3

PPE/PPT Supply Chain and Standards During COVID-19

Key Messages from Individual Speakers¹

• Given the magnitude of the COVID-19 pandemic and the inability of the Strategic National Stockpile to meet nationwide demand for PPE, a reassessment is needed to determine whether a state or local stockpiling model would work better, and if so, what the size of those local caches could be. (Fleming)
• The strong regulation accompanying the respiratory protection performance standard (42 CFR Part 84) helped some NIOSH Approved^®2 PPE manufacturers easily increase their manufacturing capacity and expand production during the COVID-19 pandemic. (McCullough)
• It would be valuable to have guidance focused not only on health care but also on other occupations and the public. (McCullough)
• In maintaining the Strategic National Stockpile, it is important to balance how long a product remains viable and how long it takes to stockpile it versus freeing space for other items and using the money to buy additional products. (Gorman)

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¹ The following list of key messages is the rapporteurs’ summary of points made by the individual speakers identified, and the statements have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They are not intended to reflect a consensus among workshop participants.

² NIOSH Approved is a certification mark of the U.S. Department of Health and Human Services (HHS) and is registered in the United States and several international jurisdictions.

• A safety management system following high reliability principles enables an organization to navigate successfully through a complex, unclear, and potentially catastrophic situation when the conditions are hazardous and unpredictable. (Worden)
• The lack of expiration dates on some PPE and changes in standards poses problems for maintaining a large enough cache to respond to surging demand during a pandemic. (Fleming)
• No single place in the United States specifies PPE requirements to meet all scenarios to which a public health department might respond. (Kice)

In the third session of the workshop, participants discussed how the COVID-19 pandemic affected all aspects of the personal protective equipment (PPE)/personal protective technology (PPT) supply chain, from manufacturers to PPE and PPT users. This session’s speakers also noted differences in standards and communication about PPE and PPT between workers and the public.

A MANUFACTURER’S PERSPECTIVE ON RESPONDING TO A SPIKE IN DEMAND FOR PPE

Nicole McCullough, vice president of global application engineering and regulatory for the Personal Safety Division of 3M, opened her presentation by noting that she would use the term “respirator” to refer to National Institute of Occupational Safety and Health (NIOSH) Approved devices designed to reduce exposure to airborne particles and not to masks or other unapproved devices. She then reminded the workshop participants that there was an unprecedented spike in demand for PPE, and N95^®3 respirators in particular, in early 2020. One contributing factor to the dramatic increase in demand was that many organizations, both industrial and health care, had not stockpiled PPE. At the same time, the Strategic National Stockpile (SNS) had products that were past their shelf life, which resulted in questions about usability. In addition, there was variability in reuse patterns across different organizations, with some health care organizations throwing aways respirators after every patient visit and others instituting or extending reuse practices.

McCullough explained that 3M has a significant manufacturing base in the United States and has had a regional manufacturing strategy in place since the 1970s. However, even with a large domestic manufacturing base, 3M operates in a just-in-time economic environment, so it does not maintain a huge inventory, and neither do its suppliers. When the

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³ N95 is a certification mark of the U.S. Department of Health and Human Services (HHS) and is registered in the United States and several international jurisdictions.

company began operating its factories on a 24-hour-a-day schedule, it immediately notified its suppliers that it would need significantly more raw materials and began aggressively hiring workers. “So even with a lot of capacity, we still had some time to ramp up to our full capacity for manufacturing,” said McCullough. In addition, 3M extended its manufacturing capacity geographically throughout the United States.

One reason the company was able to ramp up existing capacity and build new facilities and outfit them with the required production machinery was because of strong NIOSH regulation, said McCullough. “NIOSH, as part of the performance standard of 42 CFR 84,⁴ does incorporate quality plans,” she said, which means that NIOSH monitors a manufacturer’s quality plans, user instructions, and packaging, which differs from respirator performance schemes in many other nations. Because these provisions were already in place, 3M was able to easily expand its production. In addition, NIOSH also worked closely with the company, and other manufacturers, to set internal priorities that put respirators at the top of the priority list. McCullough added that NIOSH also worked quickly with the company to extend approvals resulting from raw material changes or regional need for increased capacity.

