3

Level Setting:
Policies and Standards for PPE

The second session of the workshop described current policies and standards that influence the ecosystems for disposable and reusable personal protective equipment (PPE). Elizabeth Beam, associate professor at the University of Nebraska Medical Center College of Nursing, introduced and moderated the session. She clarified that the session’s focus on standards and policies governing everyday use of PPE does not extend to crisis standards or to policies pertinent to emergency use authorization. The session featured standards and policies relevant to all major operations of the PPE ecosystem. Beam referenced the key terminology and definitions included in the workshop briefing materials (see Appendix B) and key standards for surgical and isolation gowns and noted their inclusion on PPE packaging (see Table 3-1).

POLICIES AND STANDARDS FOR MANUFACTURERS

PPE Manufacturing Standards

Jeffrey Stull, president at International Personal Protection and member of the Committee on Standards for Medical Face Masks and Protective Clothing at ASTM International (ASTM), provided an overview of medical gown standards and requirements for U.S. Food and Drug Administration (FDA) clearance. Three prominent consensus standards apply to medical gowns. Updated in 2022, the American National Standards Institute (ANSI)/Advancement of Medical Instrumentation (AAMI) standard PB70:2022 sets barrier requirements for gowns used for isolation and

TABLE 3-1 Key Standards for Surgical and Isolation Gowns

SOURCES: Presented by Elizabeth Beam on March 4, 2024, at the Reusable HCTs for PPE Workshop (AATCC, 1945, 1968; ANSI/AAMI, 2018; ASTM, 1995a,b).

surgical purposes (ANSI/AAMI, 2022). The recent revision broadened the previous version to cover additional types of medical apparel that traditionally were not effectively covered by the standard, such as togas and hoods. In addition, ASTM established ASTM F2407/F2407M-23a, a standard that applies to surgical gowns, and ASTM F3352/F3352M-23b, a standard for isolation gowns (ASTM, 2006, 2019). These standards reference ANSI/AAMI PB70:2022, include additional mandatory or optional properties, and specify a conformity assessment program, said Stull (ANSI/AAMI, 2022).

Medical Gown Performance Testing

Stull explained that ANSI/AAMI PB70:2022 sets an acceptable quality limit (AQL) of 4 percent to demonstrate barrier classification for four Classification Levels.¹ Each level has varying barrier criteria: Level 1 offers impact resistance and features the lowest level of protection; Levels 2 and 3 meet barrier criteria for both impact resistance and hydrostatic pressure; and Level 4 provides viral penetration resistance for the highest level of protection. The AQL provides a statistical basis for establishing confidence that materials and seams will perform at the specified level. The ASTM standards provide further criteria that include biocompatibility—a characteristic sought for all medical devices—as well as sterility assurance, flame spread, tensile strength, tear strength, and seam strength. Moreover, manufacturers can opt to undertake testing methods for additional properties related to comfort, durability, and lint generation. Stull remarked that the ANSI/AAMI and ASTM standards offer a comprehensive pathway for specifying protective clothing properties for health care settings.

FDA Regulatory Oversight

Stull outlined specific PPE regulations pertaining to medical devices.² The regulations differentiate between non-surgical and surgical apparel, which are categorized as Class I and Class II medical devices, respectively. Class I devices are subject to general controls that include registration and listing with FDA, as well as appropriate labeling, recordkeeping, and good manufacturing practice to prevent misbranding or misrepresentation. The FDA requirements for Class II medical devices—which include surgical gowns—are more rigorous. In addition to the general controls in place for Class I, special controls apply to Class II devices. Primary among these

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¹ An acceptable quality limit specifies the maximum allowable percentage of nonconformities detected during sampling inspection (ANSI/AAMI, 2022).

² Code of Federal Regulations, Title 21, Section 878.4040 Surgical apparel.

is the 510(k) process that involves provision of safety and efficacy data and demonstration that the product is comparable to a medical device previously cleared by FDA. In 2015, FDA issued guidance on premarket notification requirements for medical gowns (FDA, 2015), and during the COVID-19 pandemic, FDA provided enforcement guidance for gowns and other medical apparel (FDA, 2020).

