5
Certifying and Regulating Healthcare PPE: Defining an Integrated System

Effective personal protective equipment (PPE) that is used appropriately in situations that put healthcare workers at risk will save lives, just as other critical medical devices such as pacemakers or defibrillators do. In this era of working toward preparedness for a pandemic, it is important to examine the level of rigor employed to ensure that all forms of PPE are safe and effective medical devices. This chapter examines the process by which healthcare PPE products are tested before entering the market to meet certification and approval requirements, the regulation of the use of PPE in the workplace, and the extent to which PPE products are found to be effective in the post-marketing phase (Table 5-1). Recommendations are made for improvements in each step of the testing and approval process to ensure that it is an integrated process and that all relevant agencies and organizations are working as collaboratively and efficiently as possible to enhance the quality and efficacy of PPE for healthcare workers.

TABLE 5-1 Responsibilities for Testing, Certifying, and Approving PPE

 

Organizations or Agencies

Voluntary Standards Development

What standards and criteria are used to test PPE products?

Federal agencies, voluntary standard organizations (e.g., ASTM International, ISO, AAMI)



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5 Certifying and Regulating Healthcare PPE: Defining an Integrated System Effective personal protective equipment (PPE) that is used appropri- ately in situations that put healthcare workers at risk will save lives, just as other critical medical devices such as pacemakers or defibrillators do. In this era of working toward preparedness for a pandemic, it is impor- tant to examine the level of rigor employed to ensure that all forms of PPE are safe and effective medical devices. This chapter examines the process by which healthcare PPE products are tested before entering the market to meet certification and approval requirements, the regulation of the use of PPE in the workplace, and the extent to which PPE products are found to be effective in the post-marketing phase (Table 5-1). Rec- ommendations are made for improvements in each step of the testing and approval process to ensure that it is an integrated process and that all relevant agencies and organizations are working as collaboratively and efficiently as possible to enhance the quality and efficacy of PPE for healthcare workers. TABLE 5-1 Responsibilities for Testing, Certifying, and Approving PPE Organizations or Agencies Federal agencies, Voluntary Standards Development What standards and criteria are used to test PPE voluntary standard products? organizations (e.g., ASTM International, ISO, AAMI) Continued 147

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148 PREPARING FOR AN INFLUENZA PANDEMIC Organizations or Agencies NIOSH, FDA Pre-Marketing Testing and Approval or Certification Does the product meet the designated standards and criteria? OSHA, CDC, Marketing and Use in the Workplace What PPE is required or recommended and under what Joint Commission circumstances? Post-Marketing Evaluation and Product Investigation NIOSH, FDA, CPSC or Recall Are products effective in the workplace? NOTE: AAMI = Association for the Advancement of Medical Instrumentation; CDC = Centers for Disease Control and Prevention; CPSC = Consumer Product Safety Commission; FDA = Food and Drug Administration; ISO = International Organization for Standardization; NIOSH = National Institute for Occupational Safety and Health; OSHA = Occupational Safety and Health Administration. STANDARDS DEVELOPMENT Before marketing, most healthcare PPE products, including gowns, gloves, and respirators, are tested to meet specific performance standards (e.g., flammability, fluid resistance) (Appendix C). In addition, health- care PPE manufacturers need to meet quality of manufacturing standards as determined by the Food and Drug Administration (FDA). The stan- dards are detailed in FDA guidance documents and in Occupational Safety and Health Administration (OSHA) regulations. As will be dis- cussed later in the chapter, the National Institute for Occupational Safety and Health (NIOSH) certification process is available for testing and certifying respirators.1 A similar certification process is not available at the present time for other healthcare PPE (e.g., gowns, gloves, eye protection). Manufacturing, performance, and testing standards are developed by voluntary standards-setting organizations including the International Organization for Standardization, ASTM International, and the Associa- 1 N95 respirators that are approved by FDA for use in healthcare facilities (termed sur- gical respirators by FDA) must also meet a set of standards identified in the FDA guid- ance documents.

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149 DEFINING AN INTEGRATED SYSTEM tion for the Advancement of Medical Instrumentation Standards are de- veloped to establish uniform test methods for evaluating products, to specify agreed-upon practices for the use and care of products, and to detail the minimum requirements that must be met for a product to be deemed acceptable (Stull, 2006). For many types of PPE, efforts are un- der way to harmonize global standards to help ensure that products will meet agreed-upon specifications. Voluntary standards-setting organizations work through expert committees consisting of representatives from government agencies, manufacturers, employers, academia, and end users. The organizations differ in the processes used to develop and approve new standards and the extent to which public input is sought or external peer review is re- quired (Stull, 2006). These standards are generally copyright protected and available only by purchase, which greatly limits public access. As with the drug approval process, it is critically important that stan- dards-setting committees relevant to PPE devices be as independent and transparent as possible with clear limits on conflicts of interest. Recent proposed changes to FDA advisory committee participation include limi- tations on relevant financial interests allowed for committee members and requirements that voting members cannot have the potential to gain financially from the decision making (FDA, 2007e). In order to assure credibility in PPE standards setting, an area in which vested interests could appear to cloud objectivity, PPE standards-setting processes should have specific and clearly defined limits with strict adherence regarding conflicts of interest (financial and other). Further, end user participation, particularly worker representation, needs to be encouraged and increased. Manufacturers are fully engaged in this process and should encourage standards-setting organizations to increase the diversity of perspectives on their committees. Govern- ment agencies may have to financially support the standards-setting process to ensure a wide range of expertise and independent perspectives on standards-setting committees. Healthcare workers and others also need to be able to clearly identify and locate relevant PPE standards and the level of protection that the product can be expected to offer. Efforts should be made to provide easy access to the standards at minimal or no cost to the user so that the entire process is as open and transparent as possible. Further, a website catalog is needed that can provide links to relevant standards and regulations as well as to certified and approved equipment lists. This catalog should include

