The fourth session of the workshop examined the economic impacts of increasing the use of reusable versus disposable health care textiles (HCTs) with a focus on both short- and long-term infrastructure investments for health care facilities and value holders. A panel discussion featured perspectives from personal protective equipment (PPE) manufacturing, U.S. trade policy, and the health care system. Barbara Strain, principal at Barbara Strain Consulting, LLC, moderated the session and presented an overview of the value analysis process within health care settings.
Strain described how value analysis has evolved from its origin in the 1940s as “value engineering.” A variety of industries have used value analysis to express outcomes in relation to the costs to achieve outcomes, but the concept did not become prevalent in health care until the 1980s or 1990s. Value is described as equal to quality—referring to outcomes, safety, services, or other measurable components—divided by the cost of providing that level of quality. Value analysis compares the difference between the cost to obtain current outcomes and the projected cost to obtain better outcomes. Conducting a value analysis involves a series of evidence-based decision-making processes. With the facilitation of trained value analysis professionals, a multidisciplinary group of subject-matter experts proceeds through this series of processes. The first process involves determining and validating the need, identifying gaps in the
current state, and envisioning the future state. Next, the data collection process gathers information from a variety of sources, such as clinical-based evidence, financial evidence, and stakeholder identification. Data analysis is then conducted and contracts, project evaluations, or any other data needed to create a value statement are assembled in a report or executive summary. The next process, reaching a consensus decision, involves a multidisciplinary group of subject-matter experts to review the findings and arrive at a decision. Once a decision is reached, implementation logistics, education needs, and changes in practice, policies, and/or procedures are carried out. After implementation, the final process in value analysis is results monitoring, which enables assessment of whether original goals and needs have been met, Strain noted.
Value analysis related to both reusable and disposable PPE products considers upstream and downstream factors and all major operations, including those outside of health care, said Strain. She outlined factors pertaining to the five process steps of a value analysis for the implementation of reusable HCTs. Determining the need for reusable PPE involves reviewing sustainability goals and considering a range of personal and logistical factors. For instance, the sizing and fit of PPE, any issues related to donning and doffing, and any skin reactions reported by staff and visitors should be considered. Strain emphasized that PPE is not only used to protect staff and patients, but also visitors who are asked to wear isolation gowns and other HCTs when visiting patients with certain conditions. Thus, visitors constitute a portion of the PPE customer perspective. This process also considers waste disposal concerns related to costs, volumes, and environmental effects. Safety factors, such as reported fluid breakthroughs or exposures within the health care setting, could contribute to determination of need. Numerous logistical concerns—such as contracts with PPE providers, storage capacity for both clean and soiled reusable HCTs, supply chain disruptions, and any legal matters—should also be considered.
Strain explained that the determined need should drive action, with the data collection process linking back to that need. Data sources for the data collection process include (1) internal safety, quality, and employee health reports; (2) a list of all medical gowns purchased that includes manufacturer(s) and cost; and (3) annual quantities purchased and the associated cost. A list of manufacturers selling products that meet the criteria set by the multidisciplinary group should be obtained in addition to contract availability for gowns and laundering services. A comparison of the various costs and waste associated with disposable and reusable
PPE should be conducted. Product evaluations and feedback should be collected from staff that reflect the diversity of the people using PPE, such as nurses, physicians, aides, and staff from the emergency department (ED), operating room, and outpatient settings. Data collection via time studies, use of methodologies that increase value by reducing waste and eliminating components that do not contribute toward better outcomes, and review of clinical-based evidence enables fact-based decision making. Data collection should also include regulatory reviews, recalls, supply issue reports, and reports made to the U.S. Food and Drug Administration Manufacturing and User Facility Device Experience database. Professional organizations can also serve as data sources. This process should consider information related to supply chain resiliency and to the sustainability of both internal and external processes and their associated costs. Strain noted that this list of PPE value analysis data considerations is not exhaustive and additional data sources may be relevant.
