subject: Diabetics Experience Insulin Pump Problems [print this page] In a recent Wall Street Journal report, the Food and Drug Administration has been receiving an increasing number of reports of hardware and software issues with the use of their insulin pumps. These devices provide diabetics continuous insulin supply and are worn by many diabetics as an alternative to injections.
According to current records, there have been eighteen (18) instances of recall of insulin pumps by major drug manufacturers such as Johnson & Johnson, Medtronic, Inc. and Roche Holding AG. As a result, the FDA is convening an advisory panel to determine policies where risks are minimized with insulin pump devices.
Insulin pumps are normally used by Type 1 diabetics because of the metabolic condition where the body does not produce natural insulin or the body rejects the insulin produced by the body. There are also an increasing number of Type 2 diabetes users, especially when it comes to geriatric care. Type 1 diabetes is a genetic condition while Type 2 diabetes is a condition brought about by poor diet health and lifestyle. Also in the FDA report is the triple increase of the number of users since the approval of the device in 2002.
In the last two years alone, nearly 17,000 incident reports have been filed with the agency and over 12,000 injuries have been attributed to insulin pumps, with many resulting in death for the diabetic. There have been forty-one incidents resulting in death were claimed to be blamed on the pumps as the patient went into diabetic coma after incorrect blood glucose measurements.
There has been an alarming observation that incidents involving medical devices have been unreported to the FDA. This observation makes the reported injuries to be actually higher, which cause many to be alarmed since insulin pumps are so critical to diabetes management for individuals.
Aside from the questions to come from the appointed FDA advisory panel of experts, there are still many questions that linger especially advisories to explain to patients when their insulin pumps are recalled. These include the failure of the FDA to undertake more formal action at a lower rate of reported injuries, the cause of the malfunction of the products and the issue of continuing sales and marketing when these devices are defective. While some of these devices improve the quality of life of many suffering from this condition, but the danger of malfunction can mean death or disability for a diabetic.
