FDA Tackles Infusion Pump Problems

The U.S. Food and Drug Administration (FDA) plans to strengthen regulation of infusion pumps that deliver drugs and other fluids to patients. The move follows repeated problems and recalls of the devices. Infusion pumps deliver intravenous antibiotics, chemotherapy and anesthesia drugs. The pumps are used at home for patients who receive regular infusions of drugs such as insulin.

The agency has cited an increase in the number and severity of problems with external infusion pumps. FDA officials have received 56,000 reports of problems between January 2005 and December 2009, including more than 500 deaths associated with the devices. From 2004 to 2009, there were 87 infusion-pump recalls, 14 of those were Class I recalls, according to the FDA.

Under draft guidelines, the agency would require additional testing of the pumps before they go on the market and ask for more information on software and other components.

Dr. Jeffrey Shuren, head of the FDA’s Center for Devices and Radiological Health, said many of the problems seem to be related to “deficiencies in device design and engineering” more often than user error.

According an FDA press release, 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.

Shuren added that the initiative represents a “major shift” in the FDA’s device regulation. Instead of responding to each set of problems manufacturer by manufacturer, the agency wants to take an industry-wide approach, he said.

The FDA also will work to increase user awareness by launching a new website as an information source and proactively facilitate device improvements by working with manufacturers more closely before they submit applications for pre-market approval, Shuren told a recent gathering of healthcare journalists.

“They can send their software to us in advance so we can work with them rather than telling them to work it out on their own,” he said.

One of the biggest changes affecting companies allows the FDA to conduct plant inspections before new pumps are approved. The largest manufacturers of infusion pumps include Baxter Healthcare, CareFusion Corp., and Hospira Inc.

While the FDA routinely inspects company facilities, it hasn’t required that the inspections be completed before a product is approved, except for high-risk implanted devices such as heart defibrillators.

The FDA will sponsor a public workshop May 25-26. Participants will discuss observed safety problems, and explore opportunities to work with others, including foreign regulators, to improve the design of infusion pumps on the market or in development, in order to reduce pump malfunctions and errors.

The agency won’t implement official guidance until feedback from the meeting is evaluated.