5

Standards and PPE Manufacturing Capacity

Key Messages from Individual Speakers¹

• Stockpiling can allow the manufacturing community to build stock in a controlled manner, allowing companies to produce products for their regular business and for a pandemic as best as possible. (Dente)
• Businesses in the health care supply chain are for-profit businesses tasked with maximizing profits by reducing costs and increasing profitability. As a result, supply chains will always reflect demand at a steady state to achieve maximum profitability. The only way to make U.S. supply chains healthy and able to prepare for a future pandemic is to have robust demand for products. (Dillie)

Session five of the workshop focused on supply chain components and featured speakers who discussed how personal protective equipment (PPE) standards affect manufacturing capacity, both to facilitate increasing capacity and as a potential barrier. Session moderator Michelle Feinberg, owner and creative director of the New York Embroidery Studio, said the studio used its ultrasonic welding equipment to make PPE during the COVID-19 pandemic as early as April 1, 2020. The first challenge she and

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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.

her colleagues faced was finding fabric, though she used her manufacturing experience and her supply chain to source fabric. She learned quickly that PPE fabric manufacturing was largely offshore, but that fabric manufacturers would retool and innovate. “We need to support our industrial base to reinforce our supply chain so that in the future, should we need to flex and surge, the domestic base must exist,” said Feinberg.

HOW STANDARDS CAN LIMIT PPE PRODUCTION

Dan Glucksman, public affairs director for the International Safety Equipment Association (ISEA), said that his organization believes standards need to be flexible and balance performance and end-user needs. He said that if a product is overly complex and overengineered because of standards, it will either not be manufactured or not used because of the complexity of using it in the field. A product also needs to be commercially feasible, and a product with too many niche applications could make the market too small for it to ever go into production.

In general, said Glucksman, he would argue against more product standards, but would agree there are adjacent standards that provide value for product resiliency. An example would be a standard of comfort that the public could use as a first step in evaluating a product. Another example would be the available standards for disinfecting reusable respirators. As for standards that could help the PPE supply chain, he suggested developing an evaluation that could be easily conducted on expired respirators. Stockpile managers could use this to evaluate expired respirators outside of the regulatory structure that relies on the National Institute for Occupational Safety and Health (NIOSH) to conduct certification testing. An accelerated aging test that manufacturers could perform to evaluate the effects of aging on respirators would also help.

Glucksman offered that a standard that might be useful would address the physical structure of warehouses. He cited stories of warehouses with broken windows that allow humidity and light to get in and suggested using some of the available funding to have best-in-class warehouses that would maintain constant humidity and temperature.

KEY OPERATIONAL CHALLENGES TO PRODUCE AND SHIP PPE DURING SURGE DEMAND

Claudio Dente, president and chief executive officer of Dentec Safety Specialists, said standards should not hinder the ability to bring a product to market with speed. In that vein, he wondered if NIOSH could provide guidance for respirator use to the public that would allow for a reduced fit-testing protocol to help protect the public quickly.

When dealing with manufacturing for surge demand, Dente cited several elements as key operational challenges to producing and shipping a product, absent a certification issue. One challenge is procuring raw materials. Dente said that manufacturers of filtration material, resins, packaging, and other components run their businesses on historical information and are hesitant to stockpile inventory hoping it is needed, given the financial burden and space requirements that come with doing so. He said most raw materials suppliers are sitting on a glut of inventory left over from dealing with the pandemic.

Another challenge is staffing. While many companies, including his, invested in new innovation during the pandemic, their products are assembled by hand. “Finding and training staff during a pandemic is difficult, to say the least,” said Dente. In addition, once surge demand ended, it was impossible to maintain that staffing level. Manufacturing space is a third challenge because companies need additional buildings to produce, assemble, and store raw materials and finished products during periods surge demand. The financial commitment to maintain those buildings remains when the surge subsides, and many companies today are dealing with the stress of paying for additional space they no longer need. Dente noted, too, that the surge orders his company received disrupted the company’s ability to provide respirators for their regular customers, those who use Dentec’s PPE on a regular basis to protect their workers.

There are solutions to these challenges, he said. “I believe stockpiling is the best way to prepare for the next pandemic, not only by the government, but we must also have business and industry involved,” said Dente. “This will allow the manufacturing community to build stock in a more controlled manner, allowing companies to produce product for their regular business and for the pandemic as best as possible.” Manufacturers of raw materials and finished products and distributors cannot carry the burden and risk to produce product for a pandemic situation. He wondered if the Occupational Safety and Health Administration (OSHA) or another regulatory agency could impose regulations requiring the workforce to put a stockpile plan in place and if the government could provide tax incentives to do so. To deal with staffing shortages during surge demand, Dente wondered if the National Guard could be called up to help companies ramp up production. As for respirators for the public, Dente suggested offering a tax credit or incentive for users to be fit-test certified for a variety of respirators, both disposable and reusable.

