Hyperbaric Medicine Practice [4th Edition] 1947239007, 9781947239005

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Cover Photos: Courtesy of Harry T. Whelan (monoplace hyperbaric chamber); U.S. Navy Public Domain (Harry T. Whelan, diver); Kirill Egorov (back cover, three divers). Information contained in this work has been obtained by Best Publishing Company from sources believed to be reliable. However, neither Best Publishing Company nor its authors guarantee the accuracy or completeness of any information published herein and neither Best Publishing Company nor its authors shall be responsible for any errors, omissions, or claims for damages, including exemplary damages arising out of use, inability to use, or with regard to the accuracy or sufficiency of the information contained in this publication. No responsibility is assumed by the publisher or editors for any injury and/or damage to persons or property as a matter of product liability, negligence, or otherwise, or from any use or operation of any methods, product, instructions, or ideas contained in the material herein. No suggested test or procedure should be carried out unless, in the reader's judgement, its risk is justified. Because of rapid advances in the medical sciences, we recommend that the independent verification of diagnoses and drug dosages should be made. Information in this publication is current as of the date of the printing. All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without written permission from the publisher. Photos, figures, and tables included in this edition without specific recognition were provided by the chapter authors.

This textbook uses the abbreviation HBO2 for hyperbaric oxygen, which is the official abbreviation used by the Undersea and Hyperbaric Medical Society. Copyright 2017 by Best Publishing Company First Edition: 1994 Second Edition: 1999 Second Edition Revised: 2002 Third Edition: 2008 International Standard Book Number: 978-1-947239-00-5 Library of Congress Catalog Number: 2017941450 Best Publishing Company 631 US Highway 1, Suite 307 North Palm Beach, FL 33408 Printed in the United States of America

Foreword The second edition of Hyperbaric Medicine Practice (1999) by Kindwall and Whelan was my first hyperbaric textbook, and I recall studying it extensively during my fellowship (and in the years since) to learn as much as I could about my chosen profession. Back then, the content leaned a little on the anecdotal side with much less concern about evidence-based medicine and systematic metaanalyses. Much has changed in the last quarter century, as our understanding of hyperbaric oxygen physiology has become more sophisticated, and our need for quality, evidence-based practice recommendations has become more urgent. The field of hyperbaric medicine has changed as well. More facilities focus on the delivery of hyperbaric oxygen therapy for chronic wound patients rather than the treatment of urgent or emergent indications. The modern hyperbaric practitioner is more likely to come from a field with little primary training in hyperbaric physiology and is more likely to spend only a portion of his or her practice treating patients with hyperbaric oxygen. There is great concern amongst veterans of undersea and hyperbaric medicine that the scope of knowledge of the modern hyperbaric practitioner is focused only on a narrow sector of the field rather than appreciating the complexities and nuances of all of the indications for therapy. While some providers may be interested in learning more about the specialty, opportunities for in-depth education are scarce. Fellowship training is preferable for those who wish to devote themselves to the field, but it is often out of reach for established physicians who find themselves practicing hyperbaric medicine as a second career. It is for this reason that we need resources such as Hyperbaric Medicine Practice to provide a comprehensive approach for educating

practitioners on the full breadth and scope of undersea and hyperbaric medicine. The Undersea and Hyperbaric Medical Society (UHMS) has devoted itself to promoting the scientific study of hyperbaric oxygen therapy and raising the level of knowledge of hyperbaric practitioners, so it is with great pleasure that we welcome Hyperbaric Medicine Practice, 4th edition. This fourth edition includes updates to "classic" chapters, while others have been completely rewritten to address modern-day issues. There are new chapters covering the most recently accepted indications for hyperbaric oxygen therapy while removing some that are less relevant to hyperbaric medicine practice in today's environment. Overall, the fourth edition of Hyperbaric Medicine Practice is an impressive work that should serve veterans and newcomers of undersea and hyperbaric medicine alike. Enoch Huang, MD, MPH&TM, FUHM President Undersea and Hyperbaric Medical Society

Contents Preface Editor Contributors Acknowledgments

SECTION ONE Hyperbaric Oxygenation: General Considerations Chapter 1

Chapter 2 Chapter 3 Chapter 4

Chapter 5 Chapter 6

Clinical Hyperbaric Facility Accreditation-Process Improvement in Action W.T. Workman Physiologic Effects of Hyperbaric Oxygen Gerardo Bosco, Enrico M. Camporesi Oxygen Toxicity Heather Annis, Aliyah Keval, Harry T. Whelan Management of Critically Ill Patients in the Monoplace Hyperbaric Chamber Lindell K. Weaver Multiplace Hyperbaric Chamber Giacomo Garetto, Gerardo Bosco Hyperbaric Nursing Valerie Messina

Chapter 7

The Use of Drugs Under Pressure Ryan Feldman Chapter 8 Myringotomy Michael E. McCormick, Joseph E. Kerschner Chapter 9 Contraindications and Relative Risks of Hyperbaric Oxygen Treatment Phi-Nga Jeannie Le Chapter 10 Side Effects and Complications: Selected Overview and Brief Guide to Management Phi-Nga Jeannie Le, John B. Slade Jr, Jason A. Kelly, E. George Wolf Chapter 11 Pediatric Considerations for Hyperbaric Medicine Pamela C. Petersen, Michael T. Meyer, Paul A. Thombs Chapter 12 The Role of Oxygen and Hyperbaric Oxygen Mechanisms Michael B. Strauss, Lientra Q. Lu

