6

Safety and Quality Considerations

The fifth session of the workshop aimed to characterize the safety and quality considerations associated with increasing the adoption of reusable versus disposable health care textiles (HCTs) within health care settings. A panel explored the impact of reusable HCTs use on patient and health care worker (HCW) safety using a risk-based assessment framework. Nicole McCullough, vice president of application engineering and regulatory affairs in the Personal Safety Division at 3M Company, introduced and moderated the session. She emphasized that product performance regulations are critical in helping to ensure that products are safe and functional for patients and end users. Guidance typically provides direction on product selection and use. Regulations for medical devices ensure that the design, manufacture, and quality systems meet U.S. Food and Drug Administration (FDA) requirements. Given that few reusable medical gowns have received FDA clearance compared with disposable gowns in the past two decades, adapting regulations and guidance to ensure applicability to reusable gowns should be explored, said McCullough. The evolution of current regulations and guidance could also enable improved adoption rates of reusable PPE while better addressing the safety, efficacy, and usability of reusable gowns. Numerous factors may affect the feasibility and acceptance of reusable HCT programs by health care institutions, such as health care education and risk categorization profiles. McCullough noted that reusable respiratory protective devices (RPDs) share some similarities with reusable HCTs, and lessons learned about use of the former may translate to the latter.

CASE STUDY: IMPLEMENTATION OF A REUSABLE ELASTOMERIC RESPIRATOR PROGRAM DURING THE COVID-19 PANDEMIC

Sara Angelilli, director of education and professional practice at Allegheny Health Network (AHN), presented a case study on the medical use of elastomeric half mask respirators (EHMRs) during the COVID-19 pandemic—with a focus on the EHMR disinfection and decontamination procedures instituted—and she highlighted current gaps in the evidence base. In 2020, at the onset of the COVID-19 pandemic, HCWs preferred disposable N95 respirators for their RPD needs. However, challenges in the supply chain disrupted availability of disposable respirators. To ensure that all HCWs had adequate access to the personal protective equipment (PPE) needed to safely care for patients, AHN explored the use of EHMRs. Traditionally, EHMRs have been used in industrial settings, and use in health care settings was very limited at the start of the pandemic. Therefore, AHN had to consider how to safely translate use to the health care setting. Angelilli outlined implementation considerations, including the responsibility of program leaders, determinants of user assignments and deployment methods, fit testing and user training, decontamination strategies, and storage strategies.

During initial implementation, a shared-user model featured a central distribution channel in which respirators moved from central supply to hospital units at the start of each nursing shift, Angelilli explained. At the beginning of a shift, the nurse would retrieve an EHMR and use it throughout the shift while implementing intermittent disinfectant protocols between uses. At the completion of each shift, the nurse would send the respirator to the central sterile processing department for the centralized decontamination process. As AHN secured more respirators, the program shifted from this shared-user model to an individual-user model. With the shift in user models, the cleaning and disinfection models also changed.¹ As is the case with all devices, AHN follows the manufacturer’s instructions for use (IFU) and followed the EHMR instructions outlining specific details for cleaning and maintenance. Additionally, Angelilli noted that U.S. Environmental Protection Agency (EPA)-approved disinfection agents must be used.

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¹ Angelilli defined “cleaning” as the removal of visible soil from the surface of an object using water and a detergent, and she defined “disinfection” as the elimination of all pathogenic organisms, except bacterial spores, using a liquid chemical or wet pasteurization method.

Centralized Decontamination Process

In transitioning use of EHMRs from industrial to health care settings, Angelilli emphasized that disinfection protocols were vitally important to ensuring that the respirators did not become vehicles for transmitting diseases and pathogens from one person to another. Using a centralized decontamination process, AHN’s sterile processing department—staffed by employees specifically trained in cleaning, decontamination, and sterilization—decontaminated the EHMRs and ensured that IFUs were dutifully followed. The instructions for the specific EHMR used at AHN directed use of specific germicidal detergent and quaternary ammonium-based disinfectants registered with EPA and validated against SARSCoV-2. Angelilli noted that literature often indicates that cleaning and disinfection should be performed as two separate steps, but AHN performed these processes in a single step in compliance with the IFU. The centralized decontamination process began with sterile-processing department staff donning appropriate PPE. Next, staff disassembled the respirator and cleaned and disinfected the facepiece, yoke, and head strap by soaking components in diluted decontamination detergent for 10 minutes. While those components soaked, staff disinfected the filter cartridges by wiping the casings with an EPA-approved quaternary agent or with a specific disinfectant wipe approved for use by the EHMR manufacturer. At the completion of these steps, staff rinsed the facepiece, yoke, and head strap and allowed all components to dry for 1–2 hours. Once components were dry, staff reassembled the components and checked the respirator for safety before returning it to a hospital department for use in patient care, said Angelilli.

