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of safety. Our goal is a safer surgical environment for the health care provider and the patient, realized through the prevention

of sharps injuries and exposure to bloodborne pathogens.

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www.ORprecautions.comMark S. Davis, M.D. Sweinbinder Publications LLC

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ABOUT US Mark S. Davis, M.D. is an Obstetrician/Gynecologist who became concerned about his own personal safety following a deep scalpel cut during surgery in 1990. These were his thoughts at that time:

“My potential exposure to HIV and other bloodborne pathogens had become frightening. Suturing injuries were a fairly common occurrence for me and my co-workers. I considered myself fortunate not to have acquired HIV or hepatitis C to that point in my surgical career.

“I have met and known physicians and nurses who were not so fortunate. Since I plan to practice another ten or fifteen years, I will develop a strategy which will hopefully protect me and my coworkers from sharps injury and exposure to blood in the future.”

Realizing that Universal Precautions did not prevent sharps injuries, Dr. Davis researched and developed a set of what he termed Advanced Precautions, a term reflected in the title of his book. First, he eliminated the use of sharps, where possible (primary prevention). Where this was not possible, he chose to use safer sharps (secondary prevention) and safer work practices. As these strategies proved successful, he adopted them into his daily routine in the OR and delivery room.

“It is this knowledge that I wish to share through my writing, speaking and consulting.”

Sweinbinder Publications, LLC is a publishing company formed to distribute the educational resources developed by Dr. Davis. These include three “must-have” OR safety and OSHA compliance resources:

The safety handbook for all practitioners and students of invasive procedures: Advanced Precautions for today’s OR; The Operating Room Professional’s Handbook for the Prevention of Sharps Injuries and Bloodborne Exposures

by Mark Davis, MD, FACOG, Foreword by Julie Gerberding, MD, MPH Soft cover, 160 pages. Second Edition 2001, ISBN 0-9664873-6-2

The safety video Stuck in Surgery; Sharps Safety in Today’s OR A new 17 minute video for 2002 hospital-wide sharps safety education and OSHA compliance in the OR. Useful for all staff in the OR, Labor & Delivery, Emergency Department & Trauma Center. Produced by surgeon and safety / infection control consultant, Mark Davis, MD. Every hospital and surgery center should have this video.

The safety posters (set of ten) Informational and motivational daily reminders to post in the OR and L & D. New and revised for 2002 OSHA compliance; an essential risk awareness and educational tool. Printed on 8&1/2 X 11-inch heavy stock in assorted neon colors for maximum impact. Suitable for framing or laminating.

Hospitals across the country use these three resources in combination to elevate risk

perception and the adoption of effective injury prevention strategies throughout their facilities.

CONTACT USCONTACT THE PUBLISHERFor more information about OR Safety educational resources (Safety Handbook, Safety Video, Safety Posters), and for information on discount pricing for healthcare institutions and customized gift editions for corporations and healthcare networks, Email sweinpub@aol.com , fax (404) 233-5662, or call our Special Sales and Distribution Manager, Marjorie Rose at (404) 261-4595.

Sweinbinder Publications LLCP.O. Box 11988Atlanta, GA 30355

CONTACT DR. DAVISTo schedule a speaker presentation or consultation to reduce exposures to blood and sharps injuries at your hospital, or if your company would like to request a clinical evaluation of a safety product, Email Dr. Davis at msdavismd@aol.com.Phone 404-233-3359 / fax 404-233-5662

SAFETY & COMPLIANCE RESOURCES (HOME PAGE MAIN MENU ITEM)OR SAFETY HANDBOOK: "ADVANCED PRECAUTIONS FOR TODAY’S OR" (sub-menu item 1)

OVERVIEW (SCROLLING)BOOK REVIEWS (SCROLLING)TABLE OF CONTENTS (SCROLLING)FOREWORD, PREFACE, INTRODUCTION (SCROLLING)CHAPTER 1 (SCROLLING)

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"This handbook is a must-read for all levels of surgical care providers to prevent occupational sharps injuries and exposure to blood"

Advanced Precautions for today’s ORThe Operating Room Professional’s Handbook for the Prevention of Sharps Injuries and Bloodborne Exposures

by Mark S. Davis, MD Foreword by Julie Gerberding, MD, MPH 160 pages, safety checklists, bibliography, index.

2001 Edition ISBN: 0-9664873-6-2 $14.95

DEDICATIONThis book is dedicated to the healthcare workers and patients who acquire infectious diseases through bloodborne exposures each year and to their families, with the hope and belief that such events can and will be prevented by thoughtful planning and constant vigilance.

OVERVIEW (SCROLLING)

In the bloodborne pathogen era, surgical care providers must be as adept at occupational safety as they are at patient care. Written by a surgeon and safety consultant, this breakthrough book bridges the gap between universal precautions and the practice safe surgery. It provides step-by-step ways for all members of the surgical team to reduce the risk of occupational sharps injury and exposure to the common bloodborne pathogens HIV, hepatitis C, hepatitis B and others that are evolving.

The comprehensive exposure prevention strategy in this book is derived from a very credible basis, that of a practicing surgeon, and draws from published epidemiologic investigations, CDC guidelines, his own observations and experience, and most importantly, common sense. A key theme—the entire surgical team shares risk and shares responsibility for safety—makes this an especially useful handbook for all O.R. personnel, regardless of occupational status or duties. It is a must-read for all surgeons, ObGyns, nurses, technologists, PAs, midwives, students, residents and interns. It is also essential for anesthesia, emergency department, invasive radiology and ICU personnel. A one-of-a-kind resource, Advanced Precautions for today’s OR has been described as “The Bible” for all levels of surgical care providers and students.

Dozens of safety tips and many checklists make it easy to reduce your risk:

Select and integrate blunt sutures and other alternatives to sharps into daily practice Learn how to avoid use of unnecessary sharps Pass, handle and manage sharps more safely in the OR and invasive work sites Choose truly effective and user friendly personal protective equipment

Enable compliance, reduce costs and liability, improve performance and efficiency: Comply with JCAHO and avoid OSHA citations Avoid liability, litigation, and workers compensation costs Recruit and retain quality staff; improve worker morale Eliminate the need for costly and disruptive exposure workups

BOOK REVIEWS BOOK REVIEWS FROM PEER REVIEWED JOURNALS, SURGEONS, NURSES, SURGICAL TECHNOLOGISTS, INFECTION CONTROL AND RISK MANAGEMENT PROFESSIONALS:

“All OR staff and everyone involved in surgical procedures should read this book and incorporate the ideas specific to their practice. An excellent book that will raise awareness of the potentially life-altering impact of a bloodborne exposure.”...Journal of Healthcare Risk Management

“Thoughtfully presented, intellectually solid, fills a real need.”...LaMar McGinnis, MD, FACS Vice President Elect, American College of Surgeons

“A clear, informative and practical guide to relatively simple measures that may be taken to make the operating theatre a safer workplace for all members of the surgical team. There should be a place for this volume in operating suites throughout the country.”....British Journal of Surgery

“A must-read, clearly written, based in full compliance with multiple regulatory bodies.” ...Ann Kobs, RN, MS, Past Associate Director,Department of Standards, JCAHO

“Compels the reader to rethink practices in the uniquely hazardous OR environment. A useful tool in educating OR and other hospital staff of the dangers of blood exposure” ...AORN Journal (Association of Operating Room Nurses)

“Should be read by everyone involved in the care of surgical patients; it has changed the way I operate. Every time I walk through those double doors to the OR, I now think of safety”...Sidney Stapleton, MD, FACS, General Surgery

“Motivates surgical care providers to make safer choices, and tells exactly how to do it!”...Susan Bales, RN, MBA Director of Surgical and Obstetrical Services, Promina DeKalb Medical Center

“A life-saving manual for all healthcare workers in the OR...should be required readingin medical schools, nursing schools and technical training programs.”...Michael Swor, MD Assistant Clinical Professor of Ob/Gyn, University of S. Florida

“Thought-provoking...a worthwhile and needed addition to the surgical and nursing curriculums.”...Paul Browne, MD, FACOGDirector, Atlanta Maternal Fetal Medicine

“Reeducating our surgeons and nurses to protect themselves is urgent. This book does an excellent job.”...Robin Henry Dretler, MD President, Atlanta Infectious Diseases Specialists

“A great book, very practical, straight forward, easy to read and informative...a must for our unit.” ...Lilian Blair, CNS Operating Rooms Tamara Private Hospital, Tamworth, New South Wales

“I am particularly pleased to see a text written by a physician that addresses step-by-step ways for all members of the surgical team to reduce their own and others’ risks of occupational injury and exposure to blood borne pathogens. I encourage others to purchase the book.”...Lynne Reagan, RN CIC, Inf. Control Coordinator Carle Foundation Hospital, Urbana, IL

“A handbook for all OR personnel by a practicing surgeon...draws from published studies, OSHA and CDC guidelines, his own experience and common sense”...OR Manager

“Our highest must-read recommendation for hospital staff...highly informative and an excellent…essential risk management and bloodborne pathogen control. Chock full of the latest techniques, checklists and guidance. Covers everything from the history of bloodborne pathogens to the most up-to-date precautions for patient and practitioner safety, and risk management strategies.”www.safetyinfo.com

“A refreshing approach to identifying and managing everyday risks in operating theatres. Readers should adopt the principles of infection control described in this book.”...Nursing Standard (UK)

“A new book to make the OR a safer place... suggestions about gloving, surgical gown selection, needlestick prevention, and other practical ideas”...Infection Control Today

