PREPARING FOR AN INFLUENZA PANDEMIC

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Committee on Personal Protective Equipment for Healthcare Workers During an Influenza Pandemic Board on Health Sciences Policy Institute of Medicine Lewis R. Goldfrank and Catharyn T. Liverman, Editors

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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, N.W. • Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was requested by the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention and was supported by Contract No. 200-2005-10881 (Task Order #6), between the National Academy of Sciences and the Centers for Disease Control and Prevention. Any opinions, findings, or conclusions expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-11046-4 International Standard Book Number-10: 0-309-11046-7 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624- 6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2008 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Cover credits: Photographs of some of the various types of personal protective equipment are reprinted with permission from Raymond Roberge, the National Institute for Occupational Safety and Health, National Personal Protective Tech- nology Laboratory; Jessica Young, Johns Hopkins University; iStockphoto.com, Sean Warren; and Moldex Metric, Inc. (3200 Series with EZ-On® strap). Suggested citation: Institute of Medicine. 2008. Preparing for an influenza pan- demic: Personal protective equipment for healthcare workers. Washington, DC: The National Academies Press.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the re- sponsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the Na- tional Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON PERSONAL PROTECTIVE EQUIPMENT FOR HEALTHCARE WORKERS DURING AN INFLUENZA PANDEMIC LEWIS R. GOLDFRANK (Chair), Bellevue Hospital Center and New York University School of Medicine, New York HOWARD J. COHEN, University of New Haven, West Haven, Connecticut JANINE JAGGER, University of Virginia, Charlottesville SUNDARESAN JAYARAMAN, Georgia Institute of Technology, Atlanta TALMADGE E. KING, Jr., University of California, San Francisco DONALD LOW, University of Toronto, Ontario, Canada SHARON MARABLE, The Warren Alpert School of Medicine at Brown University, Providence, Rhode Island R. KENT OESTENSTAD, University of Alabama at Birmingham School of Public Health TRISH M. PERL, Johns Hopkins University School of Medicine, Baltimore, Maryland DAVID PREZANT, Albert Einstein College of Medicine, Brooklyn, New York M. E. BONNIE ROGERS, University of North Carolina School of Public Health, Chapel Hill Staff CATHARYN T. LIVERMAN, Project Director FRANKLIN BRANCH, Research Associate (since April 2007) NORA HENNESSY, Research Associate (until March 2007) JUDITH ESTEP, Program Associate v

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Independent Report Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its pub- lished report as sound as possible and to ensure that the report meets in- stitutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confi- dential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Lisa Brosseau, School of Public Health, University of Minnesota Bruce Burlington, Wyeth Pharmaceuticals Patricia Butterfield, Intercollegiate College of Nursing, Washington State University Barbara DeBaun, Patient Safety & Infection Control, California Pacific Medical Center David DeJoy, College of Public Health, University of Georgia Zane Frund, Mine Safety Appliances Company Sergey Grinshpun, Department of Environmental Health, University of Cincinnati Nancy E. Kass, Berman Institute of Bioethics, Johns Hopkins Bloomberg School of Public Health Leonard A. Mermel, Division of Infectious Diseases, Rhode Island Hospital James Platner, Center to Protect Workers’ Rights, Silver Spring, Maryland vii

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viii INDEPENDENT REPORT REVIEWERS Rosemary Sokas, Environmental and Occupational Health Sciences, School of Public Health, University of Illinois Robert D. Sparks, TASER Foundation, Scottsdale, Arizona Although the reviewers listed above have provided many construc- tive comments and suggestions, they were not asked to endorse the con- clusions and recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Linda Hawes Clever, California Pacific Medical Center, University of California. Appointed by the National Research Council and the Institute of Medicine, she was responsible for making certain that an independent examination of this report was carried out in accordance with institu- tional procedures and that all review comments were carefully consid- ered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Preface The Institute of Medicine (IOM) study that resulted in this report had its beginnings in the discussions of an IOM standing committee estab- lished to examine the role of the National Personal Protective Technol- ogy Laboratory (NPPTL) of the National Institute for Occupational Safety and Health in preventing work-related injury and illness. Our committee felt that there was no better strategy to address the NPPTL mission than through investigating how to protect healthcare workers in the event of an influenza pandemic. Influenza is a viral syndrome associated with acute manifestations of disease in the upper and lower respiratory tract. Those of us in health care know the cycle of events: discussion of the annual epidemic, plan- ning the design of the specific year’s vaccine, plans for hospital staff immunization, and the probability of significant staff illness and the deaths of 20,000 to 40,000 people across the country with billions of dol- lars in loss of life and productivity even in the best of years. The discus- sion then shifts to the possibility of pandemic influenza, which has occurred every 10 to 50 years since the 1890s. It is these thoughts, the global implications of a new disease as seen in severe acute respiratory syndrome and the recognition of the worldwide potential for catastrophe if a pandemic of influenza were to occur that led us to focus on the NPPTL mission as it relates to pandemic influenza. This problem seemed ideally suited for investigation by an interdis- ciplinary committee of the IOM utilizing experts in infectious diseases, infection control, internal medicine, emergency response and prepared- ness, emergency medicine, public health, materials engineering, and oc- cupational safety and health. The committee proved to be well balanced, ix