The number of reusable gowns that have cleared FDA requirements reflects the challenges this process entails, said Stull. Since 2004, 13 reusable surgical gowns have received FDA clearance, yet only two of these have been cleared since 2010. In contrast, over 30 disposable surgical gowns received FDA clearance in 2022 alone. Compliance expenses are substantial, with an annual fee of $7,653 for FDA registration/listing and a one-time fee of $21,760 for the 510(k) application process. The product testing required to demonstrate that three non-consecutive lots meet the 4 percent AQL pose additional costs to the manufacturer. Stull remarked that some criteria are unclear—for example, there is an expectation that whole gowns be tested, but that does not align with some of the test methods. He added that current criteria do not adequately address the effectiveness of cleaning processes.

Additional Standards-Related Resources

Stull continued that in addition to the standards for PPE manufacturing, AAMI ST65 guidelines outline requirements for processing reusable surgical textiles, including gowns, after use (ANSI/AAMI, 2018). Moreover, AAMI published a guide for designing, testing, and labeling reusable medical devices, but Stull cautioned that this guidance principally applies to hard-surface products (AAMI, 2023). However, provisions for using artificial soiling to demonstrate adequate removal of those soils via appropriate laundering methods can apply to textile products.

Stull summarized that robust standards and guidelines are currently in place for medical gowns and related apparel. These standards feature specific provisions regarding how manufacturers evaluate, represent, and qualify gowns and include details related to reusable gowns, such as tracking number of uses. FDA provides oversight and establishes two tiers for gowns: general controls for non-surgical gowns—principally isolation gowns—and more complex processes applied to surgical gowns. Although guidance documents assist manufacturers in demonstrating standards, there are gaps for demonstrating cleaning process efficacy, Stull maintained.

Reusable HCTs for PPE Manufacturing Standards

Erika Simmons, technical director at the American Association of Textile Chemists and Colorists (AATCC), a professional textile association, reviewed AATCC international standards for medical textiles and outlined standards considerations for reusable HCTs. The association provides educational content and testing support products (e.g., equipment, reference materials) to aid in the performance of AATCC standards and procedures. In addition, the association conducts test method training for AATCC, ASTM, and the International Organization for Standardization (ISO). Furthermore, AATCC is an international standards organization that creates standards to help textile producers and brands measure product performance. These standards provide a consistent, repeatable means of textile evaluation that can be used worldwide (AATCC, 2024). Simmons highlighted the association’s efforts to respond to emerging industry needs, as evidenced during the COVID-19 pandemic with the creation and approval of guidelines for general-purpose textile face coverings, which were conducted in less than a year (AATCC, 2020).

Compliant with World Trade Organization transparency guidelines, AATCC standards are created and vetted by industry experts, said Simmons. These standards are consensus-based and statistically validated to provide reproducible, data-driven results, neutral objectivity, and accessibility. She maintained that AATCC standards are preferable to internal and in-house test methods due to their ability to test, validate, and confirm the performance of textiles at multiple points throughout the process pipeline. AATCC works directly with other industry standards organizations to support the global testing community. Additionally, standards outside of the textile industry reference AATCC standards. For example, ANSI/AAMI PB70:2022 includes AATCC Test Method (TM) 42 and AATCC TM127 as methods of determining liquid barrier protection classification Levels 1-3 (AATCC, 1945, 1968). Applicable to any textile fabric, AATCC TM42 tests water resistance against impact penetration; therefore, it can be used to predict the resistance of fabrics to liquid penetration. This method involves applying liquid to a textile backed by blotting paper and then measuring the blotting paper to detect any change. Simmons highlighted that the specifications for the blotting paper required by ANSI/AAMI PB70:2022 differ from those for testing non-PPE textiles under AATCC TM42. For this reason, PPE testing should follow section 5.2 of ANSI/AAMI PB70:2022. Similarly, AATCC TM127 tests water resistance to hydrostatic pressure in any type of fabric (AATCC, 1968). Thus, when measuring the pressure required to push liquid through the health care textile (HCT), testing should follow ANSI/AAMI PB70:2022.

