Analysis of a “Simple” Medical Device

EDICAL D EVICES A RE D ESIGNED T O improve the health of an individual. Advances in the technology of medical devices may enable patients to take an active role in maintaining their own health. One example is the hand-held, battery-operated meter that patients with diabetes can use to check their blood glucose levels. Through self-monitoring, diabetes patients can determine their blood sugar levels and adjust diet, insulin, or exercise to effectively manage their diabetes. The advent of self-care, unfortunately, has some negative consequences as well. The patient must take primary responsibility for monitoring blood glucose levels without assistance from a health care professional. As a result, there may be an increase in the occurrence of errors in the use of blood glucose meters (see Laux, 1994, for monitoring difficulties when meters are unavailable). These errors can have serious consequences for the short- and long-term health of the individual, particularly because treatment is often determined from glucose level readings. Diabetes can lead to many complications if not properly treated, including high blood pressure, heart or kidney disease, vision problems or blindness, complications in pregnancy, and death. Blood glucose meters represent a class of home health care technologies in which the tasks are sequential in nature – that is, each step is reliant on the success of the previous step. The system also provides very little feedback about the accuracy of performance, and the consequences of errors are high. Other devices in this class would include blood pressure monitors, heart rate monitors, oxygen tanks, and infusion pumps. In this article, we demonstrate how human factors/ergonomics tools can be applied to medical devices in general, and blood glucose meters in particular. We focus on blood glucose meters because of their widespread use and availability, but our approach and findings can be gen