Human Error in Medicine

By Marilyn Sue Bogner | Go to book overview

15
Errors in the Use of Medical Equipment

William A. Hyman Texas A&M University

Problems with the use of medical equipment or devices can be broadly divided into two types. One type is when the equipment malfunctions as a result of a technical problem that is not caused by the user. This type of malfunction may be a result of an inherent defect in the design or manufacturing of the device (e.g., software error or inadequate mechanical assembly), or it may be a result of a random failure of a component. It may occur without warning to the user, and it can be relatively innocuous or can result in direct harm to the patient.

The second type of problem is when the user causes or initiates a malfunction. This type of malfunction can be one in which a technical failure occurs secondarily to the user's actions, or it may be one in which the medical objective of the device is compromised although the condition of the equipment remains unchanged. This can present a classic human-factors question in the evaluation of user error. Is the design adequate because it does allow proper use of the equipment, or is it inadequate in that it creates situations in which a user error is predictable?

The types of medical equipment that are associated with user problems range from the relatively simple, such as catheters and syringes, to the most technologically complex, such as computer-controlled diagnostic equipment. Inclusively, they are covered under the definition of a medical device that is used by the U.S. Food and Drug Administration (FDA). Under this definition, a medical device is:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or

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