Single user license provided by AAMI. Further copying, networking, and distribution prohibited. STERILIZATION OF MEDICAL PRODUCTS Volume VII Editors: Robert F. Morrissey, Ph.D. John B. Kowalski, Ph.D. Johnson & Johnson Sterilization Science & Technology U.S.A. Johnson & Johnson Single user license provided by AAMI. Further copying, networking, and distribution prohibited. Proceedings of the International Kilmer Memorial Conference on the Sterilization of Medical Products Scottsdale, Arizona March 2-4, 1998 ® Johnson & Johnson 1998 ISBN 0-921-317-80-8 Polyscience Publications Inc. Champlain, N.Y. Printed in Canada. Single user license provided by AAMI. Further copying, networking, and distribution prohibited. Contents Copyright Preface Opening Session Opening Remarks James T. Lenehan Fred B. Kilmer – Infection Control Pioneer Robert F. Morrissey Keynote Address Joshua Lederberg Session I – Emerging Infectious Diseases A Global View of Emerging Infections and Antimicrobial Resistance James M. Hughes Emerging Infectious Diseases: An Overview Maria Neira and David L. Heymann Controlling Antimicrobial Resistance in Health Care Systems — A Multifaceted Problem John E. McGowan, Jr. Experimental Inoculation of Plants and Animals with Ebola Virus Robert Swanepoel, Patricia A. Leman, Felicity J. Burt, Nicholas A. Zachariades, Lawrence E.O. Braack, Thomas G. Ksiazek, Pierre E. Rollin, Sherif R. Zaki, and Clarence J. Peters Emergence of Rodent-borne Viruses: Arenavirus and Hantavirus Infection in South America Delia A. Enria and Silvana C. Levis Borna Disease Infection in Humans W. Ian Lipkin and Carolyn G. Hatalski Dengue Hemorrhagic Fever Suchitra Nimmannitya Tick-borne Diseases: The Emergence of Human Granulocytic Ehrlichiosis J. Stephen Dumler SingleDiscussion user license provided – Emerging by AAMI. Further copying, Infectious networking, andDiseases distribution prohibited. Session II – The Biology and Inactivation of Prions The Prion Diseases of Animals and Humans Stanley B. Prusiner Epidemiology of Creutzfeldt-Jakob Disease Robert G. Will Iatrogenic Creutzfeldt-Jakob Disease Paul Brown Inactivation of the Causal Agents of Transmissible Spongiform Encephalopathies David M. Taylor Inactivation of Prions by Hyperbaric Rendering Procedures B.E.C. Schreuder, R. E. Geertsma, L.J.M. van Keulen, J.A.A.M. van Asten, P. Enthoven, R.C. Oberthür, A.A. de Koeijer, and A.D.M.E. Osterhaus Discussion – The Biology and Inactivation of Prions Session III – Emerging Sterilization Issues & Technologies Introduction – Emerging Sterilization Issues & Technologies Eamonn V. Hoxey Radiation Dose Setting/Substantiation Methods: Have We Got It Right? Alan Tallentire Viral Safety of Biological Products Thomas J. Lynch Resistance “Creep” of Biological Indicators Nigel A. Halls Low-Temperature Sterilization Technologies William A. Rutala and David J. Weber Sterilization of Medical Devices, Pharmaceutical Components, and Barrier Isolation Systems with Gaseous Chlorine Dioxide John B. Kowalski Development of Biological and Chemical Indicators for Monitoring Vapor-Phase Hydrogen Peroxide Sterilization Processes and Evaluation of Performance Using a Biological Indicator Evaluator Resistometer Vessel Thomas B. May and Michael S. Korczynski Global Harmonization of Premarket Review of Sterilization Technology Timothy A. Ulatowski Discussion – Emerging Sterilization Issues & Technologies General Discussion Comments from Prof. Alan Tallentire – Recipient of the 1998 Kilmer Memorial Award Single user license provided by AAMI. Further copying, networking, and distribution prohibited. Single user license provided by AAMI. Further copying, networking, and distribution prohibited. Preface By all accounts, the Seventh International Kilmer Memorial Conference was the most compelling to date, set on the centennial anniversary of the publication of Kilmer’s classic paper entitled Modern Surgical Dressings. Two Nobel Laureates participated–Joshua Lederberg presided as the Conference General Chairman and Stanley Prusiner provided insight into the biological enigma of prions. The Conference was devoted to three themes: Emerging Infectious Diseases, Biology and Inactivation of Prions, and Emerging Sterilization Issues & Technologies. The program consisted of 22 invited speakers from seven countries, representing such diverse organizations as the World Health Organization, the Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration, academia, medicine, and the health care industry. In addition to the papers published in these proceedings, the reader is encouraged to review the discussion sections to get a flavor of the spirited interaction between the delegates and speakers especially on the topics of newly