“A must-have resource for all levels of care providers in surgery and obstetrics; also applicable for anesthesia, emergency department, intensive care and invasive radiology.”...Worldwide Nurse

“Your book has provided insight; I have learned many safer approaches to everyday activities in the OR.”...Lori Kral, CST

“Logically addresses protective measures to avoid unnecessary injury...a self-professed plea for all OR workers to adopt safer methods...addresses the real fears of healthcare workers at risk for becoming infected with a bloodborne disease...identifies safe ways to function in the operating room and delivery room...encompasses practices available for years but underutilized or ignored...many midwives and obstetrical practitioners walk a fine line between being hands-on with women in labor and complying with OSHA guidelines...this book delineates thoughtful and well researched ways to protect medical professionals."...Journal of Midwifery & Women’s Health

TABLE OF CONTENTS Advanced Precautions for Today's O.R.The Operating Room Professional’s Handbook for the Prevention of Sharps Injuries and Bloodborne Exposuresby Mark S. Davis, MD, FACOG ISBN: 0-9664873-6-2Foreword by Julie Gerberding, MD, MPH© 2001 Sweinbinder Publications LLC Atlanta, Georgia

Foreword by Julie Louise Gerberding, MD, MPHPrefaceIntroduction: Why This Book Was Written

SECTION I. OVERVIEW AND PERSPECTIVEChapter 1. Bloodborne Pathogens and Occupational RiskChapter 2. Direct and Indirect Costs of Injuries and ExposuresChapter 3. Causes of Sharps Injuries and Exposures to Blood

SECTION II. PRECAUTIONS FOR THE SURGICAL TEAMChapter 4. General Prevention StrategiesChapter 5. Choices of Effective Personal Protective EquipmentChapter 6. Choices of Safer Sharps and Other TechnologyChapter 7. Blunt Alternatives to SharpsChapter 8. Team Tactics and Techniques for Safely Handling SharpsChapter 9. Safe Tactics and Techniques for Assisting in SurgeryChapter 10. Management of Surgical SmokeChapter 11. Precautions for Anesthesia Personnel

SECTION III. PRECAUTIONS FOR SPECIAL SITUATIONSChapter 12. Obstetrical ProceduresChapter 13. Minimally Invasive SurgeryChapter 14. Patients With Known Bloodborne Pathogens

SECTION IV. ADMINISTRATIVE SUPPORT AND INTERACTION

Chapter 15. The O.R. Management TeamChapter 16. The Risk Management TeamChapter 17. The Product Evaluation and Purchasing TeamChapter 18. The Infection Control Team

Appendix A. Safety Checklist for Operating and Delivery RoomsAppendix B. Summary of Public Health Service Recommendations

for Management of Occupational Exposure to Blood and Body Fluids

Appendix C. Summary of OSHA Regulations Relevant to the Operating Room The 1999 OSHA Compliance Directive The 2000 Federal Needlestick Safety and Prevention Act

Additional ResourcesGlossaryIndex

FOREWORD, PREFACE, INTRODUCTION FOREWORDby Julie Louise Gerberding, MD, MPH

“Develop a bias for action. Cultivate the habit of focus-ing simultaneously on patient safety and occupationalsafety, throughout every procedure. Constantly observe,analyze, learn, communicate, and teach.”

—M. Davis; Advanced Precautions for Today’s O.R.

Surgical health care providers created a standard of excellence in the practice of infection control at the turn of the century when the value of aseptic techniques to prevent wound infections was first demonstrated. In the past decade, awareness of the risk associated with exposure to blood containing HIV ushered in a new era in surgical infection control—one that emphasizes protection of both patients and surgical care providers. Just as patients must be protected from wound contamination and exposure to injured providers’ blood, providers must be protected from intraoperative injuries and other exposures to patients’ blood.

The operating room is clearly one of the most hazardous environments in the health care delivery system. By definition, surgery is invasive. Instruments that are designed to penetrate the patient’s tissue can just as easily injure the provider. Blood is ubiquitous. Speed is essential. Emergencies can occur at any time and interrupt routines. Clinicians are crowded together in a confined space, often with poor lighting and visibility. Cases are often long and fatigue is common. Preventing injuries and exposures under these circumstances is indeed challenging!

The Centers for Disease Control and Prevention (CDC), the Occupational Safety and Health Administration (OSHA), and many professional societies have formulated guidelines and regulations, based on the principles of “universal precautions”, to protect health care workers from blood exposures. These important efforts laid the groundwork for practice changes that led to safety improvements in many health care settings, but have not had a major impact in many operating rooms. In fact, the introduction of universal precautions created confusion in the surgical community. Some surgeons interpreted the guidelines to require the use of maximal barrier protection (plastic aprons, face shields, water-resistant foot protection, etc.) for all procedures, regardless of exposure risk. Others felt that universal precautions (sterile gloves, gowns, surgical masks) were already standard practice in surgery and were just not adequate to protect personnel from blood exposures.

In this handbook, Dr. Mark Davis bridges the gap between the principles of universal precautions and the actual practice of safer surgery. His comprehensive exposure prevention strategy is derived from a very credible basis, that of a practicing surgeon, and draws from published epidemiologic investigations, CDC guidelines, his own observations and experience, and most importantly, common sense. A key theme—the entire surgical team shares risk and shares responsibility for safety—makes this an especially useful handbook for all O.R. personnel, regardless of occupational status or duties.

The science of safety in the O.R. has not kept pace with the urgent need for prevention strategies, and many of the specific recommendations found in this handbook have not been evaluated in clinical studies. Nevertheless, the efficacy of some clearly is supported by data: hepatitis B immunization, use of protective gear appropriate to the level of anticipated exposure

risk, double-gloving, sharps management, and use of blunt needles, when appropriate. Most others merit at least a trial evaluation, if not immediate implementation.

Achieving safety in the O.R. ultimately depends on the commitment and teamwork of those on the front lines. Advanced Precautions for Today’s O.R. provides a superb framework for creating a strong “bias for action” and leading others, like Dr. Davis, to “observe, analyze, learn, communicate, and teach” the practice of intraoperative safety.

Julie Louise Gerberding, M.D., M.P.H.Associate Professor of Medicine (Infectious Diseases) and Epidemiology and BiostatisticsUniversity of California, San Francisco and San Francisco General Hospital

PREFACE

From the earliest times, the list of feared surgical complications has included hemorrhage, infection, and thromboembolism. More recently, serious hospital-acquired (nosocomial) bacterial infections, resistant to most antibiotics, have joined the list. Most recently, frequent occupational exposures to increasingly common viral bloodborne pathogens, including HIV and hepatitis C, with resultant infection of healthcare workers and patients, have come to demand our attention. These bloodborne exposures, and the infections they may cause, are extremely costly events which often find their way into the press and—in today’s litigious society—the courtroom, thereby multiplying their potential cost many times over.

The surgical environment is unique, making it a challenge to comply with the intent of the Occupational Safety and Health Administration (OSHA) regulations, but it is well worth the effort. The enormous benefits of preventing sharps injuries and bloodborne exposures extend beyond prevention of occupationally acquired infections; cost savings, efficiency, liability prevention and stress reduction also define the safe surgical workplace. Of the bloodborne pathogens most likely to be encountered during surgery—hepatitis B, hepatitis C, and HIV—the only one for which a vaccine is available is hepatitis B, ironically the least potentially lethal of the three. Universal Precautions and Standard Precautions have not, and cannot, come close to eliminating the large numbers of sharps injuries and bloodborne exposures commonly associated with surgical procedures. Focusing on individual preventive measures as well as teamwork, this book was written to help operating room professionals create a safer surgical environment through avoidance of exposures to blood and bloodborne pathogens. The required changes in technique and technology are relatively minor, but the goal of exposure prevention must be kept in clear focus during every invasive procedure. Every institution would be well served by adopting an integrated strategy to take control of these costly adverse events.

In the preface to the nineteenth edition of Williams Obstetrics, the reader is wisely counseled, “Obstetrics is art and science combined, and its practitioners must be concerned with the lives of at least two intricately woven patients—the mother and her fetus . . . it is apparent that the responsibility of the obstetrician is enormous.” Similarly, the responsibility of today’s

operating room professionals extends beyond concern for the life of the patient to the lives of fellow care givers who are intricately woven together as a surgical team.

The approach outlined in this book is simple. Because I have tried to be observant while operating, I have identified dangerous and safe ways to function in the surgical environment. Information was additionally gathered from a review of the current literature and discussions with respected surgical colleagues and other frontline healthcare workers. There may be additional appropriate ways to function safely; this book describes some approaches that have been extremely helpful.

Some of the suggestions in this book will be familiar, and you may already be using some of them. The key to success is applying these principles in an integrated and consistent manner. It requires daily attention to detail, persistence and determination. You will face the obstacles of inertia, denial, and cost containment at your institution, but these can be overcome by sufficient teamwork and education.

There is arguably nothing more frightening for a healthcare worker than to learn he or she has been exposed to HIV and then having to wait months to find out if he or she has become infected. Understanding we cannot eliminate risk entirely, those of us at DeKalb Medical Center who use the techniques and protocols described in this book have nevertheless been able to reduce our occupational risk and the accompanying anxiety. Truly, our lives have changed.

A set of Advanced Precautions—selection and deployment of the most effective (and cost-effective) currently available personal protective equipment, safety devices, and safety protocols—are described in this book. This information is directly applicable to the clinical setting. Like the deadly pathogens that inspired them, whatever precautions we select will need to evolve over time to remain successful. They must be monitored, maintained, and upgraded by a process of continuous quality improvement.

