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Bibliography

Bibliography . Amoore, J., Ingram, P. (2002, August). Quality improvement report: Learning from adverse incidents involving medical devices. British Medical Journal, 325, 272-275. Baker, D. (2002, April). Successful performance improvement. AORN, 75 (4):825-827.

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Bibliography

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  1. Bibliography • Amoore, J., Ingram, P. (2002, August). Quality improvement report: Learning from adverse incidents involving medical devices. British Medical Journal, 325, 272-275. • Baker, D. (2002, April). Successful performance improvement. AORN, 75 (4):825-827. • Benner, P. (2001, July). Creating a culture of safety and improvement: A key to reducing medical error. American Journal of Critical Care, 10 (4): 281-284. • Berman, S. (2000, July). The AMA clinical quality improvement forum on addressing patient safety. Joint Commission Journal on Quality Improvement, 26 (7): 428-433.

  2. Bibliography (cont’d) • Beyea, S. (2003, January). Tracking medical devices to ensure patient safety. AORN, 77 (1): 192-194. • Beyea, S. (2002, June). Finding patient safety internet resources. AORN, 75 (6): 1171-1173. • 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): 40-54.

  3. Bibliography (cont’d) • Ebright, P., Patterson, E., & Render, M. (2002, September). The "new look" approach to patient safety. Clinical Nurse Specialist, 16 (5): 247-253. • 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): 438-440. • Gallauresi, B. (1999, January). Collagen hemostasis devices. Nursing 1999, 29:31.

  4. Bibliography (cont’d) • Gallauresi B. (2000, April-June). Complications associated with vascular hemostasis devices. International Journal of Trauma Nursing, 6, (2): 64-65. • Killen, A., & Beyea, S. (2003, February). Learning from near misses in an effort to promote patient safety. AORN, 77 (2): 423-425. • Meaney, M. (2003, January-February). Case management and patient safety. Case Manager, 14 (1): 28-29. • 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): 202-207.

  5. Bibliography (cont’d) • Noble, A., & Brennan, T. (2001, Fall-Winter). Managing care in the new era of 'systems-think': The implications for managed care organizational liability and patient safety. Journal of Law, Medicine and Ethics, 29 (3-4): 290-304. • Safe Medical Devices Act of 1990, Pub. L. No. 101-629, 104, Stat. 4511 (1990). • Sainfort, F., Karsh, B.T., Booske, B.C., & Smith, M.J. (2001, September). Applying quality improvement principles to achieve healthy work organizations. Joint Commission Journal on Quality Improvement, 27 (9): 469-83.

  6. 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., & 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: 237-241. • 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.

  7. Internet Websites • ADVAMED: Trade association representing medical device manufacturers. http://www.advamed.org/ • Centers for Disease Control http://www.cdc.gov • CDRH website (premarket device clearance and postmarket medical device reporting requirements, medical device report submissions, safety alerts, notifications, and advisories, and Patient Safety Portal) http://www.cdrh.fda.gov • ECRI: A non-profit agency focused on healthcare technology and patient safety research http://www.ecri.org/

  8. Internet Websites (cont’d) • FDA http://www.fda.gov/ • FDA Consumer Magazine http://www.fda.gov/fdac • FDA Device Advice (device classification and procedures) http://www.fda.gov/cdrh/devadvice • FDA Patient Safety News http://www.fda.gov/psn

  9. Internet Websites (cont’d) • Institute of Medicine Report - To ERR is Human: Building a Safer Health System (you can read on line free) http://www.nap.edu/books/0309068371/html/ • Mandatory and User Facility Device Experience (MAUDE) adverse event report data base http://www.fda.gov/cdrh/maude.html • MedSun http://www.medsun.net/about.html • MedWatch http://www.fda.gov/medwatch

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