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150 PREPARING FOR AN INFLUENZA PANDEMIC • the agency with approval responsibility, • the tests used to approve such equipment and their relevance, • methods available (from manufacturers or regulators) to confirm that specific PPE meets the test requirements, • information needed by those selecting and training workers to use PPE, and • listings of equipment that have met the relevant standard. PRE-MARKET TESTING AND APPROVAL For healthcare PPE, the FDA and NIOSH have distinct although sometimes interconnected responsibilities in the pre-market phase of PPE product development and testing. NIOSH’s legislative mandate is fo- cused on the testing and certification of respirators for use in healthcare and numerous other industries. FDA’s role is focused on PPE as a medi- cal device. FDA provides manufacturers with the clearance or approval to market PPE (e.g., respirators, gowns, gloves) as well as medical masks (specified as surgical masks by the FDA) for use in the healthcare indus- try based on review of data submitted by the manufacturer. The respon- sibilities of the two agencies are interconnected in that FDA approval of respirators for use in healthcare settings requires that the respirators be NIOSH-certified. NIOSH Respirator Certification As described in Chapter 1, NIOSH has the legal authority to certify respirators; certification testing is conducted by the National Personal Protective Technology Laboratory (NPPTL). NIOSH respirator certifica- tion criteria are specified in federal regulations (42 CFR 84). The testing conducted by NPPTL includes, but is not limited to, testing the filter ef- ficiency of respirators, determining that the breathing resistance of respi- rators is within an acceptable range for workers, and ensuring that respi- rators (except filtering facepiece respirators) will fit a wide variety of workers. Manufacturers send their respirators to NIOSH for certification testing. Once certified, the NIOSH designation can be displayed on the product and its packaging. NIOSH maintains a searchable Certified Equipment List on its website (NPPTL, 2007a). NIOSH’s efforts to im- prove the certification process include work on revising the certification

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151 DEFINING AN INTEGRATED SYSTEM process regarding the testing of the faceseal through total inward leakage (see Chapter 3) and updating the sizes of faces on the anthropometric panel used for this testing (IOM, 2007a). FDA Medical Device Clearance and Approval Federal regulatory control of medical devices began in 1937 with legislation focused on the adulteration or misbranding of medical devices (Hutt, 1989). The Medical Device Amendments of 1976 extended FDA’s regulatory authority for device safety by permitting FDA to require pre- market testing of certain devices. This legislation created three classes of control with categorization and level of regulation based on the level of risk to the user. Class I devices are considered low risk to the user (e.g., infant caps); the manufacturing of these devices must meet general stan- dards for good manufacturing processes. Class II devices (e.g., powered wheelchairs, apnea monitors) are of intermediate risk and to be legally marketed must receive FDA clearance through the 510k submission process2 (based on Section 510(k) of the Federal Food, Drug, and Cos- metic Act). This process requires documentation that the device is as safe and effective as, or substantially equivalent to, a legally marketed prod- uct that was or currently is on the U.S. market (FDA, 2007d). In ap- proximately 10 to 15 percent of all 510k submissions, requirements are also made for submission of clinical data (IOM, 2005). Class III devices (e.g., cochlear implants, implantable cardiac pacemakers) are defined as those products that “support or sustain human life, are of substantial im- portance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury” (FDA, 2007a). Class III devices undergo an approval process similar to the FDA drug approval process; manufacturers must submit a pre-market approval (PMA) appli- cation to FDA including data from clinical studies that support the safety and efficacy of the device. FDA review is based on data submitted by the manufacturer or by approved third-party testing organizations. Recom- mended or required testing standards are defined in FDA guidance documents (see Appendix C for a listing of FDA testing standards for various types of PPE and for medical masks). PPE products used in healthcare settings are currently categorized as Class I or Class II devices (Table 5-2). The standards set by a number of 2 A limited number of Class I devices are also subject to the 510k requirements.

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152 PREPARING FOR AN INFLUENZA PANDEMIC voluntary standards organizations and federal agencies are included as part of the FDA clearance and approval process. FDA requires a 510k submission for some PPE products including N95 respirators used in healthcare (termed surgical respirators by the FDA). Approval of medical masks is also under the purview of FDA and requires a 510k submission (Appendix C). As noted in Chapter 1, the committee does not categorize medical masks as a type of PPE because the masks are not designed or tested to protect the wearer. However, because of the widespread use and availability of medical masks it is important that research be conducted to determine their level of protection in the event of an influenza pandemic (see Chapter 3). TABLE 5-2 FDA Classification of PPE-Related Equipment Risk to Patient or Healthcare PPE and Related Devicesa Class Device Wearer Requirements • Surgeons’ gloves I Low General standards for good manufactur- (510k required) ing processes; most • Examination Class I devices are gloves (510k exempt from 510k required) submissions • Other surgical apparel (isolation gowns, shoe covers, caps, hoods, operating room shoes) (510k exempt) • Surgical gowns II Intermediate 510k submission • Surgical masks • Surgical respirators III High Subject to pre-market None approvals must submit clinical evidence of safety and efficacy NOTE: FDA uses the terms surgical gowns, isolation gowns, surgical masks, and surgical respirators and defines each in guidance documents. a Protective eyewear used as PPE is not regulated by the FDA as a medical device.

