FDA Launches New Initiative to Address Infusion Pump Safety Issues

The U.S. Food and Drug Administration has announced a new initiative to address safety problems associated with external infusion pumps, which are often used to deliver fluids, including nutrients and anesthesia and chemotherapy medications, into a patient's body in a controlled manner, according to an FDA news release.

The FDA is moving to establish additional premarket requirements for infusion pumps as part of its new initiative, and has issued new draft guidance and a letter to infusion pump manufacturers, according to the release. The draft guidance recommends manufactures begin to provide additional design and engineering information the FDA can use during premarket review and also alerts makers that the agency may conduct additional risk assessments on new or modified devices. The guidance also provides the options to manufactures for a static analysis prior to premarket review, according to the release.

The agency is also holding a public workshop on infusion pump design on May 25-26, and is launching a new website devoted to infusion pump safety.

Infusion pumps are commonly used in hospitals and other clinical settings and in at-home care, and they allow a greater level of control, accuracy and precision in drug delivery, according to the release. They have also been a source of persistent safety problems, and in the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps that 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. Failures have been observed across multiple manufactures and pump types.

The FDA reports the following most common safety related issues in infusion pumps:

• 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 has asked clinicians to reduce infusion pump failures by taking the following steps:

• 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.

Read the FDA's release on infusion pump failures.