The next process is analyzing data across the value chain. Strain clarified that the supply chain, value chain, and sustainability chain are separate frameworks that merge at various points. The data analysis calculates and compares current cost and outcomes with the projected cost for potential new outcomes. This involves clinical, safety, risk, and quality comparisons to mitigate any risks and ensure the safety of staff, patients, and visitors. Input collected from customers, from evaluation results, and via networking is then assembled and analyzed. The fully loaded cost—that is, a calculation of all the direct and indirect costs—is determined by including the costs of manufacturing, transportation, distribution, storage, use, internal and external disposal and/or laundering, and sustainability, said Strain.
The process of reaching a consensus decision should be rooted in support from executive leadership obtained at the outset of the change effort, Strain stated. The effort of convening a group and working through the prior processes could be wasted if chief executives are against the initiative. A fully formed value analysis process features an executive steering committee that delivers messaging throughout the organization. In reaching consensus, all group members voice their perspectives. Additional data may be required to address identified gaps. A value statement is prepared that includes a full explanation of the execution of the analysis. Discussion is followed by a vote, and if the consensus is to move the change effort forward, the implementation plan is initiated. The final process of the value analysis is monitoring results. This process involves determining key metrics for monitoring the outcomes of the initiative and an appropriate timeline of milestones. In cases where one or more metrics exceed parameters, the root cause is determined. Strain concluded that monitoring results enables assessment of whether the determined need has been met and goals have been attained.
Gio Baracco, professor at the University of Miami, described a comparative cost analysis on stockpiling respiratory protective devices (RPDs) during an influenza pandemic. A literature review of cost evaluations of PPE revealed that cost analyses are conducted with different cost bases, such as: the cost of protecting one health care worker (HCW) against a specific hazard, the cost of using a specific type of PPE in a certain scenario (i.e., usual clinical practice during a pandemic), or the cost of stockpiling a certain type or combination of types of PPE. Baracco and colleagues (2015) analyzed the cost of stockpiling various types of RPDs during an influenza pandemic, using the cost of stockpiling as the basis. The resulting comparative cost analysis examined five RPD use strategies1:
The approach used to estimate the cost of stockpiling RPDs involved an existing model that calculates how a pandemic might affect community health care use and the staffing needs for a defined population, said Baracco. The population is defined in relation to the health care entity. For a health care system, the defined population could be the hospital’s market share within a community; for a county public health department, the population could be the entire community; for agencies such as the Centers for Disease Control and Prevention, the population could be the entire United States. The model’s estimates were applied to each usage strategy to determine the size and composition of the corresponding stockpile. Next, they identified the warehouse space and inventory management needs for each RPD stockpile, and then calculated the purchasing and storage costs. In determining the number of devices to stockpile, the metrics used in estimating need varied between strategies. Whereas the metric for disposable, single-contact devices is the number of contacts between an HCW and a patient, the metric for using a disposable item for multiple contacts is the
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1 Baracco explained that PAPRs are battery-powered respirators that have a pump, hose, and fluid; he also clarified that extended use or reuse of disposable N95 respirators entails use of the same respirator for a specified number of hours rather than for a single encounter.
2 N95 is a certification mark of the U.S. Department of Health and Human Services (HHS) registered in the United States and several international jurisdictions.
estimated number of patient contacts within a specified number of hours. The metric for reusable respirators assigned to individuals is the estimated number of HCWs to whom the PPE is assigned, Baracco explained. Calculations for reusable RPDs may include accessories that will need to be replaced, such as filters, batteries, tubing, hoods, or straps. In such cases, the use patterns of the reusable RPD and each accessory must be considered in estimating needed quantities.
Baracco and colleagues created a simple model within a spreadsheet that contained outbreak characteristics being estimated, inputs for the PPE being evaluated, outputs such as cost and space, and, ultimately, the total annual cost prorated to the PPE’s shelf life. He underscored that this cost analysis was conducted several years before the COVID-19 pandemic, when actual pandemic PPE usage rates were unavailable. Estimates were based on prior pandemics in terms of infection rate, numbers of patients that would seek care, hospitalization rates, intensive care unit (ICU) use, mechanical ventilation needs, mortality rates, length of hospital stay, and other metrics. From these numbers, they estimated how many patient contacts various health care scenarios would necessitate. These scenarios included a patient who presented at the ED but was ambulatory, an ED patient who required hospital admission, a patient staying in a hospital ward, a patient admitted to the ICU without mechanical ventilation, and an ICU patient on mechanical ventilation. After establishing patient contact estimates, they ascertained the unit cost for each RPD and accessory. Given that stockpiling involves storing supplies, they also collected data on the number of units packaged per box, the box dimensions, and how many pallets could be stacked. The shelf life of products was used to prorate the cost of acquisition. Estimates of warehouse leasing, utilities, and personnel costs to manage inventory were also considered.
