MRI

FDA Issues Warning for Patients with Implantable Infusion Pumps Undergoing MRIs

The FDA issued a warning regarding safety problems when patients with implantable infusion pumps undergo MRI exam. The warning was issued after the FDA received reports that “describe medication dosing inaccuracies (eg, over-infusion or under-infusion, unintended bolus) and other mechanical problems with the pump (eg, motor stall, pump not restarting after a Magnetic Resonance Imaging (MRI) exam).”

The reports indicate that implantable infusion pumps can be effected by the MR environment, and create safety hazards for patients, including injury and death. According to the FDA, patients with implantable infusion pumps should not undergo MRI screening unless the pump is labeled “MR conditional,” and safety produces outlined for the pump should be followed to avoid adverse events before, during, and after an MRI exam.
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“The specific conditions that health care practitioners and patients should follow before, during, and after the MRI exam vary by the make and model of the implantable infusion pump system. Importantly, each implantable pump model may have unique conditions that must be followed in order for a patient to safely undergo an MRI exam,” the FDA stated.

The FDA recommended that patients with implantable infusion pumps:

  • Be aware of the specific instructions for undergoing MRI screening.
  • Alert technicians and physicians of the implantable infusion pump.
  • Carry identification cards for the implantable infusion pump to MRI exam.
  • Consider obtaining a medical alert necklace or bracelet.
  • Be aware that only implantable infusion pumps labeled MRI conditional can be used for an MRI exam.
  • Be aware that the implantable infusion pump may need to be checked after the exam.

At the moment, the FDA is working with the manufacturers to update MRI safety information for the devices to ensure instructions are clear and up-to-date.

—Melissa Weiss

Reference:

The U.S. Food and Drug Administration. Implantable infusion pumps in the magnetic resonance (MR) environment: FDA safety communication—important safety precautions [press release]. January 11, 2017. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm536526.htm. January 12, 2017.