User errors involving medical devices are a common source of patient injury and death. In many cases, medical devices have user interfaces that are so poorly designed and difficult to use that they induce a variety of human errors. FDA data collected between 1985 and 1989 demonstrated that 45 to 50 percent of all device recalls stemmed from poor product design. Furthermore, the FDA recognizes that a poorly designed user interface can induce errors and operating inefficiencies even when operated by a well-trained, competent user. Other research suggests that injuries resulting from medical device use errors far exceed injuries arising from device failures. Despite the importance of user interface design in patient safety, most health care employees who participate in the selection of medical devices have very little awareness of usability evaluation techniques or the value of evaluating device usability. In addition, although manufacturers are increasingly aware of the importance of the user interface, many existing and newly designed devices still suffer from usability problems that can compromise patient safety. As a result, installed medical devices are often hard to learn, difficult to use, fail to address the users' needs, do not fit the users' workflow, and, as a result, induce a variety of errors that can greatly compromise patient safety. The purpose of this three-year project is to develop usability evaluation guidelines to assist health care providers in selecting devices designed to prevent or decrease device use errors, thereby increasing patient safety. Year 1 will examine usability problems with infusion pumps at two major hospitals and retrospectively analyze the processes used to purchase the pumps to determine how incorporating usability evaluation guidelines in the purchasing process could result in selecting a safer device. Year 2 will develop guidelines for evaluating the usability of medical devices and determine the best way to use these guidelines to improve the process of selecting medical devices. Year 3 will evaluate the resulting guidelines in a controlled experiment involving 10 mock purchasing groups from five different sites. This project will provide the first step in developing best practices for purchaser evaluation of medical devices throughout the United States.
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