FDA Infusion Pump Improvement Initiative

External infusion pumps, commonly called “infusion 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.  Infusion pumps have contributed to improvements in patient care, allowing for a greater level of control, accuracy, and precision in drug delivery, and thereby reducing medication errors.  Although widely used, infusion pumps are not without risks.

According to the FDA, from 2005 through 2009, 87 infusion pump recalls were conducted by firms to address identified safety problems. Infusion pump problems have been observed across multiple manufacturers and pump types. Through analysis of pump-related adverse event reports and device recalls, FDA has concluded that many of these problems appear to be related to deficiencies in device design and engineering.

The FDA has launched the  Infusion Pump Improvement Initiative. Through this initiative, FDA will take broad steps to prevent infusion pump problems:

  1. Establish additional requirements for infusion pump manufacturers;
  2. Proactively facilitate device improvements; and
  3. Increase user awareness.

For more information on the FDA’s Infusion Pump Improvement Initiative, click here.

Many nurses using infusion pumps have relied solely on these devices for safe medication delivery, sometimes forgetting to”double check” the rate flow and whether the pump is accurately delivering the prescribed therapy.  Remember, these infusion pumps are considered adjunct to nursing care and are not intended to alleviate the nurse’s responsibility for monitoring the infusion rate of the prescribed therapy (INS Standard 33C)

The FDA have suggested the following risk reduction strategies:

Plan Ahead

  • Have a back-up plan in case of an infusion pump failure that details:
    • How to obtain a working infusion pump and infusion tubing quickly when caring for high-acuity patients.
    • How to handle high-risk infusions when the infusion pump fails. This may include staying with and closely monitoring the patient while another staff member obtains a working infusion pump if one is not readily available.
    • How to handle infusions when the infusion pump fails in vulnerable patient populations (e.g., individuals sensitive to fluid overload). This may include clamping and disconnecting the infusion tubing from the patient to prevent over-infusion prior to obtaining a new infusion pump.
  • Participate in educational activities designed to promote the safe use of infusion pumps.
  • Consider a secondary method of checking the expected volume infused, such as a time strip indicator or a buretrol.


  • Label the infusion pump channels with the name of the medication or fluid, if your infusion pump does not display the name.
  • Label the infusion pump tubing at the port of entry with the medication or fluid name.


  • Verify that the infusion pump is programmed for the right dosage, at the right rate and volume to be infused. This is especially important at a change of shift, when any change is made to the infusion pump settings, when a new bag of medication/fluid is hung, or when new infusion tubing is primed.
  • Obtain an independent double-check of infusion pump settings by a second clinician per your hospital/facility policy when infusing high-risk medications (e.g. Insulin, Heparin, Vasopressors, Diprivan, Total Parenteral Nutrition (TPN), Morphine, etc.).  An independent double-check involves two clinicians separately checking (alone and apart from each other, then comparing results) the infusion settings in accordance with the physician’s order.
  • Monitor for signs of over- or under-infusion of high-risk medications by using other patient monitoring systems such as cardiac, pulse oximetry, end tidal CO2, and glucose meters, when applicable.
  • Monitor the patient and infusion per your facility’s protocol.


  • Use available resources, such as your Clinical/Biomedical Engineering Department, your area’s “super-users,” and infusion pump instructions or troubleshooting guides, when experiencing problems with an infusion pump.
  • Use the drug library when applicable. Promptly respond and pay close attention to displayed alerts and cautions.
  • Use the “5 rights” for safe medication administration: the right patient, the right drug, the right dose, the right route, and the right time.

Report Problems

  • Remove from use, tag with the specific problem and clinician contact information, and sequester any infusion pump if the pump shows signs of breakage or damage, including small chips or cracks, if an unexplained alarm occurs, or if the pump does not function as expected.
  • Follow your hospital/facility protocol for reporting events where the infusion pump may have caused or contributed to a death or serious injury.  You are also encouraged to report any other infusion pump safety concerns through your hospital/facility protocol.
  • You are encouraged to  file a voluntary report with the FDA for any pump problem that you may encounter.
  • HIPAA restrictions do not apply to reports submitted to FDA.

The FDA also has a new website for infusion pumps – click here. The site describes actions that patients and professionals who interact with infusion pumps – including hospital staff and administrators, as well as home users – could take to help prevent safety problems.