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U.S. Department of Health and Human Services

Medical Devices

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Infusion Pump Risk Reduction Strategies for Pharmacists

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.

Pharmacists 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, pharmacists may find them useful.

Reduce Risks

Plan Ahead

  • Participate in and develop educational activities with other hospital staff to promote the safe use of infusion pumps.
  • Label the amount of overfill in the bag when using non-prefilled bags, so that clinicians can account for the total bag volume.
  • Collaborate with other departments to standardize high-risk drug concentrations.
  • Have standardized drug concentrations readily available in the drug library, if used.
  • Collaborate with other departments to establish high and low dose ranges, as well as setting limits in the drug library to further prevent programming errors.  Consider using hard limits for high risk medications.
  • Confirm that the settings on the infusion pump are correct (if applicable) prior to releasing the infusion pump to a clinician or patient.

Monitor

  • Work with a multidisciplinary team to develop and implement a plan to monitor incident/occurrence reports about infusion pumps.
  • Monitor adherence to limits established in the drug library. Evaluate the ongoing safety of the drug concentrations and range limits.
  • Collaborate with a multidisciplinary team to implement risk reduction plans.

Research Infusion Pumps Before Purchase or Rental

  • Collaborate with a multidisciplinary team when evaluating and purchasing infusion pumps.
  • Collaborate with a multidisciplinary team to plan and implement a staged roll-out of new infusion pumps, including analysis of early trends in incidents.

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Report Problems

  • 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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