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Safe Medical Devices for Children References AAO (American Association of Orthodontists). 1975. AAO issues special bulletin on extra oral appliance care, Editorial. American Journal of Orthodontics and Dentofacial Orthopedics 68:457. AAP (American Academy of Pediatrics). 1977. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 60(1):91–101. AAP. 1995. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 95(2):286–294. AAP. 2000a. Policy statement: Use of inhaled nitric oxide. Pediatrics 106(2):344–345. AAP. 2000b. Summary Statement by the American Academy of Pediatrics. Summit: Setting a Research Agenda for Patient Safety, Washington, DC. Agency for Healthcare Research and Quality. [Online]. Available: http://www.aap.org/advocacy/washing/patientsafety.htm [accessed July 8, 2005]. AAP. 2003. Technical report: Pediatric exposure and potential toxicity of phthalate plasticizers. Pediatrics 111(6):1467–1474. AAP, APA (Ambulatory Pediatric Association), APS (American Pediatric Society), AMSPDC (Association of Medical School Pediatric Department Chairs), SPR (Society for Pediatric Research). 2004a (August 20). Letter to Food and Drug Administration re: Response to FDA’s Request for Comments on the Availability of Appropriately Designed and Adequately Studied Medical Devices. [Online]. Available: http://www.fda.gov/ohrms/dockets/dailys/04/aug04/082504/04n-0254-c00012-vol1.pdf [accessed July 8, 2005]. AAP, APA, APS, AMSPDC, SPR. 2004b. Statement for the Committee on Postmarket Surveillance of Pediatric Medical Devices, Washington, DC. Institute of Medicine. Abrams S, Peart I. 1995. Twiddler’s syndrome in children: An unusual cause of pacemaker failure. British Heart Journal 73(2):190–192. ACC (American College of Cardiology). 2004. Statement for the Committee on Postmarket Surveillance of Pediatric Medical Devices, Washington, DC. Institute of Medicine. Acute Care. No date. Heartstream Patient Analysis System Testing with Pediatric Rhythms. [Online]. Available: http://www.acutecare.com/pedsaed1.htm [accessed July 8, 2005].

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Safe Medical Devices for Children AMA. 2004b. AMA Recommends That DHHS Establish a Registry for All U.S. Clinical Trials. [Online]. Available: http://www.ama-assn.org/ama/pub/category/13934.html [accessed July 8, 2005]. Anderson J, Wood H, Allaire P, Bearnson G, Khanwilkar P. 2000. Computational flow study of the continuous flow ventricular assist device, prototype number 3 blood pump. Artificial Organs 24(5):377–385. Arcarese JS. 2002a. Medical Devices in the Home Healthcare Community: Report of a Public Conference Held September 12–13, 2002 at the Natcher Auditorium, National Institutes of Health. Rockville, MD: Food and Drug Administration. [Online] Available: http://www.fda.gov/cdrh/CDRHHHC/091202-report.html [accessed July 8, 2005]. Arcarese JS. 2002b. Report on Home Use Medical Device Meetings. Washington, DC: The Food and Drug Law Institute. [Online]. Available: http://www.fda.gov/cdrh/meetings/FDLI-home.html [accessed July 8, 2005]. Arias E, Anderson RN, Kung H, Murphy SL, Kochanek KD. 2003. Deaths: Final data for 2001. In: National Vital Statistics Report. Vol. 52. no. 3. Hyattsville, MD: National Center for Health Statistics. Unpaged. [Online]. Available: http://www.cdc.gov/nchs/data/nvsr/nvsr52/nvsr52_03.pdf [accessed July 8, 2005]. ATS (American Thoracic Society). 2003. Statement on the care of the child with chronic lung disease of infancy and childhood. American Journal of Respiratory and Critical Care Medicine 168(3):356–396. ATS. 2004a (August 31). Statement for the Committee on Postmarket Surveillance of Pediatric Medical Devices, Washington, DC. Institute of Medicine. ATS. 2004b. Written statement to the Committee on Postmarket Surveillance of Pediatric Medical Devices, Washington, DC. Institute of Medicine. Ault A. 2004. House berates FDA, drug makers. The Scientist [Online]. Available: http://www.biomedcentral.com/news/20040910/04/ [accessed July 8, 2005]. Avorn J. 2004. The role of pharmacoepidemiology and pharmacoeconomics in promoting access and stimulating innovation. Pharmacoeconomics 22(Suppl 2):81–86. Bachmann C, Hugo G, Rosenberg G, Deutsch S, Fontaine A, Tarbell J. 2000. Fluid dynamics of a pediatric ventricular assist device. Artificial Organs 24(5):362–372. Bartholomew W, Kwak S, Ring D, Snyder B. 2001. Femoral shaft fractures in children: Comparative biomechanical analysis of a new flexible interlocking nail to current treatment methods. The Orthopedic Journal at Harvard Medical School 3:79–82. [Online]. Available: http://www.orthojournalhms.org/html/pdfs/manuscript-08.pdf [accessed July 8, 2005]. Bartlett R. 1985. Esperanza. Presidential