FDA panel sees user errors with insulin pumps
Gaithersburg, Maryland: Diabetics who wear insulin pumps appear more likely to experience problems from improper use than a device defect, members of a U.S. government advisory panel said on Friday.
The Food and Drug Administration said problems with insulin pumps have occurred across the industry and asked the panel of outside experts for ways to minimize risks from malfunctions. Makers of the pumps include Medtronic Inc, Roche Holding AG and Johnson & Johnson.
Panel members said they felt user errors were more likely than defects with the tiny devices worn by tens of thousands of diabetics who need insulin injections to control blood sugar.
"The risks associated with people are much greater than those associated with known defects of the technology," said Dr. Marc Rendell, a panel member from Creighton University School of Medicine.
Lamont Weide, a panelist and physician at Truman Medical Center in Kansas City, said "the failure rate to all of us seems extremely, extremely low."
The advisers said patient education on proper settings and other matters was key to minimizing complications. They said risks from malfunctions also were minimal as long as patients checked blood sugar regularly and had other insulin sources available.
If a diabetic "has been educated and has their insulin in hand, there are little if any risks," said panel chairman William Jarvis, a South Carolina physician.
About 375,000 adults with type 1 diabetes used the pumps in 2007, up from 130,000 in 2002, the FDA said. Some teenagers also use them. They offer an alternative to multiple insulin injections throughout the day.
Various makers have recalled pumps in recent years for problems ranging from inadequate labeling to battery disconnection, that could turn the pump off without warning.
The FDA is concerned because patients can have high or low blood sugar if the machines fail to deliver the right insulin dose. Uncontrolled blood sugar levels can be fatal.
Agency reviewers examined nearly 17,000 reports of health problems in pump users over a three-year period. The reports do not prove a device caused a problem, but the FDA uses them to look for patterns.
Many reports were incomplete, making it hard to tell if problems were related to a device malfunction, improper use or diabetes complications, FDA staff said. Often pumps are not returned to manufacturers for evaluation.
"Some discussion between FDA and industry would be worthwhile in trying to figure out how to make the (medical device reporting) system more useful," panelist Jarvis said.
Medtronic spokeswoman Amanda Sheldon said the company "works closely with healthcare providers and the diabetes industry to provide proper education and develop best practices for the safe and effective use of insulin pump therapy, and we will continue to lead these efforts."
Roche supports "efforts to increase education and benefits of insulin infusion pumps, which can help patients maintain an active, healthy lifestyle," company spokesman Todd Siesky said.
J&J unit Animas, which makes insulin pumps, said in a statement issued before the meeting that the company would work with the FDA to support patients.