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153 DEFINING AN INTEGRATED SYSTEM Next Steps for Pre-Market Testing and Certification In preparation for and during an influenza pandemic, the vaccines and antiviral agents that will be developed and used as countermeasures will undergo FDA’s pre-market drug approval process, a process that requires research involving human use of the product to demonstrate safety and efficacy. However, the current process for approving respira- tors and other medical PPE devices, which may be lifesaving in the absence of adequate influenza vaccines and antivirals, does not include similar requirements for pre-market safety, efficacy, or effectiveness testing. Efforts are needed to ensure that standards and testing processes are in place so that healthcare PPE meets the unique needs of the healthcare industry. Because the healthcare worker’s job revolves around patient care, PPE testing parameters and protocols need to be geared toward the realities of the work, including facilitating interpersonal communication and medical examinations, ensuring the ability to work with multiple patients (e.g., ease of decontaminating or donning and doffing PPE), and other needs that are particularly important for this industry. Medical de- vices, such as healthcare PPE, frequently undergo redesign as technolo- gies evolve and new materials become available (Chapter 3). To get the most out of these frequent updates and improvements it is important to have certification and approval processes that can quickly adapt to and test these new approaches. Careful consideration should be given to revi- sions in these processes that will ensure the safety of the PPE wearer while being able to rapidly respond to innovations. The committee believes that more rigorous pre-market testing is needed to ensure that healthcare PPE products demonstrate functionality and usability in the clinical setting for which they are designed. These products should undergo testing to meet evidence-based performance requirements under conditions of normal clinical use; issues to be exam- ined include acceptability to workers and usability along with specific performance testing (e.g., fit testing, protection factor testing) (see Chap- ter 3). Healthcare workers need to know that the PPE products they are using have been demonstrated to be effective in preventing or reducing disease transmission. More rigorous pre-market testing that includes field or field simulation tests of PPE products should be required in NIOSH certification of respirators and in FDA approval requirements for all healthcare PPE. Controlled field testing of PPE equipment under devel- opment would be conducted after the appropriate approvals from rele-

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154 PREPARING FOR AN INFLUENZA PANDEMIC vant institutional review boards and user consent are obtained. The re- sults of the testing would be used to refine the design of the PPE (as needed), and the collected data would be submitted as part of the certifi- cation and market approval processes. Federal agencies, including OSHA, NIOSH, and FDA, should recognize the need for field testing of PPE and involve manufacturers and employers in conducting well- defined tests with specific endpoints and testing requirements. NIOSH already does considerable testing of respirators. Adding field or field simulation tests to its repertoire or requiring submission of these data will address concerns about wearability and functionality (see Chapter 3) as well as strengthening the testing of the equipment’s efficacy. The medical device approval or market clearance process at FDA has evolved through a series of legislative actions designed to reduce fraud while promoting innovation in the design and production of medical de- vices (Hutt, 1989; Merrill, 1994). The recommendations of a recent Insti- tute of Medicine (IOM) report The Future of Drug Safety emphasized enhanced rigor, independence, and transparency for the drug approval process (Psaty and Burke, 2006; IOM, 2007b). Similar considerations are needed regarding medical device testing. Consideration should be given to reevaluating the FDA classifications of healthcare PPE devices to re- quire pre-market approval for all healthcare PPE products. Raising the testing requirements would provide data on their efficacy for use in clinical settings. Just as NIOSH certification is a key criterion for FDA approval of respirators, one way to expedite FDA approval of other types of PPE would be to develop certification processes for gowns, gloves, eye pro- tection, and other relevant PPE. Certification would raise the bar on re- quirements for pre-market testing and could be incorporated into FDA approval processes. The development and implementation of certification processes should be explored by NIOSH and FDA, with certification testing occurring in the NPPTL or by a process determined to be best suited for increased pre-market testing. Before healthcare PPE products reach the marketplace there should be thorough assessments of their efficacy and wearability: Will they work and can they realistically be worn for healthcare work? These as- sessments should be conducted in an independent and rigorous manner with concomitant adequate enforcement authority.

