WASHINGTON, April 26 (UPI) — The U.S. Food and Drug Administration says it is starting an initiative designed to address safety problems associated with external infusion pumps.
Infusion pumps are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner. The FDA said it has received more than 56,000 reports of “adverse events” involving infusion pumps that have resulted in serious injuries and more than 500 deaths during the last five years.
Infusion pumps are widely used in hospitals, other clinical settings, and in homes, the FDA said. The devices allow a greater level of control, accuracy, and precision in drug delivery, helping to reduce medication errors.
The federal agency said it wants to establish additional premarket requirements for infusion pumps. The FDA also announced a May public workshop on infusion pump design, as well as a new Web page devoted to infusion pump safety.
Failures of infusion pumps have been observed across multiple manufacturers and pump types. The FDA said many of the reported problems appear to be related to deficiencies in device design and engineering.
The FDA’s public workshop will be held May 25-26, during which participants will discuss safety problems and ways to improve the design of infusion pumps on the market or in development, to reduce malfunctions and errors.
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