Bibliography Amoore, J., Ingram, P. (2002, August). Quality improvement report: Learning from adverse incidents involving medical devices. British Medical Journal, 325, Amoore, J., Ingram, P. (2002, August). Quality improvement report: Learning from adverse incidents involving medical devices. British Medical Journal, 325, Baker, D. (2002, April). Successful performance improvement. AORN, 75 (4): Baker, D. (2002, April). Successful performance improvement. AORN, 75 (4): Benner, P. (2001, July). Creating a culture of safety and improvement: A key to reducing medical error. American Journal of Critical Care, 10 (4): Benner, P. (2001, July). Creating a culture of safety and improvement: A key to reducing medical error. American Journal of Critical Care, 10 (4): Berman, S. (2000, July). The AMA clinical quality improvement forum on addressing patient safety. Joint Commission Journal on Quality Improvement, 26 (7): Berman, S. (2000, July). The AMA clinical quality improvement forum on addressing patient safety. Joint Commission Journal on Quality Improvement, 26 (7):

Bibliography (cont’d) Beyea, S. (2003, January). Tracking medical devices to ensure patient safety. AORN, 77 (1): Beyea, S. (2003, January). Tracking medical devices to ensure patient safety. AORN, 77 (1): Beyea, S. (2002, June). Finding patient safety internet resources. AORN, 75 (6): Beyea, S. (2002, June). Finding patient safety internet resources. AORN, 75 (6): Bogner, M.S. (1994). Human Error in Medicine. New Jersey: Erlbaum.Bogner, M.S. (1994). Human Error in Medicine. New Jersey: Erlbaum. Boyer, M. (2001, June). Root cause analysis in perinatal care: Health care professionals creating safer health care systems. Journal of Perinatal and Neonatal Nursing, 15 (1): Boyer, M. (2001, June). Root cause analysis in perinatal care: Health care professionals creating safer health care systems. Journal of Perinatal and Neonatal Nursing, 15 (1):

Bibliography (cont’d) Ebright, P., Patterson, E., & Render, M. (2002, September). The "new look" approach to patient safety. Clinical Nurse Specialist, 16 (5): Ebright, P., Patterson, E., & Render, M. (2002, September). The "new look" approach to patient safety. Clinical Nurse Specialist, 16 (5): FDA Modernization Act of 1997, amended, Section 519 9b) of the Food, Drug, and Cosmetic Act 21 U.S.C. 360 I (b) (1997).FDA Modernization Act of 1997, amended, Section 519 9b) of the Food, Drug, and Cosmetic Act 21 U.S.C. 360 I (b) (1997). Ferguson, S. (2001, December). To err is human: strategies for ensuring patient safety and quality when caring for children. Journal of Pediatric Nursing, 16 (6): Ferguson, S. (2001, December). To err is human: strategies for ensuring patient safety and quality when caring for children. Journal of Pediatric Nursing, 16 (6): Gallauresi, B. (1999, January). Collagen hemostasis devices. Nursing 1999, 29:31.Gallauresi, B. (1999, January). Collagen hemostasis devices. Nursing 1999, 29:31.

Bibliography (cont’d) Gallauresi B. (2000, April-June). Complications associated with vascular hemostasis devices. International Journal of Trauma Nursing, 6, (2): Gallauresi B. (2000, April-June). Complications associated with vascular hemostasis devices. International Journal of Trauma Nursing, 6, (2): Killen, A., & Beyea, S. (2003, February). Learning from near misses in an effort to promote patient safety. AORN, 77 (2): Killen, A., & Beyea, S. (2003, February). Learning from near misses in an effort to promote patient safety. AORN, 77 (2): Meaney, M. (2003, January-February). Case management and patient safety. Case Manager, 14 (1): Meaney, M. (2003, January-February). Case management and patient safety. Case Manager, 14 (1): Meurier, CE. (2000, July). Understanding the nature of errors in nursing: Using a model to analyze critical incident reports of errors which have resulted in an adverse or potentially adverse events. Journal of Advanced Nursing, 32 (1): Meurier, CE. (2000, July). Understanding the nature of errors in nursing: Using a model to analyze critical incident reports of errors which have resulted in an adverse or potentially adverse events. Journal of Advanced Nursing, 32 (1):

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Bibliography (cont’d) Tavris, D., Gallauresi, B., & Rich, S. (2001, February). Risk of serious injury or death associated with hemostasis devices by gender. Poster presentation at the FDA Science Forum, Washington, DC.Tavris, D., Gallauresi, B., & Rich, S. (2001, February). Risk of serious injury or death associated with hemostasis devices by gender. Poster presentation at the FDA Science Forum, Washington, DC. Tavris, D., Gallauresi, B., Rich, S., & Bell, C. Relative risks of reported serious injury and death associated with the use of hemostasis devices by gender. Pharmacoepidemiology and Drug Safety 2003, 12: Tavris, D., Gallauresi, B., Rich, S., & Bell, C. Relative risks of reported serious injury and death associated with the use of hemostasis devices by gender. Pharmacoepidemiology and Drug Safety 2003, 12: U.S. Department of Health and Human Services. (1999). Complications related to the use of vascular hemostasis devices: FDA dear colleague letter. Rockville, MD: Feigal, D.U.S. Department of Health and Human Services. (1999). Complications related to the use of vascular hemostasis devices: FDA dear colleague letter. Rockville, MD: Feigal, D.

Internet Websites ADVAMED: Trade association representing medical device manufacturers. Trade association representing medical device manufacturers. Centers for Disease Control for Disease Control CDRH website (premarket device clearance and postmarket medical device reporting requirements, medical device report submissions, safety alerts, notifications, and advisories, and Patient Safety Portal) website (premarket device clearance and postmarket medical device reporting requirements, medical device report submissions, safety alerts, notifications, and advisories, and Patient Safety Portal) ECRI: A non-profit agency focused on healthcare technology and patient safety research A non-profit agency focused on healthcare technology and patient safety research

Internet Websites (cont’d) FDA FDA Consumer Magazine Consumer Magazine FDA Device Advice (device classification and procedures) Device Advice (device classification and procedures) FDA Patient Safety News Patient Safety News

Internet Websites (cont’d) Institute of Medicine Report - To ERR is Human: Building a Safer Health System (you can read on line free) of Medicine Report - To ERR is Human: Building a Safer Health System (you can read on line free) Mandatory and User Facility Device Experience (MAUDE) adverse event report data base and User Facility Device Experience (MAUDE) adverse event report data base MedSun MedWatch