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155 DEFINING AN INTEGRATED SYSTEM REGULATING AND MONITORING USE OF PPE IN THE WORKPLACE As described in Chapters 1 and 3, OSHA and the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organi- zations) are both involved in efforts to ensure that PPE is being properly used in the workplace. OSHA regulations require the use of NIOSH- certified respirators and have explicit details about the responsibilities of employers to provide fit testing programs and ready access to respirators and other appropriate PPE on the worksite. Recently, OSHA released a report specifically focused on protecting healthcare workers during an influenza pandemic (OSHA, 2007b). Healthcare facilities requesting Joint Commission accreditation are required to have an infection control program. The Joint Commission does not specify the details of the pro- gram but provides a list of recommended resources for the development of a program that include the two-tiered approach of the Centers for Dis- ease Control and Prevention’s (CDC’s) infection control precautions (Chapter 1) (including the recommendations of the Health Care Infection Control Practices Advisory Committee), as well as recommendations developed by the Society for Healthcare Epidemiology of America and the Association for Professionals in Infection Control and Epidemiology. The Joint Commission and OSHA have an agreement that involves collaborations in training and communication efforts regarding protec- tion of healthcare workers from a range of workplace hazards (OSHA, 2007c). Focusing these collaborative efforts on emphasizing and improv- ing PPE compliance would bring the resources and attention of both organizations to bear on this critical issue. OSHA’s Voluntary Protection Programs (VPPs) offer another example of an approach for emphasizing appropriate use of PPE as well as recognizing effective and comprehen- sive worker safety programs in healthcare facilities (OSHA, 2007a). Performance-based criteria are used to evaluate the occupational safety and health program of each worksite that applies. Selection as a VPP site offers varying levels of recognition that are accompanied by reductions in programmed OSHA inspections as well as expectations for continuous improvement efforts. Increased efforts are needed that prioritize the emphasis on PPE in accreditation and regulatory assessments. A Joint Commission initiative focused on PPE compliance would be an immediate action that could have significant ramifications in improving awareness and appropriate

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156 PREPARING FOR AN INFLUENZA PANDEMIC use of PPE (Chapter 3). Likewise, OSHA should take further action to strengthen its efforts to assess PPE compliance in healthcare worksites. Healthcare PPE is largely under the purview of the agencies and or- ganizations that regulate occupational safety and health. In the event of an influenza pandemic, retail purchase may be a major route of acquiring PPE for home healthcare workers and others working in healthcare facili- ties. Further, retail sales are the route by which PPE is purchased by the general public, including those who will be caring for family members or who are interested in protection during a pandemic. However, PPE prod- ucts, particularly respirators, that are sold online or in retail stores are not required to be NIOSH certified. Some retail outlets have realized the value of certified products and have implemented policies to stock and sell only those respirators that are certified by NIOSH (Berry Ann, 2007). The Consumer Product Safety Commission (CPSC) has regula- tory authority for consumer products, but PPE is among the myriad of products overseen by the agency. Efforts are needed to ensure that qual- ity PPE products are available to the general public online and in retail establishments. Additionally, efforts are needed to assess and improve consumer awareness regarding the appropriate use of various types of PPE, the differences in medical masks versus respirators, and the signifi- cance of the NIOSH certification designation in decisions regarding the purchase of respirators. POST-MARKETING EVALUATION AND SURVEILLANCE Once healthcare PPE products are in the marketplace it is critically important that mechanisms are in place to monitor their effectiveness— taking defective products off the shelves, examining product effective- ness in the workplace, and providing purchasers with the comparative information necessary to assess what product best meets their needs. As has recently been noted in issues regarding drug safety, post- marketing evaluation is often the missing or weakest component of the U.S. drug safety program (Furberg et al., 2006; Wood, 2006; Surowiecki, 2007). Post-marketing efforts are generally hindered by scarce resources and lack of enforcement authority. Myerburg and colleagues (2006) in a review of life-threatening malfunction of implantable defibrillators sug- gest that design and manufacturing flaws are inevitable and that only through post-marketing surveillance can corrective actions be taken to decrease risk to the lowest possible level. They further affirm that pa-

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157 DEFINING AN INTEGRATED SYSTEM tients and providers should be given adequate product information to permit informed decisions with regard to risk and benefit. Further efforts to ensure follow-up of PPE devices are also needed. The following sec- tions provide an overview of current NIOSH and FDA post-marketing activities and then examine the next steps for PPE post-marketing. NIOSH Product and Manufacturer Audits NPPTL conducts product audits and investigations to ensure that NIOSH certification markings are used appropriately and that certified products in the marketplace continue to meet NIOSH certification crite- ria. Through the Certified Product Investigation Process (CPIP) con- ducted by NPPTL, NIOSH has the authority to issue user notices, request that manufacturers retrofit their products to meet NIOSH criteria, recall respirators, and if necessary, rescind certification approval. For products that assert NIOSH certification but have not received it, NIOSH can act against false or misleading advertising. In 2006, NIOSH revoked one respirator approval; two N95 respirator approvals were determined to be null and void because their issuance was based on the manufacturer’s false and misleading statements; and 12 user notices were issued (3 of which involved devices misrepresented as N95 respirators) (R. Berry Ann, NIOSH, personal communication, May 2007). NIOSH opened 32 product investigations in 2006 and closed 37 product investigations that had been initiated in 2006 or prior years. User notices issued by NIOSH, manufacturers, and professional associations are posted on the NIOSH website to alert users of a condition or risk that may exist with a specific product. The budget for the CPIP program is limited; in FY 2006 the program operated on a budget of approximately $545,000, with less funding available in FY 2007 (NPPTL, 2007b). Increases in available resources could expand the scope of follow-up and could be used to allow agency-initiated investigations in addition to resolving is- sues identified by others. FDA Post-Marketing Evaluation FDA’s post-marketing efforts work through both voluntary and mandatory approaches to adverse events reporting, product evaluation,

