Using usability heuristics to evaluate patient safety of medical devices
Journal of Biomedical Informatics - Patient safety
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Since medical devices are often linked to the alarmingly high rate of medical accidents, it is speculated that newer advanced user interface related technologies might mitigate some accidents. This paper describes some positive as well as negative consequences of incorporating advanced technologies with particular emphasis on technologies that directly impact the design and usability of medical device user interfaces. Notably, some technologies open opportunities to allow users more control to manipulate devices and to more effectively be alerted to usage situations with high patient safety risk. On the other hand, some technologies offer more complexity for user interface features and therefore may increase risk levels. A sample of these advanced technologies is examined for their impact on design heuristics. The paper also examines current formal risk evaluation, analysis and control methodologies used in design. These risk management methods are applied to a variety of advanced user interface technologies used in various categories of medical devices. The advanced technologies examined for risk control advantages as well as disadvantages include: (1) improved displays, e.g. large color touchscreens; (2) improved sounds, e.g. speech synthesizers for talking AED's and talking MRI systems; (3) intelligent software, e.g. drug libraries with hard and soft limits for programming devices that deliver medications; (4) advanced drug injection systems, e.g. high pressure needle-free delivery, electronic drug delivery skin patches; (5) network connectivity, e.g. internet-aware devices that warn against dangerous drug/device interactions and medication management systems that reduce medication dispensing errors; (6) robotic innovations, e.g. remote surgery systems and automatic diagnostic assay preparation systems; (7) laparoscopic advancements, e.g. 3D video cameras; innovative mechanical devices, e.g. novel metal clip artery closure systems and beating heart suturing systems; (8) RFID tracking and monitoring systems, e.g. RFID embedded in surgical sponges to reduce accidental miscounts during surgery and (9) speech controlled medical devices, e.g. operating room table adjustments and laparoscopic video camera adjustments.