FDA Warns of Implantable Infusion Pumps in MRI
Exposure to MRI may disrupt medication dosing and device functionality.
The Food and Drug Administration (FDA) has received reports of serious adverse events, including death, associated with the use of implantable infusion pumps in the magnetic resonance environment.
The adverse event reports contained medication dosing errors such as over- or under-infusion, and unintended boluses, as well as mechanical pump problems (eg, motor stall, pump not restarting) after magnetic resonance imaging [MRI] exam.
Implantable infusion pumps are typically surgically placed in the abdominal region. They deliver medications and fluids within the body through an implanted catheter. The magnetic resonance environment poses safety risks for patients with implantable infusion pumps. Only the pumps labeled as 'MR Conditional' may be used safely within a magnetic resonance environment and only under specific conditions. Depending on the make and model of the implantable infusion pump, the conditions needed for safe use may differ. Serious patient injury or death can result from failure to follow these conditions.
The FDA was alerted to a possible safety hazard with the use of these infusion pumps in a magnetic resonance environment following an analysis of adverse event data and manufacturer labeling. The Agency is working to update the labeling with MRI safety data to ensure that the guidance is clear and up-to-date.
To minimize the likelihood of serious events, the FDA recommends the following prior to, during, and after a patient with an implantable infusion pump undergoes an MRI:
Clinicians who implant infusion pumps:
- The conditions of safe MRI use may differ by manufacturer and model of the pump. This information should be discussed with the patient before and after the pump is implanted.
- Ensure that your patients receive and understand information about their implantable infusion pump, including how to use their patient implant card.
- Document the implantable device identification information in the patient's medical record.
Clinicians who prescribe MRI exams:
- Be aware that only patients implanted with MR Conditional pumps can safely undergo MRI exams, and only under specified conditions of safe use. The conditions may differ by manufacturer and model of the pump.
- You should ask all of your patients if they have any implantable pumps or other implants when determining whether an MRI exam is safe for them.
- Before ordering an MRI scan for a patient with an implantable infusion pump, determine the make and model of the implantable infusion pump and ask the patient for their implant card to confirm the pump model.
- Contact the implantable infusion pump manufacturer if there are any questions about for the MRI safety status of the implantable pump system.
- Consider the benefits and risks of an MRI exam and weigh the value of the information to be gained from the MRI exam against the risks of the exam for the patient. All medical devices present in the MR environment during the exam (including implants, external devices and accessory devices) should be included in the risk assessment.
- If needed, consult with a radiologist to determine if the MRI exam will deliver the expected benefits. For example, under some circumstances, artifacts from the pump may compromise the quality of acquired images.
- Ensure that care for your patient is coordinated between you, the physician who manages the implantable pump, and the facility that will perform the MRI exam.
Additional recommendations for patients with implantable infusion pumps, caregivers, pump managers, MRI technologists, surgeons, and radiologists can be found in the FDA's Safety Communication.
Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication. FDA safety communication; published January 11, 2017. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm536518.htm