emerging infectious diseases, microbial resistance to antibiotics, and speculation as to the ultimate impact of prion diseases on humanity. The highlight of the Conference was the presentation of the Kilmer Award to Professor Alan Tallentire, former Graduate Dean and Professor of Pharmacy at the University of Manchester, for excellence in advancing research, education, and international standardization of sterilization science. Professor Tallentire has conducted pioneering work in the fields of radiation biology, aerobiology, and sterilization science, and has been a tireless global educator. These proceedings from the seventh Conference are dedicated to Dr. Eugene R. L. Gaughran. Throughout his 33-yeartenure at Johnson & Johnson, Dr. Gaughran was a champion of and innovator in the field of medical product sterilization. Among his many and varied contributions was the creation of the International Kilmer Memorial Conference. New Brunswick, NJ R.F. Morrissey, Ph.D. J.B. Kowalski, Ph.D. Single user license provided by AAMI. Further copying, networking, and distribution prohibited. Conference General Chairman Joshua Lederberg, Ph.D. The Rockefeller University, U.S.A. Opening Session Opening Remarks James T. Lenehan Johnson & Johnson, U.S.A. Fred B. Kilmer – Infection Control Pioneer Robert F. Morrissey, Ph.D. Johnson & Johnson, U.S.A. Keynote Address Joshua Lederberg, Ph.D. The Rockefeller University, U.S.A. Single user license provided by AAMI. Further copying, networking, and distribution prohibited. Single user license provided by AAMI. Further copying, networking, and distribution prohibited. Opening Remarks James T. Lenehan Johnson & Johnson, U.S.A. It is a privilege for me to welcome such a distinguished group of speakers, delegates, and Kilmer Award recipients to the Seventh International Kilmer Memorial Conference. To our many colleagues visiting from overseas, welcome to the sunny American Southwest. The Conference was last held in the United States in 1980, and it is very fitting that we commemorate the centennial of the publication of Kilmer’s classic work, Modern Surgical Dressings, by holding the 1998 Conference here in Scottsdale. The objective during our three days of deliberations is consistent with prior Kilmer Conferences, namely, to provide a forum for the sharing of scientific information that has a direct bearing on the health and well-being of people around the world, with special emphasis on the prevention of infection through intervention in the disease transmission process. This week’s program consists of 22 invited speakers from seven countries, representing such diverse organizations as the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the Food and Drug Administration, academia, medicine, and the health care industry. We thank Professor Joshua Lederberg for agreeing to serve as Conference General Chairman and for the participation of Dr. James Hughes, the Assistant Surgeon General and Director of the National Center for Infectious Diseases — the architect of the CDC’s program to control emerging and re-emerging infectious diseases. This Conference is actually the ninth undertaking that Johnson & Johnson has been associated with over a span of 24 years devoted to the theme of infection control and sterilization science — subjects that have their roots deep in the history of our enterprise. Many of you may be wondering why Johnson & Johnson would sponsor such an event. Beginning as it did in 1886, in the infancy of modern medicine, Johnson & Johnson joined physicians in the struggle against disease and infection. It was a time when life itself was fragile, and the most modest medical advances reaped huge rewards in terms of lives saved. Probably no area of human progress has made such remarkable gains over the past 112 years as has medical science — going as it has from virtual ignorance to vast knowledge of the human body and now its genetic constituents. Contributing to that progress, Johnson & Johnson developed the first ready-to-use surgical dressings in the mid-1880s which marked the first practical application of the theory of antiseptic wound treatment. Years later, in the mid-1950s, our Ethicon division pioneered the first industrial applicationSingle user license of provided ionizing by AAMI. Furtherradiation copying, networking, for the and distributionsterilization prohibited. of medical products by using an electron accelerator to sterilize surgical sutures. More recently, Ethicon advanced minimally-invasive surgical procedures to reduce surgery time and thus the potential for nosocomial infections. As a corporation, we continue to develop new sterilization technologies and equipment to meet the surgical requirements