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158 PREPARING FOR AN INFLUENZA PANDEMIC and surveillance. The limited resources available to FDA for post- marketing assessments of medical devices are a concern (IOM, 2005). FDA’s Mandatory Medical Device Reporting Program—begun in 1976 and expanded in the Safe Medical Devices Act of 1990—requires manufacturers, importers, hospitals, and user facilities to report to FDA any deaths or serious injuries caused by or potentially associated with use of a device as well as any malfunctions that could lead to death or serious injury. Since 2002, FDA has been piloting the Medical Product Safety Network (MedSun), in which participating hospitals, nursing homes, and other healthcare facilities agree to report the mandatory device safety information through an online Internet-based system (MedSun, 2007). Currently, 350 hospitals, nursing homes, and other healthcare facilities are participating in the MedSun program (MedSun, 2007). MedSun also collects voluntary information related to improving the effective design and use of medical devices. Healthcare facilities that do not use MedSun, as well as manufacturers, distributors, and im- porters, are required to provide written documentation to FDA of any major problems. Healthcare professionals and consumers can voluntarily report ad- verse effects of medical devices (in addition to drugs, biologics, and cer- tain nutritional products and cosmetics) through FDA’s MedWatch pro- gram (FDA, 2007c). These reports can include serious adverse events, potential and actual product use errors, and product quality problems. The MedWatch system and website are also used to disseminate medical product safety alerts, recalls, withdrawals, and major labeling changes. FDA receives more than 400,000 adverse reports annually, of which ap- proximately 5 percent have been from individual healthcare workers through MedWatch (FDA, 2005). The majority of reports come from manufacturers, who are required to report serious and adverse events within 15 days of discovering a problem. Public access to the adverse events information reported to FDA by consumers, professionals, user facilities, manufacturers, and distributors is available through the FDA’s Manufacturer and User Facility Device Experience and Device Experi- ence Network databases (FDA, 2007b). Under Section 522 of the Federal Food, Drug and Cosmetic Act and updated in the FDA Modernization Act of 1997, FDA has the authority to order post-market surveillance of any Class II or Class III medical de- vice “the failure of which would be reasonably likely to have serious ad- verse health consequences or which is intended to be (1) implanted in the human body for more than one year, or (2) a life sustaining or life sup-

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159 DEFINING AN INTEGRATED SYSTEM porting device used outside a device user facility.” The relevant FDA guidance document (FDA, 2006) highlights a range of methodologic ap- proaches that are permitted as appropriate for Section 522 studies includ- ing analysis of secondary data sets, nonclinical testing, cross-sectional studies, and randomized controlled trials. FDA has the authority to fol- low through with enforcement actions that can include financial penalties (FDA, 2006). A recent IOM report on pediatric medical devices reported that only two Section 522 studies have been requested by FDA for medi- cal devices since the 1997 legislation (IOM, 2005). More often, accord- ing to the report, post-marketing studies are required at the time the pre- market application is approved and are, therefore, condition-of-approval studies (IOM, 2005). The 2005 IOM report called for efforts to bolster FDA’s capacity and resources for post-marketing evaluation of medical devices; these recommendations are relevant and applicable to needed post-marketing evaluation and monitoring of PPE products. Other Medical Device Safety Reporting Efforts A range of additional incident-reporting programs through federal, state, and nonprofit agencies and organizations examine medical device safety and adverse events with a focus on patient safety issues. For ex- ample, in accrediting healthcare facilities, the Joint Commission exam- ines sentinel events that may include the safe use of medical equipment. The ECRI Institute (formerly known as the Emergency Care Research Institute) examines device safety and provides comparative evaluations of medical devices. Next Steps for Post-Marketing Evaluation and Surveillance Studies examining the effectiveness of PPE in the workplace are needed so that workers know the extent of protection provided by approved or certified PPE. Resources for post-market evaluation and surveillance of healthcare PPE are currently limited. Issues regarding adverse events involving PPE (e.g., malfunctioning device) that are re- ported to FDA and NIOSH by manufacturers, distributors, or users are investigated and addressed to the extent feasible with limited budgets. Few resources are available for post-market evaluations of off-the-shelf equipment.

