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Operating Manual-Based Usability Evaluation of Medical Devices: An Effective Patient Safety Screening Method

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Background: 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.

Method: 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.

Results: "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.

Discussion: 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 prepurchasing evaluation, can complement more formal usability evaluation methods and be used to select a subset of devices for more extensive and formal testing.

Document Type: Research Article

Publication date: April 1, 2006

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  • Published monthly, The Joint Commission Journal on Quality and Patient Safety is a peer-reviewed publication dedicated to providing health professionals with the information they need to promote the quality and safety of health care. The Joint Commission Journal on Quality and Patient Safety invites original manuscripts on the development, adaptation, and/or implementation of innovative thinking, strategies, and practices in improving quality and safety in health care. Case studies, program or project reports, reports of new methodologies or new applications of methodologies, research studies on the effectiveness of improvement interventions, and commentaries on issues and practices are all considered.

    David W. Baker, MD, MPH, FACP, executive vice president for the Division of Healthcare Quality Evaluation at The Joint Commission, is the inaugural editor-in-chief of The Joint Commission Journal on Quality and Patient Safety.

    Also known as Joint Commission Journal on Quality Improvement and Joint Commission Journal on Quality and Safety
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