MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramImplantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions AUDIENCE: Cardiology, Surgery, Emergency Medicine, Radiology ISSUE: The FDA has received reports of serious adverse events, including patient injury and death, associated with the use of implantable infusion pumps in the MR environment. These reports describe medication dosing inaccuracies (e.g., over-infusion or under-infusion, unintended bolus) and other mechanical problems with the pump (e.g., motor stall, pump not restarting after a Magnetic Resonance Imaging (MRI) exam). MRI systems provide images of the internal structures of the body that can be useful in diagnosing a wide variety of diseases and conditions. However, the MR environment presents safety hazards for patients with implantable infusion pumps. Only implantable infusion pumps labeled as MR Conditional may be used safely within an 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 the MRI exam vary 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 MRI exam. Failure to adhere to these conditions can result in serious injury or death. An analysis of adverse event information and manufacturer labeling alerted the FDA to a potential safety problem with the use of implantable infusion pumps in the MR environment. The FDA is working with the applicable manufacturers to update MRI safety information in their labeling to ensure that instructions for the safe use of these devices are clear and up-to-date with current terminology and definitions. BACKGROUND: Implantable infusion pumps are devices that are surgically implanted under the skin, typically in the abdominal region. They are connected to an implanted catheter and are used to deliver medications and fluids within the body. Implantable infusion pumps are periodically refilled with medications or fluids by a health care provider. Implantable infusion pumps may be used to treat chronic pain, muscle spasticity, and many other diseases or conditions. Magnetic Resonance Imaging (MRI) is a medical diagnostic exam that creates images of the internal structures of the body by using strong magnetic fields and radio waves (radiofrequency energy). These images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions. Some medical devices, including some implantable infusion pumps, can be affected by the strong magnetic fields associated with MRI. RECOMMENDATIONS: See the FDA Safety Communication for recommendations specific to MRI technologists, radiologists, surgeons, MRI prescribers, and implantable infusion pump managers. Patients with implantable infusion pumps and their caregivers:
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