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160 PREPARING FOR AN INFLUENZA PANDEMIC Post-marketing evaluation of healthcare PPE products should be car- ried out through a range of approaches in multiple types of healthcare settings and including workers performing a full range of common high- exposure tasks. Studies need to be conducted that evaluate the effective- ness of PPE products in the workplace. Comparison studies or ratings systems (see Chapter 3) are also needed to provide information to pur- chasers on the effectiveness and wearability ratings of PPE products. These studies or ratings systems should be consumer oriented and dis- seminated online and in publications that are easily accessible to health- care decision makers and individual healthcare workers. Of particular importance are studies of the effectiveness of PPE use during outbreaks and epidemics of seasonal influenza. Several studies of this type have recently been initiated with CDC funding (see Chapter 2), and it is hoped that these types of research efforts will add to what is currently a scant evidence base on the impact of PPE use during exposure to influenza. One of the challenges of post-marketing evaluation and surveillance is that PPE is only one component of the efforts needed to fully protect healthcare workers against exposure to infectious agents. Other controls (e.g., ventilation, vaccination) also impact the protection of workers; fur- ther, the efficacy of PPE is subject to training, user acceptance, and ade- quate replacement or disinfection. However, because current NIOSH certification tests and FDA requirements are only surrogates for the ulti- mate purpose of healthcare PPE—protection of the wearer from infec- tious diseases—post-marketing evaluation studies are critical. PRINCIPLES AND GOALS OF AN INTEGRATED SYSTEM The varied regulatory, certification, and evaluation requirements for healthcare PPE have largely evolved in a fragmented manner and have not focused on the hazards of exposure to infectious agents. Respirators have a long history in NIOSH certification efforts, and much of the focus of those efforts has been on industrial exposures, particularly to dusts and chemicals. PPE regulations by FDA and OSHA specifically related to healthcare settings are largely focused on protection against bloodborne pathogens or on splash and body fluid protection appropriate for the sur- gical setting. While these agencies are fulfilling their own roles and ad- dressing the user population relevant to their mandate, there has not been a coordinated effort to analyze the entire life cycle of healthcare PPE or the wide spectrum of the user population.

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161 DEFINING AN INTEGRATED SYSTEM Examples of the need for coordination include several issues related to respirators used in the healthcare setting. FDA guidelines do not allow for an exhalation valve on healthcare respirators because of concerns regarding the potential for healthcare workers, who may be infected but asymptomatic, to exhale infectious pathogens. Because NIOSH works with PPE for many different types of industries, certification efforts fo- cus the manufacturers on reducing breathing resistance, which often re- sults in the design of an exhalation valve. Coordination of these and similar types of issues, such as single-use versus multiple-use limits on wearing filtering facepiece respirators,3 will focus efforts on some of the unique situations faced in health care. In developing a life-cycle approach to drug safety (Box 5-1), a recent IOM committee focused on the need to be realistic in recognizing that a single event (i.e., drug approval) cannot be the only time for the evalua- tion of a product’s safety and efficacy (IOM, 2007b). This call for a long-term perspective on drug safety necessitates that resources be devoted to examining the effectiveness of the drug once it is in the marketplace. For PPE products, such an integrated life-cycle approach is also needed (see Figure 3-3). From the design of PPE that takes functionality, wearability, and other factors discussed in Chapter 3 into account, to pre- market testing that examines the types of wear and tear and use of PPE in the workplace, through post-marketing evaluations of actual use in healthcare facilities, healthcare PPE needs to be considered an essential component of worker safety (Chapter 4), with concomitant resources devoted to the research and development efforts essential for the com- prehensive protection of healthcare workers. Additionally, this integrated approach will mean that a broader segment of the population should be considered in PPE planning, with attention given to ensuring that the general population will have access to and knowledge of certified respi- rators and other PPE. 3 Concerns about contamination of filtering facepieces has resulted in FDA guidelines that they be discarded after each use. NIOSH has indicated that these respirators could be used for a full day.

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162 PREPARING FOR AN INFLUENZA PANDEMIC BOX 5-1 Life-Cycle Approach to Drug Safety Excerpt from The Future of Drug Safety: Promoting and Protecting the Health of the Public The increasingly complex interface between innovation and regulation has been characterized by binary opposites: speed vs. safety, tight preapproval regulation vs. loose postapproval regulation, active collection of data before approval vs. passive surveillance after approval, and an abundance of clinical efficacy data before approval compared to much fewer safety data after ap- proval. The polarity of approach and emphasis is inconsistent with the widely accepted notions that risk much be considered in the context of benefits, that understanding of the risks and benefits associated with a drug changes over a drug’s lifecycle, and that the attention paid to safety and efficacy before ap- proval must therefore be sustained as a drug enters and diffuses through the market and is used by a growing number and diversity of patients. Timely ap- proval and attention to safety can become complementary rather than antitheti- cal goals as postapproval surveillance becomes more effective and regulatory authority and its exercise is commensurate with how a drug performs in real-life conditions over its lifecycle. The approval decision does not represent a singular moment of clarity about the risks and benefits associated with a drug—preapproval clinical trials do not obviate continuing formal evaluations after approval. However, the ap- proval decision is a critical juncture in a product’s lifecycle because it releases a drug to the market, where the public will gain broad exposure to it. In a strengthened drug safety system, that juncture should mark the beginning of another important stage in the lifecycle, when regulators, sponsors, health in- surers, health care providers, and independent researchers actively pursue and manage emerging knowledge about risk-benefit relationships and uncer- tainty and they communicate that knowledge to patients, and health care or- ganizations in a timely manner. SOURCE: IOM, 2007b, pp. 26-27. OPPORTUNITIES FOR ACTION As federal agencies and other partners move forward in coordinating their efforts to improve PPE, immediate action is needed on several key policy issues. The committee’s complete recommendations regarding short- and long-term goals are presented at the conclusion of this chapter.

