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FDA is informing patients and health care professionals that magnetic resonance (MR) environments can cause implantable infusion pump errors resulting in patient harm and death. Reported pump malfunctions include over- or under-infusion, accidental doses, motor stalling, and pumps failing to restart after MR exposure.
Only infusion pumps labeled as MR Conditional, with detailed conditions of safe use according to pump’s make and model, should be used in MR environments. Manufacturers with outdated or missing MR safety information are working with the FDA to include this in their labeling.
FDA recommends patients and caregivers should keep a record of the make and model of their pump and know their specific infusion pump’s recommendations regarding MR safety precautions. Patients should wear an alert wrist band or necklace providing the details of their pump’s safety precautions relating to magnetic resonance imaging (MRI) exams. They should also bring a record of the pump’s make, model, and the physician’s information who manages their pump to the MRI exam so that their implantable infusion pump’s safety information relating to MRIs can be verified by health care professionals. Health care professionals should consider inspecting implantable infusion pump inspected after an MRI, even when the manufacturer’s MRI safety precautions are followed.
Additional information is available at the following links:
- FDA MedWatch Alert – January 11, 2017
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm536526.htm - FDA Safety Communication – January 11, 2017
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm536518.htm - FDA Infusion Pump Risk Reduction Strategies – October 31, 2014
www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202498.htm