Certifying Personal Protective Technologies Improving Worker Safety (2011) / Chapter Skim
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3 Current PPT Conformity Assessment Processes
3 Current PPT Conformity Assessment Processes
Pages 55-88
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From page 55... ...
This chapter provides overviews of several approaches to conformity assessment, specifically those for respirators, healthcare worker PPT, firefighter and emergency responder PPT, ballistic-resistant body armor, hearing protection devices, personal flotation devices, and PPT for pesticide operators. For each, the process is described briefly, and the committee's assessment is provided on the strengths and weaknesses of these approaches particularly as they 55
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From page 56... ...
is the principal governmental agency with responsibility for testing and certifying respirators. Certification testing and related research is conducted at NIOSH's National Personal Protective Technology Laboratory (NPPTL)
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Respirators and respirator components that meet the testing criteria are listed on the NIOSH Certified Equipment List, and manufacturers are given approval to affix the NIOSH certified label to their products. NIOSH conducts site and product audits, although program resources for these purposes are limited (IOM and NRC, 2008)
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requires that all respirators used in workplaces be NIOSH certified. OSHA also requires a complete respiratory protection program at the worksite, including fit testing of respirators where relevant (29 CFR §1910.134)
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. Regarding the shortfall in respirator certification fees, a recent IOM/NRC committee concluded, "NIOSH should revise the respirator certification fee schedules so that certification fees paid by respirator manufacturers fully cover the cost of certification.
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PPT for healthcare workers are considered medical devices and are subject to FDA evaluation and oversight. Standards The standards for healthcare PPT include those issued by ASTM International, the American National Standards Institute (ANSI)
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FDA requires that manufacturers of surgeon and medical examination gloves demonstrate substantial equivalence to gloves already approved for market. Voluntary consensus standards are recognized by the FDA, and manufacturer compliance with the recognized standards serves to demonstrate substantial equivalence.
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The FDA identifies the devices that are determined to be high risk and therefore require the PMA process, including most Class III devices. PPT used by healthcare workers are currently categorized as Class I and II devices (Table 3-2)
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When the potential exists for healthcare workers to be exposed to blood-borne pathogens, OSHA requires use of PPT that "does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used" (29 CFR §1910.1030)
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Standards Voluntary consensus standards incor porated into FDA guidance documents Testing First party: Manufacturers submit re quired information to FDA Attestation of conformity assessment Third party: FDA reviews product data for Class II and Class III products Laboratory accreditation Not applicable
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NFPA committees have developed standards for a wide variety of PPT, including standards for protective ensembles for structural, proximity, and wild land firefighting as well as standards for garments for protection of industrial personnel against flash fire. Additionally, NFPA standards cover a broad range of emergency response applications beyond firefighting applications, in
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From page 66... ...
NFPA standards for fire and emergency services PPT do require that the products be certified by third-party, private-sector certifying organizations if the manufacturer chooses to assert that the product meets applicable NFPA standards. Standards The NFPA employs a structured process to develop standards for firefighter and emergency responder PPT.
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NFPA standards require that for conforming products, the certifying organization's label, symbol, or identifying mark be permanently attached to the product label or be part of the product label. It further requires that the certifying organization perform quality assurance audits and requires annual verification of product compliance by the certifying organization.
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It is important to recognize that the NFPA does not certify PPT; rather, the NFPA standards call for certification by private-sector certifying TABLE 3-4 Overview of the Conformity Assessment Process for Firefighter and Emergency Responder PPT (Excluding Respirators) Standards Voluntary consensus standards: NFPA Testing To state that the product conforms to NFPA standards requires third-party testing Attestation of conformity To state that the product conforms to assessment NFPA standards requires third-party certification Laboratory accreditation NFPA details the criteria for accreditation, including meeting the relevant ISO standards Surveillance and post-market Conducted by the certifying organization testing and evaluation Incentives/enforcement Worker and employer demand, grant requirements
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BALLISTIC-RESISTANT BODY ARMOR Law enforcement officers wear multiple types of PPT depending on the circumstances of their work. This section focuses on the conformity assessment processes specific to ballistic-resistant body armor.
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The NLECTC National Center has responsibility for managing the Compliance Testing Program and maintaining the Compliant Products List.
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. Requirements and Incentives Many law enforcement agencies base their purchasing decisions for body armor on the NIJ Compliant Products List.
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As with respirators, issues regarding training and use of equipment also need to be addressed. TABLE 3-5 Overview of the Conformity Assessment Process for Ballistic-Resistant Body Armor Standards Standards developed by NIJ and NIST Testing Third-party testing Attestation of conformity Third-party certification by NIJ through assessment NLECTC Laboratory accreditation NVLAP accreditation; laboratories are also required to be independent of the manufac turer and be located in the United States Surveillance and post-market NLECTC testing and evaluation Incentives/enforcement Bulletproof Vest Partnership Program, worker and employer demand NOTE: NIJ = National Institute of Justice; NIST = National Institute of Standards and Technology; NLECTC = National Law Enforcement and Corrections Technology Center; NVLAP = National Voluntary Laboratory Accreditation Program.
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that manufacturers of hearing protection devices provide a noise reduction rating (NRR) on the packaging.
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. OSHA mandates that employers select hearing protection devices based on their NRR values when employees are exposed to noise at or above the Permissible Noise Exposure (90 decibels averaged over 8 hours and measured on the A scale)
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Whether such an approach can prohibit unscrupulous distributors from importing hearing protection devices and falsifying the NRR values is not clear. Such distributors and offshore manufacturers may not have assets that the EPA can access.
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Coast Guard (USCG) is responsible for the conformity assessment processes for PFDs under its jurisdiction.
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These approaches to standards and conformance assessment could be applied to the evaluation and design of conformance assessment programs for various kinds of personal protective technologies (see Chapter 4)
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Committee Comments The conformity assessment processes for PFDs are summarized in Table 3-7. As noted above, codifying standards in federal regulations has pros and cons.
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Standards In 2009, ASTM Standard F2669, Standard Performance Specification for Protective Clothing Worn by Operators Applying Pesticides, was approved as a performance specification for protective clothing for pesticide operators. An equivalent ISO standard draft is now under review.
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If a manufacturer chooses to certify the performance of its PPT products (other than respirators) , third-party certifying organizations can test the product to determine if specific ASTM, ANSI, or other standards have been met.
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Where the use of these products is required because of high-risk worksites, third-party testing and, in many cases, third-party certification could be a mechanism for reducing the risk to workers and enhancing the certainty that the PPT products meet performance requirements. TABLE 3-8 Examples of Voluntary Consensus Standards and Certifying Organizations Examples of Relevant Examples of Certifying Standard(s)
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The mandate that all PPT products sold in the EU have the CE mark is the major driver of conformity assessment efforts, and similar mandates are not available for non-respirator PPT in the United States. Issues facing the EU 5 The European Union's documents use the term personal protective equipment (PPE)
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. Examples include fall protection, respiratory protective equipment, and clothing de signed for high- or low-temperature environments.
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2010a. Guidelines on the application of Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the member states relating to personal protective equipment.
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e Not federally mandated, but required for inclusion on the NIJ Compliant Products List. 85 f Third-party oversight of testing.
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2008. Preparing for an influenza pandemic: Personal protective equipment for healthcare workers.
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http://www.uscg.mil/hq/cg5/ cg5214/pfdselection.asp (accessed August 23, 2010)
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