Hazards With Medical Devices: The Role of Design

Annals of Emergency Medicine

Volumn 52, Issue 5, 2008, Pages 519-521

  Fairbanks, Rollin J ^a   Wears, Robert L ^b  

^a UNIVERSITY OF ROCHESTER   (United States)

^b UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CARDIOVERSION; DEFIBRILLATION; DEFIBRILLATOR; DEVICE; FOOD AND DRUG ADMINISTRATION; MEDICAL INSTRUMENTATION; PRIORITY JOURNAL; SCIENTIFIC LITERATURE; SIMULATION;

DEFIBRILLATORS; EMERGENCY MEDICINE; EQUIPMENT DESIGN; EQUIPMENT FAILURE; EQUIPMENT SAFETY; HEART ARREST; HUMANS;

EID: 54349086781     PISSN: 01960644     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.annemergmed.2008.07.008     Document Type: Article

References (26)

1. Callejas S., Barry A., Demertsidis E., et al. Human factors impact successful lay person automated external defibrillator use during simulated cardiac arrest. Crit Care Med 32 9 suppl (2004) S406-S413
2. Eames P., Larsen P.D., and Galletly D.C. Comparison of ease of use of three automated external defibrillators by untrained lay people. Resuscitation 58 (2003) 25-30
3. Macdonald R.D., Swanson J.M., Mottley J.L., et al. Performance and error analysis of automated external defibrillator use in the out-of-hospital setting. Ann Emerg Med 38 (2001) 262-267
4. Monsieurs K.G., Vogels C., Bossaert L.L., et al. A study comparing the usability of fully automatic versus semi-automatic defibrillation by untrained nursing students. Resuscitation 64 (2005) 41-47
5. Drews F.A., Picciano P., Agutter J., et al. Development and evaluation of a just-in-time support system. Hum Factors 49 (2007) 543-551
6. Bogner M.S. There is more to error in healthcare than the care provider (2005) Proceedings of the Human Factors and Ergonomics Society 49th annual meeting; Orlando, FL; September 26-30.
7. Gosbee J., and Lin L. The role of human factors engineering in medical device and medical system errors. In: Vincent C. (Ed). Clinical Risk Management: Enhancing Patient Safety (2001), BMJ Press, London, England 301-317 chapter 316.
8. Fairbanks R.J., Caplan S.H., Bishop P.A., et al. Usability study of two common defibrillators reveals hazards. Ann Emerg Med 50 (2007) 424-432
9. Karsh B.T., and Scanlon M. When is a defibrillator not a defibrillator? when it's like a clock radio. The challenge of usability and patient safety in the real world. Ann Emerg Med 50 (2007) 433-435
10. Perrow C. Complex Organizations: A Critical Essay. 3rd ed. (1986), Random House, New York, NY
11. Wickens C.D., Gorden S.E., and Liu Y. An Introduction to Human Factors Engineering (1998), Longman, New York, NY
12. Stewart J.A. Delayed defibrillation caused by unexpected ECG artifact. Ann Emerg Med 52 (2008) 515-518
13. Hoyer C.S., Christensen E.F., and Eika B. Adverse design of defibrillators: turning off the machine when trying to shock. Ann Emerg Med 52 (2008) 512-514
14. Koppel R., Metlay J.P., Cohen A., et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA 293 (2005) 1197-1203
15. Tenner E. Why Things Bite Back: Technology and the Revenge of Unintended Consequences (1997), Vintage Books, New York, NY
16. Rochlin G.I. Trapped in the Net: The Unanticipated Consequences of Computerization (1997), Princeton University Press, Princeton, NJ
17. Ash J.S., Berg M., and Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Med Informat Assoc 11 (2004) 104-112
18. Cook R.I., and Woods D.D. Adapting to new technology in the operating room. Hum Factors 38 (1996) 593-613
19. Johnson T.R., Tang X., Graham M.J., et al. Attitudes toward medical device use errors and the prevention of adverse events. Jt Comm J Qual Patient Saf 33 (2007) 689-694
20. Johnson C.W. Why did that happen?. exploring the proliferation of barely usable software in healthcare systems. Qual Saf Health Care 15 suppl 1 (2006) i76-i81
21. Deposition of David Hahn, MD, p 108-110, Case No. 07 CY CV 02477 in the Circuit Court of Clay County, MO (Oct 18, 2007).
22. Jackson D., Thomas M., and Millett L.I. Executive summary. In: Jackson D., Thomas M., and Millett L.I. (Eds). Software for Dependable Systems: Sufficient Evidence? (2007), National Academy Press, Washington, DC 1-15
23. Klein G., Woods D.D., Bradshaw J.M., et al. Ten challenges for making automation a "team player" in joint human-agent activity. IEEE Intelligent Syst 19 (2004) 91-95
24. Riegel v. Medtronic, Inc., case number WL 440744, Supreme Court, 2008.
25. Burlington D.B. Human factors and the FDA's goals: improved medical device design. Biomed Instrum Technol 30 (1996) 107-109
26. Patankar M.S., Brown J.P., and Treadwell M.D. Safety Ethics: Cases From Aviation, Healthcare, and Occupational and Environmental Health (2005), Ashgate, Aldershot, UK