SECTION TWO Disorders Approved for Hyperbaric Treatment Chapter 13 Carbon Monoxide Jillian Theobald Chapter 14 Idiopathic Sudden Sensorineural Hearing Loss Tracy Leigh LeGros, Heather Murphy-Lavoie Chapter 15 Gas Embolism Richard E. Moon Chapter 16 Effects of Hyperbaric Oxygen in Infectious Diseases: Basic Mechanisms

Chapter 17 Chapter 18 Chapter 19

Chapter 20

Chapter 21

Chapter 22 Chapter 23

Chapter 24 Chapter 25

Chapter 26

Chapter 27

Chapter 28

Rodney E. Willoughby Jr., Charles C. Falzon, Aliyah Keval, Harry T. Whelan Gas Gangrene Aliyah Keval, Harry T. Whelan Selected Aerobic and Anaerobic Soft Tissue Infections R.A. van Hulst, D.J. Bakker Hyperbaric Oxygen in Intracranial Abscess Lorenz A. Lampl, Guenter Frey, Dietmar Fischer, Enrico Staps Hyperbaric Oxygen for the Management of Chronic Refractory Osteomyelitis Michael B. Strauss, Stuart S. Miller, Lientra Q. Lu Strategic Approach to Diabetic Foot and Other Wounds Michael B. Strauss, Anna M. Tan, Lientra Q. Lu Evaluation and Management of the Diabetic Foot Ulcer Enoch Huang, Marvin Heyboer III Adjunctive Hyperbaric Oxygen Therapy for Diabetic Foot Ulcers Enoch Huang, Marvin Heyboer III Fracture Healing and Roles of Hyperbaric Oxygen Michael B. Strauss, Anna M. Tan, Lientra Q. Lu The Microcirculation and Ischemia-Reperfusion: Basic Mechanisms of Hyperbaric Oxygen Richard C. Baynosa, William A. Zamboni, John Brosious The Roles of Hyperbaric Oxygen in Crush Injury and Other Acute Traumatic Ischemias Michael B. Strauss, Lientra Q. Lu Hyperbaric Oxygen Use in Exceptional Blood Loss Anemia Keith W. Van Meter Hyperbaric Oxygen in Skin Grafts and Flaps Jenna Cusic, Chelsea Venditto, Hani S. Matloub

Chapter 29 Radiation Injury to Tissue Robert E. Marx Chapter 30 The Use of Hyperbaric Oxygen for Treating Delayed Radiation Injuries in Gynecologic Malignancies Harry T. Whelan, Chris Kilian Chapter 31 Adjunctive Hyperbaric Oxygen Therapy in the Treatment of Thermal Burns Paul Cianci, Ronald M. Sato, Julia Faulkner Chapter 32 Central Retinal Artery Occlusion Heather Murphy-Lavoie, Tracy Leigh LeGros

SECTION THREE Hyperbaric Oxygen Used in Off-Label Disorders and Investigational Areas Chapter 33 Off-Label Indications for Hyperbaric Oxygen Therapy Michael H. Bennett, Simon J. Mitchell Chapter 34 Hyperbaric Oxygen Treatment of Avascular Bone Necrosis of the Femoral Head Giuliano Vezzani, Gerardo Bosco, Enrico M. Camporesi Chapter 35 Use of Adjunctive Hyperbaric Oxygen in the Management of Invasive Fungal Infections Lisardo Garcia-Covarrubias, Diana M. Barratt Chapter 36 Treatment of the Brown Recluse Spider Bite with Hyperbaric Oxygen Therapy Matthew Stanton Chapter 37 Hyperbaric Oxygen in Traumatic Brain Injury Sarah B. Rockswold, Samuel R. Daly, Gaylan L.

Rockswold Chapter 38 Neurological Aspects of Hyperbaric Medicine Ann K. Helms, Charles C. Falzon, Aliyah Keval, Harry T. Whelan Chapter 39 Hyperbaric Oxygen in the Treatment of Hansen's Disease David A. Youngblood, Tomaz A.P. Brito

SECTION FOUR Diving, Submarine Rescue, and Life in the Sea Chapter 40 Emergency Management of Stricken Divers in Remote Areas Joseph Dituri, Carla Renaldo Chapter 41 Ketogenic Diet and Ketogenic Supplementation for Central Nervous System Oxygen Toxicity Angela M. Poff, Heather Annis, Harry T. Whelan, Csilla Ari, Joseph Dituri, Dominic P. D'Agostino Chapter 42 Submarine Rescue Diving and Hyperbaric Medicine Joseph Dituri, Harry T. Whelan Chapter 43 Dive Medicine Terrance L. Leighton III, Jonathan E. Strain Chapter 44 Closed-Circuit Rebreathers (CCR) Derek B. Covington, Charlotte Sadler, Richard L. Sadler Chapter 45 Maladies Specific to Technical and Rebreather Divers Carla Renaldo, Joseph Dituri, Brian P. O'Connell Chapter 46 Ocean Exploration-Living in the Deep Sea Harry T. Whelan, Terrance L. Leighton III, Heather Annis, Joseph Dituri

