FDA: Adverse events reported for patients with implantable infusion pumps in MR environment

The FDA recently issued a statement addressing reports of serious adverse events, such as injury or death, linked to the use of implantable infusion pumps.

The report, intended for cardiologists, surgeons, emergency medicine personnel, radiologists and patients, also highlights medication inaccuracies, such as over-/under-infusion and unintended bolus as well as other mechanical problems, such as motor stall and the inability to restart after MRI exam.

While MRI systems are helpful in providing images of internal structures and can be useful in diagnosing a variety of diseases and conditions, MRIs can cause adverse safety issues for patients with implantable fusion pumps, the FDA stated in the report.

According to the recommendation, the following issues should be considered:

Both patients and physicians should be aware that there are specific instructions which must be followed by health care providers and MR technologists before, during and after an MRI exam. These details of these instructions may differ depending on manufacturer and model of the pump.

Patients should make sure physicians and MR technicians know of an implantable infusion pump if scheduled for an MRI,

Patients should know the make and model of their implantable infusion pump — most are provided with an "implant card" that lists this information, and should bring it to any MRI exam.

The health care team must identify the specific pump model to locate the relevant MRI safety information. If the model cannot be identified, the MRI exam should not occur. If there are any questions about the make and model of implantable infusion pump, the physician who manages the pump should be contacted.

Patients should consider obtaining a medical alert bracelet or necklace in case of an emergency situation that includes information to notify medical professionals of the implantable pump and that MRI precautions need to be followed.

All stakeholders should be aware that MRI exams may affect the function or programming of an infusion pump, even when the specified conditions of MR-conditional use have been followed.

Only implantable infusion pumps labeled as MR-conditional may be scanned safely, and only under the specific conditions of safe use. Patients should consult with their physician and the MR technician to determine if it is safe to have an MRI exam.

According to the statement, risks associated with medical devices can be better understood by prompt reporting of adverse events. Anyone suspecting an implantable pump of having problems during an MRI is strongly encouraged to file a voluntary report through MedWatch, the safety information and adverse event reporting program set up by the FDA.