Annals of Emergency Medicine
Volume 50, Issue 4 , Pages 424-432 , October 2007

Usability Study of Two Common Defibrillators Reveals Hazards

Presented in part at the Human Factors and Ergonomics Society 48th annual meeting, September 2004, New Orleans, LA; and the National Association of EMS Physicians meeting, January 2006, Tucson, AZ.

  • Rollin J. Fairbanks, MD, MS

      Affiliations

    • Department of Emergency Medicine, University of Rochester School of Medicine, Rochester, NY
    • Corresponding Author InformationAddress for correspondence: Rollin J. (Terry) Fairbanks, MD, MS, NREMTP, Department of Emergency Medicine, University of Rochester Medical Center, 601 Elmwood Avenue, Box 655, Rochester, NY 14642; 585-273-3849, fax 585-275-2092
  • ,
  • Stanley H. Caplan, MS

      Affiliations

    • Usability Associates, Rochester, NY
  • ,
  • Paul A. Bishop, MPA, EMT-P

      Affiliations

    • Monroe Community College, Rochester, NY
  • ,
  • Aaron M. Marks, BA, EMT-P

      Affiliations

    • Monroe Ambulance, Rochester, NY.
    • Mr. Marks is now with Bridgeborn Government Solutions, Arlington, VA.
  • ,
  • Manish N. Shah, MD, MPH

      Affiliations

    • Department of Emergency Medicine, University of Rochester School of Medicine, Rochester, NY
    • Department of Community and Preventative Medicine, University of Rochester School of Medicine, Rochester, NY

Received 2 June 2006 ,Revised 22 March 2007 ,Accepted 27 March 2007.

