10

Envisioning a Standards System for a Resilient PPE Supply Chain

Key Messages from Individual Speakers¹

• Establish a platform to receive end-user feedback on PPE performance. (Feinberg, Morgan)
• Other countries’ PPE technology fits children, which raises the question of how the United States could consider similar technology. (Sheridan)
• If good-enough PPE is easier and more tolerable for people to use, it could provide a broader public health benefit than the most protective PPE used incorrectly. (Holm)
• There is not enough investment or incentives for creating better PPE and not enough effort being put into getting consumers to see the value of using PPE. (John)
• There is a need for a system overhaul that would lead to a broader safety culture for the entire society, not just the workplace. (D’Alessandro, Holm)
• There is a need for collaboration among industry, labor, government, and nongovernmental organizations to foster a positive safety culture in every industry sector, across community settings, and across every company, large and small. (D’Alessandro)

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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.

The workshop’s final session featured a roundtable discussion among members of the workshop planning committee focused on what it means to have a resilient supply chain for personal protective equipment (PPE) and personal protective technology (PPT). The discussion also examined how a systems approach to setting standards for PPE and PPT can help protect the health and safety of workers and the public.

THOUGHTS FOR A RESILIENT PPE/PPT SUPPLY CHAIN

Linda Hawes Clever began the session by listing a few thoughts on what a resilient PPE/PPT supply chain could involve:

• Combining the strengths of standards based on performance and standards based on design to create a better overall standard
• Increasing cooperation between industrial hygiene and the medical profession, between employer and employees, and between the National Institute for Occupational Safety and Health (NIOSH) and the Food and Drug Administration (FDA)
• Involving peers who are willing to be leaders for change and who can engage other health care leaders to begin changing behaviors
• Making better use of social media to convey information, particularly to people under the age of 35
• Considering the impact those with children can have on advocating for and leading systematic change regarding access to child-sized PPE
• Learning from other countries that have successfully developed and deployed methods for large-scale fit testing
• Fostering a manufacturing and distribution workforce that understands standards and can help companies innovate within the bounds of those standards.

ROUNDTABLE DISCUSSION

Jill Morgan said she is an advocate for safety culture and the importance of modeling correct safety behavior even in the smallest of circumstances so that people are encouraged to think about what is in their best interest. One idea she heard during the workshop was to establish a platform to receive end-user feedback. One model could be similar to the clearinghouse established during the COVID-19 pandemic where people could report side effects from COVID-19 vaccines, an idea Michelle Feinberg seconded. In Morgan’s view, this would be a better option than having more end users sit on standards committees given the highly technical nature of the discussions that occur at those committee meetings. In that

vein, she wondered if there are barriers to progress that could be recognized, such as those who have worked on standards for decades not recognizing how helpful it would be if the process was more understandable for others. She also raised the question of who in the federal government has the power and means to make the decision to invest more money and effort into innovative PPE design.

Carolyn Sheridan said she found it interesting that other countries’ PPE technology fits children, which raises the question of how to move forward on that in the United States. Similarly, Feinberg wondered why a free marketplace, which would afford innovators the chance to break into the market, does not exist in the United States.

Tinglong Dai said one thing he has not heard at the workshop is that, regardless of standards, the United States does not have the capability to ramp up PPE production by 20-fold, even over a year. The reason for this shortfall is due to limited numbers of workers, whether product designers, engineers, or managers with expertise, who can deal with the standards or know how to build capacity in a matter of weeks or more.

Stephanie Holm said a key issue she heard repeatedly at the workshop was the need for flexibility regarding standards, both in the design stage and for conformity assessments. Another issue she raised was whether the public needs to have the highest level of protection possible or if it would be acceptable to couple PPE that provides adequate protection with good education so that end users in the public understand the level of protection, they are receiving using that layered approach. In her opinion, if “good-enough PPE” is easier and more tolerable for people to use, it could provide a broader public health benefit if used correctly than could the most protective PPE used incorrectly.

Amrita John said one of her takeaways was the desire for simplicity in the design of PPE so that using it is intuitive across a range of scenarios. This would counter the fact that PPE design has gotten more complicated, but incentives for creating better PPE products are needed. Responding to John’s comment, Morgan raised the question of who in the federal government has the power and means to make the decision to invest more money and effort into innovative PPE design. Hawes Clever suggested that insurance companies that cover workers’ compensation claims might be interested in lobbying for the nation to make a bigger investment here. Unions might be another source of pressure. “It takes a movement to make a positive difference, and the question is how to put that movement together,” she said. Sheridan said she liked coupling the work that the Occupational Safety and Health Administration (OSHA) and NIOSH are doing to improve educational materials with such a movement, particularly by involving today’s students. Feinberg said that any solution to this problem will require good leadership in addition to government support

and funding that backs the local and regional industrial base involved in manufacturing PPE.

Morgan commented that when she brings complaints about PPE fit to leadership, she is often told to encourage staff to contact PPE manufacturers themselves and tell the companies what they want in their PPE. “I think we need to shift some of that from being the responsibility of the worker to being the responsibility of employers and to say that if they want workers, they are going to have to make the workplace safer,” said Morgan. She tied the lack of such pressure from employers to the lack of a safety culture. “We have, unfortunately, a culture that says that employees are disposable, and that is certainly how frontline workers of every kind felt during COVID,” said Morgan. “I think we have to say that our economy runs on human beings, and we need to value them, and part of that is valuing their safety.”

A member of the public attending the workshop asked if the health care industry regards keeping its workers safe and healthy as an obligation or burden given that no entity knows more about what health care workers do, the hazards they face, and the protection they need. The participant wondered where leadership in the health care industry could advocate for and fund research on worker protection and where it could develop and enforce practice standards for worker protection. Another participant commented that it would help for the health care industry to adopt occupational health and safety practices, including hiring industrial hygienists to help develop health and safety programs to ensure that health care workers’ health and safety is preserved.