Baracco and colleagues calculated estimates of the annual cost to stockpile RPDs for a population of 1 million people for each of the five RPD use strategies. Reusable elastomeric respirators were the least expensive RPD strategy, with an estimated annual stockpiling cost of $75,000–$125,000. The estimated annual stockpiling cost for single-use disposable N95 respirators was approximately eightfold that of reusable elastomeric respirators, at $500,000–$1 million annually. He noted that PAPRs were prohibitively expensive to acquire and stockpile, costing over $18 million per year. The strategy of providing reusable elastomeric respirators for medical and nursing personnel and disposable respirators for other HCWs was estimated to cost $274,000–$526,000 yearly. The cost of reusing disposable N95 respirators for 2.5 hours—rather than disposing of them after each patient encounter—was $87,000–$160,000 per year; extending use to 4 hours brought the cost down to that of reusable elastomeric respirators.
Baracco summarized limitations of the comparative cost analysis. In modeling a pandemic, the study estimated costs for an unpredictable event and was not based on actual RPD usage rates. Furthermore, the use of RPDs outside clinical care of infected patients was not considered. As the study was limited to health care settings, it does not account for the mask recommendations and policies issued for the general public during the COVID-19 pandemic. Costs incurred by disinfecting PPE, fit testing, training staff, distribution, waste management, and other activities were not included in cost estimates. Baracco noted that the study also did not account for factors important for product selection, such as the degree of protection offered, tolerability, user preference, and ease of storage.
Strain asked about key economic challenges affecting the balance of reusable and disposable PPE production and adoption. Laura Thurston, director of laundry services at Intermountain Health, described difficulty in predicting and adjusting to customers switching from one type of PPE to the other. She noted that during the COVID-19 pandemic, vendors allocated PPE to health care systems based on past purchase history. Therefore, Intermountain Health was unable to obtain items that they had not previously used. This scenario is relevant to stockpiling and surge planning efforts. Merrow highlighted the economic effects of manufacturing programs in local communities. When PPE is made in the United States from domestically produced fabric, the number of people who benefit from the products extends beyond those who wear them. He remarked that the number of U.S. jobs affected by fluctuations in the production of medical devices, particularly PPE, is poorly understood. During the COVID-19 pandemic, Merrow Manufacturing scaled production to address PPE supply shortages, and in so doing created an estimated 750 jobs directly related to production. He commented that four times as many jobs were likely created throughout the PPE supply chain. Dollars spent on regionally produced goods carry economic impact for U.S. communities. Merrow added that substantial, consistent demand brings down product cost; thus fluctuation in the U.S. demand for PPE is a primary consideration in the economics and viability of manufacturing PPE.
Laurie-Ann Agama, acting assistant trade representative for textiles at the Office of the United States Trade Representative (USTR), explained that USTR is responsible for developing and coordinating U.S. international trade commodity and direct investment policy as well as oversee-
ing negotiations with other countries. As acting assistant trade representative for textiles, Agama advises Ambassador Katherine Tai, the U.S. Trade Representative, on textile and apparel trade policy matters. She also closely collaborates with the U.S. Department of Commerce and U.S. Customs and Border Protection on (1) textile trade policy development; (2) the implementation, monitoring, and negotiation of trade agreements; and (3) the enforcement of textiles provisions in existing U.S. trade agreements. In the wake of the COVID-19 pandemic disruptions to global supply chains, including textiles and other vital supplies for PPE production, the Biden administration is working to proactively strengthen supply chain resilience to mitigate the effects of future disruptions, said Agama. As part of this effort, USTR is crafting a new approach to trade and investment policy that is supported by innovative tools and strategies. Closely integrated and coordinated with domestic economic policy and support for U.S. manufacturing, this approach addresses supply chain risks posed by unfair trade practices. Furthermore, this approach creates opportunities for businesses to increase sourcing options, including domestic sources, and facilitate the movement of supply chains to trusted partners. She described that this practice, called “friendshoring” or “nearshoring,” strengthens the labor standards and environmental protections governing global supply chains.
