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FDA Launches Initiative to Reduce Infusion Pump Risks

Russell Phillips, PhD

Apr 27, 2010

Agency calls for improvements in device design

Last week the U.S. Food and Drug Administration announced an initiative to evaluate safety problems that may occur with external infusion pumps. These devices are used to deliver fluids or medications to patients in a controlled manner. Insulin pumps, for example, release insulin into the body at a controlled rate to compensate for a lack of insulin production in people with type 1 diabetes.

Federal health regulators on Friday announced steps to improve the design and safety of drug pumps that have been linked to more than 500 deaths in the past five years. The FDA is issuing a draft guidance and letter to infusion pump manufacturers.

"These pumps often provide critical fluids to high-risk patients, so failures have significant implications," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health in a press release from the FDA. "It is time for a more comprehensive approach than we've taken to date."

Pumps typically allow a greater level of control, reducing medication errors and increasing accuracy, and precision in drug delivery. But infusion pumps also have been implicated in safety problems. The FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps in the past five years. 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 FDA will also sponsor a public workshop May 25-26, 2010. 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.

According to the FDA press release, 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; and
Mechanical or electrical failures, including components that break under routine use, premature battery failures, and sparks or pump fires.

The FDA has the following advice for users. To help reduce infusion pump risks, 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 for signs of over- or under-infusion.
Use available resources to prevent and respond to pump problems.
Report adverse events promptly to the FDA.

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For more information:

Center for Devices and Radiological Health information on infusion pumps.

White Paper: Infusion Pump Improvement Initiative.

Source:

FDA press release

Categories: Diabetes, Diabetes, Food, Government & Policy, Insulin, Insulin Pumps, Online Resources, Products, Type 1 Issues