References 

  1. Fairbanks RJ, Caplan S. Poor interface design and lack of usability testing facilitate medical error. Jt Comm J Qual Saf. 2004;30:579–584
  2. Weinger MB, Pantiskas C, Wiklund ME, et al. Incorporating human factors into the design of medical devices. [letter] JAMA. 1998;280:1484
  3. Crowley JJ, Kaye RD. Identifying and understanding medical device use errors. J Clin Aging. 2002;188–193summer
  4. Welch DL. Human factors in the health care facility. Biomed Instrument Tech. 1998;32:311–316
  5. Gosbee JW, Lin L. The role of human factors engineering in medical device and medical system errors. In:  Vincent C editors. Clinical Risk Management: Enhancing Patient Safety. London: BMJ Press; 2001;p. 301–317
  6. Perry SJ. An overlooked alliance: using human factors engineering to reduce patient harm. Jt Comm J Qual Saf. 2004;30:455–459
  7. Israelski EW, Muto WH. Human factors risk management as a way to improve medical device safety: a case study of the Therac 25 radiation therapy system. Jt Comm J Qual Saf. 2004;30:689–695
  8. Bogner MS. There is more to error in healthcare than the care provider. Proceedings of the Human Factors and Ergonomics Society 49th annual meeting, Orlando, FL. 2005;952–954
  9. Gosbee JW. Who left the defibrillator on?. Jt Comm J Qual Saf. 2004;30:282–285
  10. Lum TE, Fairbanks RJ, Pennington EC, et al. Misplaced femoral line guidewire and multiple failures to detect foreign body on chest x-ray. Acad Emerg Med. 2005;12:658–662
  11. Wiklund ME. Eleven keys to designing error-resistant medical devices. MDDI. 2002;24:86–102
  12. Kushniruk AW, Triola MM, Stein B, et al. The relationship of usability to medical error: an evaluation of errors associated with usability problems in the use of a handheld application for prescribing medications. Medinfo. 2004;1073–1076
  13. American National Standards Institute, Association for the Advancement of Medical Instrumentation. HE 74: 2001—Human Factors Design Process for Medical Devices. American National Standards Institute, Association for the Advancement of Medical Instrumentation; 2001.
  14. CDRH. Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. Guidance for Industry and FDA Premarket and Design Control Reviewers. 2000:2-33.
  15. Wichansky AM. Usability testing in 2000 and beyond. Ergonomics. 2000;43:998–1006
  16. Welch DL. Human factors analysis and design support in medical device development. Biomed Instrument Tech. 1998;32:77–82
  17. Gosbee JW, Klancher J, Arnecke B, et al. The role of usability testing in healthcare organizations. Paper presented at: Proceedings of the Human Factors and Ergonomics Society 45th annual meeting, Minneapolis, MN. 2001.
  18. Kushniruk AW, Triola MM, Borycki EM, et al. Technology induced error and usability: the relationship between usability problems and prescription errors when using a handheld application. Int J Med Inform. 2005;74:519–526
  19. Caplan S. Test the ergonomics. Machine Design. 2004;76:108–109
  20. Obradovich JH, Woods DD. Users as designers: how people cope with poor HCI design in computer-based medical devices. Hum Factors. 1996;38:574–592
  21. 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. 2004;32:S406–S413
  22. Eames P, Larsen PD, Galletly DC. Comparison of ease of use of three automated external defibrillators by untrained lay people. Resuscitation. 2003;58:25–30
  23. Fairbanks RJ, Crittenden CN, O’Gara KG, et al. The nature of adult and pediatric adverse events and near misses in EMS. [abstract] Prehosp Emerg Care. 2005;9:102–103
  24. Stiell IG, Wells GA, Field BJ, et al. Improved out-of-hospital cardiac arrest survival through the inexpensive optimization of an existing defibrillation program: OPALS Study Phase II (Ontario Prehospital Advanced Life Support). JAMA. 1999;281:1175–1181
  25. Faulkner L. Beyond the five-user assumption: benefits of increased sample sizes in usability testing. Behav Res Methods Instrum Comput. 2003;35:379–383
  26. Fairbanks RJ, Caplan S, Shah MN, et al. Defibrillator usability study among paramedics. Proceedings of the Human Factors and Ergonomics Society 48th annual meeting; September 24, 2004; New Orleans, LA.
  27. Pope C, Ziebland S, Mays N. Qualitative research in health care (Analysing qualitative data). BMJ. 2000;320:114–116
  28. Jordan PW. An Introduction to Usability. Bristol, PA: Taylor & Francis; 1998;
  29. Wiklund ME. Usability tests of medical products as prelude to the clinical trial. Med Device Diagnostic Industry. 1991;13:46–52
  30. ANSI/AAMI. HE 48: 1993—Human Factors Engineering Guidelines and Preferred Practices for Design of Medical Devices. 1993.
  31. Sawyer D. Do it by design. The FDA Center for Devices and Radiological Health (CDRH). Available at: http://www.fda.gov/cdrh/humfac/doit.html. Accessed August 15, 2006.
  32. Keselman A, Tang X, Patel VL, et al. Institutional decision-making for medical device purchasing: evaluating patient safety. Medinfo. 2004;11(part 2):1357–1361
  33. Ebrahimi P, Rubin SA. Electrical cardioversion resulting in death from synchronization failure. Am J Cardiol. 1994;74:100–102
  34. Department of Defense. Design criteria standard for human engineering. MIL-STD 1472F, August 1999, Paragraph 5.2.2.3.3.

 Supervising editor: Robert L. Wears, MD, MS

 Author contributions: RJF and SHC conceived the study, designed the study, and obtained research funding. RJF, SHC, and MNS supervised the conduct of the trial and data collection. RJF, PAB, AMM, and MNS undertook recruitment of participating paramedics. RJF, SHC, and MNS managed the data. All investigators participated in the qualitative analysis. MNS provided statistical advice and RJF, SHC, and MNS analyzed the data. RJF and SHC drafted the article, and all authors contributed substantially to its revision. RJF takes responsibility for the paper as a whole.

 Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article, that may create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. This research was supported by the University of Rochester Department of Emergency Medicine research seed funding. At the time of the study, Drs. Fairbanks and Shah were supported by funding from the National Institutes of Health (1R41NR009592) and Agency for Healthcare Research and Quality (1U18HS015818), and Dr. Shah, by funding from Health Resources and Services Administration.

 Available online May 11, 2007.

 Reprints not available from the authors.

PII: S0196-0644(07)00390-3

doi: 10.1016/j.annemergmed.2007.03.029

Annals of Emergency Medicine
Volume 50, Issue 4 , Pages 424-432 , October 2007