Point-of-Use Decontamination Process

In addition to the centralized decontamination process, AHN implemented a point-of-use protocol for instances when HCWs removed their respirators and needed to decontaminate them between intermittent use. Angelilli explained that the point-of-use protocol increased respirator availability by enabling each EHMR to be used for an entire shift. The method used in centralized decontamination was not feasible on hospital floors, because they lacked the space required to correctly dilute the decontamination detergent, and floor staff were not trained in this process. Therefore, AHN contacted the manufacturer for instructions on a more convenient, point-of-use decontamination method. Through this collaboration, AHN determined that the specific disinfectant wipe approved for use by the EHMR manufacturer met the qualifications for cleaning and decontaminating respirators and would not prematurely

break down any of the components. Furthermore, the wipes are approved by EPA and are validated against SARS-CoV-2. Staff received training on the point-of-use decontamination protocol, which began by wiping down all surfaces of the respirator and casings. The IFU specified that as many wipes should be used as necessary to achieve visible wetness on the surfaces. The wipe IFU indicated a “wet contact” time that HCWs adhered to. Angelilli noted that supply shortages necessitated involvement of multiple sanitary wipe vendors and the wet contact time varied between products, ranging from 2 to 10 minutes. This variance necessitated staff training to ensure compliance with various IFU. After completion of the disinfection process, the respirators were dried thoroughly to eliminate the risk of eye irritation posed by wet disinfectant. Once the respirators were dry, staff conducted a five-point device check to ensure that (1) valves were intact, (2) the elastic head band continued to stretch and spring back to form, (3) the facepiece was free of cracks or distortions, (4) the filters were dry, and (5) the filters were securely attached to the facepiece. After completing the five-point device check, HCWs could then safely store the EHMR in a paper bag or on an identified storage hook between uses.

Respirator Decontamination Research

Angelilli emphasized the importance of protecting staff and patients from the transmission of airborne infectious particles that could potentially settle on the surface of respiratory protective equipment. At the time that AHN established these protocols, limited evidence was available on the effectiveness of RPD cleaning and decontamination protocols, with much of the available literature focusing on the influenza virus (Hines et al., 2020; Lawrence et al., 2017). As such, a need persists for research comparing the effectiveness of cleaning, decontamination, and cleaning plus decontamination. Such research would facilitate the issuance of clinical practice guidelines and evidence-based guidelines for the protection of HCWs and the promotion of safe practices. She highlighted a study on RPDs used during aerosol-generating procedures for COVID-19 patients in which no samples tested positive for COVID-19 contamination (Shah et al., 2023). Furthermore, both centralized and intermittent decontamination methods were used on the devices tested, and the authors concluded that these practices in conjunction offer additional opportunities to decrease microbial load on the surface of respirators than either method in isolation. Angelilli added that the amount of contamination found on surfaces during this time frame varied significantly, ranging from 8 to 87 percent.

PANEL DISCUSSION

Panelists representing various sectors relevant to reusable HCTs delivered introductory remarks before opening the discussion.

Health Care Worker Level

Jill Morgan, critical care nurse at Emory University Hospital, serves as a co-chair of the PPE working group for the National Emerging Special Pathogens Training and Education Center, which is funded by the Department of Health and Human Services Administration for Strategic Preparedness and Response. She recalled that when she became an emergency department and critical care nurse 24 years ago, she knew very little about PPE. She was unaware of standards and risk levels, and she did not know that selection of PPE should be based on anticipated level of risk. Rather, she wore whatever PPE products were provided in her isolation cart or supply closet. Now, drawing on decades of experience, Morgan wants to ensure that the PPE she is provided will keep her safe. She questioned whether current PPE standards are adequate, given that they are based on water repellency and that water does not necessary reflect the physical properties of blood and other body fluids. Expressing her concern about the risks of exposure to blood and other potentially infectious materials, Morgan stated that HCWs have a right to be protected from such exposures. The adoption of PPE programs should consider HCW workflow, PPE donning and doffing practices and locations, product fit and comfort, and user-friendliness with practical features such as a neck closure that can be easily untied after use, said Morgan.

Health Care System Level

Mark Shirley, director of integrated resiliency management at Sutter Health, provides employee health and safety guidance and aligns health and safety practices across the Sutter Health care network. Noting a gap in understanding of which PPE products are best for the health and safety of employees and patients, he highlighted an opportunity to improve HCW understanding of performance standards in appropriate risk-based selection of PPE. Shirley remarked on misinformed distrust of reusable HCTs, which is due in part to a brand of surgical gowns that performed poorly and allowed strikethough—an issue brought to the public’s attention by media reports in 2016 (Cooper, 2016). He underscored a need for education about the safety of reusable surgical gowns.

HCT Functionality and Performance

Performance Comparison and Physiological Stress

Meredith McQuerry, associate professor and director of the ThermaNOLE Comfort Lab^© at Florida State University, is a clothing comfort physiologist who studies how PPE and clothing affect human performance. Her areas of focus include design modifications to improve heat stress relief, physiological and thermal comfort, ergonomic mobility, and other aspects of the HCW experience while wearing PPE. Working closely with standards bodies such as the Association for the Advancement of Medical Instrumentation (AAMI), the American Association of Textile Chemists and Colorists (AATCC), and ASTM International, McQuerry researches PPE performance. For example, she conducted research comparing the performance of reusable versus disposable surgical and isolation gowns and found that reusable gowns met AAMI performance requirements across 75 industrial laundering cycles, but disposable gowns did not meet requirements for water resistance or crosswise tensile strength even when new (McQuerry et al., 2021). She remarked on the need to generate more robust literature regarding comparative performance assessments of disposable versus reusable PPE. Additionally, research to maximize the thermal comfort of reusable gowns could address some of the concerns about reusable HCTs. McQuerry noted that potential mechanisms for improving reusable gown thermal comfort include technologies employed in other types of PPE or performance apparel, such as passive ventilation, and finishes with phase change materials or active cooling minerals.

Wearability and Garment-Based Wearable Technology

Lucy Dunne, professor and co-director of the Wearable Technology Lab at the University of Minnesota, researches functional clothing, electronic textiles (e-textiles), and garment-based wearable technologies. She stated the importance of a holistic consideration of functionality in designing PPE. The design process sometimes focuses on the core engineering objective of barrier resistance to the exclusion of user experience aspects of wearing PPE. Often, the success or failure of PPE is not related to its performance in a lab setting but rather to the user’s willingness to wear it and to wear it appropriately. User willingness can be disrupted by aesthetics, comfort, and other human factors. Dunne underscored that perception and experience are not always aligned. For instance, mobility challenges while wearing a medical gown are often related to sizing and fit, and a person may assume a larger gown would be more mobile. However, this generally proves to be false, as extra fabric can impede

function when lowering one’s arm, she explained. Another example is thermal balance and common perceptions that woven textiles are warmer than disposable ones. Dunne noted that this may be the case sometimes, but in other cases, the woven gown does not actually add to thermal load. Therefore, designers should differentiate what users perceive and what they experience and consider physics in assessing various options.

Manufacturing reusables is often slower and more expensive than manufacturing disposables, which creates an opportunity to produce a more complicated product, Dunne asserted. The drive to create the least expensive manufacturing method possible often compromises the design of the product. Given that reusable HCTs are already sewn by hand—a process that requires more time and expense than fully automated manufacturing—building in improved functionality may not substantially increase cost. The reusable PPE manufacturing process provides latitude to improve design to achieve increased usability in terms of mobility, sizing, fit, and thermal balance. Dunne added that some user factors, such as sizing, are connected to the entire infrastructure surrounding the product, which extends beyond manufacturing to the institution’s ability to manage multiple sizes and create accessibility for people in need of those sizes at the time of need. As such issues are addressed, possibilities for the product expand. Likewise, the concept of functionality can broaden with the use of technology to create more advanced products. For instance, building electronics into PPE could enable integrated disinfection, active filtration, and detection of leaks, wear, and pathogens. Dunne remarked that because reusable PPE lasts longer and costs more than disposable counterparts, innovative technologies can be integrated into reusable products, whereas doing so would be prohibitively expensive for disposables.

