7

Marketing, Stockpiling, and Distribution

Key Messages from Individual Speakers¹

• Having multiple standards for the same type of PPE can be a hindrance, but they can offer more choices to draw from during an emergency. (Kice)
• Private-label PPE offers an advantage to some approval holders by allowing them to extend the line of what they can sell. However, for stockpiling, NIOSH does not believe that private labeling should be considered. (C. Miller)
• Critical access hospitals are not big purchasers of PPE, so they do not have strong relationships with manufacturers and vendors, making it difficult for them to purchase any substantial quantity of PPE. (DeBaun)
• NIOSH standards were of great help during the pandemic because they provided assurance that products that met the standard would be effective, that marketing claims would be valid, and that there would be ongoing monitoring of production so every batch of product would perform to the standard. (A. Miller)

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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.

• An enforced consumer standard could help consumers know they are getting the level of protection they think they are, that they are not getting fake or substandard masks, and that they can have trust in public health and respiratory protection. (A. Miller)

Continuing along the supply chain, the next workshop session focused on the standards and logistics of marketing, stockpiling, and distributing personal protective equipment (PPE) and personal protective technology (PPT). While focus was on the standards and logistics of PPE and PPT supply chain, the panel discussed how and why PPE and PPT standards are critical to the overall supply chain. The panel examined how standards can affect the ability of different entities to market, stockpile, and distribute PPE and PPT, particularly during periods of high demand, and actions that can streamline marketing, stockpiling, and distribution to create a more resilient PPE supply chain. Session moderator Tinglong Dai, professor of operations management and business analytics at the Johns Hopkins Carey Business School, noted that to ensure frontline workers and the public have the PPE they need, it will be important for the nation to strengthen every link in the supply chain by implementing standards for marketing, labeling, and stockpiling and to develop a data infrastructure and feedback loops for equitable distribution during future public health emergencies.

HOW STANDARDS CAN AFFECT SUPPLY CHAIN DESIGN

Chris Tang, professor and chair in business administration at the University of California, Los Angeles, Anderson School of Management, said it is important to understand the link between standards and the supply chain because it affects supply chain resiliency. To illustrate this link, he discussed how the standards for N95^®2 respirators affected the supply chain during the COVID-19 pandemic.

When the demand for single-use N95 respirators skyrocketed during the pandemic, and hospitals were reusing disposable N95 respirators to alleviate supply chain disruptions, there was concern regarding the integrity of those reused N95 respirators. With the Food and Drug Administration’s (FDA) April 2020 update to its Emergency Use Authorization (EUA) allowing for the use of certain single-use filtering facepiece respirators (FFRs) manufactured internationally (FDA, 2021b), the U.S. market quickly became flooded with low-cost disposable respirators from China. The U.S.-based manufacturers could not compete as the PPE imported

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² 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.

from China was selling for less than the cost of production state side (Evstatieva, 2021; Jacobs, 2021).

Tang offered that it may be necessary to rethink the standards for PPE products like N95 respirators so as not to disadvantage domestic producers. One possible approach, he said, could be to add other dimensions to standards that would give U.S. manufacturers more opportunities for innovating and developing new types of respirators and masks, such as ones that could be used multiple times. Such a standard, Tang continued, could include requirements for washability and for disposal at the end of its life.

Tang continued that a new standard could also provide flexibility in terms of the materials used to construct respirators and masks. For example, he said, it might be possible to incorporate materials, such as copper fibers, into the manufacturing of respirators and masks that could potentially enhance the immobilization of viruses and bacteria. Another change could reflect size considerations. Tang said that because of a change in the standard, it would be necessary to consider different types of supply chains to support this type of mask, ones that might result in a more resilient domestic or regional supply chain.

THE CHALLENGE OF MEETING DIFFERENT STANDARDS IN DIFFERENT SETTINGS

Sean Kice, who spoke in an earlier session, noted that the Occupational Safety and Health Administration (OSHA) has a response matrix for PPE in the event of an Ebola outbreak. This matrix provides guidance on the standards PPE must meet in that setting. “This gives us a variety of things we can use to respond and still be under the good graces of OSHA,” said Kice. For example, gowns meeting a certain standard can replace coveralls, depending on which type of PPE an individual finds more comfortable to wear. This flexibility also opens the supply chain.

