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FDA Launches Initiative to Reduce Infusion Pump Risks
Date:4/23/2010

Agency calls for improvements in device design

SILVER SPRING, Md., April 23 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced a new initiative to address safety problems associated with external infusion pumps, which are devices that deliver fluids, including nutrients and medications, into a patient's body in a controlled manner.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

As part of its initiative, FDA is moving to establish additional premarket requirements for infusion pumps, in part through issuance today of a new draft guidance and letter to infusion pump manufacturers.  FDA is also announcing a May public workshop on infusion pump design, and launching a new Web page devoted to infusion pump safety.

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

Infusion pumps are widely used in hospitals, other clinical settings, and the home. The devices allow a greater level of control, accuracy, and precision in drug delivery, and help to reduce medication errors.

However, infusion pumps also have been the source of persistent safety problems. In the past five years, the FDA has received more than 56,000 reports of adverse events associated with
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SOURCE U.S. Food and Drug Administration
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