address. Transactions—American Society for Artificial Internal Organs 31:723–726. Bartlett R, Roloff D, Custer J, Younger J, Hirschl R. 2000. Extracorporeal life support: The University of Michigan experience. Journal of the American Medical Association 283(7):904–908. Baru JS, Bloom DA, Muraszko K, Koop CE. 2001. John Holter’s shunt. Journal of the American College of Surgeons 192(1):79–85. Baskett R, Nanton M, Warren A, Ross D. 2003. Human leukocyte antigen-DR and ABO mismatch are associated with accelerated homograft valve failure in children: Implications for therapeutic interventions. Journal of Thoracic and Cardiovascular Surgery 126(1):232–239. Basse C. 2003 (December 27). He was a mechanic, gifted at saving lives. John W. Holter, who invented a shunt that won worldwide acclaim for helping hydrocephalics, has died. He was 87. Tampa Bay Times. Unpaged. [Online]. Available: http://www.sptimes.com/2003/12/27/Tampabay/He_was_a_mechanic__gi.shtml [accessed July 8, 2005].

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Safe Medical Devices for Children Beal AC, Co JPT, Dougherty D, Jorsling T, Kam J, Perrin J, Palmer RH. 2004. Quality measures for children’s health care. Pediatrics 113(1):199–209. Becker D, Nulsen F. 1968. Control of hydrocephalus by valve-regulated venous shunt: Avoidance of complications in prolonged shunt maintenance. Journal of Neurosurgery 28(3): 215–226. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz K, Simel D, Stroup D. 1996. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. Journal of the American Medical Association 276:637–639. Bessound B, deBaere T, Kuoch V, Descuennes E, Cosset M, Lassau N, Roxhe A. 2003. Experience at a single institution with endovascular treatment of complications caused by implanted central venous access devices in pediatric and adult patients. American Journal of Roentgenology 180(2):527–532. Blevins, K. 2003. FDA’s Use of Negative Publicity as an Enforcement Mechanism: Harvard Law School Third Year Paper. (Unpublished). [Online]. Available: http://leda.law.harvard.edu/leda/data/567/Blevins.html [accessed July 8, 2005]. Bluck J, Petty JA. 2000 (February 24). NASA computer rocket science helps Debakey heart pump team. NASA News. Unpaged. [Online]. Available: http://amesnews.arc.nasa.gov/releases/2000/00_14AR.html [accessed July 8, 2005]. Blum-Hareuveni T, Rehany U, Rumelt S. 2004. Correspondance: Blinding endophthalmitis from orthodontic headgear. New England Journal of Medicine 351(26):2774–2775. Bradlyn AS, Varni JW, Hinds PS. 2003. Appendix C: Assessing health-related quality of life in end-of-life care for children and adolescents. In: Institute of Medicine. When Children Die: Improving Palliative and End-of-Life Care for Children and Their Families. Pp. 476–508. Washington, DC: National Academy Press. Bren L. 2003 (November–December). Company caught in cover-up of medical device malfunctions. FDA Consumer Magazine. Unpaged. [Online]. Available: http://www.fda.gov/fdac/departs/2003/603_irs.html [accessed July 8, 2005]. Bright RA. 2004. Panel discussion before the Committee on Postmarket Surveillance of Pediatric Medical Devices, Washington, DC. Institute of Medicine. Brown S, Bezabeh S, Duggirala H. 2005. Center for Devices and Radiological Health Condition of Approval Studies As a Postmarket Tool for PMA Approved Cohort 1998–2000. Rockville, MD: Food and Drug Administration. [Online]. Available: http://www.fda.gov/oc/whitepapers/epi_rep.pdf [accessed July 8, 2005]. Bruley ME. 1994. Accident and forensic investigation. In: van Gruting CWD, ed. Medical devices: International perspectives on health and safety. Amsterdam: Elsevier. Bruno L, Ahrens J. 2005. Examining “operational failures” to reduce home care errors. Caring 24(2):34-35. Cahill A, Baskin K, Kaye R, Fitz C, Towbin R. 2004. Transmural migration of gastrostomy tube retention discs. Pediatric Radiology 34(2):143–147. Campbell A. 2004. Appendix B: State regulation of medical research with children and adolescents: An overview and analysis. In: Institute of Medicine. Ethical Conduct of Clinical Research Involving Children. Washington, DC: IOM. Pp. 320–383. [Online]. Available: http://www.nap.edu/books/0309091810/html/ [accessed July 8, 2005]. Campbell R, Smith M, Mayes T, Mangos J, Willey-Courand D, Kose N, Pinero R, Alder M, Duong H, Surber J. 2004. The effect of opening wedge thoracostomy on thoracic insufficiency syndrome associated with fused ribs and congenital scoliosis. Journal of Bone and Joint Surgery 86-A(8):1659–1674. Carstensen PB. 1996. Overview of FDA’s New Human Factors Program Plan: Implications for the Medical Device Industry. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/cdrh/humfac/hufacpbc.html [accessed July 8, 2005].