As individuals and surgical team members, we must try to simultaneously create a safer environment for both the surgical patient and the surgical team. We are involved in a continual learning process; as knowledge deepens and technology evolves, this handbook will be updated appropriately. Readers are encouraged to share with the author their successes, as well as their persistent problems.

A complaint commonly heard—and one of the frustrating challenges to any institution— stems from individuals who are not sufficiently committed to changing the system. As more and more people learn to use safer techniques and technology, the position of the minority who do not becomes more difficult to justify and defend.Finally, OSHA regulations and employer responsibilities aside, remember it is your workplace and yours to change. By the choices you make, you take considerable control of your own destiny. Protect yourself first; then plan to work safely as a team. Visualize a safer workplace and share that vision with your co-workers. Be a vocal advocate for safety and lead by example.

Your attention will be diverted at times by other problems but, above all, be persistent. If you consistently follow an integrated system for exposure prevention such as the one found in this book, it will work for you and your co-workers. I wish you much success.MSD

INTRODUCTION

Why This Book Was Written

The AwakeningWhat prompted a busy obstetrician/gynecologic surgeon after 25 years of practice to write a book on occupational safety for operating room professionals? In the late 1980s, I was severely cut with a scalpel while performing a hysterectomy. This was when we were just becoming aware of the significance of the silently spreading HIV/AIDS epidemic. Interviewing the patient in the recovery room, I was shocked and surprised to learn of some risk factors in her husband’s lifestyle. Those factors placed both of us at risk and we had to be tested for HIV.

Although the tests were negative, I replayed the events of the injury in my mind and realized the accident could have been prevented had there been a plan in place to manage sharps more safely. Personal safety had not been addressed during my training and all I had learned were the habits, good and bad, of my mentors. In the complex, confined, and volatile environment of the operating room where things often happen unexpectedly, simply being careful had not prevented the injury. I had learned a powerful and valuable lesson. The subconscious denial of risk had been erased, and this freed me to focus on seeking solutions to the problem.

By the early 1990s, general perception of the magnitude of the HIV epidemic had increased, and by the mid-1990s, another potentially lethal bloodborne pathogen, hepatitis C, was capturing the attention of epidemiologists and surgeons. It was becoming increasingly clear the causes for the many occupational exposures being reported needed to be defined and practices developed to reduce these risks.

Life-Changing ExperiencesI attended and participated in several national and international conferences dealing with the prevention of sharps injuries and bloodborne exposures, meeting with others concerned with the problem. I met a nurse and a physician who had become occupationally infected with HIV and heard their heartbreaking stories of preventable needlestick injuries, which had resulted in seroconversion. I sensed their rage and frustration. At that time, a physician who was a good friend and colleague of mine died of chronic hepatitis C, despite a successful liver transplant.

The Search for AnswersI needed to find ways in which to make the operating room a safer workplace. Knowing that most sharps injuries are caused by suture needles and having had my skin and gloves punctured by suture needles many times, I began studying and testing a new generation of blunt-tipped suture needles that had just become commercially available. They appeared to be effective in preventing needlesticks and glove tears without causing harm to patients. After evaluating every

available brand and size of blunt-tipped suture needles for gynecological surgery and operative obstetrics and determining where and how to use them most effectively, I began to use them routinely. By almost totally avoiding the most commonly used sharp instrument in surgery, the traditional sharp suture needle, I found I was able to eliminate much of the hazard associated with suturing. What made it even better was not only was I protected, but so was every member of the surgical team.

By constantly focusing on safety in the operating room, regularly reviewing available literature, evaluating new safety-engineered devices, speaking and consulting at hospitals, and exchanging views and ideas with surgeons from around the world, I was able to collect and refine a number of useful techniques. I soon realized there were many underutilized techniques, devices, and strategies that could be implemented to decrease the risk of exposure. That knowledge, synthesized into an integrated system for exposure prevention, became the basis for this book. The information herein needs to be shared.

Who Should Read This Book?Those at Occupational RiskThis handbook was written to help create and maintain a safer working environment for every member of the surgical team and in a larger sense, for everyone who may perform in the operative environment, including: Surgeons Residents Obstetricians Midwives Anesthesia personnel Perioperative nurses Surgical assistants Surgical technologists Labor and delivery nurses Obstetrical technologists Medical students Nursing students Technology students CRNA students ED and ICU personnel Interventional Radiology personnel

Others Who Can HelpA concurrent objective of this book is to facilitate and assure compliance with OSHA’s requirements in two particularly hazardous work sites: the operating room and the delivery room. Hospital administrators and managers at various levels will benefit from reading this book, including: Surgical services directors Operating room managers Obstetrical service managers Risk managers

Materials managers Infection control team Occupational health team CQI and quality assurance teams

All of these people in the hospital organization have critical roles to play in facilitating exposure prevention. Risk managers and materials managers, in particular, need to have a firm understanding of the scope and complexity of hazards found in the surgical setting and should read the chapters in the first section of this book as well as other appropriate chapters to visualize the big picture. Doing so will facilitate well-informed purchasing decisions that optimally serve both the institution and healthcare workers at risk.

How to Use This BookUnderstanding Risks and Identifying ProblemsSection I (chapters 1 through 3) provides an overview of the problem and a broad perspective, including a review of the incidence of occupational transmission of HIV and the common hepatic viruses. Adverse consequences and costs resulting from bloodborne exposures are surveyed and causes of sharps injuries and bloodborne exposures are identified.

Identifying Solutions and Facilitating ChangeSections II and III (chapters 4 through 14) show an integrated system for exposure prevention—a head-to-toe how-to-choose and how-to-use approach—with comprehensive descriptions of safety protocols, safe surgical techniques, and choices of safer technology. Section IV (chapters 15 through 18) suggests ways in which managerial staff and administration may successfully interact with those at risk to facilitate exposure prevention. Chapter 17 also provides guidelines for conducting effective product evaluations.Three appendices are included. Appendix A provides a detailed model Safety Checklist intended for daily use that may be copied and posted on or near the door of every operating room and delivery room. The checklists serve as safety reminders and as a means of raising awareness of risk among personnel. Checklists should be tailored to procedures and personnel and regularly reviewed and updated as new technology and techniques evolve.Appendix B provides the most current recommendations (at the time of publication) for managing occupational exposures. O.R. professionals need to know how to respond promptly in the event of an occupational exposure. They should understand in advance the process of post- exposure management. Such an understanding in itself is a safety motivating factor. Infection control professionals and others caring for exposed workers will be on a learning curve for some time to come as data are collected on the efficacy and toxicity of drugs used for HIV post-exposure prophylaxis. Guidelines will change frequently. Use the section, Additional Educational Resources, to access updated protocols via web sites and other listings.

Appendix C provides a summary of OSHA regulations relevant to the operating room. Operating room professionals should know what the law requires and what the OSHA guidelines are. The guidelines are an excellent starting point, but reading them will help make it clear those at risk must make more specific safer choices of equipment and protocols to realize an effective exposure prevention plan.

Space is provided at the end of each chapter for notation of real or potential hazards you may identify specific to your work site and your planned corrective measures. Think of it not as a blank page for notes, but a powerful tool for implementing change. It is suggested this book be kept in the hospital locker and/or at the nursing station, readily accessible for reference and notation. An index, a glossary, and additional educational resources are also provided. References and suggested readings appear at the end of chapters, where appropriate.

Author’s Plea to Fellow SurgeonsAs the “captain of the ship,” the daily repetitive and habitual choices we make when we ask for scalpels, sutures, and other sharp devices have the potential of positively or negatively impacting the lives of many—the patient, ourselves, those standing across from or next to us at the operating table, others working in the room, and the families of all.Accordingly, although I may feel as competent using a sharp suture needle versus a blunt one for most suturing tasks, I also know despite the fact everyone tries to be careful, needlesticks occur in unacceptable numbers. Once an accident happens, uncontrollable negative forces are set in motion. There is immediate major stress and anxiety. Toxic drugs may have to be taken. Seroconversion, the unthinkable, looms as a possibility. One of the things I do, therefore, is to routinely choose the blunt suture needle in preference to the sharp whenever possible to protect myself and the other people involved. Because of choices I have made, my life has changed: I enjoy operating more and I sleep better at night. Everyone in the operating room is glad to see me and people want to scrub on my cases. Responsible for the choices of safer devices and protocols, surgeons have become custodians of the well being of an extended group of people beyond the patient. Like spoken words that cannot be retrieved, the seemingly trivial decisions we make many times a day may return to haunt . . . or to bless us. Think carefully before you choose. MSDCHAPTER 1Bloodborne Pathogens and Occupational Risk

The ProblemAny successful program for managing the occupational risk of exposure to bloodborne pathogens must be predicated upon understanding the scope of the problem. The most common bloodborne pathogens of concern to operating room professionals are hepatitis B, hepatitis C, and HIV. According to OSHA’s Final Rule, published in 1991, more than 4 million healthcare workers in the United States are considered at risk of occupational infection.The hepatitis B vaccination has dramatically reduced the threat to healthcare workers from that disease, but it has not eliminated it. Not everyone at risk has been vaccinated, and some individuals do not produce an adequate antibody response following vaccination.Hepatitis C, often a silent and chronic disabling disease, is highly infectious via percutaneous exposure, and there is no vaccine or post-exposure prophylaxis. While HIV and AIDS have captured most of the attention regarding occupational exposures, hepatitis C is arguably of more concern to operating room professionals.HIV will remain an occupational risk to O.R. professionals with global spread of the epidemic and evolution of strains of virus resistant to antiretroviral medications. Despite the routine use of gloves and protective apparel (Universal Precautions), large numbers of exposures continue to be reported. As of the end of 1997, an estimated 30 million persons worldwide were infected with

HIV; of these, approximately 40% were women and 1 million were children under the age of 15. Only an estimated 10% of infected individuals are aware of their condition.