Regulatory Perspective

Louise King, assistant professor and member of the Center for Bioethics at Harvard Medical School and surgeon at Brigham and Women’s Hospital, uses her experience as a surgeon, researcher, ethicist, and lawyer to approach regulatory questions from the standpoint of single-use instruments. She noted that regulatory guidance for the decontamination and reusability of instruments is similar to that of medical gowns and other PPE. King highlighted ethical considerations of PPE, including ensuring the safety of HCWs and respecting clinicians through the provision of appropriate education and PPE options from which to choose within the context of the anticipated contamination risk. Additionally, environmental ethical concerns are at play, as hospitals are often among the largest contributors of waste in their communities. Balancing HCW and patient safety concerns with the health and safety of the environment is important, said King.

Discussion

Reusable HCT Regulations and Performance Standards

McCullough asked whether current regulations and performance specifications for reusable HCTs are adequate to protect HCWs in both routine and surge situations. Morgan replied that the updated ANSI/AAMI PB70:2022 standard, which also applies to disposable garments, creates new categories for “extended surgical gowns” and “decontamination gowns” (ANSI/AAMI, 2022). She remarked that gowns used in isolation rooms do not necessarily require liquid barrier protection; therefore, the option of a gown to protect against dry fomites without liquid barrier protection could be helpful to HCWs. Morgan expressed concern that some health care settings use unrated gowns. King replied that several federal regulations are in place to prevent such situations. An employee working in a hospital using unrated gowns could file a complaint with the Occupational Safety and Health Administration, and organizations found to be using unrated gowns face liability. Nevertheless, employees are not always aware of the protections in place and may be unfamiliar with the steps needed to ensure adherence to regulations, she added.

King commented that hospitals often do not account for the variety of interactions conducted by HCWs and may distribute PPE with the highest level of protection that could potentially be required, without allowing for nuance. Furthermore, many hospitals provide only rudimentary PPE training. Alternatively, hospitals could offer more PPE options and more in-depth training on selecting appropriate PPE, thereby allowing HCWs the freedom to make informed choices. Current regulations are adequate and align with evidence regarding the highest levels of protection needed, but protocols evolve as new evidence becomes available. King contended that rather than adding regulations, legislation or incentives are needed that motivate hospitals to explore educational opportunities and alternative methods of providing PPE to enable HCWs to make meaningful choices. McCullough added that PPE with the highest level of protection is not necessarily most functional for the person using it, and therefore it may not be the best option.

Referencing her research on firefighting PPE, McQuerry remarked that PPE approaches and perspectives from other industries can inform improvements in health care PPE. She noted that in her research, not only did disposable Levels 1 and 2 gowns fail to meet ANSI/AAMI PB70 requirements, but they are inadequate to accommodate different body shapes and sizes and how one typically moves while wearing the gown (McQuerry et al., 2021). McQuerry has found that standards

and performance requirements for fire service PPE are limited to the two-dimensional nature of fabric, and they do not address the three-dimensional PPE finished products worn on three-dimensional users. Although minimum requirements are in place for sizing and fit specifications of fire service garments, the standards do not fully consider functional design. For example, fabric for use in fire service has been over-engineered to the point that lack of breathability has increased thermal stress on users, which can be fatal. McQuerry argues that standardization for health care PPE should be balanced, without overstandardizing or overspecifying to the point of hampering functionality. She added that adopting certain voluntary specifications for HCTs as mandatory could address some of these issues.

