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U.S. Department of Health and Human Services

Medical Devices

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Infusion Pump Risk Reduction Strategies for Clinical and Biomedical Engineers and Health Information Technology Professionals

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.

Clinical and biomedical engineers and health information technology professionals 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, clinical and biomedical engineers 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.
  • Be aware of infusion pump software versions in all infusion pumps and maintain a list of software versions in your infusion pump inventory.
  • Be familiar with drug libraries and hospital-specific dosing guidelines. Work with other departments, including IT, pharmacy, and clinicians, to continuously evaluate the adherence and effectiveness of the guidelines.
  • Conduct preventive maintenance on infusion pumps as recommended by the manufacturer's protocol.

Evaluate

Use a team approach* when you:

  • Collect information about issues, problems, or difficulties with infusion pumps in use. Obtain as many details as possible.
  • Follow up on incident/occurrence reports. Consider underlying causes when you see patterns of use errors or "no problem found" messages.
  • Work with manufacturers to obtain useful infusion pump log reports following reported problems.

* Includes departments such as Information Technology, Pharmacy, Materials Management, Nursing, Medicine, Patient Safety, Risk Management, Quality Assurance, and Housekeeping.

Address Known Problems

  • Address recalls and hazard alerts promptly for infusion pumps in your inventory.
  • Work with the manufacturer to comply with the recall strategy if your facility has products that are affected.
  • Communicate to all departments involved instructions for responding to a recall.
  • Monitor infusion pumps for recurring problems.

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Report Problems

 

  • Follow your hospital/facility protocol for reporting events, including device/user interface problems, 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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