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The Wednesday for implantable infusion pumps in the MRI environment, based on reports of serious adverse events, including patient injury and death, to the agency.

Serious adverse events have been reported with pumps after being exposed to the MR environment, specifically programming issues. Subsequent medication dosing and mechanical issues may include unintended bolus, over- or under-infusion of medicine, motor stall, and more, according to the FDA.

Implantable infusion pumps, typically surgically implanted into the abdomen, are used to administer targeted, chronic medications through a catheter to the patient.

Interference from an MRI has reportedly resulted in patient injury and death, when the specific make and model of the pump was not approved to safely withstand the MR environment. "Only implantable infusion pumps labeled as MR Conditional may be used safely within an MR environment, and only under the specified conditions of safe use," the agency stressed.

Patients and/or caregivers must consult with the prescribing healthcare physician and MRI technician before undergoing an MRI to determine safety, as well as carry an "implant card" detailing the specific make and model of their device. Additionally, the patient may consider wearing a medical alert bracelet or necklace for emergency events.

After an MRI, the FDA recommended all implantable infusion pumps be checked by a physician to determine if reprogramming is necessary.

Healthcare professionals and patients should report adverse events or side effects to the FDA's Safety Information and Adverse Event Reporting Program.

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