Deaths and Adverse Events Prompt FDA Action on Infusion Pumps

Washington, DC: The Food and Drug Administration (FDA) has announced that they are issuing preliminary guidelines requiring manufacturers of infusion pumps to supply them with adequate test data prior to the devices receiving federal approval for commercial sale.

The move results from numerous complaints about a variety of automated pumps used to intravenously deliver food and drugs such as cancer medications and insulin.

According to a recently issued press release, the FDA has received "more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data."

The FDA lists the most common types of reported problems as being 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.

The mechanical failure of these types of devices is evident across "across multiple manufacturers and pump types," the FDA said in its release. Baxter Healthcare of Deerfield, Ill, Hospira of Lake Forest, Ill, and CareFusion of San Diego are among the largest manufacturers of infusion pumps.

Infusion pumps are widely used in a variety of settings including hospitals, medical clinical and people's homes. The devices allow a greater level of control, accuracy, and precision in drug delivery, and help to reduce medication errors.

"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."

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Published on Apr-26-10