Specific Standards for Reusable HCTs

To meet the ANSI/AAMI PB70:2022 standard, reusable HCTs must demonstrate barrier performance at the end of a product’s use life. Stull explained that this involves testing barrier performance after a product has undergone the number of laundering and/or sterilization processes indicated by the product’s labeled use life. The standard stipulates that reusable PPE products must denote the number of times the product can be processed and include instructions for processing and for inspecting garments to ensure continued serviceability. The product design must feature an integral tracking mechanism—such as a grid for manual marking, RFID chip, or barcode—that remains functional throughout the labeled use life. He noted that although the use life of reusable gowns is often 75 washes, products have cleared the FDA requirements at up to 125 laundering cycles. In addition to barrier performance specified in the ANSI/AAMI standard, the ASTM F2407/F2407M-23a and ASTM F3352/F3352M-23b standards require physical properties testing after one laundering and sterilization cycle and again after the number of cycles indicated by the product’s use life. The ASTM standards mirror the ANSI/AAMI standards in terms of requirements for the product design and technical information, added Stull, and they stipulate that labels include a use-by date.

Additional Standards Considerations for Reusable HCTs

In addition to water resistance, several functional and static considerations should be taken into account for reusable PPE, said Simmons. For instance, antimicrobial testing may be a predictive assessment of a product’s life-cycle performance. Applicable antimicrobial tests include the AATCC TM147 and AATCC TM90, which measure antibacterial activity via the parallel streak and the agar plate method, respectively (AATCC, 1976, 1958). Antifungal activity against mildew and rot can be tested using TM30 (AATCC, 1946). The TM100 assesses antibacterial finishes, while the TM211 tests the reduction of bacterial odor on antibacterial-treated textiles (AATCC, 1961, 2021a). Although PPE is designed to provide safety, the visual condition of a reused garment should be considered, because it could affect the wearer’s self-assurance and client perception of an organization’s competence. For example, HCTs that exhibit stains or faded colors may convey negative impressions of the overall cleanliness and competence of the organization. Conducting colorfastness tests can contribute to maintaining a polished appearance. Colorfastness tests include the accelerated TM61 standard and tests for colorfastness to perspiration (TM15), colorfastness to water spotting (TM104), and colorfastness to

water (TM107) (AATCC, 1950, 1949, 1962a, b). Simmons noted that shrinkage performance reflects fitness and durability. Dimensional stability tests include the accelerated TM187 test and the TM135 and TM150 tests for home laundering (AATCC, 2000, 1970, 1977). These home laundering tests are designed to provide an accurate measure of a garment’s true shrinkage potential and therefore can be applied to commercially laundered textiles.

Simmons emphasized that sustainability is a growing metric in the value chain, and TM212 assesses fiber fragment release during laundering (AATCC, 2021b). Fiber fragment shedding contributes to microplastic pollution, and TM212 was the first published global standard addressing the quantification of fiber fragment release, she noted. Textile producers continually investigate fabric-level solutions to shedding such as changes in finishes, yarn selection, or finished construction. Manufacturers can use TM212 to inform determinations of whether such process changes reduce fiber fragment release. Moreover, the international availability of this global standard facilitates comparison of results between locations throughout the supply line.

POLICIES AND GUIDANCE FOR USE

Federal Perspective

Lynne Sehulster, retired health scientist at the Centers for Disease Control and Prevention (CDC) Division of Healthcare Quality Promotion, outlined CDC guidelines for PPE and U.S. laundry industry standards for HCTs. She explained that various federal agencies are tasked with developing and issuing recommendations for infection prevention within health care. While some agencies under the umbrella of the U.S. Department of Health and Human Services (HHS) are regulatory, CDC focuses on the collection and distribution of applied research and, in some cases, partners with international groups such as the World Health Organization. The Healthcare Infection Control Practices Advisory Committee (HICPAC) provides advice and guidance to HHS and CDC on various aspects of infection prevention for hospitals and other health care facilities. Sehulster noted that the HICPAC guidelines most relevant to reusable HCTs are associated with isolation and infection prevention within specific settings in a health care facility.

CDC Guidelines for Health Care PPE

The 2007 version of the CDC isolation guideline (Siegel et al., 2007), which contains recommendations for the selection and use of PPE, was updated in part in 2023, said Sehulster. This isolation guideline includes

some indications of the proper use, purpose, and settings for PPE garments that apply to reusable HCTs. However, information regarding the processing of reusable PPE is absent from the isolation guideline; it is also missing from the guideline on management of multidrug-resistant organisms and the guideline on surgical sites. Sehulster remarked that CDC has multiple guidelines on preventing transmission of infectious disease, but only the isolation guideline specifies donning and doffing procedures. She added that the isolation guideline is due for updating, with release expected in 2024, but she could not confirm whether the updated version will address transporting, laundering, and sterilizing soiled reusable PPE. A CDC summary of core infection prevention practices within health care settings offers those new to the health care profession an introduction to controlling infectious disease (CDC, 2022); Sehulster proposed that health care settings make this information available to staff.

