« Previous
Next »
Annals of Emergency Medicine
Volume 50, Issue 4
, Pages 424-432
, October 2007
Usability Study of Two Common Defibrillators Reveals Hazards
References
- . Poor interface design and lack of usability testing facilitate medical error. Jt Comm J Qual Saf. 2004;30:579–584
- Incorporating human factors into the design of medical devices. [letter] JAMA. 1998;280:1484
- . Identifying and understanding medical device use errors. J Clin Aging. 2002;188–193summer
- . Human factors in the health care facility. Biomed Instrument Tech. 1998;32:311–316
- . 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
- . An overlooked alliance: using human factors engineering to reduce patient harm. Jt Comm J Qual Saf. 2004;30:455–459
- . 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
- . 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
- . Who left the defibrillator on?. Jt Comm J Qual Saf. 2004;30:282–285
- Misplaced femoral line guidewire and multiple failures to detect foreign body on chest x-ray. Acad Emerg Med. 2005;12:658–662
- . Eleven keys to designing error-resistant medical devices. MDDI. 2002;24:86–102
- 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
- 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.
- 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.
- . Usability testing in 2000 and beyond. Ergonomics. 2000;43:998–1006
- . Human factors analysis and design support in medical device development. Biomed Instrument Tech. 1998;32:77–82
- 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.
- 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
- . Test the ergonomics. Machine Design. 2004;76:108–109
- . Users as designers: how people cope with poor HCI design in computer-based medical devices. Hum Factors. 1996;38:574–592
- Human factors impact successful lay person automated external defibrillator use during simulated cardiac arrest. Crit Care Med. 2004;32:S406–S413
- . Comparison of ease of use of three automated external defibrillators by untrained lay people. Resuscitation. 2003;58:25–30
- The nature of adult and pediatric adverse events and near misses in EMS. [abstract] Prehosp Emerg Care. 2005;9:102–103
- 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
- . Beyond the five-user assumption: benefits of increased sample sizes in usability testing. Behav Res Methods Instrum Comput. 2003;35:379–383
- 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.
- . Qualitative research in health care (Analysing qualitative data). BMJ. 2000;320:114–116
- . An Introduction to Usability. Bristol, PA: Taylor & Francis; 1998;
- . Usability tests of medical products as prelude to the clinical trial. Med Device Diagnostic Industry. 1991;13:46–52
- ANSI/AAMI. HE 48: 1993—Human Factors Engineering Guidelines and Preferred Practices for Design of Medical Devices. 1993.
- 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.
- Institutional decision-making for medical device purchasing: evaluating patient safety. Medinfo. 2004;11(part 2):1357–1361
- . Electrical cardioversion resulting in death from synchronization failure. Am J Cardiol. 1994;74:100–102
- 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
© 2007 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
« Previous
Next »
Annals of Emergency Medicine
Volume 50, Issue 4
, Pages 424-432
, October 2007