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Safe Medical Devices for Children Casey A, Kimmings E, Kleinlugtebeld A, Taylor W, Harkness W, Hayward R. 1997. The long-term outlook for hydrocephalus in childhood. A ten-year cohort study of 155 patients. Pediatric Neurosurgery 27(2):63–70. CDC (Centers for Disease Control and Prevention). 2001. Updated guidelines for evaluating public health surveillance systems: Recommendations from the Guidelines Working Group. Morbidity and Mortality Weekly Report 50(RR13):1–35. [Online]. Available: http://www.cdc.gov/mmwr/PDF/rr/rr5013.pdf [accessed July 8, 2005]. Cecchin F, Jorgenson D, Berul C, Perry J, Zimmerman A, Duncan B, Lupinetti F, Snyder D, Lyster T, Rosenthal G, Cross B, Atkins D. 2001. Is arrhythmia detection by automatic external defibrillator accurate for children? Sensitivity and specificity of an automatic external defibrillator algorithm in 696 pediatric arrhythmias. Circulation 103(20):2483–2488. Chalmers T. 1977. Randomize the first patient. New England Journal of Medicine 296(2):107. CHCPR (Center for Home Care Policy and Research). No date. Working Conditions and Adverse Events in Home Health Care. [Online]. Available: http://www.vnsny.org/research/projects/1_working.html [accessed July 8, 2005]. Children’s Amalgam Trial Study Group. 2003. The children’s amalgam trial: Design and methods. Controlled Clinical Trials 24(6):795–814. Clark BC. 1935 (April 2). Senate debate regarding regulation of traffic in food, drugs, and cosmetics. Congressional Record—Senate 79:4840–4851. Clark P, Leaverton P. 1994. Scientific and ethical issues in the use of placebo controls in clinical trials. Annual Review of Public Health 15:19–38. CMS (Centers for Medicaid and Medicare Services). 2004. Medicare Posts Coverage Decision to Expand Coverage of PET Scans for Alzheimer’s Disease. [Online]. Available: http://www.cms.hhs.gov/media/press/release.asp?Counter=1200 [accessed July 8, 2005]. CMS. No date. Medicare Coverage—Clinical Trials: Provider Bulletin. [Online]. Available: http://www.cms.hhs.gov/coverage/8d4.asp [accessed July 8, 2005]. Cochrane D, Kestle J. 2003. The influence of surgical operative experience on the duration of first ventriculoperitoneal shunt function and infection. Pediatric Neurosurgery 38(6):295–301. Coffey R, Edgar T, Francisco G, Graziani V, Meythaler J, Ridgely P, Sadiq S, Turner M. 2002. Abrupt withdrawal from intrathecal baclofen: Recognition and management of a potentially life threatening syndrome. Archives of Physical Medicine and Rehabilitation 83(6):735–741. Cole CH. 2000. Special problems in aerosol delivery: Neonatal and pediatric considerations. Respiratory Care 45(6):646–651. [Online]. Available: http://www.aarc.org/marketplace/reference_articles/06.00.0646.pdf [accessed July 8, 2005]. Colin A. 2003. Cystic fibrosis: Diagnosis and treatment. Pediatric Views October: Unpaged. [Online]. Available: http://www.childrenshospital.org/views/october03/fibrosis.html [accessed July 8, 2005]. Cordis. 2004. Press Release: Cordis Announces Nationwide Recall of Revised Instructions for Use for the Precise Rx Biliary Stent Contained in its Medical Device Notification. [Online]. Available: http://www.cordis.com/active/crdus/en_US/html/cordis/downloads/press/PreciseRX_IFU_Press_Release_050704.pdf [accessed July 8, 2005]. Couldwell W, LeMay D, McComb J. 1996. Experience with use of extended length peritoneal shunt catheters. Journal of Neurosurgery 85(3):425–427. Couzin J. 2004. Drug research: Legislators propose a registry to track clinical trials from start to finish. Science 305(5691):1695. Cronenwett J, Seeger J. 2004. Withdrawal of article by the FDA after objection from Medtronic. Journal of Vascular Surgery 40(2):209–210.