The SolutionThe approach to reducing the risk of exposure to any one of these bloodborne infectious agents must address all three, as well as other evolving infectious agents. Hospital occupational health departments document a wide variety of injury and exposure scenarios, but injury and exposure patterns may be site-specific and recurrent with individuals. The problem could be frequent glove failure, needlestick injury, mucous membrane exposure, or any combination. In this era of evolving bloodborne pathogens, the fundamental goal for operating room professionals is to prevent contact with the blood of all patients. To effectively reduce occupational risk, an advanced integrated strategy that takes full advantage of safety engineered devices, safety protocols, and safe work practices must be consistently applied.

Patients and Care Givers Share the RiskThe opportunities for bloodborne transmission of infectious agents are bidirectional. A surgical exposure is here defined as contact between blood of an injured surgeon or other member of the surgical team—caused by scalpels, needles, or other sharp devices—and the internal tissues of a surgical patient. The CDC refers to this as a recontact.. Recent reports have documented surgeons infected with hepatitis B and hepatitis C, acquired from patients by previous occupational bloodborne exposures, may transmit these infections to surgical patients.The French National Public Health Network has reported a case of transmission of HIV from an orthopedic surgeon to a single patient, the details of which are still under investigation. The case of the Florida dentist who transmitted HIV to several of his patients is widely known, but numerous retrospective studies have thus far failed to reveal any other instances of HIV transmission from dentists, surgeons, and other healthcare workers to patients. Despite these isolated reports, transmission of HIV to patients from surgeons is, therefore, considered extremely unlikely if appropriate precautions are taken in exposure-prone invasive settings.

Restriction of Surgical PrivilegesIn the United Kingdom, healthcare workers infected with bloodborne pathogens are restricted from participating in invasive procedures. In the United States, hospital safety and infection control committees may, at their discretion, restrict infected healthcare personnel from participating in invasive procedures. By adopting appropriate and effective precautions, operating room professionals can simultaneously protect themselves and their patients.

Infectious Blood and Body FluidsUniversal Precautions (see also Standard Precautions, below) originally defined the infectious materials encountered in operative settings as follows.Highest risk:BloodFluids containing visible bloodWound drainage or exudatesOthers:SemenVaginal secretions

TissuesCerebrospinal fluidSputumSynovial fluidPleural fluidPeritoneal fluidAmniotic fluidFeces

Universal Precautions did not apply to the following materials unless blood is visibly present:TearsNasal secretionsSalivaSweatUrineVomitIt is possible, however, for blood to be present in minute quantities without being visible. In such cases, if the blood has a high viral content (viral load), exposed workers may still be at significant risk of infection.

Standard PrecautionsStandard Precautions were defined and issued by the Centers for Disease Control and Prevention (CDC) and the Hospital Infection Control Practices Advisory Committee (HICPAC) in 1996. They combine Universal Precautions and Body Substance Isolation. The latter was designed to reduce the risk of transmission of pathogens from moist body substances. Standard Precautions apply to blood, all body fluids, secretions, and excretions (except sweat ), regardless of whether they contain visible blood. Intended to protect nonintact skin and mucous membranes, Standard Precautions are designed to reduce the risk of transmission of microorganisms from both recognized and unrecognized sources of infection in hospitals. It is logical, prudent, and hygienic to wear gloves when working with any and all body fluids.

Hepatitis B Virus (HBV)Hepatitis B virus is transmissible by needlestick in up to 30% of exposures to infectious sources; 5 to 10% of HBV infections become chronic. Fatal acute fulminant hepatitis occurs in less than 1% of cases, but months of disability may result from acute hepatitis B infection, and the potential for spread to family members is high. Fortunately, HBV is preventable in most cases by vaccination.

Hepatitis B VaccinationAll operating room professionals are at risk of contact with blood and should be vaccinated against hepatitis B. Workers who are eligible for the vaccine and have not received it place themselves and their families at unnecessary risk. The vaccines are safe and well tolerated. There is no risk of HIV infection from modern genetically engineered vaccines. Mild soreness at the injection site for one to two days may occur in up to 20% of persons. Occasionally, fatigue, headache, or fever may occur, but there have been no severe acute or chronic adverse effects reported due to vaccination. According to the CDC, the duration of protection following

vaccination is at least 14 years and studies continue. Vaccines are provided by employers at no cost to healthcare workers at risk of exposure to blood, as mandated by OSHA regulations.Three doses of 1 milliliter of vaccine are given intramuscularly at 0 month, 1 month, and 6 months, preferably in the deltoid muscle. Vaccine recipients over the age of 30, those with impaired immune response, and those who received the vaccine in the buttock rather than the deltoid muscle may not sufficiently respond with adequate antibody formation. The series of three doses of vaccine, when given as above, is effective in more than 95% of otherwise healthy young adults who respond to the vaccination. Post-vaccination testing to demonstrate sufficient antibody formation appears to be a cost-effective precaution, as this may eliminate the need for booster injections following an exposure years later when antibodies may have fallen to undetectable levels. Up to three additional doses should be administered to persons who do not respond to the initial series; about 50% will respond.A small percentage of people will not respond sufficiently to the vaccine to prevent infection following exposure (nonresponders), and post-exposure prophylaxis with HBIG (hepatitis B immune globulin) is required in such cases. (For a more detailed discussion of vaccination, see Appendix B.)

Hepatitis C Virus (HCV)First identified in 1989, hepatitis C has emerged as a highly significant occupational health risk to operating room professionals. As of 1997, there were approximately 4.5 million reported hepatitis C infections in the United States, representing 1.8% of the general population, with 2,200 infections reported in healthcare workers. Seropositivity rates in hospital personnel range from 1.4 to 5.5%. Studies of the prevalence of HCV in hospital patients vary, but up to 18% of emergency room patients may harbor the virus. Transmission of hepatitis C infection from patients to healthcare workers has been documented as a result of accidental needlesticks or cuts with sharp instruments, as well as from a blood splash to the conjunctiva. The risk of occupational infection with HCV following percutaneous injury has been reported to be from 3% to as high as 10%, depending on the accuracy of the methods used for testing and the viral load in the source patient.The human host produces an ineffective immune response to HCV. The rate of chronic infection (85%) is extremely high compared to hepatitis B. Because HCV mutates rapidly, multiple exposures to subtypes of HCV may yield multiple opportunities for infection and reinfection. About 20% of persons chronically infected with HCV will develop end-stage cirrhosis, liver failure, or liver cancer. HCV is the leading cause for liver transplantation in the United States. In no case does liver transplantation rid the host of virus, and newly transplanted livers may become infected and decompensate more rapidly than with the original infection. When this occurs, patients are not considered candidates for repeat liver transplantation. There are an estimated 8,000 to 10,000 deaths from HCV each year, and mortality is expected to triple in the next 10 to 20 years without effective intervention. Although 250 healthcare workers (HCWs) die annually from hepatitis B (HBV), the long-term lethal potential of hepatitis C in HCWs is projected to be much greater because of the high rate of chronic infection. HCV is found with increased frequency in patients with HIV, and simultaneous transmission of both pathogens has been reported following an exposure. In that instance, the infected HCW died rapidly from liver disease.There is no vaccine for HCV, nor is it likely one will be produced anytime soon because of the tendency of the virus to mutate frequently. Unlike with HIV, there is no post-exposure

prophylaxis for HCV. Medical treatment of HCV (with interferon) is expensive, has many adverse effects, is ineffective in the majority of patients, and has a high relapse rate when the drug is discontinued. Treatment with other drugs and drug combinations is currently being evaluated in clinical trials. In June, 1998 the Federal Drug Administration (FDA) approved the combination therapy interferon with ribavirin for patients 18 years or older with compensated liver disease due to hepatitis C who have relapsed after initial treatment with interferon. Although the mode of transmission of HCV is mainly bloodborne, in more than 40% of HCV-infected patients there is no obvious route of transmission found. In up to 13% of cases, HCV may be acquired through household or family contact, placing families of infected healthcare workers at risk. Given these sobering statistics, the only currently available strategy to reduce the occupational hazard of HCV is the universal avoidance of exposure to blood.

