The Food and Drug Administration Wednesday issued a warning over the use of implantable infusion pumps in MRIs.
Implantable infusion pumps are devices implanted under the skin — usually in the abdominal region — and connected to an implanted catheter. The devices help deliver medication and fluids to the body, according to the FDA.
The FDA received numerous reports of serious adverse events — including patient injury and death — regarding use of the implanted infusion pumps in the MRI environment. MRI systems may cause mechanical problems with the pumps, such as releasing inaccurate doses of medications or failing to restart after such an MRI, according to the report.
Only implantable infusion pumps labeled as "MR Conditional" are safe for use in an MRI environment and only under the specified conditions of safe use, which vary by make and model, according to the FDA. The agency recommends clinicians weigh the benefits and risks of an MRI exam for each patient prior to performing the test.
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