Daniel Gerard said the nation needs to approach solving this problem with a full economic overhaul, with the opportunity to retool, rebuild, and adequately fund NIOSH and its National Personal Protective Technology Laboratory (NPPTL). “It is not only about PPE and the things we wear, because emerging threats will always find a way to circumvent what we have, but it is the resource, the research, technology, and science, that has such a critical need to be funded,” said Gerard. “We need to have those tools so that when we need to scale up and address the threat, they are there for us.”

Dai said he agreed 100 percent at the micro level, but at the macro level the need is to spend money and invest in U.S. manufacturing and research and development to increase the nation’s capabilities to respond to an emergency. He also noted that there is no reason the United States has to be a high-cost manufacturer, but it has ignored automation for too long, which other countries have not done.

Victoria Jaqua proposed a project where her organization would put together key partners in the university system who created the designs in Open Source Medical Supplies’ (OSMS) database and have them merge

their ideas to create one design with a full manufacturing technology package and testing procedures. This design would then be posted on the National Institutes of Health (NIH) 3D Print Exchange.² In an emergency, this would allow manufacturers to focus on one design rather than have 10 manufacturers all trying to find $1.5 million and 2 years of time during a pandemic to get into manufacturing rapidly.

Hawes Clever commented on the possibility of somehow merging performance standards and design standards. Holm replied that one potential strategy could be to have a performance standard, but within it, allow specific designs to be certified separate from the entity making that product. She acknowledged that manufacturers could preserve their ability to make their own designs but said that this could be a way for those who are making open-source designs to certify them. “Even if there is lower confidence because we cannot then guarantee that the people doing that manufacturing are meeting these guidelines, the public needs to know that there is lower confidence, but still to be able to say, this design, made well, should provide this amount of protection,” said Holm.

Colleen Miller pointed out that the International Organization for Standardization’s (ISO’s) standards are the most recent development effort in terms of trying to harmonize standards for all types of respiratory devices. From the discussions that went into these standards, it was observed that it is best when standards are performance based because design standards are limiting in the long run. She noted that the NIOSH minimum performance standard is not design restrictive despite manufacturers that say otherwise. “I want us to be cautious about thinking that the answer is a design standard, because sometimes that can put us in a box that we did not realize we were going to,” said Miller. She added that the ISO standard originated from the fire service and the need for fire protection, which is the hardest situation, and as a result, the standard is rather complex. However, she said, if the international community could come back together and think about a minimum protection level, it might develop a good consensus on a performance standard.

A workshop participant commented that one approach for developing performance standards would be to set mandatory pass/fail performance criteria as a base level and then have additional sets of specific criteria if a manufacturer wanted to add additional claims to the certification. This would allow manufacturers to demonstrate capability in a standardized way over the base level, and it would assist the end user by avoiding inconsistent, vague, and confusing claims.

Holm then reemphasized the point that a system overhaul could lead to a broader safety culture for the entire society, not just the workplace.

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² Additional information is available at https://3d.nih.gov (accessed May 2, 2023).

Addressing the workshop participants, she said, “We have a responsibility to share the knowledge that all of us have and to do what we can to make sure that these standards are promoting that safety culture for our whole society.” For her, a shocking gap that still exists at the end of 3 years of the pandemic is there is still no governmental organization with the authority and mandate to make standards for all PPE types for all people. In her mind, funding is important, but the key is having such an authority if the goal is to promote supply chain resilience.

CLOSING REMARKS

To conclude the workshop, Maryann D’Alessandro provided some of her observations. The first area concerned the creation of a movement through education and collaboration that emphasizes a safety culture across the nation and the globe. She suggested starting with the workers that PPE standards address so that when people go to work, they can expect to do their job and return home safely. She noted that every year in U.S. workplaces, over 5,000 workers die on the job, and tens of thousands of workers develop an occupational illness. Protecting the public, she acknowledged, is even more complex, but again it starts with educating the public on the value and use of PPE.

Her second area of emphasis was collaboration among industry, labor, government, and nongovernmental organizations to foster a positive safety culture in every industry sector, across community settings, and across every company, large and small. “Education, collaboration, and safety culture in each workplace and for the public must be addressed,” said D’Alessandro. To make her point, she quoted Paul O’Neill, the safety leader at Alcoa Corporation, who said, “Safety is not a priority, it’s a precondition for organizational behavior.” It is this type of behavior, D’Alessandro said, that is needed so that individuals do not have to think about their safety and health as they would have become second nature.

D’Alessandro said that the National Strategy for a Resilient Public Health Supply Chain Task Force on Product Standardization partners with industry, labor, and professional societies to document those practices and safety culture and to improve health and safety standards. “Both guidelines and standards will have to continue to evolve as the nature of work continues to transform with each technological innovation and with the need for protection in community settings as well,” she said. A common theme she heard throughout the workshop was looking at PPE standards holistically within the supply chain rather than independently, which will require understanding the most salient gaps to address going forward.

Another of D’Alessandro’s takeaways from the workshop was that issues associated with health standards, guidance, and innovation associated with respirator fit can positively impact the supply chain issues experienced during the pandemic. She also heard that there could be value in a national strategy to address PPE conformity assessment in times of emergency. Such a strategy, she said would address standards and a resilient public health supply chain. “While PPE, PPE standards, and standardization are not a holistic solution, they are part of the solution,” she said in closing. She also noted that reviewing this workshop proceedings will be the next step for the Product Standardization Task Force as it begins to prioritize and address the standards gaps for the workgroup.

With that, the workshop was adjourned.

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