H
Committee Biographical Statements

Hugh Tilson, M.D., Dr.P.H. (Chair), is an epidemiologist and outcomes researcher whose career in preventive medicine and public health extends over three decades. He is currently Senior Adviser to the Dean of the University of North Carolina School of Public Health and Clinical Professor of Public Health Leadership and Adjunct Professor of Epidemiology and Health Policy at the University. Dr. Tilson chairs the National Steering Committee for the Centers for Education and Research on Therapeutics (CERTs) program for the Agency for Healthcare Research and Quality. From 1981 to 1996, he was an executive with Burroughs Wellcome and the Wellcome Foundation, where he was responsible for introducing epidemiological methods and principles. He was Founding Co-President of the International Society for Pharmacoepidemiology.

James M. Anderson, Ph.D., M.D., is Professor of Pathology, Macromolecular Science, and Biomedical Engineering in the Institute of Pathology, Case Western Reserve University, Cleveland, Ohio. He is a member of the Institute of Medicine. For the past 13 years, Dr. Anderson has been involved in the International Organization for Standardization (ISO) Task Force to Develop Standards for Medical Device Safety. He is the Chairman for Part 1 of the ISO 10,993 Standard that defines criteria for the biological response evaluation of medical devices, prostheses, and biomaterials. Dr. Anderson’s research interests range from his activity as a pathologist in clinical implant retrieval and evaluation to fundamental, mechanistic studies focused on de-



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Safe Medical Devices for Children H Committee Biographical Statements Hugh Tilson, M.D., Dr.P.H. (Chair), is an epidemiologist and outcomes researcher whose career in preventive medicine and public health extends over three decades. He is currently Senior Adviser to the Dean of the University of North Carolina School of Public Health and Clinical Professor of Public Health Leadership and Adjunct Professor of Epidemiology and Health Policy at the University. Dr. Tilson chairs the National Steering Committee for the Centers for Education and Research on Therapeutics (CERTs) program for the Agency for Healthcare Research and Quality. From 1981 to 1996, he was an executive with Burroughs Wellcome and the Wellcome Foundation, where he was responsible for introducing epidemiological methods and principles. He was Founding Co-President of the International Society for Pharmacoepidemiology. James M. Anderson, Ph.D., M.D., is Professor of Pathology, Macromolecular Science, and Biomedical Engineering in the Institute of Pathology, Case Western Reserve University, Cleveland, Ohio. He is a member of the Institute of Medicine. For the past 13 years, Dr. Anderson has been involved in the International Organization for Standardization (ISO) Task Force to Develop Standards for Medical Device Safety. He is the Chairman for Part 1 of the ISO 10,993 Standard that defines criteria for the biological response evaluation of medical devices, prostheses, and biomaterials. Dr. Anderson’s research interests range from his activity as a pathologist in clinical implant retrieval and evaluation to fundamental, mechanistic studies focused on de-

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Safe Medical Devices for Children veloping a better understanding of tissue, cell, and blood interactions with biomaterials. Erle H. Austin, III, M.D., is Professor of Surgery, Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Louisville Medical School. He is Chief of cardiovascular surgery at Kosair Children’s Hospital and also practices at other Louisville hospitals. He is a member of the Congenital Heart Surgeons’ Society (CHSS) and of the Scientific and Government Relations Committee of American Association of Thoracic Surgeons. Dr. Austin’s research and policy interests include evaluation of implanted medical devices to treat congenital heart problems and the development of criteria for evaluating the safety and effectiveness of medical devices for pediatric populations. Mark E. Bruley, is a biomedical engineer and Vice President for Accident and Forensic Investigation at ECRI, an independent nonprofit health services research agency in Plymouth Meeting, Pennsylvania. Since 1982 he has been responsible for ECRI’s health technology accident and forensic investigation programs that provide investigative and educational services worldwide. He recently developed the education and training materials for recognition, investigation, and root cause analysis of medical device adverse events in health care facilities for FDA’s new MedSun medical device problem reporting program. He publishes, lectures, and consults on medical device accident investigation, medical error and patient safety, problem reporting programs and regulations, and health care technology acquisition. Paul Citron, M.S.E.E., retired as Vice President for Technology Policy and Academic Relations at Medtronic, Inc., Minneapolis, Minnesota, after 32 years. His entire career at the company related to research and development. He is currently visiting professor at the University of California, San Diego. Mr. Citron was elected to the National Academy of Engineering (NAE) in 2003 for “innovations in technologies for monitoring cardiac rhythm and for patient-initiated cardiac pacing, and for outstanding contributions to industry–academia interactions.” He is currently a member of the NAE Division Committee on Engineering and Physical Sciences and the Bioengineering Peer Committee. He is a member of the Roundtable on Biomedical Engineering Materials and Applications. Mr. Citron was a founding member of the American Institute for Medical and Biological Engineering. William H. DuMouchel, Ph.D., is Vice-President, Research, and Chief Statistical Scientist at Lincoln Technologies, Inc., Wellesley Hills, Massa-

