A Food & Drug Administration panel will convene March 5 to discuss risks posed by insulin infusion pumps, after 18 recalls were issued for the devices over a five-year period.
In particular, the agency’s General Hospital and Personal Use Devices Panel will discuss the the findings of an agency report that looks into possible health risks related to insulin pump failures.
Among the more sobering statistics in the report, which was released to the public in advance of the meeting, is the revelation that there have been almost 17,000 adverse events reported for insulin pumps from 2006 to 2008. Of those adverse reports, the agency says 310 deaths and 12,000 injuries occurred, possibly as a result of problems caused by pump failures.
The agency does not directly link the deaths to malfunctions with the device itself. For example, in 225 of the 310 deaths reported, the “device problem was unknown and limited details of the event were provided and the root cause of the device failure was not confirmed by the manufacturer,” according to the report.
However, the FDA believes the findings warrant more research into the issue, which will be one of the central themes of the panel’s discussion. The meeting is open to the public.
The agency says that more than 375,000 people in the U.S. use an insulin pump to treat their Type I diabetes, up some 188 percent from the 130,000 people reported to use the devices in 2002.
Among the most prominent manufacturers of the popular diabetes treatment are Minneapolis, Minn.-based medical device giant Medtronic Inc. (NYSE:MDT), Johnson & Johnson (NYSE:JNJ) and Bedford, Mass.-based Insulet Corp. (NSDQ:PODD), which produces the OmniPod insulin management system.