Index

Preface 4th Edition

Eric Kindwall learned to dive while he was in high school and by necessity invented some of his own equipment. He later learned more sophisticated aspects of diving from one of the pioneers in the field, also a Milwaukee physician, Edgar End, MD, who helped develop deep mixed-gas diving with the Diving Equipment and Salvage Company (DESCO.) In his early adult years, he served on the oceans as a merchant seaman and later included an account of that period in his autobiography Unexpected Odyssey. After his residency in psychiatry at Harvard and a brief private practice, Eric was commissioned in the Navy Medical Corps, was a submarine medical officer on the nuclear submarine USS Robert E. Lee, then served at the Navy School of Submarine Medicine. When he left the U.S. Navy, he was granted the use of the two large hyperbaric chambers at St. Luke's Hospital in Milwaukee. The catch to that grant was that while the chambers had been donated to the hospital, their plumbing had never been completed, and their intended use had never been considered. Eric saw to the final installations of the plumbing in those chambers, persuaded some experts in chamber use to join him at St. Luke's, and began using the chambers for some of the earliest trials of clinical hyperbaric oxygen as well as treating more familiar dysbaric conditions. It was my privilege to have known him in his start in clinical hyperbaric medicine as well as his work with dysbaric conditions. Eric became concerned about the caisson workers he was treating for decompression sickness. These men were creating deep tunnels for sewage flow under the city and suburbs of Milwaukee. The

tunneling was often through mud and required pressurized tunnel equipment. Eric treated many of these men who had decompression sickness (bends) or one of its delayed complications, dysbaric osteonecrosis, and realized that the decompression schedules they used were inadequate. He gathered data and persuaded state authorities to change the pressure exposure and decompression schedules for caisson workers. He backed theory with action; I was present when he entered a pressurized tunnel head, deep under Milwaukee streets, to provide first aid to a tunnel worker (sand hog in industrial slang) who had badly injured his hand toward the end of an eight-hour shift. In an unusual application of surface decompression (SUR-D), the worker was rapidly decompressed, hauled by crane through a vertical shaft to the surface, sped through the city by ambulance, and recompressed at the St. Luke's chamber, where a surgeon could attend to his hand. Eric was one of the founding fathers of the Undersea Medical Society and led the organization as president for a term. The Society later added "hyperbaric" to its name, due in part, to his development of clinical uses of hyperbaric medicine. Among the patients he treated in those early days was a patient with an iatrogenic air embolus, a patient in cardiogenic shock, and several patients unconscious due to carbon monoxide intoxication. Not all of these patients recovered, but those conditions which might benefit from hyperbaric oxygen were not known at that time. Eric's Hyperbaric Medicine Department at St. Luke's Hospital became a model for other hyperbaric facilities and has remained so. He was an associate professor of the Medical College of Wisconsin. Eric remained in the U.S. Navy Reserve, was consulted frequently by the U.S. Navy, and taught classes to new Undersea Medical Officers at the Navy Diving and Salvage Training Center in Panama City, Florida. Over the course of his professional career, he led in determining which medical conditions could benefit from hyperbaric oxygen and which did not. These conditions have been accepted by the medical

mainstream, and thousands of patients have been helped across the world. Eric was ringside in watching the handful of chambers tentatively used to experiment with clinical hyperbaric oxygen grow to thousands worldwide. Eric also led in setting safety standards for safety and responsibility. Eric passed his hard-won wisdom into the first editions of this text, as well as many papers and presentations. He remained a strong supporter of professional organizations concerned with diving and clinical hyperbaric medicine. The current version of this textbook has been created without his assistance since his death in 2012. The authors have tried to meet what they believe was his rigorous attention to first-rate medical care for his special patients—those benefitting from hyperbaric oxygen. Henry J. C. Schwartz, MD, FACP Captain, Medical Corps, United States Navy (Retired) December 18, 2016

Harry T. Whelan, MD

Dr. Whelan, a Milwaukee native, is Professor of Neurology, Pediatrics and Hyperbaric Medicine at the Medical College of Wisconsin. He is also a captain and a diving medical officer (DMO) in the U.S. Navy, a consultant to the Navy Experimental Diving Unit (NEDU), and recently served as Commanding Officer of Marine Air Control Group 48 Medical and Undersea Medical Officer for Deep Submergence Unit, which is the navy's submarine rescue team and its deep sea research component. He first began scuba diving in 1966 at age thirteen and developed his interest in cellular metabolism during a National Science Foundation Summer Research Program focused on biochemistry at Wesleyan University in Connecticut. After graduating cum laude in chemistry (biochemistry option) from the University of WisconsinMilwaukee, he attended the University of Wisconsin Medical School in Madison, where he received his medical degree. He completed his pediatrics internship and residency training at the University of

Florida in Gainesville and his neurology fellowship at the University of Minnesota in Minneapolis. Dr. Whelan then joined the faculty of Vanderbilt University in Nashville, TN, where he developed a laboratory research project involving new types of treatment for brain tumors. For this he received the American Cancer Society's Clinical Oncology Career Development Award. Dr. Whelan then decided to move back to Milwaukee where he became Professor of Neurology and Pediatrics at the Medical College of Wisconsin as well as accepted a direct commission as lieutenant commander in the U.S. Navy. He developed research ties with the Hyperbaric Medicine Unit at the Medical College of Wisconsin and the U.S. Navy Experimental Diving Unit in Panama City, FL. The navy then trained him at its dive school in Panama City to become a diving medical officer. When he was promoted to full commander, his fellow officers pinned his new rank onto his uniform in an underwater ceremony, 190 feet below sea level. He has since been promoted to captain in the U.S. Navy. Dr. Whelan has over twenty years' experience conducting research on the use of new light technologies in the treatment of cancer and wounds. His use of NASA space-based light-emitting diode (LED) technology to activate cancer-killing drugs has now extended further into direct effects of near-infrared LED light on human growth stimulation. Potential benefits to Special Operations Forces and space station astronauts include prevention of deep space radiation toxicity and healing wounds, such as traumatic eye and brain injuries. In the year 2000, Dr. Whelan was inducted into the NASA Space Technology Hall of Fame for his photobiology research. As a renowned expert in the field of hyperbaric medicine, Dr. Whelan made significant contributions to the submarine rescue mission. At the international submarine rescue exercise in Singapore in 2010, he conducted multiple scientific lectures to a multinational media team. His guidance and direction were pivotal in the execution of multiple mass casualty exercises onboard a foreign vessel. His