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Safe Medical Devices for Children chusetts. He previously was Senior Scientist at AT&T Labs and Research and Professor of Biostatistics and Medical Informatics at Columbia University. He has developed Bayesian methods for disproportionality analysis of databases of spontaneous reports of adverse drug reactions that are now used within FDA and industry. His research has also focused on Bayesian models for data mining and meta-analysis and on computer advisory systems for data analysis. Dr. DuMouchel is an elected fellow of the American Statistical Association and of the Institute of Mathematical Statistics. He served previously on the National Research Council Committee on Applied and Theoretical Statistics. Ellen J. Flannery, J.D., is a partner at Covington & Burling, Washington, DC. She advises clients regarding the regulation of medical devices, pharmaceuticals, and biological products, as well as product liability law. She has chaired the American Bar Association Section of Science and Technology and the ABA Coordinating Group on Bioethics and the Law. Ms. Flannery has been counsel in cases involving the scope of FDA’s legal authority and product liability defense and has taught Food and Drug Law seminars at Boston University, University of Maryland, and University of Virginia Law Schools. She serves on the editorial boards of the Guide to Medical Device Regulation and the Food and Drug Administration Enforcement Manual and has published a number of articles related to medical device regulation. Linda Golodner is President of the National Consumers League, the nation’s oldest consumer organization. She also chairs the National Council on Patient Information and Education and serves on the Board of Directors of the National Patient Safety Foundation, the Patient Safety Institute, and the American National Standards Institute, where she has chaired the Consumer Interest Forum. Among other activities, Ms. Golodner has served on the Steering Committee of the Centers for Education and Research on Therapeutics and the National Research Council Board on Agriculture and Natural Resources, and she is a member of the Underwriters Laboratories Consumer Advisory Council. She was appointed to the White House Apparel Industry Partnership, which she co-chaired, and she now serves on the Board of Directors of its successor organization, the Fair Labor Association. She received the American Pharmacists Association’s Hugo H. Schaefer Award and has been honored by the United Nations Association (National Capitol Area) for her work in human rights. Stephen J. Haines, M.D., is the Lyle A. French Chair and Head of the Department of Neurosurgery, University of Minnesota. He serves on the Neurological Devices Panel for the Medical Device Advisory Committee of

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Safe Medical Devices for Children the FDA Office of Device Evaluation. Dr. Haines has a primary clinical interest in pediatric neurosurgery. His work focuses on the application of advanced clinical research techniques to neurosurgery and the development of resources for the evidence-based practice of neurosurgery. Patricia Hicks, M.D., is Associate Professor in the Division of General Academic Pediatrics in the Department of Pediatrics at the University of Texas Southwestern Medical School at Dallas and Adjunct Professor of Law at Southern Methodist University. She is also the mother of a son who relies on a varying array of life-sustaining medical devices that he uses at home and at school. Dr. Hicks is the Director of the Pediatric Residency Training Program and Director of the Residents’ Continuity of Care Clinic in the residency training program where she teaches residents and also cares for children with complex chronic health conditions and counsels and advises their families, schools, and community. Her teaching responsibilities include a Clinical Ethics in Medicine medical school course and a combined law school and medical school course, Law, Literature, and Medicine. As a member of the hospital’s Information Systems Committee, she is involved with projects related to electronic medical records and database organization and design for research, reporting, clinical decision support, and monitoring. Stephen W. Lagakos, Ph.D., is Chair, Department of Biostatistics, Harvard University School of Public Health. He is a member of the Institute of Medicine and recently served on the Committee to Assess the Need for Clinical Trials of Testosterone Replacement Therapy. Dr. Lagakos’ current research involves a variety of statistical issues arising in clinical trials and other longitudinal studies, with particular emphasis on statistical methods and analyses relating to HIV and other infectious diseases. George Lister, M.D., is Professor and Chairman of Pediatrics, University of Texas Southwestern Medical School. He was formerly Professor of Pediatrics and Anesthesiology and Chief, Section of Critical Care and Applied Physiology, Department of Pediatrics at Yale University School of Medicine and Lecturer in the Department of Cellular and Molecular Physiology. He was also Medical Director of Pediatric Intensive Care at the Yale-New Haven Hospital. He is past Chair of the Board of Directors of the American Board of Pediatrics, past President of the Society for Pediatric Research, and National Council Member of the American Pediatric Society. With a research focus on oxygenation and hypoxia in infants and children, Dr. Lister has chaired the NICHD Collaborative Home Infant Monitoring Evaluation study, which has examined the use of apnea monitors for children considered at risk for SIDS.

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Safe Medical Devices for Children Jonathan J. Rosen, Ph.D., is a member of the Harvard Medical School faculty, a Senior Research Scientist at the Massachusetts General Hospital, and director of the research implementation program for the nonprofit Center for the Integration of Medicine and Innovative Technology (CIMIT) Consortium. He is a member of the National Academy of Engineering’s Roundtable on Biomedical Engineering Materials and Applications. During his corporate career with Johnson & Johnson, he managed the cardiovascular development program, directed the corporate advanced research program for their Corporate Office of Science and Technology, and served as Chief Technical Officer for their Surgical Instrument Division before leaving to start a series of medical device ventures in Europe and in the United States. He is currently involved in several projects related to pediatric medical devices and the development of new technologies to improve care for underserved patient populations.

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