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FDA to Increase Regulation of Infusion Pumps

Apr 26, 2010 | Parker Waichman LLP

The Food & Drug Administration (FDA) has undertaken an initiative to boost the safety of infusion pumps. Infusion pumps are marketed by a number of firms, including Baxter International Inc, Abbott Laboratories Inc, Hospira Inc and CareFusion.

According to the FDA, it has received 56,000 reports of adverse events - including 500 deaths -associated with the use of infusion pumps over the past five years. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, the agency said.

“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 announcing the initiative “It is time for a more comprehensive approach than we’ve taken to date.”

Infusion pumps are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner through a built in software interface. 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.

Failures of infusion pumps have been observed across multiple manufacturers and pump types. The FDA says that many of the reported problems appear to be related to deficiencies in device design and engineering. 

As part of its initiative, FDA is moving to establish additional premarket requirements for infusion pumps. The agency also announced a May public workshop on infusion pump design, and launching a new Web page devoted to infusion pump safety.

Last week, the FDA issued 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.

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