Comment period for Infusion Pump Draft Guidance ends July 23, 2010

The document is available for review at "Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions" Submit comments or suggestions to (refer to docket number HFA-305) or by mail to Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1601, Rockville, MD 20852.

Report an Infusion

Pump Problem

External infusion pumps are medical devices that deliver fluids, including nutrients and medications such as antibiotics, chemotherapy drugs, and pain relievers, into a patient’s body in controlled amounts. Many types of pumps, including large volume, patient-controlled analgesia (PCA), elastomeric, syringe, enteral, and insulin pumps, are used worldwide in healthcare facilities such as hospitals, and in the home.

Clinicians and patients rely on pumps for safe and accurate administration of fluids and medications. However, FDA has identified problems that can compromise the safe use of external infusion pumps. These problems can lead to over- or under-infusion, missed treatments, or delayed therapy.

FDA is taking steps to address infusion pump problems through the Infusion Pump Improvement Initiative. (For more information, see the FDA’s White Paper.)

On this website, you can learn more about infusion pump problems, actions FDA is taking to improve pump safety, strategies to reduce pump-related risks, and steps you can take to report problems to FDA.