MR Labeling Information for Implants and Devices: Explanation of Terminology
2009; Radiological Society of North America; Volume: 253; Issue: 1 Linguagem: Inglês
10.1148/radiol.2531091030
ISSN1527-1315
AutoresFrank G. Shellock, Terry O. Woods, John V. Crues,
Tópico(s)Genetic Neurodegenerative Diseases
ResumoHomeRadiologyVol. 253, No. 1 PreviousNext Reviews and CommentaryEditorialMR Labeling Information for Implants and Devices: Explanation of TerminologyFrank G. Shellock, Terry O. Woods, John V. Crues, IIIFrank G. Shellock, Terry O. Woods, John V. Crues, IIIAuthor Affiliations1From the Keck School of Medicine, University of Southern California, 7511 McConnell Ave, Los Angeles, CA 90045 (F.G.S.); Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Md (T.O.W.); and Radnet, Los Angeles, Calif (J.V.C.).Address correspondence to F.G.S. (e-mail: [email protected]).Frank G. ShellockTerry O. WoodsJohn V. Crues, IIIPublished Online:Oct 1 2009https://doi.org/10.1148/radiol.2531091030MoreSectionsFull textPDF ToolsAdd to favoritesCiteTrack CitationsPermissionsReprints ShareShare onFacebookXLinked In AbstractThis editorial presents the U.S. Food and Drug Administration's current recommendations for MR safety terminology and labeling for medical devices and provides an explanation of how this information is applied. References 1. Shellock FG , Crues JV . MR procedures: biologic effects, safety, and patient care. Radiology 2004;232(3):635–652. Link, Google Scholar2. Shellock FG . Reference manual for magnetic resonance safety implants and device: 2009 edition. Los Angeles, Calif: Biomedical Research Publishing Group, 2009. Google Scholar3. Shellock FG , Spinazzi A . MRI safety update 2008. II. Screening patients for MRI. AJR Am J Roentgenol 2008;191(4):1140–1149. Crossref, Medline, Google Scholar4. Woods TO . Standards for medical devices in MRI: present and future. J Magn Reson Imaging 2007;26(5):1186–1189. Crossref, Medline, Google Scholar5. Levine GN , Gomes AS , Arai AE , et al.. Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention, endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. Circulation 2007;116(24):2878–2891. Crossref, Medline, Google Scholar6. A primer on medical device interactions with magnetic resonance imaging systems. U.S. Food and Drug Administration, Center for Devices and Radiological Health Web site. http://www.fda.gov/cdrh/ode/primerf6.html. Published 1997. Google Scholar7. American Society for Testing and Materials International. Designation: ASTM F2052-06e1, standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment. West Conshohocken, Pa: American Society for Testing and Materials International, 2006. Google Scholar8. American Society for Testing and Materials International. Designation: ASTM F2213-06, standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment. West Conshohocken, Pa: American Society for Testing and Materials International, 2006. Google Scholar9. American Society for Testing and Materials International. Designation: ASTM F2119-07, standard test method for evaluation of MR image artifacts from passive implants. West Conshohocken, Pa: American Society for Testing and Materials International, 2007. Google Scholar10. American Society for Testing and Materials International. Designation: ASTM F2182-02a, standard test method for measurement of radio frequency induced heating near passive implants during magnetic resonance imaging. West Conshohocken, Pa: American Society for Testing and Materials International, 2002. Google Scholar11. Guidance for industry and FDA staff: establishing safety and compatibility of passive implants in the magnetic resonance (MR) environment. U.S. Food and Drug Administration Web site. http://www.fda.gov/cdrh/osel/guidance/1685.html. Published August 21, 2008. Google Scholar12. Shellock FG , Crues JV . MR safety and the American College of Radiology White Paper. AJR Am J Roentgenol 2002;178(6):1349–1352. Crossref, Medline, Google Scholar13. American Society for Testing and Materials International. Designation: F2503-08, standard practice for marking medical devices and other items for safety in the magnetic resonance environment. West Conshohocken, Pa: American Society for Testing and Materials International, 2005. Google Scholar14. MRISafety Web site. http://www.mrisafety.com/. Accessed June 2009. 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