The U.S. Food and Drug Administration has launched a new initiative to address safety problems associated with external infusion pumps – devices that deliver fluids such as nutrients and medications into a patient's body in a controlled manner.

As part of the initiative, the FDA is moving to establish additional premarket requirements for infusion pumps, in part through issuance of a new draft guidance and letter to infusion pump manufacturers. The agency is also announcing a May public workshop on infusion pump design, and launching a new Web page devoted to pump safety.

"These pumps often provide critical fluids to high-risk patients, so failures have significant implications," said Jeffrey Shuren, MD, 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."

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.

But they've also been the source of persistent safety problems. In the past five years, 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 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;
• mechanical or electrical failures, including components that break under routine use, premature battery failures, and sparks or pump fires.

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. So, as part of its initiative, the FDA published draft guidance recommending that infusion pump manufacturers begin to provide additional design and engineering information to the agency during premarket review of the devices.

The agency also 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. In addition to alerting them of this intended change, the letter offers manufacturers the option of submitting their infusion pump software codes to experts at the FDA for static analysis – a diagnostic technique that can help detect software problems early in the device development process – prior to premarket review.

The FDA's public workshop will take place on May 25 and 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.

"Working with industry and users, we can help develop safer, more effective infusion pumps and improve patient care," said Shuren.

The agency's new infusion pump safety Web page features basic information about infusion pumps and steps that patients and healthcare professionals can take to prevent and report safety problems, even before new or redesigned pumps are brought to the market.

To help reduce infusion pump risks, the FDA asks clinicians to consider the following general strategies.

• Plan ahead and be ready to respond in the event of a pump failure.
• Label infusion pump channels and tubing to prevent errors.
• Check infusion pump settings and monitor patients for signs of over- or under-infusion.
• Use available resources to prevent and respond to pump problems.
• Report adverse events promptly to the FDA.