The National Institute for Occupational Safety and Health (NIOSH), an agency within CDC, is responsible for testing PPE for function, including the ability to prevent fluids and infectious material from penetrating through protective garments. Sehulster noted that NIOSH provides benchmarks for measuring the prevention of fluids from passing through fabric barriers and includes references to standards from AAMI, ASTM, and—for companies based in Europe—ISO (NIOSH, 2020).

Laundry Industry Standards

Sehulster outlined laundry industry standards recognized in the United States. These include the Healthcare Laundry Accreditation Council (HLAC) Accreditation Standards for Processing Reusable Textiles for Use in Healthcare Facilities, the Textile Rental Services Association (TRSA) Hygienically Clean Healthcare Standard for Producing Hygienically Clean Reusable Textiles for Use in the Healthcare Industry, and the Hohenstein Hygienically Clean for Healthcare Textile Laundry Management standard (HLAC, 2023; Hohenstein Laboratories, 2024; TRSA, 2021). Each set of standards is based on guidelines set by CDC and in some cases exceed what CDC has outlined. These industry standards specify all aspects of the laundry process needed to deliver clean HCTs to customers as well as the state of the built environment of the facility. Currently, the entities that issued these standards are conducting microbial testing of various fabrics and garments. Sehulster noted that ANSI/AAMI ST65 and PB70 also apply to laundered HCTs.

Health Care Perspective

Tiffany Wiksten, associate director of the Standards Interpretation Group at The Joint Commission (TJC), discussed TJC’s approach to assess-

ing compliance with infection prevention and control and TJC requirements pertaining to PPE, laundering processes, and contracted services. While working with health care organizations, TJC strives to lead efforts to achieve excellence in sustainability and to collectively reduce the health care carbon footprint. Reusable PPE products offer numerous benefits, including cost-effectiveness, comfort, and a small environmental footprint. Wiksten noted that in selecting and employing PPE, health care organizations must (1) choose products that protect their staff from hazards that may be present where they perform their job duties; (2) develop policies, processes, and protocols to ensure proper PPE use and handling; and (3) ensure that reusable PPE products are reprocessed correctly to be safe for reuse and to function as designed.

Assessing Compliance with Infection Prevention and Control Requirements

TJC’s approach to assessing compliance with infection prevention and control requirements is a framework developed in 2019 to aid organizations in prioritizing available sources of information for decision making regarding product choice and policy development processes and procedures, Wiksten explained. The framework outlines a process that begins with rules and regulations. When applying the framework to reusable PPE, this tier involves FDA requirements for medical device manufacturers to develop validated instructions for reprocessing. Such instructions may include indications for how an item should be laundered or dried, chemicals that can or cannot be used during laundering, methods of drying that retain PPE’s fluid-resistant properties, the maximum number of reprocessing cycles, and instructions for sterilization if appropriate. Other pertinent rules and regulations include the Occupational Safety and Health Administration (OSHA) standards for bloodborne pathogens and PPE, including respiratory protection (OSHA, 2019a,b). Wiksten noted that regulations from the U.S. Environmental Protection Agency and from state administrative codes and state hospital licensing authorities may also apply.

The framework’s second tier includes requirements of the Centers for Medicare & Medicaid Services that organizations develop policies, processes, and procedures that incorporate nationally recognized standards, said Wiksten. The third tier involves adherence to the manufacturer’s instructions for use, which are developed in accordance with FDA requirements as outlined above. The fourth tier refers to evidence-based guidelines and national standards, and the fifth tier involves consensus documents. She explained that the resources used at the fourth and fifth tiers are at the organization’s discretion, except in cases where an applicable state health care administrative code stipulates a specific evidence-based guideline, national standard, or consensus document, such as those

provided by CDC or the Association for Linen Management. The last level of the framework is the organization’s infection prevention and control processes, policies, and protocols, which cannot be less restrictive than those outlined in the preceding tiers. However, an organization’s processes, policies, or protocols may be more restrictive than those detailed by other requirements; Wiksten clarified that in these cases, employees must adhere to the organization’s requirements.