Kice said that with chemical exposure, health care organizations must deal with three standards while following OSHA practices for hospitals receiving victims exposed to a volatile release of a hazardous substance. The challenge in following these standards is that the manufacturers often have different versions PPE. For example, DuPont makes nine types of chemical hazard suits and seven types of Tyvek^®. Kappler^®, another manufacturer, has 12 types of fabric. Often, said Kice, manufacturers may dictate what is appropriate for a particular use case or environment, but end users can choose a PPE that goes far beyond meeting a minimum standard if other versions are in short supply. As Kice noted, multiple standards can be a hindrance, but they can offer more choices to draw from during an emergency. “We just have to be very conscious and know about these standards ahead of time,” he said in closing.

QUALITY CONTROL FOR PRIVATE-LABEL PRODUCTS

Colleen Miller, deputy branch chief for the National Personal Protective Technology Laboratory’s (NPPTL) Conformity Verification and Standards Development Branch, explained that a private-label version of a NIOSH Approved^®3 respirator is the same product they make and label as their own, with the difference being that the approval label or labels and user instructions will identify another entity, the private-label designee. CVS and Home Deport are good examples of this, she said. The NIOSH approval holder makes the same respirator and puts the CVS or Home Depot label on the product. The user instructions inform the consumer that it is a NIOSH Approved respirator and was made by the approval holder for the private-label assignee. While this does increase the places one can go to acquire a NIOSH Approved respirator, for example, it does not increase the capacity to make more approved respirators. Miller noted that because private-label versions of a NIOSH Approved product do not increase capacity but still require NIOSH approval program resources, the agency has assigned its lowest priority designation to private-label applications.

Miller said this is a more common practice for nondomestic FFR manufacturers. NIOSH and other users trust that the private-label company does not alter the respirator, labeling, or user instructions or make a claim that NIOSH did not see in the approval package. From the NIOSH approval program’s perspective, said Miller, private labeling can be burdensome and requires the approval holder to apply to NIOSH for an extension of approval. While the submission is not required to include the respirator for testing, NIOSH reviews the drawing, labeling, and user instructions, and NIOSH captures the model or part number associated with the private-label product in its database. One challenge with this system is tracking product lifetimes after the manufacturer distributes to the private-label entity. Typically, approval holders do not come back to NIOSH and inform the agency if a private label version of the approved respirator has expired.

As the COVID-19 emergency declaration ends and NIOSH transitions back to more conventional operations, the agency is working on steps to improve the private-label application process (HHS, 2023). One step, said Miller, will be reaching out to private-label assignees to remind them they cannot change the approval. She added that now that NIOSH has registered several certification marks, including N95, with the U.S. Patent and Trademark Office, the agency is actively conducting brand protection and authenticating whether private-label information is accurate.

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³ 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.

Miller said that private labels offer an advantage to some approval holders by allowing them to extend the line of what they can sell. However, for stockpiling, NIOSH does not believe that private labeling should be considered. “We should be looking to making sure that the approval holders, models, and brands are offered in the stockpile simply because they are more controlled,” she said.

THE CHALLENGES OF CRITICAL ACCESS HOSPITALS TO ACQUIRE PPE

Critical access hospitals, explained Barbara DeBaun, improvement adviser for Cynosure Health, are rural, 25-bed facilities with limited resources. Most have little experience with using N95 respirators and most do not have negative pressure rooms. In addition, most of these hospitals might have a daily census of perhaps two or three patients, but during the pandemic they were at capacity because they could not transfer patients to referring facilities, which were also at maximum capacity. “Over the past 3 years,” said DeBaun, “critical access hospitals have been in the same storm, but definitely not in the same boat.”

These hospitals, she said, are not big purchasers of PPE, so they do not have strong relationships with manufacturers and vendors, which made it difficult for them to purchase any substantial quantity of PPE. This was not true everywhere, said DeBaun. Montana, for example, had a great program that afforded these facilities access to stockpiles by bringing every type of facility to the table and getting them to work together as partners. “That is what I would like to see,” she said. “More collaboration, less competition, and figure this out collectively.”

