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Using External Infusion Pumps Safely

External infusion pumps provide medications, fluids and nutrients to patients in healthcare facilities and in the home. They can improve patient care by delivering drugs and other substances with a high level of control, accuracy, and precision. But they have also been a source of persistent safety problems.

In the last five years, FDA has received numerous reports of adverse events associated with external infusion pumps, including serious injuries and deaths. During roughly the same period of time, there were over 80 recalls because of safety issues. Problems have been reported with a variety of pumps, including large volume, syringe and elastomeric pumps, as well as specialty infusion pumps such as enteral, insulin and PCA pumps.

Many adverse events are attributed to use error, but some are related to problems with device design or engineering, including software defects, user interface issues, and mechanical or electrical failures. These problems can compromise patient care by leading to over- or under-infusions, missed treatments or delayed therapy.

FDA has launched a new initiative to address these problems in a number of ways --- for example, by establishing additional requirements for infusion pump manufacturers, and facilitating the development of safer and more effective pumps.

In the meantime, there are steps clinicians can take to reduce pump-related risks. Here are some of the things FDA recommends:

• Have a back up plan if the pump fails, including how to get a working pump and tubing quickly, and how to get a back-up battery or power supply.
• Use instruction manuals or trouble-shooting guides, as well as the pump's drug library, if applicable. And remember the "5 rights" for medication administration - the right patient, drug, dose, route and time.
• If appropriate, label infusion pump channels and tubing with the name of the medication or fluid to help avoid errors.
• Do not use a pump if it is broken or damaged, even if there are only small chips or cracks. And do not use a pump if an unexplained alarm occurs or if the pump does not function as you expect it to. Tag the pump with details about the problem and report it.
• Be sure that the preventive maintenance recommended by the manufacturer is performed.
FDA Patient Safety News: July 2010
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=100#6

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