PPE Evaluation Survey Elements

Numerous elements are evaluated during the TJC survey process, noted Wiksten. For instance, the survey team may assess adherence to the OSHA exposure control plan by determining whether an organization has conducted an annual assessment of risk to staff and follows the organization’s written PPE program guidelines. According to these guidelines, the PPE program should identify PPE appropriate for various activities that may require different levels of fluid resistance and different types of PPE (e.g., gowns, gloves, eye protection, face shields). Appropriate PPE should be made available to staff in accordance with anticipated occupational exposure, with consideration of whether standard precautions or transmission-based precautions are warranted. Additionally, PPE should be available in sizes that fit all health care workers (HCWs) and in the locations where it will be used. Wiksten highlighted that survey elements apply to both disposable and reusable PPE. The survey process also assesses employee training. Employees should understand why specific types of PPE should be used and be competent in choosing appropriate PPE. Furthermore, employees should be trained on proper procedures to don, doff, and discard or disinfect PPE. Wiksten emphasized that reusable PPE necessitates an additional procedural step of placing soiled reusable PPE in a specified location. Use of PPE must be enforced via monitoring and providing feedback to staff. As issues are identified, action should be taken to address the issues and improve proper PPE use.

Laundering Processes Evaluation Survey Elements

In outlining elements of the TJC survey process used to evaluate laundering processes, Wiksten differentiated between organizations with in-house laundry facilities and those that contract laundering services. In assessing laundry facilities within an organization, the surveyor may check for availability of manufacturer’s instructions for use and of all supplies and products required to complete laundering reprocessing of reusable PPE. A process should be in place for monitoring the number of times an item has been laundered and then removing items from ser-

vice after they have reached their maximum life cycle. Surveyors evaluate management of soiled linens through all phases, beginning with the point of use, followed by transport to the in-house laundry facility, and through a complete laundering cycle. Manufacturer’s instructions for use should be followed for all steps of the processes for washing, drying, inspection, monitoring life-cycle use, storage, and transportation. Laundry facility employees should be competent in inspecting PPE for holes or tears, ensuring that PPE is suitable for reprocessing, and in carrying out laundering processes. Staff who oversee the laundering process should be competent in evaluating it, while leadership should provide oversight and hold staff accountable. Wiksten noted that surveyors also assess whether a process is in place to audit adherence to policies, process, and procedures.

Organizations that contract laundering services have responsibilities related to ensuring that reusable PPE meets standards, said Wiksten. A health care organization should describe, in writing, the nature and scope of services provided through contractual agreements. An organization’s leaders should establish expectations for the performance of contracted services and communicate these in writing to the service provider. Leaders should monitor contracted services and evaluate them in relation to the organization’s expectations. Lastly, leaders should take steps to improve contracted services that do not meet expectations. For example, if the health care organization receives items with holes or items not properly laundered, the leaders should give feedback to the third-party service providers, said Wiksten.

Laundry Services Provider Perspective

Liz Remillong, division vice president at Crothall Healthcare (now Core Linen Services), described commercial medical laundry technology, processes, standards, and trends over time. She noted that Core Linen Services processes various types of reusable HCTs, including patient care linens, scrubs, lab coats, and surgical linens (e.g., towels, wrappers, gowns).

Evolution of HCT Laundering Services

Health care laundry facilities have evolved substantially in recent decades, said Remillong. Historically, larger hospitals typically featured on-premises laundry facilities. Over time, hospitals shifted toward contracted services through central commercial laundry facilities. Scale varies at commercial laundries, with facilities ranging from 30,000 to 300,000 square feet in size and capable of processing laundry in annual quantities of 10–100 million pounds or higher. Technology has evolved

from traditional open-pocket washers to more sophisticated machines that use less water, electricity, and gas, thereby increasing environmental sustainability. Automation has reduced the number of touches required by laundry staff, enabling high consistency in wash and finish in producing hygienically clean HCTs. Furthermore, improvements in washroom chemistry over recent years have increased efficiency, thereby decreasing the time, temperatures, and energy required to produce hygienically clean loads. Past processes used up to 6 gallons of water per pound of laundry; current processes require less than half a gallon per pound. Remillong highlighted that given these decreases in water, electricity, and gas usage, the laundry industry has reduced its environmental footprint.

