Appendixes



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Safe Medical Devices for Children Appendixes

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Safe Medical Devices for Children This page intentionally left blank.

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Safe Medical Devices for Children A Study Origins and Activities The Medical Device User Fee and Modernization Act of 2002 (P.L. 107–250) called for the Institute of Medicine (IOM) to conduct a study of postmarket surveillance of pediatric medical devices. IOM appointed a committee of 13 experts to oversee the study. Its task was to develop a report that specifically examined the system under the Federal Food, Drug, and Cosmetic Act for postmarket surveillance of medical devices to assess whether the system as administered by the U.S. Food and Drug Administration provides adequate safeguards for the use of devices in children. As called for in the legislation, the study committee assessed the U.S. Food and Drug Administration’s monitoring and use of adverse reaction reports, registries, clinical studies, and other postmarket surveillance activities to identify unsafe or ineffective products; the adequacy of the agency’s monitoring of commitments for further clinical studies made by manufacturers at the time of approval of specific medical devices; the adequacy of postmarket surveillance studies to evaluate how children’s active lifestyles may affect implant failure rates and longevity; and the length of studies, including whether they continue long enough to evaluate the impact of children’s growth and development given the expected length of time that a child will have an implant. The committee met five times between April 2004 and March 2005. It organized two advisory panels to provide additional technical guidance on clinical and technical issues. It commissioned two background papers. The

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Safe Medical Devices for Children committee conducted three meetings with public sessions, including one to hear the views of family support and advocacy organizations and health care groups (with written statements invited from additional organizations). The committee also met with parents and young people who had personal experiences with implants or other complex medical devices. The agendas and participants for the public meetings are listed below. INSTITUTE OF MEDICINE Committee on Postmarket Surveillance of Pediatric Medical Devices Room 204, The Keck Center, National Academy of Sciences 500 Fifth Street NW, Washington, DC Public Session—April 15, 2004 1:00 Welcome and introductions 1:10 FDA Context and Perspectives   Donna-Bea Tillman, Ph.D. Deputy Director, Office of Device Evaluation Center for Devices and Radiological Health U.S. Food and Drug Administration Rockville, MD   Thomas Gross, M.D. Director, Division of Postmarket Surveillance Center for Devices and Radiological Health U.S. Food and Drug Administration Rockville, MD 2:40 Break 3:00 Research on Postmarket Surveillance: Experience of Duke Center for Education and Research on Therapeutics   Judith M. Kramer, M.D. Principal Investigator, Duke Center for Education and Research on Therapeutics Duke University Medical Center Durham, NC 4:00 Analysis of FDA Adverse Event Reports   Mark Bruley, B.Sc. Vice President, ECRI Plymouth Meeting, PA 5:15 Adjourn * * *

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Safe Medical Devices for Children INSTITUTE OF MEDICINE Committee on Postmarket Surveillance of Pediatric Medical Devices Room 100, The Keck Center, National Academy of Sciences 500 Fifth Street NW, Washington, DC Public Session—June 24, 2004 1:00 Welcome and introductions 1:10 Update from CDRH/FDA: Thomas Gross, M.D.   Briefing on Legislative Interest in Pediatric Medical Devices: Vipul Mankad, M.D. (Robert Wood Johnson Foundation fellow with Senate Health, Education, Labor and Pensions Committee) 1:30 Discussion with Clinical Advisory Panel   Jonathan Abramson, M.D. Professor and Chair, Department of Pediatrics Wake Forest University Winston Salem, NC   Francis Sessions Cole, III, M.D. Vice Chair and Park J. White Professor of Pediatrics Washington University School of Medicine Director, Division of Newborn Medicine St. Louis Children’s Hospital St. Louis, MO   Barbara Fivush, M.D. Professor of Pediatrics Johns Hopkins School of Medicine Division Chief, Pediatric Nephrology Johns Hopkins Hospital Baltimore, MD   Susan T. Iannaccone, M.D., F.A.A.N. Director, Neuromuscular Disease and Neurorehabilitation Texas Scottish Rite Hospital for Children Professor of Neurology UT Southwestern Medical Center Dallas, TX   John K. Niparko, M.D. George T. Nager Professor Director, Division of Otology, Neurotology & Skull Base Surgery Johns Hopkins School of Medicine Baltimore, MD