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163 DEFINING AN INTEGRATED SYSTEM Immediate Opportunities In an effort to move forward in planning for an influenza pandemic, the committee highlights several immediate opportunities that if ad- dressed in the next 6 to 12 months could have significant positive im- pacts on improving PPE for healthcare workers. • Federal agency coordination—While each of the federal agencies has a distinct and vital role in ensuring the use of effective PPE, there is a strong need for a coordinated effort to ensure harmonization of require- ments and to focus on coordinating the entire process from product de- sign to use in the workplace. Many federal agencies in multiple depart- ments (including the Departments of Defense, Health and Human Ser- vices, Homeland Security, and Labor) and the CPSC and the Environ- mental Protection Agency work to ensure worker safety and to approve, develop, and implement PPE. NIOSH, through NPPTL, is the only or- ganization in the federal government with a sole focus on research on personal protective technologies and currently works with federal agency partners and others to improve PPE standards and certification. Thus, NIOSH, through NPPTL, is well suited to ensuring this integrated ap- proach. NPPTL has the specialized expertise relevant to PPE. Additional resources are needed to extend its partnering initiatives with other agen- cies and organizations and with academia and manufacturers. • Pre-market testing—Immediate attention needs to be devoted in the next 6 to 12 months to determining appropriate field testing parame- ters and methodologies for enhancing pre-market testing of healthcare PPE to focus the testing on efficacy against transmission of infectious disease and on enhancing wearability and other critical factors for use. Additional Challenges: PPE for the General Public In working on its charge to examine PPE for healthcare workers in the event of an influenza pandemic, the committee became aware of sub- stantial gaps in knowledge regarding the design and implementation of PPE for family members and others who will provide care to influenza patients during a pandemic or who wish to use preventive measures to avoid influenza transmission. For example, challenges and considera- tions for the next generation of respiratory protection appropriate for use by the general public will need to take into account the benefits of mini-

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164 PREPARING FOR AN INFLUENZA PANDEMIC mizing or negating the need for fit testing, the issues involved in protect- ing people with a range of face sizes (including children), as well as is- sues regarding respiratory protection for individuals with respiratory dis- eases or impairment. Further, as discussed earlier in the chapter, the committee recognized the limited oversight of PPE sold in the retail marketplace, which is often the location for purchases by home health- care workers in addition to the general public. The need for coordinated and focused efforts to address these gaps is critical to moving forward in planning for an influenza pandemic. Although it is beyond the purview of this report to provide recommendations on these issues, the committee wishes to express its view that further attention to these issues is needed. SUMMARY AND RECOMMENDATIONS The varied regulatory and evaluation requirements for healthcare PPE have largely evolved in a fragmented manner and without a focus on exposures of healthcare workers to infectious agents. Greater coordina- tion between federal agencies and other relevant organizations is needed, as is a means to fill gaps in responsibilities for PPE, particularly as re- lated to home healthcare workers and others who may purchase their equipment in the consumer marketplace. An integrated life-cycle ap- proach to healthcare PPE will ensure that this essential component of worker safety undergoes a rigorous testing and evaluation process that provides healthcare workers with the protection they need during an in- fluenza pandemic. Resources need to be provided to NIOSH for a more focused effort to improve PPE and develop the next generation of PPE that will meet the needs of healthcare workers during an influenza pan- demic. The opportunities for improving each step in the life-cycle of PPE devices are summarized in Table 5-3, and the committee’s recommenda- tions to address these issues are provided below. Recommendation 9 Ensure Balance and Transparency of Standards-Setting Processes Federal agencies (e.g., FDA, NIOSH, OSHA) should use stan- dards developed through a consensus-based transparent process that sets specific and clearly defined limits regarding conflicts of interest (financial or other) and involves broad representation of all affected parties.

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165 DEFINING AN INTEGRATED SYSTEM TABLE 5-3 Issues in Healthcare PPE Evaluation and Marketing Opportunities for Improvement • Standards Development and Increase the degree of independence and Dissemination reduce conflicts of interest in standards- setting committees • Increase input from end users and peer reviewers • Catalog and provide easy access to ap- plicable standards, regulations, and lists of certified or approved equipment • Certification and Approval Increase pre-market testing in workplace Pre-Market Testing conditions • Develop evidence-based certification criteria for gowns, gloves, and other types of PPE • Marketing and Use in the Develop and increase partnering efforts Workplace between OSHA and healthcare accredit- ing organizations (e.g., Joint Commis- sion) to ensure that appropriate PPE use is a priority and sentinel event (see Chapter 3) • Ensure oversight for PPE products sold commercially • Post-Marketing Evaluation Increase resources for post-market evaluation and surveillance Recommendation 10 Strengthen Pre-Market Testing of PPE for Healthcare Workers FDA, NIOSH, and other relevant agencies and organizations should strengthen pre-market testing requirements for healthcare PPE by requiring field testing of PPE prior to ap- proval and by reevaluating the FDA medical device classifi- cation for healthcare PPE. Testing requirements should use rigorous standards while also providing expeditious review of innovative approaches. Consideration should be given to • changing FDA requirements so that all healthcare PPE undergoes pre-market testing prior to approval;