experience and expertise were crucial in planning the medical portions of the exercise, and he received multiple invitations to assist other nations in their submarine rescue medical efforts as a result of his performance. Dr. Whelan assumed directorship of the Medical College of Wisconsin's Hyperbaric Unit in 1998 and has been awarded the Bleser Foundation Endowed Chair of Neurology. He has over 100 publications including cancer, laser, LED, and diving/hyperbaric studies, and he has served as an advisor to the Director of Net Assessment in the Office of the Secretary of Defense and the Defence Research and Development of Canada (DRDC). In 2015, he was awarded the Legion of Merit medal by the U. S. Marine Corps, which is given for exceptionally meritorious conduct in the performance of outstanding services and achievements.

Contributors A Heather Annis, MD LT MC USN Risk Manager, Naval Hospital Pensacola

Csilla Ari, PhD Department of Molecular Pharmacology and Physiology Hyperbaric Biomedical Research Laboratory Morsani College of Medicine University of South Florida Tampa, FL

B D. J. (Dirk Jan) Bakker, MD, PhD, FUHM Professor of Surgery and Medical Director of the Academic Medical Center (Emeritus) University of Amsterdam

Diana M. Barratt, MD, MPH Director of Neurology Clerkship and Associate Professor, Florida International University Herbert Wertheim College of Medicine, Miami, Florida Neurologist, Camillus Health Concern, Miami, Florida

Richard C. Baynosa, MD, FACS

Associate Professor and Chief, Division of Plastic Surgery Program Director, Integrated Plastic Surgery Residency UNLV School of Medicine

Tomaz A.P. Brito, MD Assistant Instructor, Anesthesiology Medical Resident Program, Federal University of the State of Rio de Janeiro, School of Medicine, Gafrée e Guinle Hospital, Rio de Janeiro Medical Director, Hyperbaric Medicine Centre, OHB-RIO Silvestre Adventist Hospital, Rio de Janeiro

Gerardo Bosco, MD, PhD Associate Professor, Environmental Physiology Dept. of Biomedical Sciences, University of Padova Padova, Italy

John Brosious, MD Assistant Professor, Division of Plastic Surgery University of Nevada School of Medicine Las Vegas, NV

Michael H. Bennett, MD, MBBS, FANZCA, FFARCSI, MM(Clin Epi), ANZCA Cert DHM, DA, SPUMSDipDHM, FUHMS Director, Australian Diving and Hyperbaric Medicine Research Group Prince of Wales Medical School Faculty of Medicine, University of NSW Sydney, Australia

C Enrico M. Camporesi, MD

Emeritus Professor of Surgery/ Anesthesiology and Molecular Pharmacology/ Physiology University of South Florida Attending Anesthesiologist & Director of Research TEAMHealth Anesthesia Tampa, FL

Paul Cianci, MD, FACP, FUHM Emeritus Medical Director, Department of Hyperbaric Medicine Doctors Medical Center, San Pablo, CA

Derek B. Covington, MD Assistant Professor Department of Anesthesiology University of Florida College of Medicine Gainesville, FL

Jenna Cusic, MD Resident Fellow, Department of Plastic Surgery Medical College of Wisconsin Milwaukee, WI

D Dominic P. D'Agostino, PhD Associate Professor Department of Molecular Pharmacology and Physiology Morsani College of Medicine University of South Florida Tampa, FL

Samuel R. Daly, B.A. Division of Neurosurgery Department of Surgery

Hennepin County Medical Center

Joseph Dituri, MS, CDR, US Navy Saturation Diving Officer (ret) Director, International Board of Undersea Medicine Tampa, FL

F Charles C. Falzon, MD, MBA Osher Center for Integrative Medicine Northwestern Medical Group

Julia Faulkner Research Assistant Doctors Medical Center, San Pablo, CA

Ryan Feldman, PharmD Clinical Pharmacy Specialist, Emergency Medicine Froedtert & The Medical College of Wisconsin Froedtert Hospital Wisconsin Poison Center Children's Hospital of Wisconsin

Dietmar Fischer, MD Deputy Medical Director, Intensive Care Medicine Federal Armed Forces Hospital Oberer Eselsberg 40 D-89081 Ulm, Germany

Guenter Frey, MD, LtCol MC (Retired) Anesthesiology and Intensive Care Medicine Hyperbaric Medicine Consultant Tokajerweg 72 D-89075 Ulm, Germany

G Lisardo Garcia-Covarrubias, MD, FACS Staff Cardiothoracic Surgeon Baptist Health of South Florida Associate Professor of Surgery and Chief of Cardiothoracic Surgery Florida International University Herbert Wertheim College of Medicine Miami, Florida

Giacomo Garetto, MD Specialist in Anesthesiology, Intensive Care and Hyperbaric Therapy Medical Director ATIP Hyperbaric Medical Center Padova, Italy

H Ann K. Helms, MD, MS Associate Professor Department of Neurology Medical College of Wisconsin Milwaukee, WI

Marvin Heyboer III, MD, FUHM, FACEP, FACCWS Associate Professor, Emergency Medicine SUNY Upstate Medical University Syracuse, NY

Enoch Huang, MD, MPH&TM, FACEP, FUHM, FACCWS Program Medical Director Hyperbaric Medicine/ Wound Care Clinic Legacy Emanuel Medical Center

