PREVENTING TRANSMISSION OF PANDEMIC INFLUENZA AND OTHER VIRAL RESPIRATORY DISEASES

Personal Protective Equipment for Healthcare Personnel

UPDATE 2010

Committee on Personal Protective Equipment for Healthcare Personnel to Prevent Transmission of Pandemic Influenza and Other Viral Respiratory Infections: Current Research Issues

Board on Health Sciences Policy

Elaine L. Larson and Catharyn T. Liverman, Editors

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

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Committee on Personal Protective Equipment for Healthcare Personnel to Prevent Transmission of Pandemic Influenza and Other Viral Respiratory Infections: Current Research Issues Board on Health Sciences Policy Elaine L. Larson 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. 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 #8) between the National Academy of Sciences and the Centers for Disease Control and Prevention. Any opinions, findings, conclusions, or recommendations 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: 978-0-309-16254-8 International Standard Book Number-10: 0-309-16254-8 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 2011 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. Suggested citation: IOM (Institute of Medicine). 2011. Preventing transmission of pandemic influenza and other viral respiratory diseases: Personal protective equipment for healthcare personnel. Update 2010. 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 responsibility 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 National 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 PERSONNEL TO PREVENT TRANSMISSION OF PANDEMIC INFLUENZA AND OTHER VIRAL RESPIRATORY INFECTIONS: CURRENT RESEARCH ISSUES ELAINE L. LARSON (Chair), Professor of Pharmaceutical and Therapeutic Research, Columbia University GLORIA ADDO-AYENSU, Director, Fairfax County Department of Health ALLISON E. AIELLO, John G. Searle Assistant Professor of Public Health, University of Michigan School of Public Health HOWARD J. COHEN, Consultant, Professor Emeritus, University of New Haven ROBERT COHEN, Director, Pulmonary and Critical Care Medicine, Cook County Health and Hospitals System, and Chair, Division of Pulmonary Medicine/Critical Care and Occupational Medicine, Stroger Hospital of Cook County KAREN COYNE, Research General Engineer, U.S. Army Edgewood Chemical Biologic Center DAVID M. DEJOY, Professor, University of Georgia KEN GALL, Professor, Georgia Institute of Technology WILLIAM H. KOJOLA, Industrial Hygienist, Department of Occupational Safety and Health, AFL–CIO ALLISON MCGEER, Director, Infection Control, Mount Sinai Hospital, University of Toronto PETER PALESE, Professor and Chair, Mount Sinai School of Medicine DAVID PREZANT, Chief Medical Officer and Special Advisor to the Fire Commissioner for Health Policy, Fire Department of the City of New York, and Professor of Medicine, Pulmonary Division, Albert Einstein College of Medicine M. E. BONNIE ROGERS, Director, North Carolina Occupational Safety and Health Education and Research Center and Occupational Health Nursing Program, School of Public Health, University of North Carolina–Chapel Hill RICHARD P. WENZEL, Professor and Former Chair, Department of Internal Medicine, Virginia Commonwealth University v

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Study Staff CATHARYN T. LIVERMAN, Project Director ANDREW M. POPE, Director SARAH CODREA, Associate Program Officer (until July 2010) LARA ANDERSEN, Research Associate JUDY ESTEP, Program Associate vi

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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, University of Minnesota Benjamin Cowling, University of Hong Kong Lewis R. Goldfrank, Bellevue Hospital Center and New York University Medical Center Kathleen Harriman, California Department of Public Health Sundaresan Jayaraman, Georgia Institute of Technology Mark Nicas, University of California Daniel R. Perez, University of Maryland Trish M. Perl, Johns Hopkins University School of Medicine Peg Seminario, AFL–CIO Michael Tapper, Lenox Hill Hospital, New York City David Weber, University of North Carolina–Chapel Hill Annalee Yassi, University of British Columbia Although the reviewers listed above have provided many construc- tive comments and suggestions, they were not asked to endorse the con- vii

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viii REVIEWERS clusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Caroline Breese Hall, University of Rochester School of Medicine, and Johanna T. Dwyer, Tufts University School of Medicine. Appointed by the National Research Council and Institute of Medicine, they were re- sponsible for making certain that an independent examination of this re- port was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Contents ACRONYMS AND ABBREVIATIONS xi SUMMARY 1 1 INTRODUCTION 15 Scope of the Report, 15 Background and Context, 17 Healthcare Personnel and PPE, 21 Overview of Influenza and Other Viral Respiratory Diseases, 23 Defining an Integrated Approach to PPE Research, 25 References, 27 2 UNDERSTANDING THE RISK TO HEALTHCARE PERSONNEL 29 Background and Context from the 2008 Report, 29 Update on Recent Research, 35 Summary of Progress, 57 Findings and Research Needs, 57 Recommendations, 60 References, 60 3 DESIGNING AND ENGINEERING EFFECTIVE PPE 71 Background and Context from the 2008 Report, 72 Update on Recent Research, 74 Summary of Progress, 101 Findings and Research Needs, 102 Recommendations, 104 References, 105 ix

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x CONTENTS 4 USING PPE: INDIVIDUAL AND ORGANIZATIONAL ISSUES 113 Background and Context from the 2008 Report, 113 Update on Recent Research, 116 Summary of Progress, 123 Findings and Research Needs, 124 Recommendations, 127 References, 128 5 POLICY RESEARCH AND IMPLEMENTATION: HEALTHCARE SYSTEMS, STANDARDS, AND CERTIFICATION 133 PPE Standards and Certification, 133 Lessons Learned from 2009 H1N1 Policies Relevant to PPE for Healthcare Personnel, 141 Summary of Progress, 148 Findings and Research Needs, 149 Recommendations, 150 References, 152 APPENDIXES A Workshop Agenda 157 B Participants List 163 C Studies of the Clinical Effectiveness of Personal Protective Equipment During Outbreaks of Severe Acute Respiratory Syndrome and Respiratory Syncytial Virus 173 D Examples of Relevant Voluntary Consensus Standards 177 E Committee Biographies 179

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Acronyms and Abbreviations AAMI Association for the Advancement of Medical Instrumentation B.R.E.A.T.H.E. Better Respiratory Equipment Using Advanced Technologies for Healthcare Employees CBRN chemical, biological, radiological, and nuclear CDC Centers for Disease Control and Prevention CFR Code of Federal Regulations CI confidence interval CO2 carbon dioxide DOL Department of Labor FDA Food and Drug Administration FFP2 or FFP3 filtering facepiece respirator class P2 or P3 HHS Department of Health and Human Services ICU intensive care unit IOM Institute of Medicine IV intravenous MPPS most penetrating particle size NaCl sodium chloride NIOSH National Institute for Occupational Safety and Health xi

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xii ACRONYMS AND ABBREVIATIONS NPPTL National Personal Protective Technology Laboratory NVHA Northern Virginia Hospital Alliance NYC New York City OSHA Occupational Safety and Health Administration PAPR powered air-purifying respirator PPE personal protective equipment PPT personal protective technologies RNA ribonucleic acid RSV respiratory syncytial virus RT-PCR real-time polymerase chain reaction SARS severe acute respiratory syndrome SNS Strategic National Stockpile TICD50 tissue culture infective dose50 TIL total inward leakage UV ultraviolet WHO World Health Organization