A Case Study In Medical Error The Use Of The Portfolio Entry

Following a high-risk , the device manufacturer must perform a root cause analysis.

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On the positive side, implementing a design change could prevent a use error in the future.

However, manufacturers rushing to validate their devices might need to take time-consuming and expensive steps backward to fix their flawed designs.

There are usually underlying, design-related causes for use errors that might at first seem to be the user’s fault.

That is both good and bad for manufacturers seeking to obtain regulatory clearance for new products.

A better design would bring the need to prime the device to the user’s attention and check to ensure the task was completed successfully.

The sensible approach to root cause analysis of use errors is to start by assuming that the medical device, not the usability test participant, is to blame.A superior design would not place such a burden on the user.As another example, a test participant might not bother to prime a tubing set because she previously used a comparable device that did not require priming.That means they don't need anyone's permission to get married.Depending on the type of physical disability and the level of care they need, they can or cannot live together.It takes discipline—courage even—to adopt and maintain this mindset.This is particularly true in scenarios in which the development organization is pressing to validate a device, perhaps before passing a deadline to apply for regulatory clearance.test participant acts forgetful, inattentive, fatigued, careless, or in another way that appears to cause an error, view the user’s behavior as normal and expected rather than the root cause of the error.For example, a test participant might forget to perform a step when setting up a device because there are 25 separate steps that must first be remembered and performed in order.—an instance when a test participant made a mistake while performing a task.And perhaps the mistake occurred while the test participant was performing a high-risk task, thereby causing angst among the development team members because the use error imperiled a successful validation test.


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