Agama highlighted the tariffs levied against China under Section 301 of the Trade Act of 1974, which are currently undergoing a statutory 4-year review.3 This review was initiated to examine matters including the effectiveness of the tariffs toward the elimination of China’s acts, policies, and practices involving the unfair and harmful acquisition of U.S. technology. These tariffs have had measurable and substantial effects on supply chains and, as part of the review, USTR is currently considering the overall structure of the tariffs, including which products should be subject to additional duties. In December 2023, USTR extended all Section 301 exclusions—including 352 reinstated exclusions and 77 exclusions related to the COVID-19 pandemic—through May 31, 2024, and these reinstated and COVID-19–related exclusions cover PPE products. Additionally, USTR opened the docket for public comments on the possible extension of specific exclusions. The docket closed on February 21, 2024, after receiving 866 comments. In considering whether to extend exclusions, the office is currently reviewing these comments. The focus of the evaluation will be on the availability of products covered by the exclusion from sources outside of China and on efforts to source products domestically and from third countries, Agama noted.
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3 Trade Act of 1974, Public Law 93-618, 93rd Cong., 2d sess. (January 2, 1975), 19 U.S.C. §§ 2411–2420.
Strain asked how to monitor the success of PPE sustainability programs. Merrow replied that he monitors demand to determine whether Merrow Manufacturing is influencing customers to continually—or increasingly— choose the domestic PPE supply chain. Noting that product innovation can drive demand, he highlighted the opportunity for innovation within the domestic supply chain through an iterative approach involving collaboration with health care systems. Thurston commented that Intermountain Health measures cost per use and calculates a cost comparison between reusable and disposable PPE. The cost of reusable PPE includes numerous factors throughout the supply chain—such as distribution, labor, storage, laundering, and collection of soiled items—in addition to the acquisition cost. These costs are then divided by the number of uses recommended by the manufacturer. The cost of disposable PPE includes expenses for collecting and transporting waste. She commented on costs of chemical discharge into wastewater through local sewer systems from laundry operations processing reusable PPE and HCT products. Thurston remarked that after the disposable PPE supply shortages during the COVID-19 pandemic, consideration is also given to maintaining a balance of products. Given the numerous metrics at play, organizations must prioritize factors in selecting PPE, she added.
In addition to environmental savings, reusable gowns carry cost savings for hospitals, Overcash highlighted. He collected 2021 data from six laundry facilities on the processing services provided to 179 hospitals and associated incurred charges. He calculated the cost of purchasing new disposable gowns equivalent to the number of isolation gown processing cycles conducted by the laundry facilities. Comparing the cost of purchasing disposable gowns with the cost of purchasing and laundering reusable isolation gowns, he identified a 52 percent cost savings by opting for reusable gowns. This signifies that hospitals using disposable isolation gowns pay 200 percent of the cost of using reusable gowns. Overcash and his colleagues also conducted this cost analysis for surgical gowns and incontinence pads as well as environmental cleaning devices, flat mops, and wipers. The cost savings were similar or greater than the isolation gowns savings, with reusable products delivering up to 90 percent cost improvement. He emphasized that these savings are based on actual cost analysis and are not hypothetical. Furthermore, in consulting with HCT laundry facilities in Europe, where reusable products constitute an estimated 70–80 percent of PPE used in health care organizations, Overcash learned that cost savings would scale in the United States with increased use of reusable PPE.
In response to a question about methods of measuring sustainability in the PPE industry, Agama replied that the COVID-19 pandemic and resulting PPE supply shortage crisis revealed the medical community’s reliance on disposable PPE and the need for alternatives. USTR data indicate that approximately 44 million nonwoven PPE items are used by frontline HCWs each day, generating 15,000 tons of waste destined for landfills or incineration. She remarked that the upfront purchase cost of reusable PPE is a key concern for health care facilities. Although demand can drive decreases in cost, increasing the production of reusable HCTs to lower the cost could foster demand, thereby increasing HCW access and use of reusable products. A relative decline in purchases of disposable PPE could benefit the environment and natural resources. Agama commented that more research is needed to inform policy decisions that enable better outcomes.
