The Food & Drug Administration made its first moves toward stricter regulation of infusion pumps, issuing proposed new guidelines advising manufacturers of the devices that they’ll likely have to run more in-depth clinical trials before the FDA clears new pumps.
In March, the federal watchdog agency convened a panel to review the risks posed by the pumps, after 18 recalls were issued for the devices over a five-year period.
The agency’s General Hospital and Personal Use Devices Panel discussed the the findings of an agency report that looks into possible health risks related to insulin pump failures. There have been almost 17,000 adverse events reported for insulin pumps from 2006 to 2008, according to the report. Of those, the FDA 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.
Use of insulin pumps by Type I diabetics has soared this decade, according to the FDA. The agency says that more than 375,000 people in the U.S. use an insulin pump, up some 188 percent from the 130,000 people reported to use the devices in 2002.
Today the FDA said it is "moving to establish additional pre-market requirements for infusion pumps, in part through issuance today of a new draft guidance and letter to infusion pump manufacturers," according to a press release. The draft guidance proposed that manufacturers be required to "provide additional design and engineering information to the agency during premarket review of the devices," according to the release. The FDA also sent a letter to infusion pump manufacturers "informing them that they may need to conduct additional risk assessments to support clearance of new or modified pumps."
The letter also said manufacturers can voluntarily submit the devices’ software code for analysis prior to the FDA’s review of an application. The agency previously encouraged device makers to use an open-source software safety platform, developed by Generic Infusion Pump project, to improve pump design safety.
A public meeting is scheduled for May 25-26 to discuss the devices’ safety issues and how they can be improved in cooperation with international regulatory bodies.
"These pumps often provide critical fluids to high-risk patients, so failures have significant implications," Center for Devices and Radiological Health direcgtor Jeffrey Shuren said in prepared remarks.
Among the most prominent manufacturers of insulin infusion pumps 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.
