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

_____

Kelsey R. Babik, Autumn Downey,
and Joe Alper, Rapporteurs

Board on Health Sciences Policy

Health and Medicine Division

Proceedings of a Workshop

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by contracts between the National Academy of Sciences and the Department of Health and Human Services (Contract 75D30122F00007/75D30121D11240). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-70450-2
International Standard Book Number-10: 0-309-70450-2
Digital Object Identifier: https://doi.org/10.17226/27094

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2023. Personal protective equipment and personal protective technology product standardization for a resilient public health supply chain: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/27094.

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PLANNING COMMITTEE FOR A WORKSHOP ON PERSONAL PROTECTIVE EQUIPMENT AND PERSONAL PROTECTIVE TECHNOLOGY PRODUCT STANDARDIZATION FOR A RESILIENT PUBLIC HEALTH SUPPLY CHAIN¹

LINDA HAWES CLEVER (Chair), President, RENEW, Clinical Professor-Affiliate, Stanford University School of Medicine

CRAIG COLTON, Founder, CCR Consulting, LLC

TINGLONG DAI, Professor of Operations Management and Business Analytics, Johns Hopkins University Carey Business School, Hopkins Business of Health Initiative, and Johns Hopkins University School of Nursing

MICHELLE FEINBERG, Owner and Creative Director, New York Embroidery Studio

STEPHANIE M. HOLM, Director, Western States Pediatric Environmental Health Specialty Unit, University of California, San Francisco, and Public Health Medical Officer, Children’s Environmental Health Center, Office of Environmental Health Hazard Assessment, California Environmental Protection Agency

AMRITA REBECCA JOHN, Assistant Professor of Medicine, Case Western Reserve University, Division of Pulmonary, Critical Care, and Sleep Medicine, University Hospitals Cleveland Medical Center

JILL MORGAN, Critical Care Nurse, Emory University Hospital

CAROLYN SHERIDAN, Executive Director and Founder, Ag Health and Safety Alliance

TENER GOODWIN VEENEMA, Senior Scholar, Center for Health Security, and Senior Scientist for Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health

Health and Medicine Division Staff

AUTUMN DOWNEY, Senior Program Officer

REBECCA ENGLISH, Senior Program Officer

KELSEY R. BABIK, Associate Program Officer

ASHLEY BOLOGNA, Senior Program Assistant

CLARE STROUD, Senior Director, Board on Health Sciences Policy

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¹ The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Consultants

JOE ALPER, Science Writer

SARAH LUNSFORD, Workshop Facilitator

Reviewers

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings:

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings, nor did they see the final draft before its release. The review of this proceedings was overseen by HUGH H. TILSON, UNC Gillings School of Global Public Health. He was responsible for making certain that an independent examination of this proceedings was carried

out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

We also thank staff member KASIA KORNECKI for reading and providing helpful comments on this manuscript.

Acknowledgments

The National Academies’ staff wish to express their gratitude to the National Institute for Occupational Safety and Health’s National Personal Protective Technology Laboratory for sponsoring the workshop; to the speakers whose presentations and discussions helped inform workshop discussions on the challenges and opportunities with addressing standards gaps related to personal protective equipment and personal protective technology (PPE and PPT) to promote supply chain resiliency; to the members of the planning committee for their work in developing the workshop agenda and shaping the discussions; and to additional National Academies staff and consultants, without whom this workshop and the accounting thereof would not have been possible: Joe Alper, Christie Bell, Ashley Bologna, Lori Brenig, Samantha Chao, Robert Day, Rebecca English, Sarah Lunsford, Amber McLaughlin, Alexandra Molina, Rachael Nance, Marguerite Romatelli, and Taryn Young.

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Contents

Boxes, Figures, and Table

Abbreviations and Acronyms

1 INTRODUCTION

Organization of the Proceedings

2 The Role of Standards in a Resilient PPE/PPT Supply Chain

Industry Perspective on the Role of Standards

Federal Government Perspective on the Role of Standards

PPE Supply Chain and the Role of Standards

Discussion

3 PPE/PPT Supply Chain and Standards During COVID-19

A Manufacturer’s Perspective on Responding to a Spike in Demand for PPE

Stockpiling and Use of PPE in the National Strategic Stockpile During Covid-19

Safety Management Framework for PPE and PPT

Maintaining Local Caches of PPE

Different Standards for Different Health Care Scenarios

The Challenges EMS Faced to Procure PPE/PPT

The Role of Public Health in Providing PPE and Guidance for its Use

Discussion

4 DEVELOPING STANDARDS FOR PPE/PPT DESIGN

How Standards Influence Product Development and Supply

The Impact of Standards on the Design of Respiratory Protection and Supply Chain Resilience

Exploring Open-Source Design of PPE to Increase Equitable Public Access

Innovative PPE Designs to Meet the Needs of a Diverse Population

Discussion

5 STANDARDS AND PPE MANUFACTURING CAPACITY

How Standards Can Limit PPE Production

Key Operational Challenges to Produce and Ship PPE During Surge Demand

Manufacturing Standards and Supply Chains

The Role of the Apparel Supply Chain to Meet Surge Demand for PPE

Tracing the Origins of PPE Production

Discussion

6 CONFORMITY, CERTIFICATION, AND CONTINUED PRODUCT PERFORMANCE

Conformity Assessment in the National Strategy for a Resilient Public Health Supply Chain

Certification and Conformity Assessment

Conformity Assessment Beyond Respirators

The Role of Scientific Knowledge in Developing Standards

Evaluating Supply Chain Resilience

Discussion

7 MARKETING, STOCKPILING, AND DISTRIBUTION

How Standards Can Affect Supply Chain Design

The Challenge of Meeting Different Standards in Different Settings

Quality Control for Private-Label Products

The Challenges of Critical Access Hospitals to Acquire PPE

Streamlining Access to PPE for Settings Most in Need

The Small Practice Perspective and Private Distribution Networks

Discussion

8 STANDARDS FOR COMMUNICATING WITH AND EDUCATING END USERS

The Responsibility of Employers, Government, and the Medical Community

Communicating with and Educating the Public

Communicating with Farm Workers

Communicating with Health Care Service Workers

Discussion

9 CONSIDERING APPROACHES TO PRIORITIZING FILLING GAPS IN STANDARDS

Criteria for Approaches to Prioritizing Gaps

Potential Options to Address the Gaps in Standards Development

10 ENVISIONING A STANDARDS SYSTEM FOR A RESILIENT PPE SUPPLY CHAIN

Thoughts for a Resilient PPE/PPT Supply Chain

Roundtable Discussion

Closing Remarks

References

Appendix A Workshop Agenda

Appendix B Biographical Sketches of the Speakers, Session Moderators, and Project Staff

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Boxes, Figures, and Table

BOXES

1-1 Statement of Task

1-2 Key Terminology and Definitions

FIGURES

1-1 Standards and U.S. government oversight for PPE

2-1 Existing areas of PPE and PPT standards and gaps and where they sit along the supply chain

2-2 Framework for a resilient medical supply chain

2-3 Mapping resiliency measures to a supply chain’s risk profile

6-1 Conformity assessment and confidence: Who watches the watchers?

6-2 Standards and U.S. government oversight for PPE

9-1 Existing areas of PPE and PPT standards and gaps and where they sit along the supply chain

9-2 A potential framework for prioritizing the development of standards for PPE

TABLE

3-1 Components of a Chemical, Biological, Radiological and Nuclear Response

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Abbreviations and Acronyms

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¹ 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.