Proceedings of a Workshop

Personal Protective Equipment and Personal Protective Technology Product Standardization for a Resilient Public Health Supply Chain

The National Academies of Sciences, Engineering, and Medicine convened a public workshop March 1-2, 2023. The workshop aimed to examine standards gaps related to personal protective equipment (PPE) and personal protective technology (PPT) and to explore innovative approaches and technologies to update and streamline the U.S. standardization system for PPE and PPT to support public health supply chain resiliency.

Statements and opinions expressed are those of individual workshop presenters and participants.1

Sundaresan Jayaraman

“This is a starting framework for us to think in terms of taking a structured approach to it as opposed to an emotional approach. … Our ultimate objective is to develop a thriving, resilient, and a trustworthy supply chain... for PPE. And this is the dream I have. Linda started us off by saying every life is precious. And to me, standards impact every life. So, that is the foundation on which we need to start thinking in terms of creating this resilient supply chain.”

Sundaresan Jayaraman

Maryann D’Alessandro

“I heard [in the discussions today] that we cannot just look at PPE standards independently. We must look at these issues holistically. And I wholeheartedly agree that we cannot look at the standards in the supply chain... independently. But what this group can do is identify the most salient gaps that must be addressed as we go forward to take action to address those gaps. With that being said, another one of my biggest takeaways from today's session includes issues associated with health standards, guidance, and innovation associated with respirator fit that can positively impact the supply chain issues experienced during the pandemic. And the third take away as they relates to conformity assessment and the need for a national strategy to address PPE conformity assessment in times of emergency. This crosses standards and a resilient public health supply chain. And each of us is here today to identify actions we can take together to be best prepared with a resilient public health supply chain. And while PPE, and PPT standards, and standardization are not a holistic solution, they are part of the solution.”

Maryann D’Alessandro

Anne Miller

“When we know that certain populations have been disproportionately impacted by COVID, by policies that have been put in place by many decades that have limited their access to healthcare, we know... the black, Latinx and tribal populations have been disproportionately impacted by COVID, and we should be able to do something about that as a society, and that’s part of what Project N95 is working on. So I think that there are opportunities to put together standards, as we’ve heard today. I sometimes think, another standard, right? But we know that standards, product and marketing standards and supply chain improvements can help.”

Anne Miller

Standards and a Resilient PPE/PPT Supply

  • Standards can enable supply chain data to be interoperable and be useful for the entire enterprise of users that need to understand information about the applicability and accessibility of PPE. (Gordon Gillerman)
  • It is important that standards not hinder the ability to bring PPE products to market with speed. (Claudio Dente)
  • Standards are required for creating and sustaining a resilient and trustworthy PPE supply chain that is complex but that needs to be agile to deliver customized responses to a diverse population using processes, technologies, and people. (Sundaresan Jayaraman)
  • 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. (Anne Miller)
  • Dan Shipp

    “[A standard] is a document that is essential to speeding good along the supply chain, because the manufacturer, distributor, specifier, end user and regulator are all using the same language. Standards are the shorthand of commerce.”

    Dan Shipp

  • Gordon Gillerman

    “Mapping of the technical requirements for PPE and PPT for standards that are used here in the US against standards that are used in other regions, particularly in areas where they have ... manufacturing capability would be valuable. And a regulatory assessment of our capability to minimize the barriers to using PPE and PPT that’s been demonstrated to meet other regulatory systems can really be a thoughtful way to think about surge moments in time in emergencies when a supply of PPE is necessary and strained. ”

    Gordon Gillerman

  • Özlem Ergun

    “Medical product supply chains are complex, multi-stage global systems that involve people, processes, technologies, and policies. [T]hey are complex systems... for building resilience ... into our medical product supply chains, there is no one size fits all strategy…because all these types of different products come with different supply chains, different market structures, different risk profiles, and given all of these differences really there is a challenge to match resilience measures to products in a cost-effective manner.”

