GAITHERSBURG, MD. — Members of a Food and Drug Administration advisory panel agreed that although there are technological issues with insulin infusion pumps, these issues are outweighed by user-related issues.
The meeting of the FDA's General Hospital and Personal Use Devices Panel meeting was convened to discuss postmarketing reports of safety issues related to insulin infusion pumps in people with diabetes. These reports are from the FDA adverse event reporting database for devices. The panel was not asked to vote on any questions related to the topic.
Several endocrinologists on the panel stressed the importance of education for patients who receive an insulin pump in how well they do on insulin pump therapy, which is most commonly used in patients with type 1 diabetes.
Panelist Dr. Lamont Weide, an endocrinologist at Truman Medical Center, Kansas City, Mo., said that pump failure rates “seem to be very low” and that problems are usually patient driven.
Between Oct. 1, 2006, and Sept. 20, 2009, the FDA received 16,849 reports of adverse events associated with insulin pumps; most of the reports were provided by the manufacturers. At the meeting, the FDA presented information on the 16,797 reported events (including 310 deaths) for pumps made by the five top manufacturers.
The reports were far from complete: In most cases the problem with the pump was not described nor was the patient's age included; the cause of deaths associated with the pumps had not been thoroughly investigated or evaluated, according to the FDA. In approximately 20% of the reports, the problem with the device was listed as “unknown,” and in 9% the problem was listed as “replace.” These were the two most common explanations listed among the device problems reports. And as panelists pointed out, there is no denominator so event rates cannot be calculated.
The other most common problems listed were described as display of an error message on the device (almost 5%), failure to deliver (3%), and repair (3%). Less commonly reported problems included inaudible alarms, failure to prime or infuse, battery failure, or a blank screen.
The most commonly reported patient-related problems included hospitalization (21% of reports) and high blood glucose (almost 17% of reports). The other most commonly reported problems in patients included diabetic ketoacidosis (8%), hyperglycemia (8%), and low blood glucose (almost 5%).
Of the 310 deaths, the most commonly listed causes were diabetic coma, hyperglycemia, hypoglycemia, diabetic ketoacidosis, and unresponsiveness. There were 29 deaths associated with a motor vehicle.
Safety issues included the scenario of a pump recall or pump dysfunction and the risk associated with a patient having to change the mode of insulin treatment to insulin injections while waiting for a new pump. In the short-term (within 48 hours), the time usually needed by a manufacturer to provide a patient with a new pump, panelists said the risks were minimal, provided that patients and their families had been educated about what to do in that situation and had nonexpired insulin available for injections. The long-term risks include poorer glucose control, since insulin pumps provide better glucose control and a lower risk of hypoglycemia than do multiple daily injections, according to panelists.
When asked about the relative risks associated with the continuing use of a defective pump, panelists said that a pump failure that results in overinfusion of insulin and the risk of severe hypoglycemia would be their biggest concern, particularly during the night, when patients who do not have a glucose sensor are not testing their blood glucose.
Advisory panel members have been screened for potential conflicts of interest related to the products under discussion prior to panel meetings.