Human Immunodeficiency Virus (HIV)The epidemic spread of HIV has heightened awareness of this virus as an occupational risk factor for healthcare workers. The first case of occupational transmission of HIV infection was reported in 1984. Through September 1993, 120 healthcare workers had been reported to the CDC as having occupationally acquired AIDS/HIV infection. Of these, 39 were considered by the CDC as documented, and 81 were considered possibly occupationally acquired. Through December 1996, the number of documented cases reported to the CDC had risen from 39 to 52 and the number of possibly occupationally acquired cases had risen from 81 to 111. More than 80% of cases of occupationally acquired HIV infections in healthcare workers were the result of sharps injuries.In one year there were at least 500,000 reported injuries due to contaminated needlesticks and other sharp objects. Of these, an estimated 16,000 may have been HIV-contaminated. Most involved hollow-bore needles. According to various studies, HIV seroprevalence in hospital and surgical patients may vary from 0.5 to 23% or more in urban centers. A prospective study showed a majority of sharps injuries and mucocutaneous exposures to blood occurring in the operative setting were not reported, and most involved suture needles. CDC officials have voiced the following concern: incomplete data on exposures in surgery due to incomplete reporting limits their ability to define the risk of seroconversion in operative settings. The risk of seroconversion to HIV following hollow needlesticks is 0.3% on average, but risk is significantly increased in the following cases: where the source patient has very advanced AIDS, where the needle was visibly contaminated with blood, and where the needle had been used in an artery or vein before the exposure occurred. Post-exposure prophylaxis with zidovudine (ZDV) has been shown to significantly decrease the risk of seroconversion but may be less effective in the presence of increased risk factors. Two, or possibly three, antiretroviral drugs may be offered in exposures considered high risk. (See Appendix B for post-exposure prophylaxis guidelines and information on how to obtain updates.)The average risk of seroconversion to HIV following suture needlesticks is thought to be significantly lower than with hollow-bore needles, but this risk is more difficult to define because of incomplete reporting of suture needle injuries. As the titer of HIV in blood (viral load) increases, the risk of seroconversion increases. The incidence of sharps injuries during surgical procedures has been reported to be as high as 15% when dedicated observers are used to monitor procedures, and the majority of reported sharps injuries in operative settings are from suture needlesticks.

The CDC estimates the risk of seroconversion to HIV after mucous membrane or nonintact skin exposure is 0.1%, and the risk of seroconversion after intact skin exposure is less than 0.1%. As with needlesticks, these are average risk calculations. The incidence of mucocutaneous exposure to blood during a surgical procedure has been observed to be as high as 40 to 50%. If one considers the operating room professional’s 30-year-career risk of occupationally acquiring HIV by factoring in the number of sharps injuries per year (most of which go unreported), the projected rise in the percentage of surgical patients harboring HIV in the future and the potential for multidrug-resistant strains of HIV, one’s perception of risk increases. As with hepatitis C, universal prevention of exposure to blood is the paramount strategy for reducing the risk of occupational transmission of HIV.

HIV Post-Exposure ProphylaxisThe most current recommendations published by the CDC can be found in Appendix B. Guidelines for treatment of occupationally exposed healthcare workers with antiretroviral medications will continue to evolve as experience is gained regarding the efficacy and toxicity of various drugs and drug combinations. Epidemiologists are concerned that, unless and until a vaccine against HIV is produced, we are caught in a race between finding new and better antiretroviral prophylaxis drugs and the development of drug-resistant strains of HIV.

Hepatitis D (HDV)Hepatitis D is a defective virus that is unable to replicate in the human host without binding to hepatitis B virus. Infections with HDV are generally more severe than with HBV alone, and chronic HBV carriers with HDV superinfection have a 70% incidence of developing chronic liver disease with cirrhosis. Vaccination against hepatitis B protects against HDV.

Other Bloodborne Infectious DiseasesTuberculosis and other serious infectious diseases have been transmitted to healthcare workers through percutaneous exposure. Bloodborne m.Tuberculosis is found with increased frequency in patients with HIV, and the emergence of drug-resistant strains of tuberculosis has become an additional cause for concern. Rarely seen agents such as the Ebola virus and malaria could be spread by occupational exposure to blood, as could a long list of other serious but uncommon diseases. It is neither the purpose nor the scope of this book to consider all of these in detail, but an important point can be made: If O.R. professionals use an integrated strategy to deal with the common bloodborne pathogens HIV, HCV, and HBV, little or no adjustments will be necessary when faced with operating on patients with exotic diseases.

Unreported Injuries and ExposuresAlthough the focus of this book is prevention, exposures cannot be totally eliminated. If despite our best efforts an exposure occurs, it should be reported. While reporting and post-exposure follow-up does generate anxiety, nonreporting generates both anxiety and denial and could lead to disastrous consequences. In the case of significant exposure to HIV, initiation of post-exposure prophylaxis should begin as soon as possible, preferably within one to two hours, according to the U.S. Public Health Service (see Appendix B). Timely and accurate data collection following an exposure helps to ensure the exposed healthcare worker receives prompt and appropriate treatment and a clearly outlined course of follow-up.

Workers are more likely to report if a well-established and known plan is in place. Currently, computerized self-reporting systems are being developed to facilitate immediate and direct reporting by the exposed worker, preserve confidentiality, and facilitate appropriate counseling and follow-up.

ABOUT THE AUTHORABOUT THE AUTHORMark S. Davis, M.D. is a gynecologic surgeon with over 30 years experience, as well as a consultant and speaker on safety and infection control in the Operating Room, Delivery Room, and other invasive hospital work sites. To request a consultation or speaker presentation for your hospital, organization or association, please Email msdavismd@aol.com.

New Safety Products: Dr. Davis consults with healthcare industry on development and testing of safety products. Interested companies may Email msdavismd@aol.com

SAFETY VIDEO: “Stuck in Surgery; Sharps Safety in Today’s OR”ONE OF THREE ESSENTIAL O.R. SAFETY AND OSHA COMPLIANCE RESOURCESFacilitate 2002 OSHA compliance in the OR and hospital-wide sharps safety education. A safety champion speaks out in this essential 18-minute video for all levels of OR professionals. Infection control expert Mark S. Davis MD brings together the key points your staff need to know to prevent exposures. See the author "live" in the OR demonstrating safety techniques and discussing ways to prevent sharps injuries. Perfectly complements all surgeons and staff reading the safety handbook, Advanced Precautions for Today's OR; The operating room Professional's Handbook for the Prevention of Sharps Injuries and Bloodborne Exposures. Essential for all staff in the OR, Labor & Delivery, Surgicenter, Emergency Department and Trauma Center.

Stuck in SurgerySharps Safety in Today’s OR

(Add Scanned image of video product, also (side by side): opening shot of blood on glove and/or nurse)

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SAFETY POSTERS (set of 10) ONE OF THREE ESSENTIAL O.R. SAFETY AND OSHA COMPLIANCE RESOURCES Informational and motivational daily reminders to post in the OR and L & D. Printed on 8&1/2 X 11’’ heavy stock in neon colors for maximum impact. Suitable for framing or laminating. Order enough sets of posters for each of your ORs and delivery rooms. $30.00 plus $5.00 shipping & Handling

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New and revised for 2002 OSHA compliance An essential risk awareness and educational tool Post at scrub sinks, OR staff, surgery, OB lounges Motivate and reinforce safer behavior

POSTER TITLES / KEY POINTS ADDRESSED1. Guidelines for no-hands passing of sharps

Using the Safe Zone (Neutral Zone) safely2. Blunt Suture Needles

How, When and Where to Use, How to Identify and Select3. Barrier Selection

Appropriate Selection Criteria for PPE4. Precautions for Anesthesia Personnel

Eye protection, needle safety5. Cost of Exposures

Informs staff of costs and risks; motivates safe behavior6. Infectivity Rates of the 3 common Bloodborne Pathogens

HIV, hepatitis B and C risk following various types of exposures7. Labor & Delivery Safety Checklist

A must for all levels of maternity care providers 8. Laparoscopic / Endoscopic Safety Checklist

Safe handling of sharps, management of smoke and plume9. Planning Ahead For Safety #1

PPE, Safe Work Practices, Sharps management10. Planning Ahead For Safety #2

How to focus on safety when using sharps

Order enough of these informational and motivational Safety Posters for each of your ORs and delivery rooms today! Adapted from Advanced Precautions for Today’s OR, the best- selling breakthrough safety handbook for operating room staff and surgeons. These posters are the perfect adjunct to each member of your staff owning this “must-have” book.

ORDERING INFORMATION / ORDER FORMThe 3 Essentials: OR Safety handbooks, videos, postersThree ways to order By mail Print the order form below; mail with your check to:

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SAFETY HANDBOOKAdvanced Precautions for Today’s O.R. The Operating Room Professional’s Handbook for the Prevention of Sharps Injuries and Bloodborne Exposures by Mark Davis, MDForeword by Julie Gerberding, MD, MPH$14.95 per copy plus $5.00 shipping for 1-3 copies (Priority Mail) U.S.A.Call, fax, or Email sweinpub@aol.com for shipping on orders of 4 or more copies.

DISCOUNT BOOK PRICESBe proactive—eliminate exposures! Motivate and educate your personnel —Purchase enough copies of Advanced Precautions for Today’s O.R. For every at-risk care provider at your hospital at discount prices. For maximal savings, purchase direct from the publisher.

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COST OF SHARPS INJURIES Injury prevention saves healthcare dollars and lives.

WHAT DO INJURIES AND EXPOSURES TO BLOOD COST YOU?Hospitals have reported spending as much as $3500.00 for the follow up of a single sharps injury

or other bloodborne exposure. The EPINet study found 30 injuries per 100 occupied hospital

beds (national EPINet data for 1996). The significant cost of follow up of every sharps injury or

other bloodborne exposure—even if no infections occur—is preventable in most cases.