STREAMLINING ACCESS TO PPE FOR SETTINGS MOST IN NEED

Skip Skivington, vice president for health care continuity and support services at Kaiser Permanente, remarked that even larger organizations such as his were competing to access the PPE supply chain. “Size matters in most things, but in this case, size did not matter at all,” said Skivington. “It helped, but it did not solve the problem.”

The pandemic, he said, is a situation that the nation has been in before, particularly regarding the supply of N95 respirators. In his view, this problem is a national security issue. He added that he does not think that stockpiling is the solution, but rather that this will take an all-of-government approach. California, for example, had a huge stockpile of N95 respirators to use during the 2009 influenza pandemic, but when they were subjected to fit tests on health care workers, few achieved pass rates.

The problem was not due to any defect with the respirators (NIOSH, 2010) Rather, Skivington said, it was that many of the N95 respirators were those typically found in industry and health care workers, and fit testers were likely not as familiar with how to wear and test them. “Who knew there were two different products and standards?” said Skivington.

What can help, he said, is to streamline the process for acquiring PPE to make it easier for those who need it the most. Skivington recounted how in a meeting with his organization’s chief medical officer, other health system leaders, and Alex Azar, then secretary of the Department of Health and Human Services, those in attendance were told that the health care industry would need to take the lead through this crisis because government would not be able to respond in enough time to meet the demand.

While the EUA issued by the FDA during the pandemic relaxed some PPE standards (FDA, 2021b) and allowed health systems to eventually match their access to PPE with their needs, it was a struggle, said Skivington. As he put the situation, acquiring PPE was a bit of a clandestine operation because there were so many nontraditional, unqualified vendors from around the world providing PPE and demanding money up front before they would deliver product. Sorting out those who were legitimate from the scam artists required significant due diligence, such as demanding to see a newspaper with a current date next to the certification document.

THE SMALL PRACTICE PERSPECTIVE AND PRIVATE DISTRIBUTION NETWORKS

The session’s final speaker, Anne Miller, executive director of Project N95, explained that the nonprofit organization began in the early days of the pandemic to get PPE to doctors, nurses, and small clinics. In addition, Project N95 is working to meet the needs of Black, Latina/o, tribal, and other populations that have been disproportionately affected by COVID-19.

NIOSH standards, said Miller, were of great help during the pandemic because they provided assurance that products that met the standard would be effective, that marketing claims would be valid, and that there would be ongoing monitoring of production so every batch of product would perform to the standard. However, NIOSH standards only apply to occupational users, and no agency looks out for consumers. “We need an enforced consumer standard so that consumers know they are getting the level of protection that they think they are, and not getting fake or substandard masks,” said Miller.

Though it sounds complicated to create such a standard for PPE intended for use by consumers in the general public, other countries have done this, so it will not be necessary to create one from scratch. Moreover, there is a lack of fit requirements to accommodate the wide range of ages in the general population and limited places for individuals to access fit testing. Another alternative is to innovate against the standard to produce a mask that does not require fit testing.

A performance standard for consumers in the general public could also include items relevant to marketing claims, given the rampant misrepresentation that has occurred for PPE used by the public during the COVID-19 pandemic. Miller remarked that consumers have been forced to buy inferior products at inflated prices online. She said she has seen people in the public wearing KN95 respirators that she can tell from their visual appearance do not meet the standard. “We need an agency that is looking to protect consumers and that can enforce standards,” said Miller. Unfortunately, said Miller, consumers at this point have lost trust in public health and lost trust in respiratory protection. A standard would help address both these issues. A standard for consumers in the general public would enable manufacturers to innovate against the standard and produce new products that are reusable, washable, and recyclable while creating confidence for consumers. “Everybody needs protection, and we need to put in the new standards that will give it to us,” said Miller.

On a final note, Miller said that an increase in domestic manufacturing capacity or regional manufacturing could alleviate some of the stress on the supply chain. She added that most of the domestic manufacturers started during the pandemic have closed or are headed that way, so developing and sustaining a domestic or regional manufacturing base could be challenging.