One factor that enabled 3M to deal with the spike in demand was that many health care institutions, because of their preparations for the H1N1 influenza outbreak and the Ebola incident, understood the role general-use respirators, reusable respirators, and powered air-purifying respirators (PAPRs) could play in their response to the COVID-19 pandemic. Health care organizations also had the Respiratory Protection Toolkit for Health Care developed by NIOSH and the Occupational Safety and Health Administration (OSHA) to serve as a guide on respirator use (NIOSH, 2015).

To address questions about respirators and N95 respirators in particular, 3M established fraud and counterfeit hotlines and websites around the world and worked with distributors and end users to help them identify if a product was authentic or fraudulent. McCullough noted that the company has been working with prosecutors to deal with those offering fraudulent or counterfeit products.

As a final comment, McCullough pointed to the conflicting and changing guidance regarding respirator use outside of a health care environment, both for nonhealth care workplaces and for the general public. She said 3M’s technical health line, which is staffed with people trained in occupational safety and health to answer questions from anyone, experienced a significant spike in call volume from people trying to understand the guidance. Looking forward, she said having clearer, more accessible guidance focused not just on health care but on other occupations and the public would be valuable.

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⁴ Approval of respiratory protective devices, 42 CFR § 84 (June 8, 1995).

STOCKPILING AND USE OF PPE IN THE NATIONAL STRATEGIC STOCKPILE DURING COVID-19

Susan Gorman, director of the Office of Science in the SNS, managed by the Administration for Strategic Preparedness and Response (ASPR), explained there was a limited supply of PPE in the SNS at the start of the COVID-19 pandemic that had been purchased a decade earlier, during the H1N1 influenza pandemic. She noted that the SNS held onto that PPE because NIOSH was studying the viability of older PPE stored in different environmental conditions and for different lengths of time. The 3-year NIOSH study ended around the time the COVID-19 response was taking off, and fortuitously, the results allowed the SNS to use some of the PPE that had exceeded its expiration date, as the NIOSH data indicated that the protection the expired PPE offered had not diminished.

Gorman added that ASPR conveyed that message to the jurisdictions that received this PPE through Dear Health Care Provider letters and via phone calls.⁵ These communications informed recipients about the different conditions under which they could and could not use older PPE and that they would need to inspect the PPE before use to make sure it did not look damaged. “If we had not been able to use the old PPE in the stockpile at the time, we would have started out the response with nothing available to send out to our state and local partners,” said Gorman.

Historically, said Gorman, the SNS has procured large amounts of PPE with supplemental funding only during actual emergencies, such as the H1N1 influenza pandemic in 2009, the Ebola outbreak in 2014 and 2015, and the current COVID-19 event. She noted that some items in the stockpile had expiration dates, but other PPE items did not have expiration dates or were not required to have expiration dates. This is true for the current PPE stockpile acquired during the COVID-19 pandemic. Expiration dates “are helpful to us in determining when we need to budget to try to replenish these PPE items, assuming that funding is available,” said Gorman.

Expiration dates can also provide a guide for how long after the product expires that the SNS might consider holding onto various items if there is no subsequent funding to replace them, said Gorman. She noted

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⁵ Dear Health Care Provider letters are mass mailing correspondences from the manufacturer or distributor of a medical product or from the FDA that is intended to alert health care providers about important new or updated information regarding the medical product. Here, the letters were sent from the SNS to the state, local, tribal, and territorial partners that were receiving PPE from the SNS. More information is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dear-health-care-provider-letters-improving-communication-important-safety-information (accessed May 2, 2023).

that it is expensive to store and maintain the hundreds of millions of items in the stockpile today. “We want to be able to strike a balance between how long we could viably use these products and how long to stockpile them or store them or not, because that space could be freed up for other things, and the money could be freed up to buy additional products as well,” she said.

