FDA Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance Environment

PUBLISHED: Jan 11, 2017

The US Food and Drug Administration FDA) has issued a safety communication about safety concerns with implantable infusion pumps in the magnetic resonance environment. 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 an 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.

The benefits and risks of an MRI exam must be considered for each patient. The value of the information to be gained from the MRI exam should be weighed against the risks of the exam. All medical devices present in the MR environment during the exam (including implants, external devices and accessory devices) should be considered.

Recommendations:

To help reduce the likelihood of serious adverse events, FDA recommends the following before, during, and after a patient with an implantable infusion pump has an MRI exam (for specific patient/caregiver recommendations please see the safety communication, link below):

MRI Technologists:

  • Be aware of and follow the policies and procedures at your site for patient screening prior to MRI exposure. Be sure all patients are screened for implantable devices such as implantable infusion pumps.
  • Do NOT scan the patient until the pump model has been positively identified and instructions for safe MRI exposure are understood. Before scanning a patient with an implantable infusion pump, ask the patient for their implant card to confirm the pump model. If there are any questions about the specific pump model a patient has, contact the health care provider managing the pump.
  • Only implantable infusion pumps labeled as MR Conditional may be safely scanned, and only under the specific conditions of safe use. Contact the implantable infusion pump manufacturer if there are any questions about the MRI safety status of the implantable pump system.
  • Be aware that the steps that must be followed before, during, and after an MRI exam may be different for each manufacturer and model of pump. Be sure to verify that the conditions of safe MRI use can be followed prior to scanning the patient.
  • Ensure that the MRI system at your site meets all conditions provided in the MR Conditional labeling of the implantable pump. For example, some implantable pump models can be safely imaged only at 1.5 tesla (T), but not 3T. (Tesla or "T" is a measure of magnetic field strength.)

Radiologists:

  • Consider the benefits and risks of an MRI exam for each patient and weigh the value of the information gained from the magnetic resonance images against the risks of the exam for the patient. All medical devices present in the MR environment during the exam (including implants, external devices and accessory devices) should be included in the risk assessment.
  • Only implantable infusion pumps labeled MR Conditional may be safely scanned, and only under the specified conditions of safe use. Contact the implantable infusion pump manufacturer if there are any questions about the MRI safety status of the implantable pump system.

Health Care Providers who implant infusion pumps:

  • When selecting the appropriate pump for each patient, please be aware that only patients implanted with MR Conditional pumps can safely undergo MRI exams, and only under very specific conditions of safe use. The conditions of safe MRI use may differ by manufacturer and model of the pump. This information should be discussed with the patient before and after the pump is implanted.
  • Ensure that your patients receive and understand information about their implantable infusion pump, including how to use their patient implant card.
  • Document the implantable device identification information in the patient's medical record.

Health Care Providers who manage implantable infusion pumps:

  • Be aware that only patients implanted with MR Conditional pumps can safely undergo MRI exams, and only under the specified conditions of safe use. The conditions of safe use may differ by manufacturer and model of the pump.
  • Before ordering an MRI scan for a patient with an implantable infusion pump, determine the make and model of the implantable infusion pump and ask the patient for their implant card to confirm the pump model.
  • Only implantable infusion pumps labeled as MR Conditional may be safely scanned, and only under the specific conditions of safe use. Contact the implantable infusion pump manufacturer if there are any questions about the MRI safety status of the implantable pump system.
  • Be aware that specific instructions must be followed before, during, and after MRI exams of patients with implanted infusion pumps, and that these instructions may differ by manufacturer and model of the pump.
  • Inform your patients that they should notify you before having an MRI exam that another health care provider orders. MRI exams may affect the function or programming of the implantable infusion pump. For example:
  • Some pump models may automatically stop delivering medication during the MRI exam, and some may need to be reprogrammed before and/or after the exam. Depending on the medication delivered by the implantable pump, alternative drug therapy may need to be considered to prevent drug withdrawal.
  • Some pump models may need to be completely emptied of drug prior to the MRI exam to prevent unintended over delivery of medication and drug overdose.
  • Ensure that your patients have received their implant card, and are aware of the MRI safety information specific to their pump.
  • Ensure that care for your patient is coordinated between you, the physician who ordered the MRI exam, and the facility that will perform the MRI exam.

Health Care Providers that prescribe MRI Exams:

  • Be aware that only patients implanted with MR Conditional pumps can safely undergo MRI exams, and only under specified conditions of safe use. The conditions may differ by manufacturer and model of the pump.
  • You should ask all of your patients if they have any implantable pumps or other implants when determining whether an MRI exam is safe for them.
  • Before ordering an MRI scan for a patient with an implantable infusion pump, determine the make and model of the implantable infusion pump and ask the patient for their implant card to confirm the pump model. If there are any questions about the specific pump make and model a patient has, contact the health care provider managing the pump.
  • Only implantable infusion pumps labeled as MR Conditional may be safely scanned, and only under the specific conditions of safe use. Contact the implantable infusion pump manufacturer if there are any questions about for the MRI safety status of the implantable pump system.
  • Consider the benefits and risks of an MRI exam and weigh the value of the information to be gained from the MRI exam against the risks of the exam for the patient. All medical devices present in the MR environment during the exam (including implants, external devices and accessory devices) should be included in the risk assessment.
  • If needed, consult with a radiologist to determine if the MRI exam will deliver the expected benefits. For example, under some circumstances, artifacts from the pump may compromise the quality of acquired images.
  • Ensure that care for your patient is coordinated between you, the physician who manages the implantable pump, and the facility that will perform the MRI exam.

Included with today’s notice are example policies related to safety for implantable infusion pumps in the magnetic resonance environment.

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