The U.S. Food and Drug Administration (FDA) announced a new initiative to address safety problems associated with external infusion pumps. Infusion pumps are devices that deliver fluids, such as nutrients and medications into a patient’s body in a controlled manner. The problem with them, is that each manufacturers pumps work differently and many can be difficult to operate resulting in improper delivery of medications.

Infusion pumps have 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, leading to 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.

The FDA is moving to establish premarket requirements for infusion pumps through issuance of a new draft guidance and letter to infusion pump manufacturers.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

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.