Merrow stated that although reusable PPE manufacturers are working to increase sustainability related to PPE, limited interaction between health care systems and manufacturers poses a challenge to achieving sustainability goals. Merrow Manufacturing has created a medical gown that can maintain protective properties through 200 industrial laundry wash cycles, enabling each gown to remain in service for a lengthy period. Furthermore, the gown is made from recycled products. Technology is in place to build Level 1, 2, 3, and 4 medical gowns from 100 percent recycled material. Moreover, Merrow Manufacturing can craft bespoke products designed for individual health care systems and providers via a circular supply chain. Gowns in a circular supply chain are manufactured, shipped to health care facilities, used for months while being laundered at facilities increasingly adopting sustainable practices, shipped back to Merrow Manufacturing at use life completion, and in turn shipped to the material manufacturer to recycle anew into raw material. This capability is in place; however, while many health care systems have established environmental, social, and governance programs, their stated goals are not aligned with uptake of innovative, sustainable products, said Merrow. The peak of the COVID-19 pandemic demonstrated the capacity to manufacture a million reusable gowns per week, yet current demand is one-tenth of that capacity.
Noting that cost parity between reusable and disposable gowns was achieved during the supply disruptions of the COVID-19 pandemic, a workshop participant asked why health systems abandoned reusable PPE programs once availability of disposable PPE was restored. Merrow remarked that current hospital system cash management does not support reusable PPE programs. In the mid-1990s, reusable medical gowns were predominant and hospital systems had laundering and manage-
ment operations in place. However, hospitals moved toward disposable products in the 2000s; Merrow pointed to cash flow patterns as a driver of this trend. Although amortized costs of reusable PPE generate savings in comparison with disposable counterparts, the upfront costs are higher for reusable products.
Thurston commented that the cost of reusable gowns shows some variance in response to prices for cotton and other raw materials. She remarked that stagnation in health care adoption of reusable PPE can be driven by contracts with vendors. When a health care system has a contract in place with a specific vendor, they are likely unaware of innovative products available from competitors. Thurston noted that national organizations could play a role in raising awareness of innovation in PPE. During the COVID-19 PPE supply shortage, Intermountain Health was processing 1,500 reusable gowns per day for a single hospital. However, as soon as disposable gowns became available, this figure dropped to 100 reusable gowns per day. She remarked that health systems often do not consider cost and sustainability in these decisions; rather, they default to disposable products because they are familiar and convenient. Nonetheless, hospitals are once again exploring reusable PPE as they investigate methods of reducing costs and waste in the supply chain.
Given the limited usage of reusable PPE, Strain asked about processes, regulations, or other efforts that could increase adoption rates. Agama replied that USTR is aware of the reusable PPE manufacturing capacity highlighted by Merrow and how the textile industry pivoted during the COVID-19 pandemic to produce PPE. She said USTR is focused on this issue and actively monitoring it. To foster supply chain resilience and create more opportunities for manufacturers, USTR is working on wide-ranging engagement efforts to better understand the perspectives of stakeholders—including the textile, apparel, and health care industries—on how to support the manufacturing base. Agama referenced USTR announcements expected in coming weeks about these issues.
Merrow expressed optimism about reusable PPE adoption related to three current dynamics. In the past 3 years, advancements in sustainable materials have enabled production of high-quality medical products fundamentally different from the previous generation. He remarked that the availability of these sustainable health care products is reaching critical mass and offers an opportunity for increased sustainability in the U.S. health care system. Additionally, the COVID-19 pandemic spotlighted how U.S. manufacturing capacity limits affect the supply chain. Merrow commented on an acute awareness in the U.S. government that current
manufacturing capacity is not improving and requires attention. Also, in anticipation of another global crisis, manufacturers and health care systems are working to increase supply chain resilience while decreasing risk. These events provide an opportunity to create substantive change in the supply chain, said Merrow.