Ensuring Safety in Laundered Reusable PPE

Numerous steps are in place to ensure that laundered reusable PPE continues to provide necessary protection to HCWs, Remillong noted. Tracking via RFID technology not only indicates how many washes an item has been through within its life cycle but also works with internal laundry software to provide the location of PPE and length of time at that location. This technology can determine how long PPE has been stored on a shelf since laundering and provide documentation for customers or infection prevention personnel. She emphasized that the HLAC and TRSA Hygienically Clean standards have increased the level of sophistication in providing hygienically clean HCTs and, through third-party testing, demonstrating consistent service provision (HLAC, 2023; TRSA, 2021). Prior to the publication of these guidelines, which contain hundreds of standards, laundry facilities lacked HCT processing guidance specific to the industry. Remillong described how Core Linen Services operates under universal precautions with the assumption that all incoming items are heavily soiled with biohazardous waste. Therefore, all staff who receive linen are scrubbed, gowned, masked, and vaccinated, while all items are processed with the chemistry required to produce hygienically clean HCTs. Core Linen Services works closely with chemical providers to ensure that chemistry, temperature, and finishing are correct for the specific products received. Commercial laundry facilities that process PPE have on-site testing areas to ensure that water resistance and pressure testing standards are met.

Current Trends in Reusable PPE

Over the past two decades, demand for laundering reusable HCTs has decreased as the demand for disposable PPE has increased, said Remillong. The COVID-19 pandemic created a tremendous effect on demand, increasing

the number of reusable PPE products processed daily by 100- to 1,000-fold. Core Linen Services worked to link textile manufacturers with health care systems that, in turn, used their processing services. The PPE supply shortage was such that health care systems searched for any U.S. manufacturers able to provide their staff with products to keep them safe. Core Linen Services works with industry associations and with chemical and textile manufacturers to develop best practices both for typical business conditions and for crisis situations. Emergency preparation related to reusable PPE involves storage and processing capability in addition to processes documented by accreditation and certifications to provide safe and hygienically clean products for health care staff. Remillong emphasized that reusable PPE offers a consistent, cost-effective, environmentally preferrable method of keeping staff safe from occupational exposure to biohazards.

COMPARISON OF U.S. AND INTERNATIONAL POLICIES AND STANDARDS

Henk Vanhoutte, secretary general at the European Safety Federation (ESF), provided an overview of European Union (EU) PPE-related legislation and standards. As a trade association of PPE manufacturers, importers, and distributors, ESF provides guidance to support the provision of certified, high-quality PPE. EU Regulation 2016/425 contains requirements for PPE manufacturers and suppliers.³ He noted that the EU defines PPE as equipment designed and manufactured to be worn or held by a person for the protection of his health and safety; this definition may be narrower than that within the United States. EU medical device legislation pertains to devices designed to protect the patient rather than the wearer. In the EU, both PPE and medical devices have essential requirements and are linked to conformity assessment procedures and to CE marking.⁴

Vanhoutte said that standards translate general requirements from legislation into practical requirements with test methods. Because of the risk of exposure to harmful biological agents and possibly chemicals in health care settings, the EU categorizes PPE in the highest risk category, Category III. Therefore, conformity assessment procedures for PPE involve examination by a third party. In contrast, most non-sterile medical devices are categorized as Class I, the lowest risk class, because these devices typically do not have invasive contact with patients. Con-

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³ Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on Personal Protective Equipment and Repealing Council Directive 89/686/EEC.

⁴ An acronym for the French “Conformite Europeenne” certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the EU and abroad must meet CE marking requirements where applicable in order to market their products in Europe (International Trade Adminstration, n.d.).

formity assessment procedures for Class I medical devices do not involve a third party. However, the quality of the sterilization process for sterile medical devices is subject to third-party conformity assessment testing. He used the example of masks and respirators to illustrate differences in classification. Filtering facepiece respirators worn to protect the wearer are categorized as PPE Category III, whereas surgical masks with the primary function of protecting the patient are Class I. Although the conformity assessment is less stringent for Class I medical devices than for Category III PPE, some requirements for medical devices are stricter than those for PPE. For example, all products and economic operators of medical devices must be registered. Vanhoutte added that PPE is subject to legislation regarding overall occupational health and safety that is based on risk analysis. Employers are required to provide appropriate PPE—in accordance with occupational risk analysis—free of charge to employees. Furthermore, employers are responsible for appropriate PPE maintenance and for training employees on the correct use of PPE products. In turn, employees are obligated to use the PPE.

