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Medical Devices

Design Aids

Designer's Aid for Infusion Pumps to Minimize User Error. Completed research and developed a computer-based design aid that to minimize errors during the operation of infusion pumps. As part of the system development, a nationwide survey of nurses was conducted to examine sources of human error in the use of medical infusion systems. The survey determined (1) types, severity, and relative frequencies of error, and (2) the factors that ultimately lead to error in medical settings (i.e., operator, equipment, environmental, organizational, and social factors). In addition, laboratory experiments were conducted to investigate cognitive sources of user error in the use of medical infusion pumps--nurses' mental models of how infusion pumps work, and working memory overload while using an infusion system. (National Cancer Institute)

Preference Testing of I.V. Infusion Pump Operating Manuals. Performed research comparing user preferences for a home infusion pump manufacturer's manual and a manual we developed and wrote using FDA's Write it Right.. Comparative follow up testing utilizing actual and potential users of home infusion pumps revealed a clear preference for the manual we wrote using these recommendations. (U.S. Food and Drug Administration)

Human Factors in Medical Equipment

Human Engineering Services to Support Design of a ICU Bedside Equipment. Performed human factors analyses to support the design of microprocessor-based ICU bedside unit. Performed a detailed task and subtask analysis of user functions and assessed the design implications of the task analysis. Identified display and control technologies for the operator interface, recommended a user-computer dialogue structure, and developed recommendations for system configuration and layout. Developed extensive sample screen layouts to illustrate user interface concepts, mode transitions, and display content, information and format. (Project work performed for a major biomedical manufacturing firm)

Human Factors Seminar for the FDA. Conducted a four-day seminar, "Fundamentals of Human Factors for Engineering and Design" for the Center for Devices and Radiological Health of the Food and Drug Administration. Seminar topics included: the human factors model of information processing and performance, task analysis, principles of display control design, human-computer interface design, principles and criteria of layout, and test and evaluation methods. Each topic included a practical exercise to provide an opportunity to practice the principles and techniques presented. (U.S. Food and Drug Administration)

Workshop on Human Factors Principles & Standards for the FDA. Developed and conducted a workshop on human factors principles and standards for the Center for Devices and Radiological Health of the Food and Drug Administration (FDA). The workshop was designed for FDA representatives who participate in the development of standards for the design and manufacture of medical devices. The objective of the workshop was to provide a basic understanding of human factors, present human factors principles applicable to the design of medical devices, and provide practice in addressing human factors issues in design problems. (U.S. Food and Drug Administration)

Design of an Environmental Test Kit. Conducted user analysis and applied human factors engineering principles to the design of Quik-Screen test kit for detection of toxic substances in fluids. Designed the test card, user instructions, and test-kit packaging. The kit subsequently gained extensive user acceptance among agriculture inspectors. (Environmental Diagnostics, Inc.)

Physician Decision Aids

Research on Aiding Physician's Decision. Research determined the feasibility of a sophisticated system for retrieving statistical data about risk and prognosis to aid physicians' decisions whose practice includes breast cancer patients. The research used a survey methodology to determine practicing physicians' statistical environment, including their training, their perceived need for and attitudes about statistical data, and their use of computers and computerized data bases. Data was used to characterize the responding population and identify potential barriers to physicians' use of computerized data retrieval and decision systems. Results were used to develop guidelines for a user interface for such systems, with particular emphasis on compensating for the identified barriers. (National Science Foundation)


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