Turley James P, Johnson Todd R, Smith Danielle Paige, Zhang Jaijie, Brixey Juliana J
School of Health Information Sciences, University of Texas Health Science Center at Houston, USA.
Jt Comm J Qual Patient Saf. 2006 Apr;32(4):214-20. doi: 10.1016/s1553-7250(06)32027-2.
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 prepurchasing evaluation, can complement more formal usability evaluation methods and be used to select a subset of devices for more extensive and formal testing.
医疗设备的使用常常直接导致医疗差错。由于改变现有设备的设计困难或不可能，提高医疗设备安全性的最佳时机是在采购过程中。然而，大多数医院工作人员并不熟悉旨在识别用户界面中不支持直观和安全使用方面的可用性评估方法。本文提出审查医疗设备操作手册作为一种更实用的可用性评估方法。
本研究选取了三家制造商生产的五台容积式输液泵的操作手册（2003年1月至4月）。对每份手册的安全信息内容进行评估，以确定该信息是否表明设备设计特征违反了已知的可用性原则（启发式原则）或表明违反了设备的可供性。
“最小化记忆负荷”这一启发式原则在各输液泵中被违反的次数最多，达65次。注意到各输液泵之间的差异，包括每种泵违反原则的频率和严重程度。
结果表明，手册审查可为实际医疗设备的启发式评估提供替代。这种方法旨在作为采购前评估的一个组成部分，可以补充更正式的可用性评估方法，并用于选择一部分设备进行更广泛和正式的测试。
