If you have an implantable infusion pump, it may be a safety hazard for you to undergo an MRI exam. Only implantable infusion pumps labelled as MR Conditional may be used safely within a Magnetic Resonance (MR) environment, and only under the specified conditions of safe use. The specific conditions that health care practitioners and patients should follow before, during, and after an MRI exam varies by the make and model of the implantable infusion pump system. Importantly, each implantable pump model may have unique conditions that must be followed in order for a patient to safely undergo an Magnetic Resonance Imaging (MRI) exam. Failure to adhere to these conditions can result in serious injury or death.
What is an implantable infusion pump?
An implantable infusion pump is a device that is surgically implanted under the skin, typically in the abdominal region. It is connected to an implanted catheter, and is used to deliver medication and fluids to the patient’s body. Implantable infusion pumps are periodically refilled with medications or fluids by the treating doctor. Implantable infusion pumps may be used to treat chronic pain, muscle spasticity, and many other diseases or conditions.
FDA reports
The US Food and Drug Administration (FDA) has received reports of serious adverse events – which includes patient injury and death, associated with the use of implantable infusion pumps in the MR environment. These reports describe medication dosing inaccuracies such as over or under-infusion and unintended bolus; and other mechanical problems with the pump such as the motor stalling, and the pump not restarting after an MRI exam.
The FDA is working with the affected manufacturers to update the MRI safety information on their labeling to ensure that instructions for the safe us of the devices are clear and current. MRI Technologists, Radiologists, Surgeons, MRI Prescribers and Implantable Infusion Pump Managers can review the recommendations released by the FDA here.
What to take note of if you have an implantable infusion pump
If you have an implantable infusion pump, or you are the caregiver of one, you should take note of the following:
- Specific instructions must be followed by your health care providers and MR technologist before, during, and after an MRI exam.
- If you are scheduled for an MRI, make sure your physicians and the MR technician know that you have an implantable infusion pump.
- Be able to identify the make and model of your implantable infusion pump. Most patients are provided with an “implant card” that lists this information.
- Bring the implant card for your implantable infusion pump with you when you go for your MRI exam. Before you can safely have an MRI exam, your health care team will need to identify your specific pump model to locate the specific MRI safety information for your pump.
- If there are any questions about the make and model of an implantable infusion pump you have, contact the physician who manages your pump and do not have the MRI exam until the specific implantable pump model is identified.
- Consider obtaining a medical alert bracelet or necklace in case of an emergency situation. Include information to notify medical professionals that you have an implantable pump and that MRI precautions need to be followed.
- Be aware that MRI exams may affect the function or programming of your infusion pump, even when the specified conditions of MR Conditional use have been followed. For example, your implantable pump may need to be checked and/or reprogrammed by your physician before and after your MRI.
- Only implantable infusion pumps labeled as MR Conditional may be safely scanned, and only under the specific conditions of safe use. Consult with your physician and the MR technician to determine whether it is safe for you to have an MRI.
Health care professionals and patients in the US are encouraged to report adverse events or side effects related to the use of any implantable infusion pump to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online or by calling 1-800-3321088.
