FDA Calls for Reducing Infusion Pump Risks

The Food and Drug Administration (FDA) announced on Friday that new steps are being taken to address safety problems associated with external infusion pumps—including establishing additional premarket requirements for the pumps used in all environments, such as hospitals, clinics, and at-home settings.

According to the FDA, infusion pumps have been the source of "persistent safety problems": In the past five years, the organization has received more than 56,000 reports of adverse events. Between 2005 and 2009, 87 infusion pump were recalled to address identified safety concerns, according to FDA data.

More than 700 reported deaths have been linked to infusion pump malfunctions, but that number may be a "gross underestimate" because most deaths from the devices may not be reported as device malfunctions, said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, on Friday.

"These pumps often provide critical fluids to high risk patients, so failures have significant implications," Shuren said. "It is time for a more comprehensive approach than we've taken to date."

Infusion pump failures have been observed across multiple manufacturers and pump types, the FDA said, and many of the problems reported may be related to deficiencies in design and engineering.

In a new draft guidance and letter to infusion pump manufacturers, FDA is calling for the device manufacturers to provide additional design and engineering information to the agency during premarket review of the devices. It also said additional risk assessments were needed to support clearance of new or modified pumps.

The most commonly reported problems associated with the pumps, according to the FDA. 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.

The FDA will hold a public workshop May 25 26. Participants will discuss safety problems and explore opportunities to work with others, including foreign regulators, to improve the design of pumps on the market or in development.