    Özlem Ergun

PPE and PPT Standards and Guidance for Workers and the Public

  • Supply chain failures affected the ability of essential workers and the general public to procure sufficient supplies of PPE, which led to the sickness or deaths of many nurses, doctors, first responders, frontline servers, and other individuals. (Linda H. Clever, Sundaresan Jayaraman)
  • There are almost no standards for public use of PPE along the entire supply chain. (Tener G. Veenema)
  • There is no single place, regulatory body, official guidance, or mandating authority in the United States for conformity assessment of all PPE or to find PPE requirements to meet all scenarios to which a public health department might need to respond. (Jon Szalajda, Sean Kice)
  • A globalized set of standards would reduce confusion among end users and allow them to make clear comparisons of technologies and products to make the best decision for them and their application. They would also make it easier for manufacturers to more quickly design products and get them to the people who need them the most. (Joe Worple)
  • An enforced consumer standard is needed so 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. (Anne Miller)
  • Jessica Tredinnick

    “N95 respirators can and do work for members of the public, and the more similar that public health and healthcare respirators are to N95s, the more adaptable and robust the supply chain will be.”

    Jessica Tredinnick

  • Andrew Levinson

    And as long as the standards allow the bare minimum, the people … in charge of purchasing [PPE] are going to keep selecting the cheapest devices available. If there ... really is a desire to elevate the baseline or the foundation PPE that’s provided to … workers, I think it is going to require a change in the standards to prohibit some of these cheaper devices from being used in those settings.”

    Andrew Levinson

  • Sarah Coefield

    “[PPE] need[s] to be super intuitive because…the products aren’t … designed for use by the general public, and that makes the guidance even more ... difficult… PPE…can cause discomfort and heat stress, and if something is uncomfortable, you’re not going to want to use it.”

    Sarah Coefield

  • Alexis Guild

    “Even when [farm] workers have access to PPE, they may be reluctant to use it. PPE can exacerbate heat stress, which is a major issue faced by farm workers ... due to the more frequent and intense heat waves happening throughout the country... Workers may also choose not to wear PPE because it can slow them down or make them more susceptible to heat related illness. Farmworkers do not have sick leave, and they are often working on a piece rate, meaning that the amount they earn is based on their productivity.”

    Alexis Guild

Existing Areas of PPE Standards and Gaps

“The challenge is not exclusively to address gaps in standards, but also in the complexity of the existing standards for manufacturers, distributors, purchasers, and end users… We need to center equity more intentionally in PPE regulation and education.”

Tener G. Veenema

Use of Standards in Improving Availability, Use, and Equity in PPE/PPT Design and Manufacturing

  • It is important to enhance the engagement of diverse stakeholders when developing standards. (Dan Shipp, Gordon Gillerman)
  • A major problem with anthropometric databases, which can enable the design of products that fit a broader range of individuals, is that they have poor representation of people of color and children. (Susan Sokolowski)
  • There is a gap in standards that account for ensembles of PPE—goggles, a respirator, a gown, and gloves, for example—and that account for the interoperability of the equipment and its functionality. (Stephanie M. Holm)
  • NIOSH’s performance-based standards for respirators, rather than design-based standards, allow manufacturers to address the diversity of the U.S. population in terms of size and comfort and for particular applications. (Jessica Tredinnick, Jennifer Schneider)
  • Having open platforms for manufacturers to collaborate with one another could facilitate communication and resiliency by allowing all of the different parts of the PPE supply chain to work together in an efficient way. (Andrew Moy, Victoria Jaqua)
  • Equity in the distribution and availability of PPE is important given the diverse health care workforce. (Elizabeth Royal)
  • Jennifer Schneider

    “Accessibility is not providing equity just in case someone shows, but rather expecting all types of persons to be present and participate. More importantly, we know that these inclusive actions benefit more than just the directly disabled; they make it better for us all.”

    Jennifer Schneider

  • Brent Dillie

    “[Our company] didn’t even try to make the N95 [respirator] because of the regulatory hurdles... A simplification of the standards and a demystification or clarification would be extremely helpful... and would promote more [manufacturers submitting designs].”

    Brent Dillie

  • Elizabeth Royal

    “We need robust, consistent education programs on why PPE is important, how to don and doff properly, proper fit testing and medical evaluations. These are often required for certain settings but not for all, and there is not often an enforcement mechanism that is really reliable if they’re not happening.”

    Elizabeth Royal

  • Maryann D’Alessandro

    “[I heard in the discussions today,] education, collaboration, and safety culture in each workplace and for the public must be addressed…These points tie into wisdom from Alcoa Corporation safety leader Paul O'Neill, who said, "Safety is not a priority, ... it's a precondition for organizational behavior," .... Individuals should not have to think about safety and health. These topics should be second nature.”

    Maryann D’Alessandro

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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 rapporteur(s) with acknowledgment of the assistance of staff as appropriate 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.