The SNS has PPE set aside primarily for use by health care workers and rarely stockpiles PPE for the general public. Having said that, Gorman noted that the presidential directive to send out N95 respirators to the general public resulted in what was likely the largest distribution of PPE in the United States. The SNS made about 250 million N95 respirators available through pharmacies and federally qualified health care centers in 2022.

The initial distribution of stockpiled PPE was done pro-rata and determined based on the population of a jurisdiction. This was difficult because these jurisdictions may not have received the exact products they were used to using or for which they had conducted fit tests. “Because we were supplying . . . all across America and not [for] a localized event, we tried to equitably distribute the different sizes and the different products to each of the [jurisdictions],” said Gorman. This was challenging, she added, given there were no clear guidelines for delineation between different sizes of PPE and how it was to be equitably allocated.

Another challenge was that the SNS was trying to procure PPE for the entire United States when everyone else in the world was trying to procure the same PPE. Gorman and her colleagues had to review the standards and available PPE products they were less familiar with to ensure they met the standards. “That was difficult to do during an emergency, and people were ordering everything they could get their hands on,” said Gorman. Ultimately, some of those products did not meet current standards or were counterfeit, she said in closing.

SAFETY MANAGEMENT FRAMEWORK FOR PPE AND PPT

Cory Worden, safety adviser for the Houston Health Department, explained that Houston’s safety management system enabled the health department to adapt to an ever-evolving situation during the COVID-19 pandemic. Without such a system to help guide the health department, he said, there would have been a high risk of the health department missing something or not managing something that could have made the situation worse.

A safety management system, said Worden, is a means of risk control and enables an organization to navigate successfully through a complex,

unclear, and potentially catastrophic situation when the conditions are hazardous and unpredictable. It does so through implementing high reliability principles. The result, he added, is a framework that allows for continual improvement, particularly when the situation changes, such as when a pathogen changes or the supply chain changes.

This type of framework is important when engaging in a chemical, biological, radiological, or nuclear response, such as with the COVID-19 pandemic, where protecting responders and workers is a key component of the response plan (Table 3-1). Worden emphasized that being unable to carry out the response plan properly increases the risk of negative outcomes. For example, being unable to communicate properly about how to stop the spread of the biological agent makes it harder to promote actions such as source control, social distancing, quarantine, and isolation. As for protecting responders, Worden said that being unable to have a proper logistics trail for PPE results in price gouging, counterfeiting, and issues with product storage and shelf life. “Ultimately, we want to make sure that all these things are secure so that . . . the response can happen . . . [and] prevent it from worsening,” he said.

Risk management in public health, said Worden, focuses on the frequency and severity of issues that pose a threat to the population. For example, respiratory protection is frequently used by health care workers in hospital settings. When it adequately protects against the respiratory hazard and is also easily accessible, use of respiratory protection can be considered an activity of low severity (i.e., use of it is unlikely to stop overall operations or shut down a hospital). However, if respiratory protection for a hospital’s employees is not adequate or accessible during an event like COVID-19, the situation can impact an entire health care facility, increasing the severity of the event, and may eventually lead to community spread. This happened with COVID-19, which went from being an issue of respiratory protection and isolation rooms to shutting down the world economy. “The more we are able to do with hazard controls, the more we are able to prevent these types of situations from worsening,” said Worden.

On a final note, Worden said that engaging in effective safety management would directly affect the demand for PPE. Implementing other measures, such as increased physical separation and social distancing, improving mechanical ventilation, and employing source control, leaves more PPE available for those who absolutely must be in the hazardous area, which could mean the difference between needing billions versus millions of N95 respirators and potential alternatives, such as PAPRs.

TABLE 3-1 Components of a chemical, biological, radiological, and nuclear response

SOURCE: Presented by Cory Worden on March 1, 2023, at the PPE/PPT Standardization for a Resilient Public Health Supply Chain Workshop.

