1

Introduction¹

Key Messages from Individual Speakers²

• The inability to procure personal protective equipment and personal protective technology led to the deaths of thousands of nurses, doctors, first responders, frontline servers, and other individuals. (Hawes Clever)
• Innovation in standards can improve availability, use, and equity, and spur the development of new PPE products. (D’Alessandro)

The failure of the global supply chain for personal protective equipment (PPE) and personal protective technology (PPT) became apparent at the beginning of the COVID-19 pandemic when health care organizations were left without supplies needed to protect health care providers from contracting COVID-19 (Bhaskar et al., 2020). Supply chain failures also affected the ability of essential workers and the general public to procure sufficient supplies of PPE. According to Linda Hawes Clever, founding chair of the Department of Occupational Health at California Pacific Medical Center and president of the nonprofit RENEW, the inability to procure PPE and PPT led to the sickness or deaths of thousands of nurses, doctors, first responders, frontline servers, and other individuals (Cohen and Rodgers, 2020).

One of the federal government’s many responses to the COVID-19 pandemic has been to develop a strategy aimed at facilitating a coordinated effort between the federal government and U.S. industry to build a better public health supply chain and to increase its resilience. The resulting National Strategy for a Resilient Public Health Supply Chain

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¹ The planning committee’s role was limited to planning the workshop, and the Proceedings of a Workshop has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.

² 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.

(National Strategy)³ was developed through a collaboration among the Departments of Health and Human Services, Defense, Homeland Security, Commerce, State, Veterans Affairs, and the White House Office of the COVID-19 Response. The National Strategy lays out the U.S. federal government’s vision to protect the health and security of Americans by ensuring a supply chain for PPE, medical devices, medicines, and other public health supplies that is resilient against disruptions from pandemics and other biological threats (DoD et al., 2021). Through a series of more than 30 plans of action and milestones (POAMs), the U.S. government seeks to enable a more ethical, equitable, environmentally sustainable, innovative, and constructive U.S. public health supply chain. The National Institute for Occupational Safety and Health’s (NIOSH’s) National Personal Protective Technology Laboratory (NPPTL) is responsible for POAM 23 of the National Strategy: Launching a New Product Standardization Task Force.⁴ The objective of POAM 23 is to convene a task force of experts who would work to improve the efficacy, effective use, safety, supply stability, and accessibility of PPE and PPT that would be used (1) in U.S. health care settings, (2) by critical infrastructure workers, and (3) by the general public. The task force aims to protect workers and reduce exposure to infectious diseases in workplaces and community settings by addressing standards related to PPE and PPT in the U.S. standardization system. Over the past year, the Product Standardization Task Force has identified multiple gaps in PPE and PPT standards and related supply chain systems.

To examine gaps identified by the task force and to explore innovative approaches and technologies to update and streamline the U.S. standardization system for PPE and PPT to support supply chain resiliency, the National Academies of Sciences, Engineering, and Medicine’s Board on Health Sciences Policy hosted a 2-day virtual workshop on March 1–2, 2023. In designing the workshop, the planning committee considered a resilient supply chain to be one that is agile, nimble, and capable of absorbing shocks. Box 1-1 provides the Statement of Task for the workshop, which was sponsored by NIOSH’s NPPTL.

In her opening remarks, Maryann D’Alessandro, director of NPPTL, noted that while current PPE standards are adequate for some occupational circumstances, innovation can catalyze improved availability, use, and equity to provide protection for all workers and for underserved populations. Innovation can also spur the development of new products and standards to address limitations. Examples include standards

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³ Available at https://www.phe.gov/Preparedness/legal/Documents/National-Strategy-for-Resilient-Public-Health-Supply-Chain.pdf (accessed May 2, 2023).

⁴ Additional information is available at https://aspr.hhs.gov/newsroom/Pages/SupplyChain-9Mar2022.aspx (accessed May 2, 2023).

to improve fit for all users, to improve fit-testing methods for respirators such as tabletop fit testing to enable rapid fit assessment, and to address other supply chain challenges. “Innovation and improvements to address the gaps associated with PPT and PPE standards will not solve all of the challenges but are expected to contribute to improvements in PPE demand outpacing supply,” said D’Alessandro. As an example, she noted that standards can provide greater assurance that PPE will fit the intended users.

D’Alessandro identified three steps within the National Strategy to address PPE and PPT standardization gaps: (1) creating the Product Standardization Task Force, (2) cataloging and prioritizing issues pertaining to PPE standards, and (3) establishing consensus recommendations that identify actions to address the priority issues. She added that the task force falls under the Department of Health and Human Services’ (HHS) Joint Supply Chain Resiliency Workgroup which itself is part of the Critical Infrastructure Partnership Advisory Council.⁵ As such, the task force provides the opportunity for federal and private sector partners to come together to discuss the priorities, provide recommendations, and establish consensus actions for the nation.