The monetary costs, human costs and damage to institutions and facilities are inseparably

linked. Here are some benefits of exposure prevention at your hospital or surgery center:

1. Save up to $3500 on follow up of each preventable exposure.

2. Save workers compensation costs.

3. Prevent transmission of bloodborne pathogens from patients to healthcare workers.

4. Prevent transmission of bloodborne pathogens from healthcare workers to patients.

5. Avoid risk of liability and litigation.

6. Avoid OSHA fines of up to $70,000 per incident.

7. Comply with JCAHO.

8. Protect the community image of your institution.

9. Attract and retain quality OR staff.

10. Reduce staff stress, improve morale, avoid burnout and job abandonment.

11. Create team spirit, communication and cooperation in a safer working environment.

12. Enhance quality, performance and efficiency.

13. Market your safer workplace to staff, patients, networks and managed care.

14. Enhance managed care vendors’ image of your facility as safe and cost effective.

Perhaps there are more benefits than you might have thought!

If you are a CEO, COO, CFO or risk manager, you can cost-effectively

purchase our educational resources and prevent sharps injuries & exposures.

WHERE do sharps injuries and exposures commonly occur? Operating rooms Labor and delivery ICU Emergency Department

WHAT are some unique hazards in the perioperative environment which prevent focusing on safety?

Fatigue Invasive radiology Crowding Need for speed Sub optimal lighting and visualization Under-utilization of safety equipment Distractions Multiprocessing

HOW can injuries and exposures be prevented?

By grass roots education of operating room professionals in injury prevention. Provide convenient educational resources, easily accessed by all at risk on a daily basis. Heighten perception and awareness of the magnitude of risk. Understand the causes of injuries Understand how safer systems prevent exposures, and how to properly apply those systems. Establish safer options as the default setting in the OR.

WHAT can administrators do to help? Utilize healthcare networks and alliances to cost effectively purchase educational materials

and safer equipment. Collect data on injuries and exposures and identify causes of errors Identify corrective systems and evaluate their effectiveness Educate the users in use of new safer technology and practices Educate care providers and assess their knowledge Implement safer systems and provide unimpaired access to safer devices 24 hours / 7 days a

week

WHAT are some obstacles to education and compliance, which can be overcome?

False perception of risk of injury False perception of utility and risk of safer systems Diverse group of device users—education level and background vary Failure to establish a team approach which includes administration, management and care

providers

Overcome the obstacles:

Purchase enough copies of the safety handbook Advanced Precautions for Today’s O.R. for every at-risk care provider at your hospital.

Purchase the safety video Stuck in Surgery for each hospital in your network.

Purchase sets of Safety Posters for each of your ORs and delivery rooms.

INJURY & EXPOSURE DATAINJURY AND EXPOSURE DATA, RISK OF INFECTIONSurgeon to patient transmission of bloodborne pathogensHIV Documented transmission of HIV from surgeons to patients has been reported twice; by a

dentist in the US to six patients, and an orthopedic surgeon in France to one patient.HBV Documented transmission of hepatitis B from thoracic surgeons to multiple patients has been

reported in the UK and US.HCVIn the US, several health care provider to patient transmissions of HCV infection were reported in 2002: US: Anesthesiologist to patient: Cody et al. HCV Transmission by Anesthesiologist to a

patient. Arch Int Med 2002;162:345-350

US: Cardiac surgeon to 3 or more patients. Rabin R. Officials: Surgeon likely infected 3 patients. Newsday, 3/27/02, p.A3

US: Cardiac surgeon to patient. Fiser W. Letter to the editor. Should Surgeons be Tested for Bloodborne Pathogens? Inf Control Hosp Epidem 2002;23:296-297

In Spain, UK, Germany, anesthetists have transmitted HCV to patients.

Patient to healthcare worker transmission of bloodborne pathogens;occupationally infected healthcare workers HIV—The CDC monitors the number of occupationally acquired HIV infections in

healthcare workers. As of December 1999, the number was 192 (56 documented and 136 suspected). Over 80% were the result of sharps injuries. Assuming that between 1% and 2% of patients are HIV-positive (and therefore that 1% to 2% of needlesticks are HIV-contaminated) between 18 to 35 new occupational HIV infections would occur from percutaneous injuries each year. Infections resulting from blood exposures to non-intact skin or mucous membranes would add between 2 to 4 cases (based on a transmission rate of .09% for a mucous membrane exposure).

Hepatitis B—250 healthcare workers die annually due to hepatitis B despite the availability of vaccines. The CDC estimates that 400 new occupational HBV infections occurred in 1995 among U.S. health care workers, down from 17,000 in 1983. (Arch Intern Med 1997;157:2601-2603)

Hepatitis C—There is not a vaccine and chronic infection is the rule. Healthcare workers are at an estimated 20-40 fold greater risk occupationally from HCV than HIV. Of the estimated 400,000 health care worker sharps injury exposures in the acute care setting annually in the US, 20,000 to 30,000 are to HCV. Of those exposed health care workers, 500 to 700 will acquire the disease. Hepatitis C is the most common chronic bloodborne infection in the US. Healthcare workers face greater exposure and disease risks as the prevalence of HCV in the patient base increases. HCV is the cause of half of chronic liver disease deaths each year; chronic liver disease being the 10th leading cause of death among adults in the US. (Source: Frontline Healthcare Workers Safety Conference, Aug. 6-8, 2000 Washington, DC.)

Number of injuries annuallyThe CDC estimates 500,000 to 800,000 injuries occur annually.

Under-reporting of injuries in the ORUnderreporting of sharps injuries, blood contamination of the hands, and splashes to the eyes and face is most evident in surgery. Surveys indicate that as few as 30% to 4% of exposures may be actually reported by surgeons.

Average risk of Infection Following a Single HIV, HBV, or HCV-Contaminated Needlestick or Sharp Instrument Injury (Source: CDC)(revised 10/13/99)

HIV 0.3%

HBV 6% - 30%

HCV - 1.8%

Annual estimated new occupational HBV infectionThe CDC estimates that 400 new occupational HBV infections occurred in 1995 among U.S. health care workers, down from 17,000 in 1983. (Arch Intern Med 1997;157:2601-2603)

Annual estimated new occupational HIV infectionAssuming that between 1% and 2% of patients are HIV-positive (and therefore that 1% to 2% of needlesticks are HIV-contaminated) between 18 to 35 new occupational HIV infections would occur from percutaneous injuries each year. Infections resulting from blood exposures to non-intact skin or mucous membranes would add between 2 to 4 cases (based on a transmission rate of .09% for a mucous membrane exposure).

Annual estimated new occupational HCV infectionData presented at the 2001 Frontline Healthcare Workers Safety Conference in Washington, DC predict 400 to 700 healthcare workers will occupationally acquire HCV infection annually. There is no vaccine or CDC approved post exposure prophylaxis for HCV. Early treatment may prove effective, but therapeutic agents are costly and toxic. Most of the predicted infections may be preventable through education, safer devices and safer work practices.

The consequences of occupational exposure to bloodborne pathogens, whether infections occur or not, annually cause psychological trauma to thousands of health care workers during months of waiting for notification of serological results. Other personal consequences include postponement of childbearing, altering sexual practices and side effects of prophylactic drugs. In the worst case scenarios, infection, chronic disabilities, loss of employment, denial of worker compensation claims, liver transplant, and premature death may result.

OSHA COMPLIANCE WHAT OSHA REQUIRES IN THE ORThe New OSHA Compliance Directive:

Relevance for Surgical Work sites Physician and Surgeon Responsibility Liability of Physicians and Surgeons to Citation

Abstract: The Compliance Directive issued by OSHA (DIRECTIVES NUMBER: CPL 2-2.44D), effective November 5, 1999, establishes policies and provides clarification to ensure uniform inspection procedures to enforce the Occupational Exposure to Bloodborne Pathogens Standard. This is a Federal Program Change which applies OSHA-wide; all states are expected to have standards, enforcement policies and procedures which are at least as effective.

Background: On December 6, 1991, OSHA issued its final regulation on occupational exposure to bloodborne pathogens, based on a review of information which showed health care workers face a significant health risk as a result of occupational exposure to blood and other potentially infectious materials which may contain bloodborne pathogens. (Current estimates vary between 590,000 and 800,000 injuries annually.) Bloodborne pathogens include but are not limited to those which cause hepatitis B, AIDS, hepatitis C, Creutzfield-Jacob disease, syphilis, malaria, viral hemorrhagic fever, leptospirosis, brucellosis, babesiosis, arborviral infections, relapsing fever, and HTLV-1. The agency further concluded these hazards can be minimized or eliminated by using a combination of engineering and work practice controls, personal protective clothing and equipment, training and medical surveillance, and signs and labels.

New Technology and Work Practices: In the new Compliance Directive, OSHA clarifies its position regarding the implementation of effective engineering controls to reduce needlesticks and other sharps injuries. Effective engineering controls include the use of safer medical devices to prevent percutaneous injuries before, during, or after use through safer design features. The employer must use engineering and work practice controls to eliminate or minimize occupational exposure. Examples cited include no-hands passing of sharps, blunt suture needles, needleless IV connectors, and self-sheathing or retracting needles or syringes. Significant improvements in technology are most evident in the growing market of safer medical devices. There is now a large body of research and data available to OSHA and the public concerning the effectiveness of these engineering controls. Where engineering controls will reduce employee exposure either by removing, eliminating or isolating the hazard, they must be used.

Training and Education: OSHA does not advocate the use of one particular safer device over another, but expects employers and users to use CDC studies of efficacy, pilot tests by the employer or data available in published studies to choose from available safer devices and implement them. Employers must train and educate employees who use safer devices and work practices to ensure acceptance and proper use. If a combination of engineering and work practice controls used by the employer does not eliminate or minimize exposure, the employer shall be cited for failing to use engineering and work practice controls.