Affiliate Assistant Professor, Emergency Medicine Oregon Health and Science University

K Jason A. Kelly, MD, Lt Col, USAF, MC, SFS Physician, Hyperbaric Medicine United States Air Force

Joseph E. Kerschner, MD, FACS, FAAP Dean of the School of Medicine Executive Vice President Professor of Otolaryngology and Communication Sciences, Microbiology and Immunology Medical College of Wisconsin Milwaukee, WI

Aliyah Keval Undergraduate Student, Chemistry major University of Wisconsin- Madison

Chris Kilian, MD Eric P. Kindwall, MD (Deceased) Associate Professor Emeritus Medical College of Wisconsin Executive Director American College of Hyperbaric Medicine

L Lorenz A. Lampl, MD, PhD Professor of Anesthesiology Medical Director, Anesthesiology and Intensive Care Medicine

Federal Armed Forces Hospital Oberer Eselsberg 40 D-89081 Ulm, Germany

Phi-Nga Jeannie Le, MD Tracy Leigh LeGros, MD, PhD, FACEP, FAAEM, FUHM Associate Clinical Professor Emergency Medicine Program Director Undersea and Hyperbaric Medicine University Medical Center New Orleans, LA

Terrance L. Leighton III, DO LT, MC, Undersea/Dive Medical Officer USN Special Physicals (Team Valor) USS Tranquillity Branch Medical Clinic Federal Health Care Center Chicago, IL

Lientra Q. Lu, BS Research Coordinator Tibor Rubin VA Medical Center Long Beach, CA Long Beach Memorial Medical Center Long Beach, CA

M Robert E. Marx, DDS Professor of Surgery and Chief Division of Oral and Maxillofacial Surgery University of Miami Miller School of Medicine

Chief of Surgery Jackson South Community Hospital, Miami, FL

Hani S. Matloub, MD, FACS Professor, Department of Plastic Surgery Medical College of Wisconsin Milwaukee, WI

Michael E. McCormick, MD Assistant Professor Department of Otolaryngology and Communication Sciences Medical College of Wisconsin and Children's Hospital of Wisconsin Milwaukee, WI

Valerie Messina, RN, CWCN Program Director, Wound Care & Hyperbaric Medicine Long Beach Memorial Medical Center Long Beach, CA

Michael T. Meyer, MD, FCCM Associate Professor and Chief of Pediatrics, Critical Care Associate Director, Pediatric Intensive Care Unit Medical College of Wisconsin and Children's Hospital of Wisconsin Milwaukee, WI

Stuart S. Miller, MD Medical Director, Hyperbaric Medicine Long Beach Memorial Medical Center Long Beach, CA Associate Clinical Professor, Family Medicine University of California Irvine School of Medicine Irvine, CA

Simon J. Mitchell, MB ChB, PhD, FANZCA Professor, Department of Anaesthesiology University of Auckland and Auckland City Hospital Auckland, New Zealand

Richard E. Moon, MD, FACP, FCCP Professor of Anesthesiology Professor of Medicine Medical Director, Center for Hyperbaric Medicine & Environmental Physiology Duke University Medical Center Durham, NC

Heather Murphy-Lavoie, MD, FAAEM, FACEP, FUHM UHMS Education Committee, Chair Associate Professor Emergency Medicine Residency Associate Program Director Hyperbaric Medicine Fellowship LSU School of Medicine/ UMC New Orleans, LA

O Brian P. O'Connell, Ed.D International Board of Undersea Medicine, (IBUM) Training Development

P Pamela C. Petersen, MD, FAAP PGY5 Pediatric Critical Care Fellow Medical College of Wisconsin and Children's Hospital of

Wisconsin Milwaukee, WI

Angela M. Poff, PhD Research Associate Department of Molecular Pharmacology and Physiology Morsani College of Medicine University of South Florida Tampa, FL

R Carla Renaldo, DO Medical Director, International Board of Undersea Medicine Tampa, FL Board Certified Internal Medicine & NOAA / UHMS trained Diving Physician

Sarah B. Rockswold, MD Medical Director, TBI Center Medical Director, Outpatient TBI Program Department of Physical Medicine and Rehabilitation, Hennepin County Medical Center Department of Physical Medicine and Rehabilitation, University of Minnesota Minneapolis, MN

Gaylan L. Rockswold, MD, PhD Division of Neurosurgery, Department of Surgery, Hennepin County Medical Center Department of Neurosurgery, University of Minnesota Minneapolis, MN

S Charlotte Sadler, MD Assistant Clinical Professor of Hyperbaric and Emergency Medicine University of California-San Diego

Richard L. Sadler, MD, FACS, UHM Thoracic and Vascular Surgery Medical Director Dive Rescue International San Diego, CA

Ronald M. Sato, MD Plastic Surgeon, former Medical Director Burn Center, Doctors Medical Center San Pablo, CA

John B. Slade, Jr., MD Staff Physician, Hyperbaric Medicine Flight 60th Medical Group, Travis Air Force Base, CA 94535

Matthew Stanton, PharmD, BCPS, DABAT Emergency Medicine Pharmacist Froedtert & The Medical College of Wisconsin Milwaukee, WI

Enrico Staps, MD Assistant Medical Director, Anesthesiology and Intensive Care Medicine Federal Armed Forces Hospital Oberer Eselsberg 40 D-89081 Ulm, Germany

Jonathan E. Strain, MD

LT, MC, Undersea/Dive Medical Officer USN Special Physicals (Team Valor) USS Tranquillity Branch Medical Clinic Federal Health Care Center Chicago, IL

