MRI Compatibility

Skin Staplers / Staples are indicated for closure of skin in a wide variety of surgical procedures. Medical literature supports the determination that skin staplers are MRI compatible as they are comprised of 316L stainless steel. The determination according to the American College of Radiology, ''with the increasing advent and use of the 3.0 Tesla and higher strength magnets, users need to recognize that one should never assume MR compatibility or safety information if it is not clearly documented in writing" ( Kanal 2).

Page 11 ( Kenal et al ) notes that for patients who have skin staples/ superficial metallic sutures may undergo the MR examination if the staples/SMS are nor ferromagnetic and are not in the anatomic volume of the RF power deposition for the study to be performed. Cormed skin staples are comprised of 316L stainless steel ( ASTM Fl 38 Grade 2 ), which is not Ferromagnetic, but Austenitic.

According to the commentary of the white paper, ''many investigators have reported little or no heating occurs for small implants ( e.g., clips, wires)". It goes on to conclude there were no reports in the peer reviewed literature in which the authors were aware of heating of staples or sutures caused a patient injury, or that application of a cold compress or ice pack could prevent such injury. Cormed staplers do not introduce risk of patient injury when subjected to MR therapy according to these data.

In summary, Cormed does not consider there to be an inherent risk to patents based on the information cited. Please note that this assessment is based only on a literature review: Cormed has not performed product compatibility testing with high magnetic fields.

 David Corasanti 

References
Kanal, E et al. "American College of Radiology guidance document for safe MR practices 2017 ." American College of Radiology
AJR. 188 (2007): 1-27. Html.
View Reference

Kanal,E. et al. "American College of Radiology white paper on MR safety." American College of Radiology AJR.178 ( 2002): 1335-1347. Print

"MRI safety and the American College of Radiology white paper" Comentary. AJR:178. Jun. 2002: 1349-1352. Print.

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MRI Compatible
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