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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-