Michael B. Strauss, MD, FACS, AAOS, AOFAS Medical Director (Retired) Hyperbaric Medicine Long Beach Memorial Medical Center Long Beach, CA Clinical Professor, Orthopedic Surgery University of Irvine School of Medicine Irvine, CA Consultant Orthopedic Surgeon PAVE (Preservation-Amputation for Veterans Everywhere) Clinic Tibor Rubin VA Medical Center Long Beach, CA

T Anna Maria M. Tan, DPM Hyperbaric Medicine & Wound Care Program Long Beach Memorial Medical Center Long Beach, CA

Jillian Theobald, MD, PhD Assistant Professor Department of Emergency Medicine Section of Medical Toxicology Medical College of Wisconsin Milwaukee, WI

Paul A. Thombs, MD

Diplomate, American Board of Pediatrics (ABP) and Hyperbaric and Undersea Medicine (ABPM) Medical Director Emeritus Hyperbaric Medicine Center Presbyterian/St. Luke's Medical Center Denver, CO

V R.A. (Rob) van Hulst, MD, PhD, FUHM Professor of Hyperbaric and Diving Medicine Department of Anesthesiology Academic Medical Center Amsterdam, Netherlands Captain Royal Dutch Navy (retired) Director of Diving and Submarine Medicine, Royal Netherlands Navy

Keith W. Van Meter, MD LSU-HSC Emergency Medicine Section Head Clinical Professor of Medicine, LSU-HSC Baton Rouge, LA Clinical Professor of Surgery, Tulane School of Medicine New Orleans, LA

Chelsea Venditto, MD Resident Fellow, Department of Plastic Surgery Medical College of Wisconsin Milwaukee, WI

Giuliano Vezzani, MD Professor on contract, II Level Master in Hyperbaric Medicine Dept. of Biomedical Sciences, University of Padova Padova, Italy

W Lindell K. Weaver, MD, FACP, FCCP, FCCM, FUHM Medical Director and Division Chief, Hyperbaric Medicine LDS Hospital, Salt Lake City, UT and Intermountain Medical Center, Murray, UT Professor of Medicine, University of Utah School of Medicine Adjunct Professor, Department of Anesthesia, Duke University, Durham, NC

Harry T. Whelan, MD Bleser Professor, Department of Neurology Director of Hyperbaric Medicine Medical College of Wisconsin Milwaukee, WI

Rodney E. Willoughby, Jr., MD Professor of Pediatrics Division of Infectious Diseases Medical College of Wisconsin Milwaukee, WI

E George Wolf, MD 59th Medical Wing, Hyperbaric Medicine JBSA-Lackland, TX

W.T. Workman, MS, CAsP, CHT-A, FAsMA Director, Quality Assurance & Regulatory Affairs UHMS San Antonio San Antonio, TX

Y David A. Youngblood, MD, MPH&TM

Z William A. Zamboni, MD (Deceased) Professor, Division of Plastic Surgery University of Nevada School of Medicine Las Vegas, NV

Acknowledgments This work was supported by the Bleser Endowed Chair in Neurology (to Dr. Whelan) as well as the Baumann Research Endowment (to Dr. Whelan). The editor would like to thank each one of the authors for contributing their time and expertise to this textbook. It is greatly appreciated. The editor would also like to acknowledge the valuable contributions of the publishing and design teams and their enthusiastic dedication to the textbook. The authors and editor wish to greatly acknowledge Lisa Jome for her valuable administrative support in the publication of this textbook.

SECTION

1

SECTION

Hyperbaric Oxygenation: General Considerations

CHAPTER

1

CHAPTER

Clinical Hyperbaric Facility Accreditation-Process Improvement in Action CHAPTER ONE OVERVIEW Introduction Background Program Design Status Opportunities for Improvement External Recognition International Expansion Summary References

Clinical Hyperbaric Facility Accreditation-Process Improvement in Action W.T. Workman

INTRODUCTION In the late 1970s, there were fewer than 30 hyperbaric facilities operational in the United States. Most were military, commercial, or highly specialized research facilities. It is estimated that there are now around 1,350 operating in hospitals and hospital-affiliated facilities.(3) We have seen the primary role of hyperbaric facilities transition from the treatment of diving-related disorders to providing an important primary and adjunct treatment modality for multiple medical conditions as described in this publication. Refined research efforts will no doubt validate continued efficacy and support new indications. The location of facilities is expanding from hospitalbased to nonaffiliated outpatient settings, some with appropriate medical supervision, others without. In the past decade, certification in hyperbaric technology and hyperbaric nursing has become a staffing requirement in a growing number of programs. After years of dedicated efforts by many members of the Undersea and Hyperbaric Medical Society (UHMS), the American Board of Preventive Medicine, the American Board of Emergency Physicians, and the American Osteopathic Association have established board certification for physicians in Undersea and Hyperbaric Medicine. Minimum recommended staffing and training standards were first presented in the UHMS Operations Committee Report in 2000.(1) Now, they are an important part of a more comprehensive set of

guidelines and recommended practices. The UHMS Guidelines for Hyperbaric Facility Operations, 2nd Edition, set these foundational standards of practice for hyperbaric medicine.(6) Each of these milestones reflects a continuing maturation and professional recognition of clinical hyperbaric medicine in the United States. As in any growth process, success has not come easily. There are still many challenges that must be faced. There have been many in the field of hyperbaric medicine who felt an appropriate response to these challenges was to create an external means of quality assurance and performance improvement: a formal clinical hyperbaric facility accreditation program. Programs that evaluate the adequacy of the facility and equipment, the appropriateness of the staff and their training, quality of care, and patient safety have proven useful to professional organizations in ensuring that quality is maintained within their specialty. In 2000, the UHMS accepted this challenge and established a professional, comprehensive clinical hyperbaric facility accreditation program. The UHMS believes that such a program is the most efficient method to ensure that clinical hyperbaric facilities are staffed with the proper specialists who are well trained, clinical hyperbaric facilities are using quality equipment that has been properly installed and maintained and is being operated with the highest level of safety possible, clinical hyperbaric facilities are providing high quality of patient care, and clinical hyperbaric facilities are maintaining the appropriate documentation of informed consent, patient treatment procedures, physician involvement, etc.

