Infusion Pumps May Cause Injuries During MRI Scan, FDA Warns
Federal health regulators are warning about reports of serious injuries and deaths among individuals with implanted infusion pumps who underwent magnetic resonance imaging (MRI).
In a safety communication issued on January 11, the FDA indicates that MRI scans on patients with drug pumps in their bodies can cause a variety of problems, and warns that only infusion pumps labeled as “MR Conditional” can be safely used within an magnetic resonance (MR) environment.
The agency said it has received reports of medication errors following infusion pump exposure to MRIs, including over-infusion, under-infusion, unintended bolus, pump motors stalling and pump motors not restarting after the MRI exam. The FDA indicates that it is working with manufacturers to update safety labels on infusion pumps to include instructions for safe use in an MR environment.
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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,” the FDA warning notes. “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.”
The FDA did not state in the communication how many injuries or deaths have been associated with infusion pumps that underwent an MRI exam.
The warning urges patients, health care providers, and MR technologists to be aware of the specific instructions involving the infusion pump and the effects of an MRI exam. The FDA says patients with infusion pumps should make sure their healthcare provider and the MR technician know about it. They should also be able to tell the health care professionals the make and model of their implantable infusion pump.
The FDA notes that most patients are provided with an “implant card” which provides medical staff with the relevant information about their infusion pump. They should carry that card with them when they go for an MRI exam.
The agency also recommends that patients carry a medical alert bracelet or necklace in case of an emergency situation that includes information on the infusion pump.
Even if an infusion pump is labeled as MR Conditional, meaning it can safely undergo an MRI scan, there still may be specific conditions under which the scan must be performed the FDA notes, and even then, the device may have to be rechecked or reprogrammed before it functions properly again.
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