The FDA issued a warning today that the strong magnetic fields used in an MRI exam can affect implantable infusion pumps. The federal watchdog has received reports of serious adverse events, including patient death, associated with using an infusion pump in an MR environment. The reports claim that some patients have experienced inaccurate medication dosing and mechanical problems with the pump after having an MRI.
Only implantable infusion pumps that are labelled as “MR Conditional” are safe to use within an MR environment, and only under specific conditions, according to the FDA. To reduce the probability of a serious adverse event, the FDA recommends that patients tell their physicians and MR technician if they have an implantable infusion pump and be able to identify the make and model of the pump. The federal group also recommended that patients have their devices checked before and after the imaging procedure.
MRI technologists were cautioned to check with the patient regarding their infusion pump model. Each patient should carry an implant card that will confirm the make and model of the device.
The FDA recommended that radiologists weigh the risks and benefits of an MRI exam for their patients and that they should incorporate the patient’s implantable infusion pump into their risk assessment.
Healthcare providers who implant or manage implantable infusion pumps should be aware that only patients implanted with MR conditional pumps can safely undergo MRI exams, the FDA said. Healthcare providers are required to give patients their implant card and document the device identification information in the patient’s medical record.
Before ordering an MRI scan for a patient with an implantable infusion pump, physicians should confirm the make and model of the device with their patients. Some patients will need to consult with their doctors about a supplementary medication regimen, because the implantable infusion pump may automatically stop delivering medication during the exam. Alternative drug therapy may be necessary to prevent drug withdrawal, the federal watchdog warned.