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U.S. Department of Health and Human Services

Medical Devices

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Infusion Pump Risk Reduction Strategies for Clinicians

Introduction

Performance problems have occurred across all types of external infusion pump (see What Is an Infusion Pump?) in a variety of clinical settings. The problems are not specific to one infusion pump manufacturer. These problems can lead to over- or under-infusion and/or delays in therapy.

The causes of these performance failures include, but are not limited to:

  • Software defects
  • Inadequate user interface design ("human factors" issues)
  • Damaged mechanical parts (e.g., doors and latches)
  • Battery failures

For more information on specific problems, see Examples of Reported Infusion Pump Problems

Healthcare facilities that use infusion pumps should have policies and procedures in place to promote patient safety. Additional practices such as using "smart pump" technology may also be in place to help reduce risks.

Clinicians may consider the following strategies to help reduce risks to patients. While these strategies are not applicable to all types of infusion pumps in all clinical settings and patient populations, clinicians may find them useful.

Reduce Risks

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

  • 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.

Check

  • 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

  • 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.

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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.

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