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Safe Medical Devices for Children   Ramon L. Ruiz, D.M.D., M.D. Assistant Professor, Oral/Maxillofacial Surgery & Pediatrics University of North Carolina at Chapel Hill Director, Pediatric Oral/Maxillofacial Surgery North Carolina Children’s Hospital Chapel Hill, NC   Frederick J. Schoen, M.D., Ph.D. Professor of Pathology and Health Sciences and Technology Harvard Medical School Executive Vice Chairman, Department of Pathology Brigham and Women’s Hospital Boston, MA 3:45 Break 4:00 Discussion with Methods Advisory Panel   Elizabeth B. Andrews, Ph.D., M.P.H. Vice President Pharmacoepidemiology and Risk Management RTI Health Solutions Research Triangle Park, NC   Roselie A. Bright, Sc.D. Epidemiologist Division of Postmarket Surveillance Office of Surveillance and Biometrics Center for Devices and Radiological Health U.S. Food and Drug Administration Rockville, MD   Robert T. Chen, M.D., M.A. Chief, Immunization Safety Branch National Immunization Program Centers for Disease Control and Prevention Atlanta, GA   Harry A. Guess, M.D., Ph.D. Professor of Epidemiology School of Public Health University of North Carolina at Chapel Hill Chapel Hill, NC 5:30 Adjourn * * *

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Safe Medical Devices for Children INSTITUTE OF MEDICINE Committee on Postmarket Surveillance of Pediatric Medical Devices Lecture Room, National Academy of Sciences 2101 Constitution Avenue, NW, Washington, DC Public Session—August 31, 2004 8:20 Welcome 8:30 Advanced Medical Technology Association   Susan Alpert, M.D. Vice President, Chief Quality and Regulatory Officer Medtronic Minneapolis, MN 9:00 American College of Cardiology, Congenital Heart Disease and Pediatric Cardiology Committee   Mark Boucek, M.D. Director of Pediatric Heart Failure and Transplant Research Programs The Children’s Hospital Denver University of Colorado School of Medicine Denver, CO   Pediatric Section, American Thoracic Society   Ann C. Halbower, M.D. Assistant Professor of Pediatrics and Medical Director of Pediatric Sleep Disorders Program Johns Hopkins University Baltimore, MD 9:45 American Academy of Pediatrics   Jon Abramson, M.D. Weston L. Kelsey Chair of Pediatrics Wake Forest University Baptist Medical Center Winston-Salem, NC   Pediatric Orthopedic Society of North America Michael Vitale, M.D., M.P.H. Chair, Evidence Analysis Work Group and Assistant Professor in the Division of Pediatric Orthopaedic Surgery Columbia University New York, NY 10:30 Break

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Safe Medical Devices for Children 10:50 National Association of Children’s Hospitals and Related Institutions1   Joelle Mast, M.D., Ph.D. Chief Medical Officer and Chief of Pediatrics Blythedale Children’s Hospital Valhalla, NY   Edwin Simpser, M.D. Executive Vice President and Chief Medical Officer St. Mary’s Hospital for Children Assistant Professor of Clinical Pediatrics New York University School of Medicine New York, NY 11:30 National Consumers League Alison Rein Assistant Director, Food and Health Policy Washington, DC 12:00 Adjourn NOTE: The following organizations endorsed the statement of the American Academy of Pediatrics: Ambulatory Pediatric Association, American Pediatric Society, Association of Medical School Pediatric Department Chairs, Society for Pediatric Research. Additional written statements were provided by: Section on Neurological Surgery (of the American Academy of Pediatrics); Society for Pediatric Anesthesia; American Pediatric Surgical Association; and Anthony D. Slonim, M.D., M.P.H. (of Children’s National Medical Center, Washington, DC). * * * INSTITUTE OF MEDICINE Committee on Postmarket Surveillance of Pediatric Medical Devices Lecture Room, National Academy of Sciences 2101 Constitution Avenue, NW, Washington, DC Public Session—August 31, 2004 (afternoon) Meeting with Families Wendy Baskins Nancy Harder and Ben Harder 1   Statements are those of guest speakers who represent member hospitals of NACHRI but who are not speaking for NACHRI.

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Safe Medical Devices for Children Donya Hartley Melisande Statz-Hill and Benjamin Hill Penny Hill and Amanda Hill Kim L. Katka Karen Marston