One of the principal focuses of the guidance article is on the new "MR Safe" language approved by ASTM International, which is expected to be adopted by the U.S. Food and Drug Administration soon. The greatest confusion in the transition from the old "MR Safe" to the new "MR Safe" is that the two standards use the exact same term to mean profoundly different things.
The old term meant that an object or device was safe, as long as it was used in accordance with the limitations set by the manufacturer for exposure to gradients, field strength, or induced current. The new term means that an object is safe under all magnetic or radiofrequency (RF) conditions. Additional information on the vocabulary change is available in "The new 'MR Safe': Language changes for the FDA."
ECRI's article goes to great lengths to describe the differences, and also offers guidance and warnings to advise facilities on making the transition from one set of standards and terms to the newer versions. Among the recommendations offered by the article, all devices that bear the old "MR Safe" or "MR Compatible" designations should be presumed to be "MR Conditional" in the new standard. And until a facility has completely embraced the new standards and markings, nothing with an "MR Safe" label should be assumed to be the new MR Safe unless specific product compliance is known for that piece of equipment.
In related points in the guidance article, ECRI addressed the development of ferromagnetic detection systems and accidents in the MRI suite.
Although ECRI deferred from making specific statements countermanding an earlier recommendation against the use of metal detectors and support of the use of ferromagnetic detection, the article was very encouraging about the initial test data from Dr. Emanuel Kanal and the University of Pittsburgh Medical Center in Pennsylvania.
"These detectors at least have the potential to reduce the risk of patient injury and damage to equipment, as well as to reduce MR downtime that could occur in the event of an incident," the ECRI wrote.
The clear implication, if Kanal's results are reproducible, is that ECRI will consider endorsing ferromagnetic detection systems to enhance patient screening and safety.
Parallel to the section on ferromagnetic detection was a revealing survey which indicated that, of those facilities that had experienced medical-device-related incidents, more facilities reported missile or projectile accidents than patient burns, biostimulation device interference, and other incidents combined!
The ECRI survey, even though it is from a sample of only 70 respondents, echoes recent data on near misses from the State of Pennsylvania Patient Safety Authority. In that report, projectile incidents or near misses were at least as frequent as other MRI patient safety concerns. These new data sources each lend a small light to a growing illumination of dramatic gaps in the current reporting of MRI accidents (missile accidents in particular) to the FDA.
The ECRI article, although an excellent piece on explaining the new standard and facilitating the transition to it, does not identify the ASTM and FDA bias in the development of this new standard for classifying the safety of objects in the MRI suite.
ASTM and the FDA are primarily interested in safety as it applies to regulated medical devices. Safety issues surrounding nonregulated items, even if they directly impact the safety of patients inside the bore of an MRI system, have not received a level of attention comparable to that of pacemakers, ventilators, or other regulated devices.
Sandbags, floor mops, ladders, and chairs, all devices that are brought into MRI suites on a regular basis, are being shoehorned into a clinical device standard. The ferromagnetic projectile risks, which data suggest are one of -- if not the -- most common patient safety threat, are not specifically addressed in the standard.
To anyone concerned with MRI patient safety and suite operation, the October 2005 ECRI guidance article is very useful and deserves a place in your library of safety reference materials. Although MRI safety is too broad of an issue to be bounded by the ECRI article, when used in concert with other resources including the "ACR White Paper on MR Safety" and the MRI Newsletter, this piece can help to inform improved patient safety and care.
By Tobias Gilk
AuntMinnie.com contributing writer
March 28, 2006
Reprinted from www.mri-planning.com by permission of the authors. If you would like more information on any aspect of MR facility design or safety, please contact Robert Junk or Tobias Gilk at Jünk Architects.
Doubling down: Raising the stakes of MRI patient safety, March 9, 2006
Ten questions patients should ask their MRI provider: Is this real or is it hype? February 15, 2006
MRI-guided cancer treatment, February 1, 2006
MRI and cancer diagnosis, January 6, 2006
Hurricane epilogue: An MR emergency preparedness primer, December 26, 2005
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