A FDA Safety Communication has been released due to receiving reports of adverse events with the use of implantable infusion pumps in the Magnetic Resonance (MR) setting. The reports involve injury and death and describe medication dosing inaccuracies and other mechanical problems with the pump.
Implantable infusion pumps, along with an implanted catheter, are used to aid in the delivery of medication and other fluids in the body. The pumps are typically implanted under the skin, near the abdominal area. Many diseases and conditions can be treated with the use of implantable infusion pumps such as chronic pain and muscle spasticity.
A Magnetic Resonance Imaging (MRI) exam provides internal images of the body and can be used to diagnose a variety of conditions. However, only if the implantable infusion pump is labeled as MR Conditional may it be used safely with an MRI and only under the conditions of safe use. The conditions that should be followed before, during, and after an MRI exam may differ between the make and model of the implantable infusion pump and each implantable pump model may have its own unique conditions that must be followed to avoid serious adverse events and safely undergo an MRI.
The FDA has issued Safety Recommendations to help reduce the likelihood of serious adverse events. The complete lists of recommendations for Patients, MRI Technologists, Radiologist and Health Care Providers can be found at in the FDA Safety Communication. Below are the recommendations from the FDA Safety Communication for Patients with implantable infusion pumps and their caregivers:
- Be aware that specific instructions must be followed by your health care providers and MR technologist before, during, and after an MRI exam. These instructions may differ by manufacturer and model of the pump.
- 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 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.
The FDA and applicable manufactures are working to update safety information of the implantable pumps’ labeling.
To report a problem with an implantable pump during an MRI exam, you can file a voluntary report through the FDA Safety Information and Adverse Event Reporting program. The FDA uses this information to help identify and develop a better understanding of the risks associated with medical devices.