Not clear if troubles stem from the devices or patient error, FDA panel says
FRIDAY, March 5 (HealthDay News) -- The makers of insulin pumps used to treat diabetes should try to supply more information to U.S. officials when filing reports about potential problems with the devices, an advisory panel to the U.S. Food and Drug Administration said Friday.
Makers of medical devices are required to report when a device malfunctions or may have contributed to the death or serious injury of a patient. The FDA said it has seen a sharp rise in the number of "adverse events" related to insulin pumps, which have become increasingly popular in recent years, the Dow Jones news wire reported.
The panel of outside medical advisors met to discuss the increase in problems and whether anything could be done to minimize potential risks to patients. Panel members said more information is needed in adverse-event reports to help the FDA gauge if an insulin pump contributed to a patient's problem, the news service reported.
"It could be a pump failure or it could be people failure," said Marc Rendell, a panel member and director of the Diabetes Center at Creighton University in Omaha, Neb., noting it can be difficult to train patients to properly use the devices. Other doctors on the panel -- the General Hospital and Personal Use Devices Panel -- also said they find many pump problems are due to patients not following instructions, such as changing some pump parts every three days or using the proper settings, Dow Jones reported.
Problems with the pumps have resulted in deaths and injuries. This prompted the FDA to ask the advisors to review the matter and come up with ways to get manufacturers to do a better job of finding, reporting and fixing the problems.
According to an FDA review of insulin pump problems, there have been 16,849 adverse-event reports since 2006, including 310 deaths, 12,093 injurie
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