MANUFACTURING STANDARDS AND SUPPLY CHAINS

Brent Dillie, managing director at Premium-PPE, noted that over the past 2 to 3 years, his company had produced about 250 million masks,

100 million of which went to the federal government. He stated that many businesses in the health care supply chain are for-profit businesses tasked with maximizing profits by reducing costs and increasing profitability. As a result, supply chains will always reflect demand at a steady state to achieve maximum profitability. In his view, the only way to make U.S. supply chains healthy and able to prepare for a future pandemic is to have robust demand for products. Unless the federal government can provide incentives with tax breaks or reimbursement schemes, the nation will struggle to have resilient supply chains for PPE.

As for modifying standards, Dillie pointed out that counterfeit PPE and personal protective technology (PPT) has become a major issue over the last few years, so any reduction in the stringency of standards will invite more counterfeiting. On the other hand, any increase in the stringency of standards is inviting a decrease in supply and rapid availability of PPE during future crises.

THE ROLE OF THE APPAREL SUPPLY CHAIN TO MEET SURGE DEMAND FOR PPE

Paul Dillinger, vice president and head of global production at Levi Strauss & Co. (Levi’s), said that the nation has a huge, underutilized resource in the form of the apparel supply chain. The reason, he said, is that as a globally decentralized and generally standardized resource for manufacturing, apparel manufacturing companies all have the same tools and same sort of capabilities, and while apparel manufacturers do not have the capabilities of 3M or other big PPE manufacturers, they can all cut and sew garments. During the pandemic, the question was whether apparel manufacturers could design an effective filtering facepiece respirator that would have commensurate protection for filtration, airflow, and fit properties as a NIOSH Approved^® N95^®2 respirator using the basic tools and globally standardized minimum capabilities of a cut-and-sew apparel manufacturer.

Dillinger said, “Through ideation and a lot of work at the beginning of the pandemic, we developed a solution that was able to pass the performance prequalification testing that was necessary to submit for N95 certification.” His team designed a respirator at the Levi’s facility in San Francisco and prepared to mass produce the device at Levi’s facilities around the globe. However, Dillinger explained, there were aspects of the process that his team found too restrictive to enable this worldwide production, such as some facility-based conformity assessment elements.

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² NIOSH Approved and N95 are a certification marks of the U.S. Department of Health and Human Services (HHS) and are registered in the United States and several international jurisdictions.

“[This] was going to be a real barrier for us,” he said. “There was going to be a lot more complexity to this than we realized.” To protect workers at its production facilities around the world, Dillinger and his team developed a respirator that the company could distribute to each facility and that they could easily produce for its workers. “The challenge was what do we call it and how do we describe its value without being able to go through one of the established certification protocols,” he said. To achieve some validation, the company entered the National Mask Innovation Challenge sponsored by the Division of Research, Innovation, and Ventures (DRIVe) in the Biomedical Advanced Research and Development Authority (BARDA). Over the nearly 2-year process, his team learned a great deal and came through as the runner-up with a mask that has a well-documented performance and can be manufactured at a moment’s notice. “We have stockpiled materials, we have a small stockpile of masks, we have archived the mask design, and we have the patents on the mask design,” said Dillinger.

The question, Dillinger posed, is what to do in a scenario of uncertain demand, when the only way to describe the validity of the mask’s performance is through a manufacturing or facilities-based certification protocol despite that the whole value of the design is its interchangeability, its draftability, and its ability to start and stop production on a dime at an apparel manufacturer. His team has been struggling to quantify, leverage, and activate the value of this product because the certification process is so inconsistent with the way the apparel supply chain works and the interchangeability of production lines.

TRACING THE ORIGINS OF PPE PRODUCTION

Andrew Moy, chief executive officer, board member, and founder of Aegle, an N95 manufacturer, said that as a Chinese-American with extensive experience helping U.S. companies establish manufacturing capacity in China, he received many requests to import masks during the COVID-19 pandemic. Failing to find adequate supply through traditional supply chains, Moy established Aegle and set up production facilities in Houston. The company faced many challenges with PPE standards and certification including the lack of established standards for children’s masks and dealing with issues of counterfeit and ineffective masks and materials they imported. “We saw a lot of other substandard or falsified test reports used to defraud hospitals and government organizations,” said Moy.

