FDA warns of deaths, injuries associated with implantable infusion pumps in MRI environment

The FDA announced on Jan. 11 that the agency had received reports of serious adverse events associated with the use of implantable infusion pumps in the magnetic resonance environment.

Patients have been injured and died due to medication dosing inaccuracies and other mechanical problems associated with the use implantable infusion pumps during magnetic resonance imaging (MRI) exams.

The FDA has designated certain pumps with an MR conditional labeling, which means they are safe to use during MRIs. All other pumps are not considered safe in an MR environment.

“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 said in a news release. “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.”

Manufacturers are working with the FDA to update their MRI safety information on labels, according to the safety alert. Surgeons implant the infusion pumps under the skin and attach them to a catheter to deliver medications and fluids without the body. They are used in cardiology, radiology and other medical specialties.