The US Food and Drug Administration (FDA) has received reports of serious adverse events, including patient injury and death, associated with the use of implantable infusion pumps in the magnetic resonance environment, the agency said today in a safety communication.
The reports include medication dosing inaccuracies, including overinfusion or underinfusion or unintended bolus, and mechanical problems with the pump, such as motor stalling and the pump not restarting after MRI.
The magnetic resonance 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 FDA said.
"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 agency said.
The FDA is working with implantable infusion pump 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. In the meantime, the FDA recommends that health providers:
Be aware that only patients implanted with "MR Conditional" pumps can safely undergo MRI, 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 MRI for a patient with an implantable infusion pump, determine the make and model of the implantable infusion pump and ask the patient for the implant card to confirm the pump model.
Be aware that 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 undergoing an MRI exam that another healthcare provider orders, noting that MRI exams may affect the function or programming of the implantable infusion pump. Note that 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. Some pump models may need to be completely emptied of drug before the MRI exam to prevent unintended overdelivery 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 among you, the physician who ordered the MRI exam, and the facility that will perform the MRI exam.
Healthcare professionals and patients are encouraged to report adverse events related to the use of these products to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: FDA: Implantable Infusion Pump May Malfunction During MRI - Medscape - Jan 11, 2017.
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