Personal Protective Equipment: The type and amount of PPE must be chosen to protect against contact with blood or other potentially infectious materials based upon the type of exposure and quantity

of these substances reasonably anticipated to be encountered during the performance of a task or procedure.

Physicians' and Surgeons' Responsibility: Compliance is required when physician or surgeon is the employer of one or more employee(s) who may have contact with blood or body fluid. Physician or surgeon must control or prevent bloodborne pathogen hazards that expose their employees and/or hospital employees at the hospital in surgery or other invasive procedures. Physician/surgeon practices must have an Exposure Control Plan, identify employees at risk for exposure and provide bloodborne pathogen education at time of employment and annually. Identified employees must be offered hepatitis B vaccination free of charge. Post exposure evaluation and follow up must be provided if an exposure occurs, to include medical evaluation and post exposure prophylaxis if indicated. Required record keeping for education records is 3 years and exposure records is 30 years. While in the hospital, as in the office, physicians and surgeons must use safer devices when they will remove, eliminate or isolate the exposure hazard, use personal protective equipment and safe work practices, and follow the hospital Exposure Control Plan.

Surgeons as Employees or Employers:In the section of : CPL 2-2.44D defining Multi-Employer and Related Worksites (pages 5-7), OSHA states that physicians and healthcare professionals who have established an independent practice may be employers or employees. Physicians who are unincorporated sole proprietors or partners in a bona fide partnership are employers for purposes of the OSH act and may be cited if they if they employ at least one employee (such as a technician or secretary). Such physician-employers may be cited if they create or control bloodborne pathogens hazards that expose employees at hospitals or other sites where they have staff privileges. Physicians may be employed by a hospital or other healthcare facility or may be members of a professional corporation and conduct some of their activities at host employer sites where they have staff privileges. Where professional corporations are the employers of their physician-members, professional corporations may be cited for exposure of its physicians and other workers at a host employer site.

Summary: In order to comply with OSHA COMPLIANCE DIRECTIVES NUMBER CPL 2-2.44D, employers who provide surgical and obstetrical services and physicians who use those facilities will need to update their existing exposure control plan, choose and implement effective engineering and work practices from the broadening market of safety devices, and eliminate or minimize occupational exposures.

FREQUENTLY ASKED QUESTIONS:

Q. Why the need for a new Compliance Directive?A. The Occupational Safety and Health Administration (OSHA) issued a revised directive intended to protect healthcare workers from bloodborne pathogens. The directive stressed the importance of annual reviews of employers' bloodborne pathogens programs and the use of safer medical devices and work practices to reduce needlesticks and other injuries from sharp products. The new OSHA directive will help minimize serious health risks faced by workers exposed to blood and other potentially infectious materials (OPIM). Among the risks are human immunodeficiency virus (HIV), hepatitis B and hepatitis C. Hepatitis C virus (HCV) is the most common chronic bloodborne infection in the United States.

Q. What's new about it?A. OSHA has always required employers to use engineering and work practice controls. The employer now must use engineering and work practice controls that eliminate or minimize occupational exposure. It updates an earlier directive issued in 1992 and reflects the availability of improved devices, better treatment following exposure and OSHA policy interpretation.

Q. What is its function and purpose?A. The directive guides OSHA's compliance officers in enforcing the standard that covers occupational exposure to bloodborne pathogens and ensures consistent inspection procedures are followed. Effective November 5, 1999, employers, including hospitals and physicians, may be cited for failure to comply with the new directive.

Q. What are the key points of the new OSHA Compliance Directive?A. The following is a summary of some of the key revisions.

The directive emphasizes the use of effective engineering controls, including safer medical devices such as blunt suture needles, work practices including no-hands passing of sharps in the operating room, administrative controls and personal protective equipment.

Employers must ensure that their annually reviewed Exposure Control Plan reflects consideration and use of commercially available safer medical devices. The plan must document consideration and implementation of appropriate commercially available and effective engineering controls designed to eliminate or minimize exposure, subject to citation.

Employers should rely on relevant evidence in addition to FDA approval to ensure effectiveness of devices designed to prevent exposure to bloodborne pathogens.

Employee acceptance and employee training are required for the engineering control to be effective.

Q. What if my state has its own OSHA regulations?A. The Compliance Directive applies OSHA-wide. States are to have standards, enforcement policies and procedures at least as complete as federal OSHA.

Q. How are safety devices selected?A. Each healthcare setting is urged to have its own tailored program that is developed with input and review from workers. In addition, devices should be used and evaluated as part of a comprehensive program of safe work practices, in which workers are trained in certain safety practices.

Q. How effective have exposure prevention programs been? A. Some institutions have achieved success in reducing injuries by as much as 88 per cent.

Q. How common are sharps injuries?

A. The CDC estimated that there are 600,000 to 800,000 occupational needlestick injuries each year, which could lead to serious or potentially fatal infections such as hepatitis C or HIV, particularly in surgery. The precise number could be higher because needlesticks often go unreported, especially in the OR.

Q. What if safety controls cannot be used?A. Employers must take advantage of new technological devices and replace risky work practices to eliminate risk of exposure to blood and other infectious materials in the workplace. In instances where it is impossible to use safety controls, OSHA compliance officers will expect employers to have documented why.

Q. How much can OSHA fine, and are multiple violations possible?A. Employers who do not update their exposure control plans annually and do not use safety devices are in double violation of the standard. Fines range from $7000 to $70,000, with the largest fines assessed against employers who knew about a hazard, knew employees were exposed and purposely chose not to do anything about it (willful violations). Penalties are made on a case-by-case basis.

Q. Which types of employers, other than hospitals, may be liable to citation?A. The Multi-Employer Work sites section of the new Compliance Directive focuses on physicians in independent practice, employment agencies, personnel services, home health services, and independent contractors. Physicians on staff at hospitals who are not hospital employees may not be cited for exposing themselves to the hazards of bloodborne diseases, however, under the multi-employer guidelines, such physicians or their professional corporations (employers) may be cited if they cause exposure of associates or employees at hospitals, surgicenters or other sites where the surgeons have privileges.

Q. Who is responsible for education?A. The onus is on the employers to educate personnel to use safety devices correctly and to monitor to ensure compliance with safe use practices. The use of effective training and education is required for employees whenever safer devices are implemented. Interactive training sessions are stressed rather than just the use of films or videos that do not provide the opportunity for discussion with a qualified trainer.

Q. How many inspections does OSHA conduct per year in response to possible violation of the Bloodborne Pathogen Standard (BPS), and how many citations are issued?A. In fiscal year1999, 34,245 inspections were conducted in all categories; of those, 806 were in the health care setting, and 539 were for violations of the BPS (1910.1030). Total citations for violations of the BPS was 1,026.

Q. How many citations are challenged annually by employers, and what percentage of challenges are successful?A. Of 806 inspections for BPS violations, 69 were contested. As of April, 2000, no data was available on the outcome of the contested violations.

Q. What is the cost of exposures?

A. Hospitals have reported paying up to $3500 for follow-up, monitoring and testing of an employee with a high risk exposure, and up to $1 million for employees who become infected with HIV on the job. High-risk exposure could lead to hepatitis C, with an 85% chance of developing chronic liver disease with a 75% chance of requiring a liver transplant. (See also Cost of Sharps Injuries).

References and resources for information access:1. To receive a hard copy of the 263 page Compliance Directive, call the OSHA Office of Health Compliance Assistance (202) 693-2190. To download the document, visit the OSHA web site at www.osha.gov.The directive replaces and updates appendices. It includes the following: examples of committees in health care facilities; sample engineering control evaluation forms; an Internet resource list; a "fill-in-the-blanks" sample exposure control plan; and CDC guidelines pertaining to HIV exposure, control and prevention of hepatitis C, and hepatitis B vaccinations.

2. Advances in Exposure Prevention Vol 5, No 1-2000:1-10.Visit the web site of the International Health Care Worker Safety Research and Resource Center at the University of Virginia: http://www.med.virginia.edu/~epinet

3. Visit the Premier Safety Web site at http://www.premierinc.com/safety

4. Visit www.NAPPSI.org for an extensive list of all classes of safety devices.

NEEDLESTICK SAFETY & PREVENTION ACT 2000 Federal Needlestick Safety and Prevention Act - FAQs

Q: What are the key provisions of the Federal Needlestick Safety and Prevention Act? A: The Federal Needlestick Safety and Prevention Act: Sets forth in greater detail requirements for employers to identify, evaluate, and implement

safety-engineered medical devices. Requires the maintenance of a sharps injury log Mandates involvement of non-managerial employees in evaluating safety devices.

Q: Is the law in full effect?A: In 2002, all medical practices and facilities should be using safety devices whose safety feature is integral to the device.

Q: How will OSHA enforce the Needlestick Safety and Protection Act?A: As of April 1, 2002, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) will require full compliance with the new Bloodborne Pathogen Standard, including the use of safety devices, in order to receive accreditation.

Q: Who must use safety devices?A: The Act applies to all employers who have employees with reasonably anticipated occupational exposure to blood or other potentially infectious materials (OPIM), including: • Hospitals Surgery Centers Medical Clinics Physician offices Nursing homes Home Care/ Home Infusion

Q: Have citations been issued, and which types of facilities have been fined?A: Since the law was passed, OSHA officials have inspected all types of healthcare facilities, and have issued citations and fines to those not in compliance. This has included hospitals, physician practices, surgery centers and nursing homes.

