FDA Safety Communication: Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment

Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment

On January 11, 2016, FDA informed patients, caregivers, MR technologists, and health care providers of important safety precautions to help patients with implantable infusion pumps safely have an MRI exam.

The FDA has received reports of serious adverse events, including patient injury and death, associated with the use of implantable infusion pumps in the MR environment. These reports describe medication dosing inaccuracies (e.g., over-infusion or under-infusion, unintended bolus) and other mechanical problems with the pump (e.g., motor stall, pump not restarting after an MRI exam).

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Helene D. Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration