After receiving reports of injury and death, the U.S. Food and Drug Administration (FDA) has issued a warning about patients with implantable infusion pumps undergoing MRI scans.
The January 11 document cited mechanical malfunctions where the pump motor has stalled or failed to restart after the MRI scan, as well as cases of overinfusion, underinfusion, and unintended bolus related to medication dosing inaccuracies.
Implantable infusion pumps generally are inserted in the abdominal region and are connected to an implanted catheter to deliver medications and fluids to treat chronic pain, spastic muscles, and other diseases or conditions.
The FDA is urging healthcare practitioners and patients to make sure implantable infusion pumps are MR-conditional and can be scanned safely in an MR environment. The agency also recommends strictly following usage guidelines.
"Importantly, each implantable pump model may have unique conditions that must be followed in order for a patient to safely undergo an MRI exam," the FDA stated. "Failure to adhere to these conditions can result in serious injury or death."
The FDA's recommendations for MRI technologists include the following:
- Be aware of and follow the policies and procedures at the facility for patient screening prior to MRI scans, and ensure all patients are screened for implantable devices such as implantable infusion pumps.
- Do not scan a patient until the pump model has been positively identified and instructions for safe MRI exposure are understood.
- Be aware that only implantable infusion pumps labeled as MR conditional may be safely scanned, and only under the specific conditions of safe use.
The FDA is also asking radiologists to evaluate the risks and benefits of an MRI scan for each patient, especially individuals with implantable and external medical devices. In addition, only MR-conditional implantable infusion pumps should be allowed in the MRI suite.