BACKGROUND At the present time, there are approximately 18 different organizations in the United States that have some level of interest in the practice of hyperbaric medicine.(3) They include federal agencies

such as the Centers for Medicare and Medicaid Services (CMS/Medicare) and the Food and Drug Administration (FDA); codes and standards organizations like the National Fire Protection Association (NFPA); and professional groups like the UHMS, the American College of Hyperbaric Medicine (ACHM), the Baromedical Nurses Association (BNA), and the National Board of Diving & Hyperbaric Medicine (NBDHMT). With the exception of the professional medical groups, there is little effort to coordinate among these organizations to foster a greater understanding of our community and on matters important to us. Many advantages can result from accreditation and thus impact the regulatory environment, individual hyperbaric facilities and programs, and the specialty of hyperbaric medicine. Of immediate importance is the community response to the regulatory climate. In October of 2000, the Office of the Inspector General (OIG) of the Department of Health and Human Services released a report on Hyperbaric Oxygen Therapy: Its Usefulness and Appropriateness.(5) Among its findings, the OIG reported that a lack of testing and treatment monitoring raised a variety of quality-of-care concerns and that the Health Care Finance Administration (HCFA, now The Centers for Medicare and Medicaid Services (CMS) guidance to the field of hyperbaric medicine was limited. Specific OIG recommendations were for HCFA to initiate a national coverage decision policy for HBO2; improve policy guidance (e.g., practice guidelines and physician attendance policy); and improve oversight by requiring contractors to initiate edits and consistent medical review procedures and by exploring the creation of a national registry of facilities and/or physicians. Without a doubt, this report laid the foundation for increased government involvement and intervention. By creating a national clinical hyperbaric facility accreditation program, the UHMS responded proactively to the OIG findings and recommendations. This action was a sign to the various regulatory agencies that the organized hyperbaric medical community was concerned with our current situation and responded to the recognized need to assure quality of care and patient safety

across the continuum of clinical hyperbaric facilities are promoted, achieved, and maintained. Equally important are the advantages that an accredited clinical hyperbaric facility may realize. Though not all-inclusive, some of the more immediate include the following: improved quality of care enhanced patient safety increased efficiency at the facility level more effective risk management programs outward symbol of code compliance and adherence to recognized standards of practice possibly lower liability insurance premiums staff motivation and esprit de corps maximized public relations and marketing efforts ability to recruit and retain quality staff alliances developed with other provider groups credibility of legitimate nonaffiliated outpatient facilities established among their professional referral base Achieving the regulatory and facility-level advantages provides the foundation for significant advancements in the acceptance and credibility of hyperbaric medicine as a growing, recognized medical specialty, thus enhancing professional organizations such as the UHMS, the ACHM, the BNA, and the NBDHMT, who are at the forefront of the field. Further, a successful accreditation program will establish nationally recognized Standards of Practice for clinical hyperbaric medicine and brings hyperbaric medicine in line with many other specialties such as radiation oncology and rehabilitative medicine, each of which sponsors specific accreditation programs for their respective specialty.

PROGRAM DESIGN For the most part, the focus areas of the UHMS accreditation program are a compilation of national codes and standards that

relate to hyperbaric medicine and facilities as well as common quality-of-care improvement areas as defined by accrediting organizations such as the Joint Commission (JC), Commission on Accreditation of Rehabilitation Facilities (CARF), and Det Norske Veritas-Germannishcer Lloyd (DNV-GL). Central to the areas that represent compliance to national codes and standards are references from the National Fire Protection Association's (NFPA) Health Care Facilities Code (NFPA 99), the NFPA's Life Safety Code (NFPA 101), the American Society of Mechanical Engineers' Code for Pressure Vessels for Human Occupancy (ASME PVHO-1), the Compressed Gas Association, and others. The focus areas related to staff, training, certification, physician credentialing, supervision, continuing education, and so on are adopted from the UHMS Guidelines for Hyperbaric Facility Operations, 2nd Edition. The above compilation is represented in 24 concentration areas: (4)

Governance Administration Operations Maintenance Facility Construction Hyperbaric Chamber Fabrication Hyperbaric Chamber Ventilation Hyperbaric Chamber Fire Protection Hyperbaric Chamber Electrical Systems and Services Hyperbaric Gas Handling Patient Rights Patient Assessment Patient Care Environment of Care Patient Education Quality Improvement Professional Improvement Leadership Human Resources

Information Management Infection Control Medical Staff Teaching and Publication Clinical Research Surveys are conducted by a voluntary team of three highly experienced members: a hyperbaric physician, a board-certified hyperbaric nurse, and a board-certified technologist. Each survey is two full days to allow the team sufficient time to evaluate compliance to all concentration areas noted above. Each facility is provided a written report of the assessment, and recommended improvement areas are identified. The survey teams do not make the determination for accreditation; that responsibility resides with the UHMS Accreditation Council (AC). Membership of the AC is comprised of a cross section of UHMS members representing physicians, nurses, and technologists. The AC responds to each survey report in the following manner: accredit (valid for three years) accredit with a written plan of action accredit after a written plan of action has been completed accredit with distinction (valid for four years) do not accredit

