PMID: 16649652May 3, 2006Paper

Operating manual-based usability evaluation of medical devices: an effective patient safety screening method

Joint Commission Journal on Quality and Patient Safety
James P TurleyJuliana J Brixey

Abstract

Use of medical devices often directly contributes to medical errors. Because it is difficult or impossible to change the design of existing devices, the best opportunity for improving medical device safety is during the purchasing process. However, most hospital personnel are not familiar with the usability evaluation methods designed to identify aspects of a user interface that do not support intuitive and safe use. A review of medical device operating manuals is proposed as a more practical method of usability evaluation. Operating manuals for five volumetric infusion pumps from three manufacturers were selected for this study (January-April 2003). Each manual's safety message content was evaluated to determine whether the message indicated a device design characteristic that violated known usability principles (heuristics) or indicated a violation of an affordance of the device. "Minimize memory load," with 65 violations, was the heuristic violated most frequently across pumps. Variations between pumps, including the frequency and severity of violations for each, were noted. Results suggest that manual review can provide a proxy for heuristic evaluation of the actual medical device. This method, intended to be a component of...Continue Reading

References

Dec 1, 1978·Anesthesiology·J B CooperB McPeek
Feb 1, 1996·Journal of Advanced Nursing·E A McConnellJ Manning
Oct 9, 2003·Quality & Safety in Health Care·K Taxis, N Barber
Oct 14, 2003·Journal of Biomedical Informatics·Jiajie ZhangTate Kubose
Oct 14, 2003·Journal of Biomedical Informatics·Alla KeselmanJiajie Zhang
Oct 20, 2004·International Journal of Medical Informatics·Mark J GrahamVimla L Patel

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Citations

Oct 12, 2013·Biomedical Instrumentation & Technology·Ganesh BhutkarGaur G Ray
Sep 27, 2019·International Journal of Medical Informatics·Kaifeng LiuHing-Yu So

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