MAINTAINING LOCAL CACHES OF PPE

John Fleming, chief of the Public Health Preparedness Bureau at the Houston Health Department, said his department began stockpiling N95 respirators when planning for the H5N1 influenza pandemic in 2003 and continued to do so in preparation for the H1N1 pandemic in 2009. However, as the focus was primarily on stockpiling PPE for health care workers, the Houston Health Department did not have a large cache of masks or respirators for the community to use when COVID-19 hit. In addition, he and his colleagues had not initially recognized the investment it would take to monitor the department’s PPE supplies, which led to a fair amount of waste from the cache as PPE deteriorated over time.

Fleming said the lack of expiration dates on some PPE and changes in standards poses problems for maintaining a large enough cache to respond to surging demand during a pandemic. He noted that it is possible to conduct inspections and viability testing on PPE that is past its expiration date, but the question then becomes whether it is possible to get guidance on using equipment past that date.

Before the advent of the SNS, there was a great deal of emphasis on local jurisdictions to develop caches of PPE and other critical medical products like antibiotics, said Fleming. As the national stockpile evolved, the stress of maintaining local caches was replaced by a dependence on the federal government. Given the magnitude of the COVID-19 pandemic and the inability of the SNS to meet nationwide demand for PPE, a reassessment could determine whether a state or local model would work better, including the ideal and manageable cache sizes.

Fleming said the logistics of maintaining local caches is full of challenges, mainly because it requires ensuring that the cache has the right types of PPE for the local workforce. “We need to find ways to integrate our fit-testing data with our actual caches and make sure we are stockpiling the right masks,” said Fleming.

DIFFERENT STANDARDS FOR DIFFERENT HEALTH CARE SCENARIOS

Sean Kice, the SNS coordinator for the Tennessee Department of Health, noted that he has valued standards for some time, particularly the emergency response component of the Hazardous Waste Operations and Emergency Response standard, 29 CFR 1910.120,⁶ as it has provided his health department with a baseline of PPE standards to reference when considering transmission-based precautions for a general health care

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⁶ Hazardous Waste Operations and Emergency Response, 29 CFR § 1910.120 (June 27, 1974).

response. However, he noted that it can be challenging to manage evolving situations (such as during the COVID-19 pandemic) as changing circumstances can trigger the use of different standards and it is not always clear which ones take precedent or are best to follow. For instance, Kice described his department’s recent response to a radioactive emergency at a national laboratory, where use of P100 full-face respirators is the standard under the Radiation Emergency Medical Management system (HHS, n.d.). However, this is a standard above what many health care facilities can meet, so the guidance he was able to provide the health care workers responding to this situation was limited.

One challenge, said Kice, is explaining to health care organizations the correct way their employees should wear their PPE. However, there is no single place in the United States where he can find PPE requirements to meet all the scenarios to which his department might have to respond. In the case of the COVID-19 pandemic and the Emergency Use Authorization (EUA) for non-NIOSH Approved FFRs respirators (FDA, 2021b), there was the need to explain to health care facilities that not all available KN95 respirators meet the EUA requirements for health care settings of achieving at least a 95 percent filtration efficiency.

Furthermore, the existence of multiple standards meant Kice had to separate whatever PPE was available into separate buckets for health care and the general public and then explain to these two user groups why different types of PPE are suitable for different scenarios. Kice said one thing that created a challenge for the United States was the lack of standards applicable to the general public. During the COVID-19 pandemic, the Centers for Disease Control and Prevention (CDC) created new standards related to workplace use of PPE that met the needs of the general public because the general public, like workers outside of health care, were not in close proximity to active COVID-19 cases all the time.

Kice noted that in July 2021, with the CDC’s evidence showing that universal masking in conjunction with portable high efficiency particulate air (HEPA) cleaners met a level of protection acceptable for the general public (Lindsley et al., 2021), Kice and his colleagues could explain to the public that they did not need PPE that met the EUA requirements for health care settings of achieving at least a 95 percent filtration efficiency. This, he said, freed up a great deal of PPE that could then go to hospitals and reduced the strain on the state’s internal supply chain.

THE CHALLENGES EMS FACED TO PROCURE PPE/PPT

Daniel Gerard, president of the International Association of Emergency Medical Services Chiefs, said that during the COVID-19 pandemic, acquiring PPE was a challenge. Before the pandemic, many Emergency

Medical Services (EMS) organizations had transitioned to just-in-time stocking, mirroring what was occurring in the health care system at large. “Pre-pandemic, few organizations had more than a 14- to 30-day supply of PPE on hand,” said Gerard.

