Last week, I wrote a story about the Centers for Medicare and Medicaid reconsidering its policy on reimbursement for MRIs on patients with implantable pacemakers and how it might benefit Medtronic. Following the lead of other reporters who have covered the topic previously, I used the term “MRI-safe pacemaker” both in the headline and the story to describe the Fridley, Minnesota company’s Revo SureScan pacemaker.
A day later, I got an email from a concerned reader from a firm that is Medtronic’s competitor. While appreciating Medtronic for the technical innovation it achieved in the design of the Revo SureScan pacemaker, the reader nonetheless urged that MedCity News remove the term “MRI-safe” from our lexicon when describing pacemakers, or other complex medical devices that can be used safely in an MRI environment.
“The appropriate terminology for pacemakers is ‘MR Conditional,’ and an international group of experts coined this term for an important reason,” the email noted. “While there are some simple medical devices, such as certain catheters or stents, that might accurately receive the label of ‘MR Safe,’ most complex medical devices are only safe under specific conditions. This is true because MRI systems are extremely powerful and complex, with increasing power and complexity every day as the technology advances, so completely and inherently safe pacemakers (as the phrase ‘MRI-safe’ implies) do not yet exist.”
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The reader added that such “improper and misleading terminology has a real potential to negatively impact patient safety.”
Much chastened, (and after reading Medtronic’s own press release about Revo’s FDA approval where the term “MRI-safe” is never used), I went to the U.S. Food and Drug Administration for direction.
Karen Riley, a spokeswoman with the FDA, responded Monday and reinforced the reader’s main point.
“Most medical devices that are approved to be used in the MR environment require certain conditions to be met in order to ensure safety and effectiveness. As such, very few medical devices are designated as MR Safe and it is very unlikely that a pacemaker will ever receive an MR Safe designation.”
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And that’s that. I solemnly swear never to use the term “MRI-safe” to describe pacemakers or other complex medical devices ever again.
