MRI’s Pose Dangers for Patients with Drug Infusion Pumps

 
Category: 
Defective Medical Devices
Tags: 
Infusion Pumps and MRIs

By Lynn Shapiro, Staff Writer

Patients with drug infusion pumps implanted in their bodies are in danger of experiencing potentially lethal drug reactions and mechanical failures while undergoing Magnetic Resonance Imaging (MRI) scans, the FDA warns in a January 11, 2017 safety alert.

The FDA’s warning notes that patients relying on drug infusion devices who undergo MRI’s, may fall victim to drug dosing inaccuracies, such as receiving too much or little medication; and mechanical problems with the pumps themselves, such as motors stalling and not restarting.

Infusion pumps are devices that are implanted under the skin, typically in the abdominal region. They are connected to an implanted catheter and are used to deliver medications and fluids to the body.

These drugs are administered to treat chronic pain, muscle spasticity, and other diseases. A health care provider regularly refills the implanted pump with medications or fluids.

MRI Conditional Infusion Pumps and MRIs

The FDA warns that only infusion pumps labeled as “MRI Conditional” can be safely used on people who are undergoing MRI’s.

Patients with infusion pumps should make their healthcare provider and MRI technician aware of the model of their implantable drug pump, FDA advises.

Patients are given an implant card that provides medical staff with this information. The FDA urges patients to carry this card with them when they go for an MRI exam.

The agency also recommends that patients wear a medical alert necklace or bracelet in case of emergency, which includes the infusion pump’s model number.

FDA warns that even if an infusion pump is labeled as” MRI Conditional”-- meaning it can safely withstand an MRI exam-- the pump may have to be restarted after the MRI is completed.

Meanwhile, the agency says it’s advising infusion pump makers on how to update safety labels on drug infusion pumps, so the medical devices can function properly during an MRI scan.

“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,” the FDA warning says.

“Importantly, each implantable pump model may have unique conditions that must be followed in order for a patient to safely undergo an MRI exam.

“Failure to adhere to these conditions can result in serious injury or death,” FDA warns in its January, 2017 safety alert.

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