STATUS By the end of 2016, the UHMS had accredited a total of 252 hyperbaric medicine programs, 3 of which were international. Of the remaining 249, 8 were facilities that were not affiliated with a healthcare system resulting in approximately 17% of the 1,350 hospitalaffiliated hyperbaric medicine programs in the country being accredited.(3) This figure is impressive when one considers the fact that, with few exceptions, participation is voluntary. There are two notable

exceptions. Beginning in 2006, the Utah Medicaid Management Office mandated UHMS-specific accreditation in order for facilities to receive Medicaid funding for hyperbaric oxygen therapy. In 2014, the third-party payor Mohawk Valley Physicians (MVP) began requiring facility accreditation for their beneficiaries in upstate New York, Vermont, and New Hampshire who required hyperbaric oxygen therapy. More specifically, MVP stipulated that physicians, in order to receive payment, must be on staff at an accredited facility. Hyperbaric facility accreditation has not gone unnoticed by Medicare. A 2013 draft Local Coverage Determination (LCD) for hyperbaric oxygen therapy published by Novitas-Solutions, Inc., a major Medicare Administrative Contractor (MAC) with jurisdiction in 11 states, proposed that UHMS hyperbaric facility accreditation be a mandate for Medicare reimbursement.(2) While this requirement was not retained in what was to be the final LCD, it represented a major acknowledgment of the program and its potential link to Medicare reimbursement on a broad scale. Many believe this is a sign of things to come. There are those who recognize that there are a variety of issues common to the hyperbaric medicine community regardless of the country of operation. This is especially true when you consider those related to hyperbaric facility safety. This is one common bond that ties the international hyperbaric community together. As a result, the UHMS has been honored to have been asked by international facilities to evaluate their programs for accreditation. Thus, the UHMS has accredited programs in Brazil, Canada, and Thailand. Surveys are pending in 2017 for facilities in Singapore and Saudi Arabia.

OPPORTUNITIES FOR IMPROVEMENT Preparing for an accreditation survey is a lot of work. There are those who might question if the effort is worth it. If the process does not add value, then why bother? Well, after 15 years of effort, the UHMS can say, without doubt, that the process indeed has merit and has demonstrated that it has succeeded in improving the quality-of-

care and patient safety elements in those facilities that have accepted the challenge. Equally important, it has identified a number of areas where opportunities for improvement are most evident. Several of these areas are quite surprising. The biggest surprise is related to the privileging process for physicians. UHMS accreditation surveyors frequently discover weak or nonexisting policies regarding the granting of physician privileges specifically for hyperbaric medicine. Surveyors have even documented instances in which hyperbaric physicians were not credentialed for hyperbaric medicine at all, yet they were routinely supervising the treatment of hyperbaric patients! An even more egregious omission was one hospital was allowing physicians to practice hyperbaric medicine with no formal training in the specialty! This is not acceptable. Surveyors rarely find a process to proctor physicians new to the specialty and/or facility for a period of time before they are granted full unsupervised privileges. Credentialing bodies seem to be receptive to allowing a physician who has just completed a recognized 40-hour introductory course in hyperbaric medicine to independently supervise patients. This, too, is not acceptable. Currency of continuing medical education (CME) related to hyperbaric medicine is also lacking. It is common to survey a facility in which physicians had been practicing for 20 years and have not had a hyperbaric-related CME since their initial course. Can they be considered current in the specialty? I suggest not. While these opportunities for improvement are prevalent, the UHMS has found that medical staff offices are very receptive to guidance that the UHMS can provide. An excellent source for such guidance is the UHMS Guidelines for Hyperbaric Facility Operations, 2nd Edition, which includes a complete section on recommendations for credentialing, etc. With regard to nurses and allied health-care providers such as respiratory therapists, specialty-specific board certification is not yet the norm. While improvements have been made in recent years in

the number of nurses and allied health-care providers who are board certified as a Certified Hyperbaric Registered Nurse (CHRN) or a Certified Hyperbaric Technologist (CHT), there is still much upside potential. Hospitals are strongly encouraged to make board certification a requirement for employment. Proactive hospitals occasionally require certification within two years of employment. This is a reasonable goal. From an operational safety perspective, one of the biggest concerns is the failure of the designated hyperbaric safety director to assume the responsibilities of the position as outlined in the National Fire Protection Association's NFPA 99, Health Care Facilities Standard, which has now become a national mandate. When the NFPA first established hyperbaric facility safety standards in 1968, they recognized the importance of a hyperbaric facility safety director and stipulated that one be designated at each facility. This requirement went largely ignored until the UHMS implemented their accreditation program in 2000, and surveyors began assessing this requirement. While hyperbaric safety directors are now common in hospital-based or affiliated programs, they are scarce in nonaffiliated, freestanding centers. Even though safety directors are now being designated in the hospital setting, many are not fulfilling their obligations with regard to creating and managing a comprehensive hyperbaric safety program. An all-too-common finding is the failure to conduct recurring medical and operational emergency drills so that the entire staff is competent in their execution. For many, conducting emergency drills stop at participating in hospital-directed fire drills. The practice of emergency procedures related to loss of chamber pressure, loss of power, communications, contaminated gas, etc. have been absent. Closely related to the lack of safety director involvement is the availability of additional training to provide the safety director with the added knowledge and tools in order to better fulfill his or her responsibilities as a safety director. It was not until a little more than 15 years ago that there was any additional training that focused on the