Using technology that his company developed for authenticating semiconductor chips, Moy developed a proprietary authentication and traceability platform, complete with a smartphone app, that allowed the end user to identify the manufacturing date and expiration date and pro-

vide third-party and internal test reports for every physical lot of masks the company produced. The app also provides users with instructions for how to access the technology and how to don the mask. He also spoke of the technology’s usefulness in dealing with the issue of recalls. Aegle distributed masks produced by another U.S. manufacturer that had to recall product. Without a way to trace where things went wrong, the company was forced to recall the entire lot. He noted that this technology is now a finalist in the NIOSH National Personal Protective Technology Laboratory (NPPTL) and National Aeronautics and Space Administration (NASA) Tournament Laboratory challenge for anti-counterfeiting.

DISCUSSION

Feinberg opened the discussion by asking the panel for their ideas regarding the standards that would be helpful for promoting manufacturers to explore innovative approaches to PPE manufacturing. Glucksman suggested developing a standard for a general public mask would ease the demand for the public to procure N95 respirators or KN95 respirators. Along similar lines, a workshop participant suggested it might be good to have one globally accepted set of standards for filtration and breathability accompanied by tiered levels of fit factor aligned with a class of the user’s performance needs and exposure (i.e., general public, industrial, health care).

Dente added that since NIOSH’s focus is on the workplace, its respirator certification process has not been designed with the public in mind. Yet while PPE for the public does not fall directly under NIOSH’s scope, NIOSH is in the best position to do something to protect the public. Dente expressed hope that NIOSH could recognize the benefit in having more flexibility in being able to bring approved products to market. Dillie also noted that NIOSH, which has been underfunded and understaffed, serves as the gatekeeper for N95 respirators to reach the market. He challenged the federal government to do more to regulate this market and reduce the barriers to entry, as well as to regulate marketing of bad PPE as a matter of public health.

Dillinger thought that standards outside the context of the certification process might spur innovation. “Fluency in government certification is not necessarily a core competency in every company, and frankly, those documents are frightening,” he said. His company brought in outside counsel to help navigate the certification process, and the advice he received was to not go for certification because it was too complicated. Dillie agreed that simplifying the standards and demystifying the certification process is important. His firm did not make an N95 respirator

because it thought that getting through the NIOSH certification process was going to be unattainable for any reasonable amount of time or money.

Moy said it took three tries and 6 months to attain NIOSH certification for Aegle’s product, and he had to hire a professional team with previous experience working on medical device approvals for the Food and Drug Administration (FDA) to go through the process. Getting six NIOSH certifications, including for a surgical respirator, required raising a great deal of money, he added, and even with that, he said that the company missed a big portion of the potential market because of delays in the approval process. He noted, too, that the company designed an antimicrobial mask and is trying to use bio-based raw materials to be more environmentally friendly, but the standards do not accommodate those kinds of innovations. He added that not having standards for children’s masks was a huge problem during the pandemic and resulted in over 50 percent of the masks his company purchased for children being fake.

Feinberg then asked the panelists for their reflections on standards for other types of PPE that protect against threats that are not respiratory infections, such as wildfires or toxic chemicals. Glucksman said that the proper standards could be helpful for guiding the public’s use of PPE for these other threats. Dillinger said that his company has done work to address concerns for firefighters in the western United States, but there is a liability concern. He explained that meeting the standards provides a certain indemnification for the manufacturer. However, while there is a rigorous process to enter the personal protective equipment space, there is little regulation of the source control space. At the same time, almost every product available is for source control, but everyone wants PPE certified by NIOSH. In his view, circumstances such as exposure to fire and chemicals could be brought into a broader, general public use certification if possible.

Dente noted that the Environmental Protection Agency (EPA) has documents that provide specific advice regarding the type of respirator to use when exposed to wildfire smoke and when dealing with respiratory hazards associated with floods. While some of this information is intended for the workplace, he said, it is good advice for the public too. Dillinger agreed that such resources are available but said that the message that they exist could be better distributed to the public. Such information in the hands of the public could reduce the outsized demand for N95 respirators by promoting the use of alternative PPE when suitable.

Feinberg asked the panelists if they thought it would help to have one globally accepted set of standards for PPE and tiered levels aligned with different exposures and protection needs, such as for the general public, industrial workers, health care workers, and children. Dente, who sits on

various certification committees, said that trying to reach an international agreement on particular types of standards will be an enormous task, a statement to which Dillie agreed. Daniel Gerard added that an international standard would only work with trusted partners.

As a final comment, Dente said that the market and manufacturers have developed new solutions, available today, that provide comfort greater than typical disposable respirators. The challenge is getting the word out and developing a business case for a new product.