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Safe Medical Devices for Children FDA. 1998k. New Section 513(f)(2)—Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff. [Online]. Available: http://www.fda.gov/cdrh/modact/classiii.html [accessed July 8, 2005]. FDA. 1999a. A Device Clinical Trials Data Bank—Public Health Need and Impact on Industry: A Report to Congress. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/cdrh/modact/113(b)main.pdf [accessed July 8, 2005]. FDA. 1999b. Guide to Inspections of Quality Systems. [Online]. Available: http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm#page47 [accessed July 8, 2005]. FDA. 1999c. Medical Devices; Current Good Manufacturing Practice (CGMP) final rule; Quality system regulation. In: Medical Device Quality Systems Manual: A Small Entity Compliance Guide, 1st ed. [Online]. Available: http://www.fda.gov/cdrh/dsma/gmpman.html [accessed July 8, 2005]. FDA. 1999d. Milestones in U.S. food and drug law history. FDA Backgrounder [Online]. Available: http://www.fda.gov/opacom/backgrounders/miles.html [accessed July 8, 2005]. FDA. 1999e. Product Development Protocol. [Online]. Available: http://www.fda.gov/cdrh/pdp/pdp.html [accessed July 8, 2005]. FDA. 1999f (January 8). Shunt technology: Challenges and emerging directions. Conference for the Systematic Technology Assessment of Medicinal Products, Bethesda, MA. FDA. [Online]. Available: http://www.fda.gov/cdrh/stamp/shuntconf.pdf [accessed July 8, 2005]. FDA. 2000a. Draft guidance for infant/child apnea monitor 510(k) submissions; availability. Federal Register 65(185):57355–57356. [Online]. Available: http://www.fda.gov/ohrms/dockets/98fr/092200d.htm [accessed July 8, 2005]. FDA. 2000b. Guidance for Industry and FDA Premarket and Design Control Reviewers: Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/cdrh/humfac/1497.pdf [accessed July 8, 2005]. FDA. 2000c. Guidance for Industry: Medical Device Reporting - Alternative Summary Reporting (ASR) Program. [Online]. Available: http://www.fda.gov/cdrh/osb/guidance/315.html [accessed July 8, 2005]. FDA. 2000d. Medical devices; performance standard for the infant apnea monitor; withdrawal notice. Federal Register 65(185):57303–57307. [Online]. Available: http://www.fda.gov/ohrms/dockets/98fr/092200b.htm [accessed July 8, 2005]. FDA. 2000e. Medical Device Recalls—Class I Recall: Continuous Ventilator (Respirator). [Online]. Available: http://www.fda.gov/cdrh/recalls/recall-122200.html [accessed July 8, 2005]. FDA. 2000f. Note Concerning the March 27, 2000 Amendments to the MDR Regulation to Implement FDAMA Changes. [Online]. Available: http://www.fda.gov/cdrh/postsurv/note_932700.html [accessed July 8, 2005]. FDA. 2000g. Safety Notice: Potential for Injury from Circumcision Clamps. [Online]. Available: http://www.fda.gov/cdrh/safety/circumcision.html [accessed July 8, 2005]. FDA. 2001a. Appendix B: Alphabetical Patient Codes. [Online]. Available: http://www.fda.gov/cdrh/mdr/appendixb.pdf [accessed July 8, 2005]. FDA. 2001b. Appendix C: Numerical Patient and Device Codes. [Online]. Available: http://www.fda.gov/cdrh/mdr/appendixc.pdf [accessed July 8, 2005]. FDA. 2001c. Draft “guidance for clinical trial sponsors on the establishment and operation of clinical trial data monitoring committees”; Availability. Federal Register 66(224):58151–58153. [Online]. Available: http://www.fda.gov/ohrms/dockets/98fr/112001c.htm [accessed July 8, 2005].

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