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Pump Problems, People Problems
March 16, 2010
For many people with diabetes, insulin pumps are an essential tool — offering better blood glucose control, more flexibility in the timing of meals and exercise, and greater independence from syringes, vials, and pens. But insulin pumps also carry risks, such as the potential for an infusion set to fall out or for the pump to malfunction, delivering too much or too little insulin. As the popularity of insulin pumps has grown, so has the incidence of such “adverse events.”
According to an article from HealthDay, since 2006, 12,093 injuries and 310 deaths associated with insulin pumps have been reported to the US Food and Drug Administration (FDA). This, combined with 4,294 reported pump malfunctions and several recalls of pumps, prompted the FDA to convene an advisory panel of outside medical experts to make recommendations for how to deal with the issue. The panel concluded that the FDA should require pump manufacturers to provide more detailed information on adverse events. Currently, according to the panel, manufacturers often do not mention what specific pump difficulty occurred in the adverse events they report, and they even frequently give incomplete information about deaths associated with their pumps. Thus, the reason for most of these deaths remains unknown. By requiring manufacturers to be more detailed in their reporting, the panel hopes, both manufacturers and the FDA will have more information to figure out — and solve — potential pump problems.
If you use a pump, have you ever felt in danger because of a mistake or malfunction? Do you think pumps are more dangerous than traditional insulin injections? Can you think of any tips — for manufacturers, health-care providers, or pump users — that might reduce the likelihood of mistakes? How much should pump manufacturers be held responsible for mistakes made by users? Should they be required to investigate every potential pump-related injury or death in detail? Leave a comment below!
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