Infusion Pumps Face More FDA Scrutiny

U.S. health regulators want to decrease the risks associated with <"">infusion pumps. According to the Food & Drug Administration (FDA), it has received 56,000 reports of adverse events associated with the use of infusion pumps over the past five years. Some of these have involved serious injuries and deaths.

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.

Infusion pumps are marketed by a number of firms, including Baxter International Inc, Abbott Laboratories Inc, Hospira Inc and CareFusion.

Unfortunately, infusion pumps have been the source of persistent safety problem. According to the FDA, over the last five years, 500 deaths have been attributed to faulty infusion pumps. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, the agency said.

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. The most common types of reported problems have been related to:

• software defects, including failures of built-in safety alarms;

• user interface issues, such as ambiguous on-screen instructions that lead to dosing errors; and

• mechanical or electrical failures, including components that break under routine use, premature battery failures, and sparks or pump fires.

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.

“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.”

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