U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. General Hospital Devices and Supplies
  5. Infusion Pumps
  6. Infusion Pump Risk Reduction Strategies for Home Health Nurses
  1. Infusion Pumps

Infusion Pump Risk Reduction Strategies for Home Health Nurses

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.

Home health nurses 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, home health nurses may find them useful.

Reduce Risks

Plan Ahead

  • Have a back-up plan in case of an infusion pump failure. The plan should include:
    • How to obtain a working infusion pump and infusion tubing quickly.
    • How to obtain a back-up battery or power supply.
  • Participate in educational activities designed to promote the safe use of infusion pumps.
  • Train the patient and/or caregiver how to use the infusion pump and teach your patient the back up plan for infusion pump failures.
  • Provide the patient or caregiver with the infusion pump instructions and/or troubleshooting guides.
  • Instruct the patient or caregiver on what to do if the infusion pump malfunctions or they observe signs of an over- or under-infusion.
  • Provide the patient with 24-hour contact information for questions and problems.

Check

  • Verify the settings on the infusion pump prior to starting the medication or fluid.
  • Verify the infusion pump's settings before you leave the patient or caregiver alone with the infusion pump.
  • If there is a lockout mechanism, verify that it is in use before leaving the patient or caregiver alone with the infusion pump.

Use

  • 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.
  • Use available resources, such as infusion pump instructions or troubleshooting guides, when experiencing problems with an infusion pump. If the instructions for use are not readily available, request them from the durable medical equipment supplier.

Report Problems

  • Do not use an infusion pump if it shows signs of breakage or damage, including small chips or cracks, if an unexplained alarm occurs, or if the pump does not function as you expect it to. Tag it with details about the problem.
  • 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.
 
Back to Top