Shirley highlighted the opportunity to improve post-market surveillance of PPE products, including solicitation of end-user feedback. Front-line workers have reported strikethrough, most often at the glove-sleeve interface, but it can be difficult to discern whether strikethrough is caused by a failure in performance or by user error. Improved post-market surveillance could lead to solutions for such issues. McCullough replied that such surveillance is the responsibility of manufacturers and could be considered from a regulatory standpoint. Beyond the 510(k) premarket submission to FDA, medical devices entail numerous implications for manufacturers, including establishment of a medical device quality system. She added that this should include post-market surveillance and suggested that regulatory considerations should extend beyond regulations that apply directly to the product to encompass the entire regulatory framework.

Education and Training Gaps

McCullough asked about education and training gaps related to risk assessment and PPE selection as well as steps that could increase the adaptability of reusable HCT programs. Morgan pondered whether any research has been conducted that assesses HCW ability to anticipate risk of exposure. Some procedures, services, and specialties carry higher exposure risk than others, such as turning patients in their beds or working with mental health or pediatric populations, she noted. However, HCWs may or may not anticipate which scenarios are more likely to entail splashing or spraying of fluids, leaning against contaminated surfaces, or holding patients contaminated with harmful substances. Additionally, PPE is often removed from its packaging before reaching HCWs; therefore, safety and use information is not readily available. Morgan asserted that ready access to PPE information should be provided by placing this information in the carts and cabinets from which HCWs take the items. Shirley remarked on an anecdotal understanding that a knowledge gap

exists among HCWs—and among infection preventionists and environmental health and safety professionals—about how to select the appropriate PPE for certain situations. Further research could clarify and identify such knowledge gaps. McQuerry commented that HCWs need training on how to wear PPE appropriately and why that is important. Her research with the fire service revealed that many female firefighters are unaware that women’s gear is on the market. Increasing end-user awareness of the products currently available to them could enable professionals to locate options that are more functional for their bodies, she suggested.

King highlighted the need for educational efforts and legislative endeavors to support a shift from single-use products toward reusable products. Noting that the conversation around PPE typically focuses on safety, she suggested that environmental considerations should also be prioritized alongside protective effects. For example, legislation incentivizing environmental sustainability could enable progress toward dual goals of implementing PPE that keeps people safe and generates less waste. Educational efforts could then inform employees about the environmental benefits of reusable PPE. Given the substantial pressure on hospital leadership to keep people safe, she posited that incentives encouraging leadership to consider environmental effects could help to push reusable HCT programs forward.

Risks Associated with Reusable and Disposable Gowns

McCullough advised that equitable health care, diversity, and inclusion efforts should extend to HCW access to products that fit properly, as oversized or undersized garments can pose safety risks. She asked about the risks associated with both reusable and disposable gowns and how these influence user preferences. Dunne replied that differentiation often improves functionality, and a more customized size range can increase mobility. At the same time, adding options also increases the complexity of using the product, placing responsibility on users to determine which option fits best. She noted that this can have unexpected effects and result in user rejection of the product or a solution that meets one criterion while failing to meet others. Sometimes organizations faced with the need to train staff on how to select the most appropriate size instead opt to purchase only the largest size of PPE, requiring staff to make adjustments—such as using duct tape to gather excess material—that harm the core functionality of the product. The issue of engineering a sizing system and communicating that system to users and organizations is a design challenge that also applies to other forms of PPE, such as respirators. Morgan emphasized that wearing an oversized gown leads to additional grooves and creases that can hide contamination. Furthermore, the gown is likely

to sweep the floor when the user leans, stoops, or bends, thereby creating a safety hazard. Likewise, undersized gowns pose hazards; HCWs with large bodies or who are pregnant should not face difficulty in locating products that fit them. These aspects of fit affect end-user acceptance of a product, Morgan concluded.

McQuerry emphasized that in the 2018 study she conducted following media reports about strikethrough in a brand of gowns used in the 2014–2016 Ebola crisis, reusable gowns consistently outperformed disposable gowns (Cooper, 2016; McQuerry et al., 2021). After two brands of gowns were tested per level (for Levels 1, 2, and 3 gowns), the disposable gowns failed to meet ANSI/AAMI PB70, AATCC test method (TM) 42, and AATCC TM127 requirements for liquid barrier protection. The protection offered by reusable gowns held throughout the manufacturer recommended number of laundering cycles, said McQuerry.