The task force, formed in March 2022, consists of participants from many federal agencies as well as participants from the private sector, including academia, industry, labor, and standards development organizations. The task force’s work was informed by a NIOSH-hosted workshop on equitable PPE protection workshop held in November 2022,⁶ which identified potential PPE standards gaps associated with PPE equity, as well as a meeting of the National Academies Committee on Personal Protective Equipment for Workplace Safety and Health in December 2022. This latter meeting focused on all NIOSH Approved^®7 air-purifying respirators and additional PPE standards issues associated with respirator use in health care. At the time of this workshop, the task force’s annual report was in review, although NIOSH provided a draft of the report to the planning committee for the workshop.

This workshop, said D’Alessandro, would serve as a key component and the final step to fulfilling the objective of cataloging and prioritizing PPE standards issues. To conclude her remarks, D’Alessandro noted that the task force will assess the output of this workshop to identify actions that the nation can take immediately to address near-term PPE and PPT

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⁵ Additional information is available at https://www.cisa.gov/resources-tools/groups/critical-infrastructure-partnership-advisory-council-cipac (accessed May 2, 2023).

⁶ Additional information is available at https://www.cdc.gov/niosh/npptl/EquitablePPEworkshop.html (accessed May 2, 2023).

⁷ 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.

standardization gaps. She noted that there will be touchpoints throughout the life of the task force to address quick wins and near-term priorities that arise along the way.

ORGANIZATION OF THE PROCEEDINGS

This Proceedings of a Workshop is based on the discussions of the individual workshop participants and summarizes the workshop’s presentations. The speakers, panelists, and workshop participants presented a broad range of views and ideas that have been summarized in the contents, none of which should be construed as consensus. As such, their comments are their independent views and opinions and are not necessarily evidence-based statements.

The Proceeding’s chapters correspond, in general, with the sessions of the workshop (see Appendix A for the workshop agenda). Chapter 2 discusses the role standards can play in establishing a resilient PPE and PPT supply chain. Chapter 3 reviews the links between standards and PPE and PPT supply chains during the COVID-19 pandemic. Chapter 4 explores standards for PPE design, and Chapter 5 examines the role of standards in PPE manufacturing capacity. Chapter 6 discusses conformity, certification, and continued product performance, and Chapter 7 reviews issues related to marketing, stockpiling, and distribution of PPE and PPT. Chapter 8 explores standards for communicating with and educating end users of PPE and PPT. Chapter 9 presents potential approaches to prioritizing efforts to fill gaps in standards, and Chapter 10 recounts a final discussion on a cohesive and complex standards system for a resilient supply chain. Appendix A contains the workshop agenda and Appendix B provides biographical sketches of the speakers, session moderators, and project staff. The workshop speaker’s presentations have been archived as video files online.⁸

Defining Key Terminology

While the use of PPE has grown among the U.S. population since the pandemic, there is still inconsistency in how it is described and understood. Therefore, to promote clarity, Box 1-2 presents the definitions for different types of PPE and other related terms. In addition to these terms,

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⁸ The workshop speakers’ presentations are available at https://www.nationalacademies.org/event/03-01-2023/personal-protective-equipment-and-personal-protective-technologyproduct-standardization-for-a-resilient-public-health-supply-chain-a-workshop (accessed May 16, 2023).

the following section provides additional information on respirators and masks, two forms of PPE that are among the most commonly misclassified.

Respirators and Masks

While Nicholas Smit, former executive director of the American Medical Manufacturers Association (formally the American Mask Manufacturers Association), stressed that the use of respirators and masks is important for infection control, he also emphasized that it is important to understand that masks and respirators are distinct types of PPE. Respirators are devices designed to protect the user from inhaling hazardous atmospheres including fumes, vapors, gases, particulate matter, and airborne infectious agents, and operate by either removing contaminants from the air (filtering) or by supplying clean respirable air from another source (NIOSH, 2021d). Masks, however, are designed primarily to protect others by acting as source control when covering a user’s mouth and nose, helping reduce the spread of large respiratory droplets when the user talks, sneezes, or coughs (Cichowicz and D’Alessandro, 2020).

For a device to be certified as a respirator in the United States, it must undergo a series of conformity assessments (see Box 1-2) to determine that it meets the government’s standards for respirators. NIOSH regulates and evaluates respirators, approving those that meet the conformity assessment standards for use in occupational settings.⁹ Masks undergo a separate regulatory procedure. While masks used in health care settings (i.e., surgical masks) are subject to oversight from the Food and Drug Administration (FDA), Jeffrey Stull, president of International Personnel Protection, Inc., said that FDA clearance is different from NIOSH certification and conformity assessment processes (FDA, 2021a). The conformity assessment and certification processes for respirators and other types of PPE are covered in more depth in Chapter 6. Additionally, Figure 1-1 provides an overview of the various government oversight and standards for PPE.

Smit also stated that knowing what type of PPE to use under certain circumstances can impact PPE supply. For instance, respirators that protect against airborne transmission, such as N95^®10 and elastomeric respirators, also protect against droplet transmission. When facing an unknown danger, as in the early days of the COVID-19 pandemic, using PPE with multiple layers of protection (e.g., using a respirator rather than a mask) may be preferred by both workers and the public, affecting demand.

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⁹ Approval of Respiratory Protective Devices, 42 CFR § 84 (June 8, 1995).

¹⁰ 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.

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