He explained that calculations for utilization rates were difficult, in part because there was no experience pre-pandemic for what day-to-day needs would be during the height of the pandemic. For N95 respirators, for example, it was impossible to calculate utilization effectively because there was no guidance on whether they could be used only once, as intended, or multiple times.

Gerard said that the nation was and still is dependent on foreign producers of PPE, and the competition between EMS and everyone else who required PPE created a competitive and chaotic scenario. Hospitals and health care systems received first priority for all PPE, and orders placed for respirators were embargoed on arrival in the United States, redistributed to hospitals, and never made it to EMS. Requests for PPE were backlogged up to 2 years, he said.

This situation was not limited to respirators. “Everything we required was in short supply and made us resort to crisis standards of care,” said Gerard. “The price of gloves, for example, skyrocketed from $8 per box to $35 per box.” He noted that to address the issues surrounding N95 respirators, one state secured a contract to supply EMS and health care providers with N95 respirators. These respirators were purchased overseas and had a 40 percent failure rate. “This is not a criticism of that state,” said Gerard. “Instead, they should be applauded for their efforts, but it highlights the hurdles that were almost impossible to overcome in the midst of the pandemic.”

Gerard noted that single-use, single-patient respirators and masks are cheap and easier to use but are not meant for long-term use, nor do they lend themselves to the unforgiving environment under which EMS operates. In addition, the scenes at which EMS operates—car crashes, shootings, cardiac arrests, and others—are not controlled as is the case in a hospital or skilled nursing facility. Aerosol-generating procedures, such as suctioning, intubation, and administering nebulized medications, all occur in enclosed spaces with poor ventilation, increasing the chance of exposure.

Gerard said that elastomeric half-face respirators are better and more durable than single-use, single-patient surgical N95 respirators, but they too have problems, such as increasing the heat burden on those wearing them and making patient communication impossible. During the COVID-19 pandemic, the gowns provided to EMS were not meant to be used in the field, and spun paper suits, while offering better protection, increased the heat burden on those wearing them, increasing fatigue.

Reuse and decontamination of PPE were problematic, said Gerard. Decontamination processes, regardless of type, may have destroyed the SARS-CoV-2 virus on the outside of the respirator, but they degraded its ability to provide protection.

Still, he explained, EMS responders frequently wore the same single-use (disposable), single-patient surgical N95 respirators for 8 to 16 hours at a time. Typically, when PPE and respirator supplies are not limited, these surgical N95 respirators would be discarded at the end of the shift. However, during the pandemic, these surgical N95 respirators were stored and worn repeatedly in the same demanding conditions. Continued use made it harder to achieve a fit that would provide the protection required for use. “Elastic head straps would stretch out, the foam padding across the bridge of the nose would be compressed, and the metallic wafer would deform,” said Gerard.

THE ROLE OF PUBLIC HEALTH IN PROVIDING PPE AND GUIDANCE FOR ITS USE

The final speaker in this session was Jennifer Kiger, director of the COVID-19 Division of the Harris County Public Health Department. She explained that public health’s role during the pandemic was to provide guidance to the public, support the effort to provide PPE to health care providers, and offer guidance to health care providers on what PPE to use and how. She noted that the health department, like everyone else, struggled with finding PPE, whether it was for its own vaccination and testing operations or to support hospitals and vulnerable populations, such as the residents of skilled nursing facilities. The federal government did, on occasion, provide PPE for the department’s testing and vaccination efforts. “We would store those PPE caches on site, and we had to have 24/7 security,” said Kiger. Even with that, she said that several shipments disappeared.