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x PREFACE thoughtful, and provocative and worked diligently to examine the scien- tific literature and discuss the wide range of relevant issues. Throughout this study, the committee was disappointed to learn of the remarkable scientific and public policy limitations that hinder pro- gress in the area of preparedness for a pandemic: limitations in under- standing the behavior of the influenza virus, limitations in the extent of testing (pre- and post-market) of personal protective equipment (PPE) products to meet real-world working conditions, and limitations in edu- cation, training, and institutional support for improving PPE compliance by healthcare workers. Many critical questions about influenza transmission must be an- swered to enable progress in the technical design of individual PPE com- ponents (such as respirators and appropriate PPE ensembles including gowns, eye protection, and gloves). The standards for PPE approval and ongoing evaluation at the Food and Drug Administration do not adhere to the same high standards as for new drugs or vaccines. It is our belief that healthcare workers will feel secure only when the PPE that they are asked to wear is as safe and effective as the vaccines and medications they are asked to take. The concept of the culture of safety must assure each worker that in- stitutional policies are devoted to protecting all patients and healthcare workers to the greatest extent possible. Success can only be achieved by individual discipline and integrated team training of all participants (in- cluding nurse aides, nurses, respiratory therapists, clerks, housekeepers, physicians, and others) in a natural environment and/or a simulated envi- ronment that reinforces understanding of errors, risks, and ultimately competence. Our committee suggests many local, national, and international ap- proaches that could, in fairly short order (possibly 1 to 3 years), fill the numerous gaps in preparing for pandemic influenza—healthcare team development, coordination of federal efforts, and a renewed commitment to the study of influenza transmission and prevention through an interna- tional research network. Expeditious efforts are needed to advance this action plan so that healthcare workers will feel secure enough to leave their homes, come to work, work effectively, and return to their loved ones during an influenza pandemic. Lewis Goldfrank, Chair Committee on Personal Protective Equipment for Healthcare Workers During an Influenza Pandemic

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Acknowledgments The committee wishes to acknowledge the valuable contributions that were made to this study by many individuals who shared their expertise with us. The committee is very appreciative of the presentation by Michael Bell at its first meeting in December 2006. The committee greatly benefited from the opportunity for discussion with the researchers and healthcare professionals who presented informative talks at the committee’s scientific workshop in February 2007 (Appendix A). We also thank those individuals who provided testimony during the public comment session (Appendix A). The National Personal Protective Technology Laboratory (NPPTL) sponsored this study; and the committee greatly appreciates the assistance and the support that it received from Les Boord, Maryann D’Alessandro, and Roland Berry Ann among many others at NPPTL. The committee wishes to thank the many individuals who discussed specific issues with committee members. The committee particularly wants to thank Robert Couch, Fred Hayden, Edwin Kilbourne, Marc Lipsitch, Anice Lowen, Arnold Monto, Samira Murbaeka, John Oxford, and John Treanor. We also thank Joseph Schwerha for the technical review he provided. We appreciate all the input received from interested individuals and organizations. xi

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Contents SUMMARY 1 1 INTRODUCTION 19 2 UNDERSTANDING THE RISK OF INFLUENZA TO HEALTHCARE WORKERS 47 3 DESIGNING AND ENGINEERING EFFECTIVE PPE 77 4 USING PPE: INDIVIDUAL AND INSTITUTIONAL ISSUES 113 5 CERTIFYING AND REGULATING HEALTHCARE PPE: DEFINING AN INTEGRATED SYSTEM 147 6 MOVING FORWARD WITH URGENCY 169 APPENDIXES A WORKSHOP AGENDA 173 B ACRONYMS 179 C PPE-RELATED STANDARDS AND REGULATIONS 181 D STANDING COMMITTEE ON PERSONAL PROTECTIVE EQUIPMENT IN THE WORKPLACE AND BOARD ON HEALTH SCIENCES POLICY 183 E COMMITTEE AND STAFF BIOGRAPHIES 185 xiii

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