Standards in Europe are designed to be technology-neutral and user-neutral, said Vanhoutte. This signifies that legislation for protection against infectious agents applies to health care, the pharmaceutical industry, the food industry, and all other industries. Moreover, the standards apply regardless of the technology employed, meaning that the same requirements apply to disposable and reusable PPE. For the latter, manufacturers must provide information on the proper maintenance and disinfection procedures, tests to apply, and the maximum number of washing cycles in a product’s use life. Thus, if a manufacturer claims that a reusable PPE garment has a life cycle of 100 uses, they must indicate the exact decontamination procedure and prove that the product continues to offer consistent protection through 100 decontamination processes. Vanhoutte remarked that the COVID-19 pandemic increased the demand for products that simultaneously protect both the wearer and the patient; thus, efforts are underway to standardize products that function both as PPE and as medical devices. He added that in the context of sustainability, the European Green Deal and the Green and Digital Transformation of the EU are policies that have substantial effects on products and on users.⁵

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⁵ More information about the European Green Deal is available at https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal_en (accessed March 26, 2024). More information about the Green and Digital Transformation of the EU is available at https://digital-strategy.ec.europa.eu/en/news/eu-countries-commit-leading-green-digital-transformation (accessed March 26, 2024).

DISCUSSION

Restrictions on Toxic Substances in HCTs

Noting growing concern among HCWs regarding toxic exposure from PPE, Beam asked about whether any standards are in place regarding toxic substances in HCTs, such as phthalates, bisphenol A, or bisphenol S used to achieve color fastness or other desired properties. Stull replied that specific standards are in place for each type of toxic substance. Restricted-substance lists contain banned and restricted chemicals such as PFAS, phthalates, and heavy metals. Several organizations set limits for restricted substances. For example, the OEKO-TEX^® Association created the OEKO-TEX Standard 100 to certify that garments pass safety tests for the presence of harmful substances.⁶ Stull added that these harmful substances number in the hundreds, and OEKO-TEX updates specific limit values for these substances on an annual basis. Vanhoutte noted that the EU Registration, Evaluation, Authorisation, and Restriction of Chemicals regulation restricts manufacture and import of substances on a list that includes phthalates and some PFAS. This regulation ensures that toxic substances are not allowed in the manufacturing of PPE or medical devices, he added.

Disposable and Reusable PPE Testing

Beam asked whether differences apply within PPE standards with respect to test procedures or minimum required values in disposable versus reusable PPE. Stull explained that the performance criteria are the same for both types of PPE. A major difference in the application of ANSI/AAMI and ASTM surgical and isolation gown standards to disposable and reusable products is that the tests are also performed on reusable products after being processed to the maximum number of washing and sterilization cycles claimed by the manufacturer. He remarked that one would reasonably expect reusable products to be more robust than disposable PPE, but current standards do not account for higher physical property performance levels for reusable garments as compared to disposable products.

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⁶ More information about the OEKO-TEX Standard 100 is available at https://www.oeko-tex.com/en/our-standards/oeko-tex-standard-100 (accessed March 26, 2024).

Cost Associated with Reusable PPE Testing

Given that reusability testing can be expensive, Beam asked about steps that FDA could undertake to facilitate the manufacturing of reusable products versus single-use items. Stull replied that when he last cleared a reusable gown through FDA’s process in 2010, ambiguity in demonstrating soiling cleanliness (as opposed to microbial cleanliness or sterilization) was a challenge. The process involves testing for carbohydrates, proteins, and blood matter, but there is no agreed-upon protocol specific to textiles. The expectation that manufacturers conduct this expensive testing may inhibit entry into the reusable product market, said Stull.

Requirements for In-House PPE Laundering

Beam asked whether there are procedures, such as inspections, that can enable a nursing home without access to a commercial laundry facility to launder PPE in-house in accordance with requirements. Wiksten stated that a nursing home would have to meet the minimum requirements specified in any applicable state regulation for laundering HCTs. Remillong added that in addition to meeting state requirements, a nursing home would need to follow the recommended process specified by the manufacturer. Any PPE classified above Level 1 is subject to requirements for additional testing. She remarked that both the HLAC and TRSA Hygienically Clean standards involve arduous processes, hundreds of specific standards, and independent inspections. To obtain accreditation, a nursing home would first need to meet the standards and then prove that standards are met by sending samples to a third-party laboratory for biotesting. Remillong emphasized that this thorough process ensures that standards are met and that the procedures involved in meeting the standards yield a hygienically clean product.

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