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166 PREPARING FOR AN INFLUENZA PANDEMIC • incorporating pre-market field testing requirements into NIOSH certification for respirators; and • requiring certification of other types of PPE (e.g., gowns, gloves). Recommendation 11 Strengthen Post-Market Evaluation of PPE for Healthcare Workers NIOSH, FDA, and other relevant agencies and organizations should support and strengthen adverse event reporting and post-market evaluation studies and surveillance regarding the effectiveness of PPE used by healthcare workers. These efforts should include • workplace effectiveness studies; • head-to-head comparison studies of the efficacy of PPE to allow the employer and wearer to compare and evaluate products; • adverse events reporting of problems with PPE use; and • worker health and medical surveillance where possi- ble (e.g., infectivity rates). Recommendation 12 Coordinate Efforts and Expand Re- sources for Research and Approval of PPE Congress should expand the resources provided to NIOSH to further research efforts on the next generation of PPE and to coordinate and expedite the approval of effective PPE. Ef- forts to coordinate PPE testing, certification, and approval across all relevant federal agencies should include developing evidence-based performance standards for all types of PPE for healthcare workers. REFERENCES Berry Ann, R. 2007. National Personal Protective Technology Laboratory. Presentation at the Institute of Medicine Workshop on Personal Protective Equipment for Healthcare Workers in the Event of Pandemic Influenza: Next Steps and Research Directions. February 22, 2007. Washington, DC.

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167 DEFINING AN INTEGRATED SYSTEM FDA (Food and Drug Administration). 2005. CDER 2005 Report to the nation: Improving public health through human drugs. Rockville, Maryland: U.S. DHHS. http://www.fda.gov/cder/reports/rtn/2005/rtn2005.PDF (accessed July 3, 2007). FDA. 2006. Guidance for industry and FDA staff—Postmarket surveillance un- der section 522 of the Federal Food, Drug and Cosmetic Act. http://www.fda.gov/cdrh/osb/guidance/316.html (accessed July 3, 2007). FDA. 2007a. Device classes. http://www.fda.gov/cdrh/devadvice/3132.html (accessed July 3, 2007). FDA. 2007b. MAUDE database. http://www.accessdata.fda.gov/scripts/cdrh/cf docs/cfMAUDE/search.cfm (accessed July 3, 2007). FDA. 2007c. MedWatch. http://www.fda.gov/medwatch (accessed July 3, 2007). FDA. 2007d. Premarket notification 510(k). http://www.fda.gov/cdrh/devadvice /314.html (accessed July 3, 2007). FDA. 2007e. Draft guidance for the public, FDA Advisory Committee mem- bers, and FDA staff on procedures for determining conflict of interest and eligibility for participation in FDA advisory committees. http://www.fda.gov /oc/advisory/waiver/COIguidedft.html (accessed July 3, 2007). Furberg, C. D., A. A. Levin, P. A. Gross, R. S. Shapiro, and B. L. Strom. 2006. The FDA and drug safety: A proposal for sweeping changes. Archives of In- ternal Medicine 166(18):1938-1942. Hutt, P. B. 1989. A history of government regulation of adulteration and mis- branding of medical devices. Food, Drug, Cosmetic Law Journal 44:99-117. IOM (Institute of Medicine). 2005. Safe medical devices for children. Washing- ton, DC: The National Academies Press. IOM. 2007a. Assessment of the NIOSH head-and-face anthropometric survey of U.S. respirator users. Washington, DC: The National Academies Press. IOM. 2007b. The future of drug safety: Promoting and protecting the health of the public. Washington, DC: The National Academies Press. MedSun. 2007. MedSun. https://www.medsun.net/about.html (accessed July 3, 2007). Merrill, R. A. 1994. Regulation of drugs and devices: An evolution. Health Af- fairs 13(3):47-69. Myerburg, R. J., D. W. Feigal, Jr., and B. D. Lindsay. 2006. Life-threatening malfunction of implantable cardiac devices. New England Journal of Medi- cine 354(22):2309-2311. NPPTL (National Personal Protective Technology Laboratory). 2007a. Certified equipment list. http://www.cdc.gov/niosh/npptl/topics/respirators/CEL/ (ac- cessed July 3, 2007). NPPTL. 2007b. CPIP report status by FY, budget, and milestones. Submitted by NIOSH. OSHA (Occupational Health and Safety Administration). 2007a. Voluntary pro- tection program. http://www.osha.gov/dcsp/vpp/index.html (accessed July 3, 2007).

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168 PREPARING FOR AN INFLUENZA PANDEMIC OSHA. 2007b. Pandemic influenza preparedness and response guidance for healthcare workers and healthcare employers. OSHA 3328-05. Washington, DC. OSHA. 2007c. National alliances, the Joint Commission and Joint Commission resources. http://www.osha.gov/dcsp/alliances/jcaho/jcaho.html (accessed July 3, 2007). Psaty, B. M., and S. P. Burke. 2006. Protecting the health of the public— Institute of Medicine recommendations on drug safety. New England Journal of Medicine 355(17):1753-1755. Stull, J. 2006. PPE standards development and certification needs. Presentation to the Institute of Medicine Committee on Personal Protective Equipment in the Workplace. October 23, 2006. Washington, DC. Surowiecki, J. 2007. A drug on the market. New Yorker, June 25. http://www.newyorker.com/talk/financial/2007/06/25/070625ta_talk_surowie cki (accessed July 3, 2007). Wood, A. J. 2006. A proposal for radical changes in the drug-approval process. New England Journal of Medicine 355(6):618-623.