DISCUSSION

Dai opened the discussion by asking the panelists if they felt more optimistic or pessimistic today. Tang said he is more optimistic because this workshop has exposed the issues but that the challenge will be in taking the next step. “We have the physical supply chain and the digital supply chain, but then we need to also have the common understanding of the standards,” he said. Gaining the public’s trust and collaborating will be critical for success moving forward. DeBaun also felt optimistic because of having these discussions. “I am very hopeful that we are recognizing opportunities and looking at ways for us to collaborate and make this term ‘standard’ actually mean something,” said DeBaun.

Skivington, on the other hand, was not optimistic that the nation would perform any better when the next pandemic occurs. The problem,

he said, is that while complexity serves the nation well during peacetime, it does not help when the nation is in a crisis environment, as it was during the COVID-19 pandemic There are too many fiefdoms, Skivington said, with each telling users they have to do things a certain way even with national standards in place. Kice was also less than optimistic because of the complicated nature of explaining the different standards to different users.

Colleen Miller said that at the beginning of the pandemic, she hoped that the world would understand that NIOSH Approved respirators are not approved for specific industries and that there was plenty of product that health care workers could use. She was hopeful, too, that people would gain an understanding of the differences between a mask and a respirator. However, health care workers demanded surgical N95 respirators, even though NPPTL had done the work to show that the additional requirements for surgical N95 respirators did not add to respiratory protection. Similarly, NIOSH developed an interim rule to update its standard for powered air-purifying respirators (PAPRs) based on health care workers wanting to get away from large, heavy, industrial versions of the devices. However, health care workers were then concerned that the new standard would not offer the same level of protection even though the standard was designed for it to be the same. Her hope going forward is there will be a fit requirement added to the regulations. She noted that NPPTL is developing a facial scanning app and has a respirator fit challenge aimed at creating ways to achieve just-in-time fit testing. NPPTL is also working on training-the-trainer models with fire and health departments to assist with fit testing.

Several members of the public attending the workshop remarked that taking the time now to train the health care community in establishing and operating respiratory protection programs and fit testing to eliminate some of their fears would be beneficial. A participant noted that justifying the use of inadequate PPE seems to have arisen from a desire to avoid this work. Anne Miller agreed that education of health care workers is essential. “We need to change our practices, and we need to start in health care, and we need to be honest with people about what they really should be using,” she said.

Anne Miller added that it seems to take too long and is too complicated to achieve the necessary changes. She called for a national focus on developing a domestic manufacturing supply chain and then having surge needs satisfied by offshore producers. She said she would like to see NIOSH’s purview expanded to include consumers in the general public, recognizing that could require an act of Congress. Colleen Miller noted that NIOSH has been working on the web-based PPE Info database

(NIOSH, 2023) that provides PPE information for all types of end users, but the agency does not have the resources needed to maintain it.

Responding to a question about how states can collaborate better to maintain stockpiles and efficient distribution of PPE, Kice replied that his department works closely with four regional states and across regions. However, he said, collaboration can be difficult since every state has its own set of rules and regulations.

Dai then asked the panelists for their vision for an ideal supply chain structure. Skivington replied that for the health care industry, an ideal supply chain would be simpler so that there are fewer subcategories of PPE. What he wants to see is a standard for a universal respirator that is comfortable when worn according to the manufacturer’s instructions and will fit properly. “I think the technology is there to bring that to bear,” said Skivington, which he said would make other issues moot.

Dai noted that a standard about fit does not address availability, and Colleen Miller commented that NIOSH regulations require that respirators be designed to fit a variety of face sizes and shapes. However, Colleen Miller continued, at this time there is no way for a manufacturer to demonstrate this for particulate-only respirators. NIOSH has been addressing this issue for over 20 years with the hope of incorporating the ASTM respirator fit capability standard, developed by a consensus group, into the NIOSH regulation. Colleen Miller identified that the expense of demonstrating that a respirator fits a large number of people might be an issue if the goal is to have a product that meets this requirement for respirators designed for the public to use.

To conclude the discussion, DeBaun said the solution to many of these issues is to have products that fit faces better than current products do. Anne Miller pointed toward being more flexible with material requirements and other innovations. Along those lines, a workshop participant noted that researchers have developed varieties of antimicrobial compounds that can be added to respirator particulate filter materials, but any advantages those compounds offer for disposable products is not high enough to justify the cost.

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