FDA To Evaluate Insulin Pump Problems
The Food and Drug Administration has announced that it is seeing an increased number of hardware and software problems with many different brands of insulin pumps and will be evaluating the issue. Over the past five years, there have been 18 recalls of the devices.
An advisory panel will be created of medical experts will discuss what actions should be taken to minimize the risks that are associated with the recalled insulin pumps. Multiple manufacturers are involved, including Johnson & Johnson, Medtronic, and Roche Holding.
Insulin pumps are primarily used by people with Type I diabetes, an autoimmune condition in which the pancreas produces little or no insulin. An insulin pump replaces the need for periodic injections by delivering rapid-acting insulin continuously throughout the day using a catheter. The FDA has said that the number of diabetics using pumps have increased in recent years. The Juvenille Diabetes Research Foundation estimates that between 375,000 and 400,000 adults and children with Type 1 diabetes used pumps.
Some advantages of using an insulin pump instead of insulin injections include more accurate delivery of insulin, greater improvement in blood sugar control with fewer extreme highs and lows, and making diabetic management easier.
The FDA has received about 17,000 reports from manufactures between October 1, 2006 and September 30, 2009 regarding adverse events associated with insulin pumps. Of the reports, about 12,000 reported a patient injury (such as problems with blood glucose levels) and 310 deaths.
Unfortunately, many of the reports have not been thoroughly investigated and remain unsolved. The FDA, for example, has found that 225 of the 310 deaths have listed the device failure as “unknown”.
In a separate study, conducted at the Sansum Diabetes Research Institute and the University of California, Santa Barbara, researchers concluded that changing the height of an insulin pump in relation to its tubing and infusion set can significantly affect the expected insulin delivery rate because of a change in the siphon action or hydrostatic pressure. This isn’t a failure of the device, but an action that can easily occur with activities such as dressing, sleeping or showering and should be noted in the instructions for users.