FDA Addresses External Infusion Pump Safety Issues

New initiative includes additional premarket requirements for manufacturers
By Beth Gilbert
HealthDay Reporter

MONDAY, April 26 (HealthDay News) -- The U.S. Food and Drug Administration has announced a new initiative to address safety issues related to external infusion pumps, which are commonly used in hospitals, other clinical settings, and patient's homes.

As part of the initiative, the agency is asking manufacturers to provide it with additional design and engineering information as part of premarket review. In addition, the agency has informed these manufacturers that they may need to perform additional risk assessments to support approval of new or modified pumps. The FDA is also holding a public workshop in May dedicated to infusion pump design, and launching a Web page focused on infusion pump safety.

Although external infusion pumps help reduce drug delivery errors by providing more control and accuracy, they have been associated with a number of safety issues. Over the last five years, the FDA has received over 56,000 reports of adverse events associated with infusion pump use, including over 500 deaths. In addition, there were 87 external infusion pump recalls due to safety issues between 2005 and 2009. Many safety issues appear to be related to defects in the design and engineering of these pumps.

"These pumps often provide critical fluids to high-risk patients, so failures have significant implications," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a statement. "It is time for a more comprehensive approach than we've taken to date."

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