Thurston noted that radio-frequency identification (RFID) and other tracking innovations have minimized the labor involved in monitoring each reusable PPE item’s use life, ensuring that PPE retains its protective barrier properties. Intermountain Health is exploring ways to facilitate the use of reusable HCTs, such as designing products that are easy to don and doff and that can be folded into less bulky configurations that lie flat, making them easier to store and to quickly grab when needed. Such features improve ease of use and decrease resistance to reusable HCT adoption, she maintained.
In response to a question about the role of incentives in increasing reusable PPE adoption, Merrow remarked that incentives for health care systems to choose reusable products should be put into place because reusable products are sustainable and provide value within a sustainable supply chain. Additionally, incentives for U.S. health care systems to purchase PPE regionally should be established, he said. Merrow also called for federal and state organizations to lead by example in purchasing products that are better for the environment and better for U.S. communities. Thurston commented that the development of best-practice standards issued by the federal government could increase acceptance and adoption of reusable PPE. Monetary incentives can be helpful, but prices will inevitably increase with time. An established best practice, universally accepted in the medical and manufacturing industries, would help foster understanding that reusable PPE is effective and efficient, she maintained.
Agama spoke of the need for consumer education to drive demand for reusable PPE within health care settings. Overcash emphasized the influence that surgeons could have by collectively asking hospital leadership to convert to reusable PPE for the environmental and cost benefits it offers and to request that the GPO locate laundry facilities that meet CDC guidelines. He remarked that PPE is one of the highest operating costs within a hospital, and GPOs have an opportunity to respond to health care systems and lower costs. Strain commented that in the institutions where she has worked, surgeons prefer reusable gowns due to patient-safety factors, such as reduced lint.
Noting nationwide workforce challenges, Strain asked about current workforce demand within U.S. PPE manufacturing. Merrow replied that
a misconception persists that the U.S. manufacturing workforce is insufficient to meet need. He contended that the issue is not worker shortage, but rather an inconsistent demand for work. Frequently, PPE manufacturing jobs increase and decrease in response to product demand, resulting in unpredictable work availability for employees. It is possible to scale PPE manufacturing, if scaling entails steady jobs and that investment is made in automation. Merrow remarked that technology for automated material handling, which is incorporated into all soft goods manufacturing, is particularly needed in health care manufacturing due to quality standards. He posited that automated material handling and quality assurance programs, combined with consistent demand, would enable tremendous scaling within the industry. Investment in automation and in strengthening long-term demand signals to manufacturers that implementing long-term workforce training programs would generate growth, said Merrow. Agama added that U.S. trade policy is focused on supporting domestic economic policy in U.S. manufacturing, including textiles, and prioritizes job creation in the United States. USTR is currently working to support U.S. workers and ensure that greater numbers of products are made in the United States. Feedback from U.S. textile industry stakeholders indicates that there is capacity for sustainability, supply chain resiliency, and scaling capability, she noted.
Thurston commented that shortages in the entry-level workforce have led Intermountain Health to explore investments in automation. In addition to technology that reduces labor needs, such as RFID tracking, automation helps maintain the hygienic properties of PPE by efficiently moving laundered products from the washer to the dryer and into packages without manual contact. Although commercial laundries continue to rely on human labor, opportunities for automation offer numerous benefits.
To a question about research needed to demonstrate the benefits of reusable PPE, Merrow commented on the need to analyze supply chain resiliency of reusable PPE versus disposable products. Although a health care system that has adopted reusable PPE should face fewer PPE supply shortages during a health care crisis than systems that rely on disposable PPE, he was unaware of an analysis that has achieved consensus on this matter. Studies have demonstrated that cost parity between reusable and disposable PPE is possible, even when accounting for laundering and management costs. However, generating more robust data in this area could further highlight the advantages of reusable PPE, particularly given the sustainability benefits it offers. Research is also
needed on the environmental benefits of a regional supply chain that calculates the carbon footprint of regionally produced reusable PPE versus imported products, added Merrow. Agama remarked on the usefulness of case studies that communicate the complexities of the supply chain and value analysis in an easily understandable format. Given that available literature indicates that both the cost and environmental effects of reusable PPE are better than disposable counterparts, Overcash emphasized the need for economists to identify the barriers to adoption that prevent health systems from taking advantage of those financial and environmental benefits.
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