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Yes, there was an initial use error. However, the user subsequently corrected it before there was a significant chance of. The FDA typically regards this kind of event as a case of a risk mitigation working properly. Therefore, the event does not warrant reporting as a use error or a close call. ” in this chapter). In our experience, there are fewer—perhaps half as many—close calls than use errors during a usability test. This reduced frequency is likely due to the fact that users often are unaware that they have erred, and as a result, they do not take corrective action.

The LCD display might produce more glare, causing users to misread critical parameter values. Users might struggle to interpret icons and read colored text presented on different color backgrounds, perhaps selecting incorrect menu options and delaying patient treatment. Users might misinterpret the trend graphs, leading to a misdiagnosis and improper patient treatment. These kinds of problems, which can arise when a manufacturer refreshes an aging design, can be quickly detected during usability testing.

Multiple close calls, which suggest a greater chance of an uncorrected use error, can indicate a user interface problem that should be fixed. Cases in which a medical device detects a use error, directs the user to ­correct the problem, and the user does correct the problem are not technically close calls. Rather, they are cases of a risk control measure working properly. You probably know the expression “Yikes! ” One is likely to say it when just avoiding a traffic accident or almost spilling hot coffee on your lap.

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