Q: What fines will OSHA issue if a healthcare facility is cited for noncompliance? Each citation can lead to a fine of up to $7,000. “Willful” violations can lead to fines as high as $70,000. Failure to use a safety product, such as blunt tipped suture needles where applicable, can lead to multiple citations, which could include: • Failure to document evaluation and use of the safety product in the Exposure Control Plan. • Failure to include involvement of exposed employees in the evaluation and selection of safety products. • Failure to implement safety products.

Q: What if no one on our staff has had a sharps injury?A: OSHA intends to prevent occupational injuries, exposures and illnesses.

Q: What if a safety-engineered option is not available for a medical device?A: Employers also must investigate availability of safety devices each year, and document that fact in their Exposure Control Plan. If a safer device is available, but back ordered or delayed, this must be documented. The device must be implemented as soon as it becomes available, and documented.

Q: We have tried safety-engineered devices, and we don't believe they are safer than what we use today. Do we still need to convert to safety products?A: This judgment will likely be challenged since OSHA has already collected data from across the country demonstrating that safety-engineered devices do effectively reduce needlesticks. Deciding not to use safety devices needs to be based on clinical justifications that are clearly documented in the Exposure Control Plan. In the absence of such clinical evidence, employers are expected to adopt available safety devices.

Q: What if safety-engineered devices are “too costly”?A: Before passing the Needlestick Act, OSHA conducted an industry-wide cost/benefit analysis and concluded that the use of safety medical devices was beneficial due to the reduction in expenses associated with testing and treating injured healthcare workers. For example, workup and prophylaxis of a high-risk exposure to HIV can cost as much as $3500. Moreover, $500,000 to $1,000,000 may be spent to treat a worker who contracts hepatitis C or HIV.

Q: May we use the safety product for only ‘high-risk” situations? A: No. The Law requires employees to use safety devices in all cases where safer medical devices are available.

Q: Does OSHA publish a list of available safer medical devices? A: No. OSHA does not approve or endorse any product. It is your responsibility as an employer to determine which engineering controls are appropriate for specific hazards, based on what is appropriate to the specific medical procedures being conducted, what is feasible, and what is commercially available. For more information on blunt sutures, see Advanced Precautions for today’s OR.

Q: Does the safety legislation still apply when the physician is both the employer and employee?A: The BBP standard applies to all workplaces, regardless of size, as not only are the practicing physicians at risk of needlesticks, but also those employees working with them and downstream.

Q: Who must keep a sharps injury log? Does it have to be confidential?A: If your practice has 10 or more employees, you must maintain a sharps injury log for recording injuries from contaminated sharps. The Sharps Log must detail the injury, the type and brand of device involved in the injury (if known), the department or work area where the exposure occurred, and an explanation of how the incident occurred. The log must protect the confidentiality of the injured employee.

Q: What information do I need to include in my written Exposure Control Plan? How often to I need to update it?A: In addition to what is already required by the 1991 standard, the revised standard requires the documentation of annual consideration and implementation of appropriate engineering controls, and solicitation of non-managerial workers in evaluating devices. The plan must be reviewed and updated every year.

Q: How does the revision affect states that have their own federally-approved occupational

safety and health programs?A: States with state OSHA programs were required to adopt the revised standard by Oct. 18, 2001. States may choose to implement their own, more stringent standards independently of the Needlestick Act.

Q: Where can I get further information about what is expected of an employer?A: Employers should read the OSHA Bloodborne Pathogens Standard and the Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, which can be obtained at http://www.osha.gov or by phone at 1-800-321-OSHA. The National Institute for Occupational Safety and Health (NIOSH) and the Centers for Disease Control and Prevention (CDC) also have documents related to the prevention of occupational exposure to blood and OPIM.

RISK MANAGERSFROM THE VIEWPOINT OF ENTERPRISE-WIDE RISK MANAGEMENT,Consider the economic and human factors…

Benefits of exposure prevention at your hospital or surgicenter:1. Avoid liability and litigation.2. Avoid OSHA fines of up to $70,000 per incident.3. Comply with JCAHO4. Save workers compensation costs.5. Save up to $3500 on follow up of each exposure. (facilities average 30 exposures per 100 beds annually — source: EPINet))6. Protect community image of your institution.7. Preserve and Promote your facility image as safe and cost effective. 8. Prevent patient-to-care provider infection with bloodborne pathogens.9. Prevent care provider-to-patient infection with bloodborne pathogens.10. Reduce staff stress, improve morale, avoid burnout and job abandonment.11. Create team spirit, communication, and cooperation in a safer working environment.12. Attract and retain qualified OR staff .13. Market your safer workplace to current and prospective staff, patients and managed care networks.14. Ensure quality, performance and efficiency

Be proactive—eliminate exposures! Motivate and educate your personnel;Purchase enough copies of Advanced Precautions for Today’s O.R. for every at-risk care provider at your hospital at discount prices. For maximal savings, purchase direct from the publisher.

Facilitate the transformation to safer surgical and obstetrical work sites by providing cost-effective education. Advanced Precautions for Today’s O.R is an enduring resource which provides easy-to-read information for all care providers at risk. Prevent injuries and exposures to

blood in all hazardous invasive work sites—the OR, labor & delivery, ED, ICU/CCU, interventional radiology. Order copies for all staff and physicians at risk of exposure.Dr. Davis is a member of ASHRM and a member of ASHRM's Environmental and Occupational Health Task Force.

Advanced Precautions for Today’s O.RAn invaluable quality improvement, risk management and error reduction tool

A life saving manual...should be required reading.” Michael Swor, MD, Asst. Clinical Professor, Dept. of ObGyn, Univ. of South Florida

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HEALTHCARE ADMINISTRATORS Consider these economic and human factors…

The benefits of exposure prevention at your hospital or surgicenter:1. Save up to $3500 on follow up of each exposure.

(facilities average 30 exposures per 100 beds annually — source: EPINet))2. Avoid OSHA fines of up to $70,000 per incident.3. Comply with OSHA and JCAHO4. Save workers compensation costs..5. Avoid liability and litigation.6. Protect community image of your institution.7. Preserve and promote image of facility as safe and cost effective. 8. Prevent patient-to-care provider infection with bloodborne pathogens.9. Prevent care provider-to-patient infection with bloodborne pathogens.10. Reduce staff stress, improve morale, avoid burnout and job abandonment.11. Create team spirit, communication, and cooperation in a safer working environment.12. Attract and retain qualified OR staff .13. Market your safer workplace to current and prospective staff, patients and managed care networks.14. Ensure quality, performance and efficiency.

Take control—prevent exposures! Motivate and educate your personnel.Purchase enough copies of Advanced Precautions for Today’s O.Rfor every at-risk care provider at your hospital. For maximal savings, Purchase direct from the publisher (See below).

Facilitate the transformation toward safer surgical and obstetrical work sites by providing cost-effective education. Advanced Precautions for Today’s O.R is an enduring resource, which provides easy-to-read information for all at-risk care providers to prevent injuries and exposures to blood in all hazardous invasive work sites.

Advanced Precautions for Today’s O.R. The Operating Room Professional’s Handbook for the Prevention of Sharps Injuries and Bloodborne Exposures By Mark Davis, MD, Foreword by Julie Gerberding, MD, MPH 160 page paperback, ISBN 0-9664873-6-2First printing March 1999, Sweinbinder Publications LLC

"A life saving manual...should be required reading.” Michael Swor, MD, Asst. Clinical Professor,

Dept. of ObGyn, Univ. of South Florida

Save by Ordering Direct from Publisher:Please contact: Sweinbinder Publications LLC, PO Box 11988, Atlanta, GA 30355Phone: (404) 261-4595 Fax: (404) 233-5662 Email: sweinpub@aol.com

HEALTHCARE INDUSTRY HEALTHCARE INDUSTRY

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BOOK ORDERS: Please contact:Sweinbinder Publications LLC, PO Box 11988, Atlanta, GA 30355Phone: (404) 261-4595 Fax: (404) 233-5662 Email: sweinpub@aol.com

CONTACT DR. DAVISTo sponsor a speaker presentation on safety to your sales staff at your company, at your client's hospital or other facility, or if your company would like to request a clinical evaluation of a safety product,Call 404-233-3359 Fax 404-233-5662 or Email Dr. Davis at msdavismd@aol.com

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CONTACT THE PUBLISHERFor more information about educational resources (Safety Handbook, Safety Video, Safety Posters), and for information on discount pricing for healthcare institutions and customized gift editions for corporations and healthcare networks, Email sweinpub@aol.com , fax (404) 233-5662, or call our Special Sales and Distribution Manager, Marjorie Rose at (404) 261-4595.

Sweinbinder Publications LLCP.O. Box 11988Atlanta, GA 30355

SAFETY LINKS

Premier Safety Web Sitehttp://www.premierinc.com/safety

NAPPSI National Alliance for the Primary Prevention of Sharps Injuries http://www.nappsi.org

International Health Care Worker Safety Research and Resource Center at the University of Virginiahttp://www.med.virginia.edu/~epinet

OSHA http:// www.osha.gov

Center for Disease Control and Prevention CDC http:// www.cdc.gov

Association of Operating Room Nurses AORN http:// www.aorn.org

Association of Surgical Technologists AST

Association for Professionals in Infection Control and Epidemiology, Inc. APIChttp://www.apic.org

Society for Hospital Epidemiology of America, Inc. (SHEA)http://www.medscape.com/Affiliates/SHEA

American Society for Healthcare Risk Management (ASHRM)http://www.ashrm.org

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