In exploring the balance of risks and benefits of reusable PPE, Overcash and Sehulster co-authored an analysis of the risk for health care-associated infections (HAIs) associated with reusable HCTs (Overcash and Sehulster, 2022). Examining published records from the United States and the United Kingdom from the 1970s through the 2020s, they determined that 69 patients had HAIs attributed to the use of reusable PPE. To account for underreporting, Overcash and Sehulster made a conservative estimate that only 1 percent of HAIs related to reusable PPE were reported. Multiplying the 69 cases by 100 results in 6,900 reusable PPE–attributed HAI patients, which averages to 0.37 per day over the 50-year period. In comparison, approximately 5,500 cases of HAI occur within the United States or United Kingdom each day. The risk of HAI from reusables is approximately 1 in 15,000 (Overcash and Sehulster, 2022). Overcash emphasized that complete elimination of all risk of HAIs is not feasible, whereas understanding the true risk from HAIs faced by HCWs and patients resulting from use of reusable HCTs and implications of actions to reduce that risk in other areas is a practical path forward.

Technologies to Improve Reusable Gowns

Panelists were asked about the application or development of technologies to improve comfort, confidence in safety, efficacy, or any other aspect of reusable medical gowns. Dunne remarked that the COVID-19 pandemic sparked innovation and research in respirators, some of which translates to gowns. Active products can sense and, in some cases, respond to threats. For instance, adding an electrostatic charge to a garment could attract and trap particulates rather than allowing them to propagate through the room. Leak detection is potentially feasible, but it would require a network of electrodes attached to a removable device that would supply a current.

This network would detect moisture inside the barrier garment, whether from sweat or strikethrough. Gowns could potentially monitor whether the wearer is approaching heat stress or integrate accessory technologies, such as fans, to maintain a healthy thermal balance. Although such technology has not yet been tested, it could potentially improve functionality. She added that silver, which is antimicrobial, is currently used in thread to produce gowns with antimicrobial properties. McQuerry noted that zinc ion nylon fiber has antimicrobial properties from the time it is extruded and is therefore resistant to SARS-CoV-2 (McQuerry and Dodson, 2024). Furthermore, when used in face coverings, nylon reduces the clingy, damp sensation that some users perceive while wearing face coverings. McCullough remarked that thermal comfort can be a barrier to adoption of reusable gowns, so this technology could potentially increase uptake. Additionally, some of these technologies could improve PPE used in other industries.

Dunne explained that because the addition of smart systems generally increases the complexity and cost of products, these technologies give rise to issues of durability and reusability. Adding technology to disposable products is not feasible, while making products more durable creates opportunities to add technological innovations. Noting the tremendous textile waste generated by everyday clothing, she remarked that a universal design, in lieu of hundreds of individual models, could yield far-reaching benefits. Dunne acknowledged that adding materials needed for technological devices—such as silicone, metals, and semiconductors—to cotton or polyester garments generates disposal challenges by increasing the difficulty of recycling or composting the textiles. However, if such products are designed for durability and last a year longer than the original versions, this could potentially balance drawbacks with benefits.

Economic Considerations of Improved PPE Design

Replying to a question about the costs associated with increasing the comfort and protection offered by reusable PPE and whether health care organizations are willing to pay for it, Dunne remarked that numerous factors affect cost, such as the feature being added, how it is built into the gowns, and the relationships in place between the PPE manufacturers and the organizations using the PPE. She was optimistic about the feasibility of an incremental approach that begins with increasing the adoption of currently available reusable PPE products, then shifts to design improvements with various features over a span of time. Dunne remarked that she has worked in wearables and e-textiles for over 20 years, and she has learned that adoption is a slow, but not impossible process.

King stated that changing entrenched systems is expensive; thus switching to a reusable HCT program would likely be very expensive for

a health care system. Hospitals currently operate on tight budgets and rarely have incentives in place to promote such change. She reiterated the need for legislation that incentivizes sustainable practices in health care. Infrastructure for reusable PPE manufacturing is in place and innovators are developing improved products, but until the financial costs are offset, hospitals are unlikely to make an expensive change solely for environmental benefit, King remarked. McCullough noted that while technologies can overcome some barriers to reusable PPE adoption, cost is likely the biggest obstacle. She described the formidable challenge of convincing a health care facility with tight financial margins to make a large upfront investment in hopes of recouping future cost savings.

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