04 March 2010

US FDA seeks ways to minimise insulin pump risks

U.S. health officials are looking for ways to minimize risks from potentially dangerous malfunctions of insulin pumps used by tens of thousands of diabetics.

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WASHINGTON (Reuters) - U.S. health officials are looking for ways to minimize risks from potentially dangerous malfunctions of insulin pumps used by tens of thousands of diabetics, documents released on Wednesday said.

The FDA report did not name specific manufacturers, but makers of insulin pumps include Medtronic Inc, Roche Holding AG, and Johnson & Johnson. The worry is that defective pumps can lead to high or low blood sugar if the machines fail to deliver the proper amount of insulin. Improper blood sugar levels can be fatal.

"Device problems critical to insulin pumps exist across manufacturers," Food and Drug Administration staff said in a report prepared for an advisory panel that meets Friday.Medtronic spokeswoman Amanda Sheldon said "the quality and safety of insulin pump therapy is not in question.

"The pumps "can provide greater control over glucose fluctuations over multiple daily injections, as well as freedom and flexibility for patients," she said.Melissa Katz, a spokeswoman for J&J unit Animas, said the company was reviewing the FDA report and "will work closely with the FDA to best support patients using insulin pumps.

"Roche supports efforts "to increase the education and benefits of insulin pump devices," company spokeswoman Nina Schwab-Hautzinger said.

The pumps are worn by adults and children, most of them type 1 diabetics who need daily insulin shots to keep their blood sugar under control. They offer an alternative to multiple injections during the day.Use of the devices is growing. The FDA said about 375,000 adults with type 1 diabetes used the pumps in 2007, up from 130,000 in 2002.

In recent years, various manufacturers have recalled the pumps for problems ranging from inadequate labeling to battery disconnection that could turn the pump off without warning.The FDA said there was "an increasing trend in software and hardware device problems across manufacturers.

"The agency said it will ask the panel of outside experts for recommendations on how makers can improve the reporting and investigation of problems and the handling of recalls.

FDA device reviewers examined nearly 17,000 reports of health problems in insulin pump users from 2006 through 2009. The reports do not prove a device caused a particular problem, but the FDA uses them to search for patterns.

The reviewers said many reports were incomplete, making it hard to tell if problems were related to a device malfunction or the underlying complications of diabetes. Problems also can occur when patients use the devices improperly.

"In a large number of reports, no evaluation was performed because the device was not returned, preventing manufacturers from performing failure analysis," the FDA report said.

Reports of deaths of insulin pump users "have not been thoroughly investigated and evaluated by manufacturers in determining causality and device failure," the agency said.

Reviewers examined 310 reports of deaths but in 225 of them "the device problem was unknown and limited details of the event were provided," the FDA staff said. In 41 reports, patients experienced diabetic coma, low blood sugar or other problems before they died.


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