In addition, said Kiger, the public health department would share with other organizations in the area that could not be the highest bidder for these PPE caches. When PPE shipments were delayed, either from the federal government or from companies that had promised to provide PPE promptly, the public health department had to temporarily close some of its testing and vaccination sites. To stretch supplies, public health staff would use its PPE for up to 5 days in a row, raising concerns because that had never been the practice before the pandemic. During the summer, however, PPE utilization increased because the region’s high temperatures and humidity levels caused staff to sweat through their PPE, making it unsanitary to reuse. The department did use three-dimensional printers to create some PPE, she added.

Communication with the public was often difficult as knowledge about the virus and the standards for PPE changed, said Kiger. This often led to the community losing trust in the guidance from the public health department. She also noted the challenge of trying to balance what PPE people should use given their situation and how that affected access to PPE for the department’s health care partners, particularly when there was a shortage across the region and the nation.

DISCUSSION

Session moderator and planning committee member Jill Morgan, a critical nurse at Emory University Hospital, began the discussion by thanking the speakers for highlighting the importance of the hierarchy of controls and the other actions that can help decrease the overall need for PPE. Given the struggles they noted in their remarks, Morgan asked the panelists for their ideas on steps to take to make the next situation that calls for large amounts of PPE better. McCullough suggested looking at ways to keep the manufacturing base alive during times of low demand and to better manage stockpiles, so they are active and turning over.

Morgan than asked the panelists how the SNS could be nimbler and supply local needs more efficiently. Kice responded by noting that there is a supply chain requirement in ASPR health care preparedness program grants. The issue, he said, is that it is not a standardized requirement for information gathering, but producing a standard for information gathering could help identify gaps in PPE supplies and where there might be overlapping supplies.

Gerard said the nation would benefit from more local and regional stockpiles of PPE so that different health care systems would not have to compete for PPE. He suggested engaging accountants to develop a first-in/first-out stockpiling system so an organization needing PPE would draw down their own cache and backfill as needed. The challenge, though, would be in developing a dynamic plan in which health care organizations of all sizes would work together rather than competing. Both Gerard and Morgan said, considering equity is important in developing a plan to move forward.

Several members of the public attending the workshop commented on the stockpiling issue. One participant wondered if more reliance on reusable products could shift stocking locations to a more micro level, such as homes and other localities. In the same vein, a participant asked if health care systems are considering moving away from using disposable N95 respirators and instead using full-face elastomeric respirators, which would also have the benefit of making the user’s full face visible to patients, potentially improving communication. Another participant

noted that California now requires hospitals to stockpile a 45-day supply of PPE, and the issue now is how to rotate and stockpile these items and whether a 45-day supply provides enough of a buffer for the market to catch up with demand.

Kiger responded to a question about the knowledge gap among users regarding identifying hazards and what to use for those hazards. She said that she and her colleagues have discussed getting the word out that scientists and public health officials do not have all the answers at the start of an event and that the advice they give will likely change as more knowledge is acquired. She also suggested that public health and health care officials could be more proactive in assisting the public regarding things such as fit testing.

McCullough said 3M staff monitoring the company’s technical help line tried to address the knowledge gap by starting with the science of protection and the latest guidance from the U.S. government. One thing that could be done better, she said, is to make sure that science is communicated as a whole by the health and safety community, not just by 3M. It is important, as Kiger noted in her remarks, to be up front and honest with people regarding the state of knowledge. It is also important to help people understand there are different types of PPE and what each can do best and to better use the media to spread that knowledge.

In terms of standards for expiration dates, Morgan wondered if those standards could be modified to accommodate the fact that some items will still be functional 1, 2, or even 3 years after their expiration date. McCullough noted that there is no current standard for how a manufacturer determines a product’s shelf life, and having such a standard could prove valuable. Such a standard, she said, would enable distributors, purchasers, and users to understand how much effort had gone into determining and validating a product’s shelf life. Worden added that it is critical to make sure that shelf life and other attributes are reliable and valid scientifically.

Fleming called for the community to better engage experts to help manage inventory. Gorman pointed out that accessing the SNS requires a federal decision to deploy it, so it serves as a backfill and resupply source of PPE rather than a first-response mechanism. She suggested that regional stockpiles that are not governed by the federal government and from which organizations could draw before making a federal request could be beneficial.

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