non-respirator conformity assessment efforts.
BOX 6-1 Findings on Conformity Assessment Range of Conformity Assessment Efforts
Product Standards
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Role of Government Agencies
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Recommendation 1: Develop and Implement Risk-Based Conformity 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 injury, illness, or death that could result from failure of the PPT to protect the user from workplace hazards.
NIOSH’s National Personal Protective Technology Laboratory (NPPTL) should serve in a leadership role and convene other relevant government agencies, certifying and accrediting organizations, manufacturers, and end users to develop and implement 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 degree 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
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Components of the tiered PPT conformity assessment framework include the following categories and actions:
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Low risk—manufacturer’s attestation to meet relevant standards,
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Medium risk—third-party testing and certification, and
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High risk—third-party testing and certification with government involvement to provide oversight and to assist in enforcement;
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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;
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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 engage in developing and implementing the appropriate conformity assessment processes;
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NPPTL and other government agencies should have the appropriate level of engagement in the conformity assessment processes for non-respirator PPT depending on the risk level; and
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Government contracts should specify that PPT used in work to fulfill those contracts must meet the requisite level of conformity assessment based on the comprehensive risk-based PPT framework.
RESEARCH, SURVEILLANCE, AND COMMUNICATION
As outlined in its vision statement, NPPTL aims to be the leading provider of quality and timely PPT research, training, and evaluation. NPPTL is already substantively involved in many aspects of conformity assessment for non-respirator PPT, particularly through active involvement in voluntary standards development and development of test methods. Continued efforts in standards setting would be enhanced with NPPTL working with stakeholder organizations and other government agencies to encourage and promote end-user involvement in the development of voluntary consensus standards.
As a research agency, NPPTL is well suited to furthering its ongoing efforts to develop test methods and conduct research that contributes to the development of voluntary consensus standards and other conformity
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 control precautions.
Increased post-marketing testing, evaluation, and surveillance are key factors in enhancing PPT products for worker use. The limited availability of data on product effectiveness across the life cycle of PPT, and in particular on PPT use in the workplace (including use of PPT in emergency conditions), is currently hindering improvements in PPT and PPT conformity assessment processes. A surveillance network that draws on and expands current surveillance systems already in place (see Chapter 2) could provide information needed to identify workplace tasks where injuries, illnesses, or deaths are occurring because of noncompliant and/or poorly manufactured PPT, inadequately or incorrectly labeled PPT, the PPT not being provided by the employer, and/or any end-user performance issues associated with PPT (e.g., the incorrect use of PPT due to inadequate or improper training that could shed light on PPT training needs). This type of information will also support the development of an effective PPT recall system to prevent additional worker injury or illness when PPT performance problems are identified.
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 certified equipment or find independent information on non-respirator PPT. NPPTL currently administers its Certified Equipment List, which details the respirators and respirator components that meet certification criteria. This has been found to be valuable to end users and administrators responsible for selecting and providing respirator protection for workers. Similarly, the Responder Knowledge Base is a comprehensive resource for selecting emergency responder PPT. A single reputable source of information on all certified PPT is needed to provide end users, employers, and purchasers the ability to make informed PPT selections for a wide range of jobs and job tasks. This listing (available through a website and/or other sources) should include data on the product, relevant standards, the certification mark, date of certification, training requirements for safe use, and any product recalls and safety alerts about PPT. This expanded list of certified equipment could link to lists of certified equipment from accre-
dited third-party certifying organizations. Integrating information into this resource from the proposed surveillance system could provide additional information on PPT products. Box 6-2 summarizes the commit-tee’s findings on research, surveillance, and communication issues.
BOX 6-2 Findings on Research, Surveillance, and Communication NPPTL Expertise
PPT for Healthcare Workers in an Influenza Pandemic
Limits on Current Data and Need for Enhanced Surveillance and Post-Marketing Evaluation Data
Communication of PPT Conformity Assessment
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Recommendation 2: Enhance Research, Standards Development, and Communication
NIOSH NPPTL should continue and expand its role in PPT conformity assessment. Specifically, NPPTL should
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Continue its involvement in standards-setting processes and committees and facilitate end-user participation in voluntary consensus performance-based standards;
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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;
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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;
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Expand its role and become the primary clearinghouse for reliable information on non-respirator PPT;
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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
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Expand its efforts in influenza pandemic-related research and conformity assessment for infection control ensembles.
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), Occupational 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 collection 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 expanding where needed to incorporate data collection on PPT use across industries including product recall information. The surveillance system should link to the expanded Certified Equipment List. Potential sources of collaboration include
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Other NIOSH surveillance and data collection systems, including the Fatality Assessment and Control Evaluation program, health hazard evaluations, and the Sentinel Event Notification System for Occupational Risk (SENSOR);
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CPSC’s recall database, unsafe product reporting system, and the National Electronic Injury Surveillance System (NEISS);
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The FDA’s surveillance and adverse event reporting databases, such as the Medical Product Safety Network (MedSun), the FDA Safety Information and Adverse Event Reporting Program (MedWatch), and the Manufacturer and User Facility Device Experience (MAUDE) database; and
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OSHA’s injury and fatality investigations and surveys to collect information about injuries or illnesses potentially due to the failure of PPT.