FDA: Infusion Pump Implants May Malfunction in MRIs

MRI Infusion Pump Injury

January 11, 2017 — Implantable infusion pumps can malfunction and cause serious injury or death during MRIs, according to a Safety Communication issued by the FDA.

Magnetic Resonance Imaging (MRI) is a medical diagnostic exam that creates a picture of the inside of a patient’s body using very strong magnets and radio-waves.

Infusion pumps are mechanical devices that are usually implanted in a patient’s abdomen. They deliver medications like painkillers, muscle-relaxers, or fluids to patients in controlled amounts.

Magnets interact with metal, which is why only “MR Conditional” infusion pumps are safe to use in an MRI. The FDA says patients should know what pump they have and tell doctors before an MRI.

There are reports of MRI exams causing infusion pumps to stop delivering medication or deliver all of their medication at once. This could result in a life-threatening medication over-dose or under-dose.

The FDA has also received reports of mechanical malfunctions, including motor stalling, or not re-starting after the MRI. According to the agency:

“Some pump models may automatically stop delivering medication during the MRI exam, and some may need to be reprogrammed before and/or after the exam. … Some pump models may need to be completely emptied of drug prior to the MRI exam.”

All patients should be asked if they have an implantable infusion pump. Doctors should NOT scan a patient in an MRI until after the pump has been positively identified. Only pumps labeled “MR Conditional” are safe, and only in certain conditions, FDA warns.

Patients should also be aware of the risk. “Make sure your physicians and the MR technician know that you have an implantable infusion pump,” the FDA tells patients. Also, be able to identify the make and model of your infusion pump, and bring your “implant card” to the MRI.

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