ABSTRACT
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. The second type of problem is when the user causes or initiates a malfunction. 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. The distinction between technical failure of medical equipment and user-initiated failure or malfunction of the equipment is an important one with respect to prevention of related patient injuries. Medical devices sold in the United States are under the regulatory purview of the Food and Drug Administration (FDA). The FDA has invited proposals from time to time for outside investigators to study user error and other issues associated with particular equipment.
