title: Response to Standardized MR Terminology and Reporting of Implants and Devices as Recommended by the American College of Radiology Subcommittee on MR Safety.
abstract: The U.S. Food and Drug Administration (FDA) continually works toward the goal of safety. For patients with magnetic resonance (MR) Conditional devices, safety is achieved when MR Conditional labeling is clear and accessible and can be unambiguously interpreted and applied. The FDA supports the three facets of standardization listed by the American College of Radiology (ACR) Subcommittee on MR Safety in their special report: (a) standardization in terminology and reporting of spatial gradient magnetic fields associated with MR systems; (b) standardization in reporting of ferromagnetic testing results for implants and devices; and (c) standardization, consistency, and clarity in radiofrequency power deposition guidelines and terminology. While the FDA is in agreement with the ACR Subcommittee on MR Safety that patient safety is of primary concern, the authors disagree with the Subcommittee on several important points and offer a point-by-point response to the Subcommittee's four recommendations. (©) RSNA, 2015.
authors.affiliation: From the Offices of Science and Engineering Laboratories (T.O.W.), In Vitro Diagnostics and Radiological Health (J.G.D.), and Device Evaluation (M.J.S.), U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993.
authors.forename: Terry O
authors.initials: TO
authors.lastname: Woods
authors.affiliation: From the Offices of Science and Engineering Laboratories (T.O.W.), In Vitro Diagnostics and Radiological Health (J.G.D.), and Device Evaluation (M.J.S.), U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993.
authors.forename: Jana G
authors.initials: JG
authors.lastname: Delfino
authors.affiliation: From the Offices of Science and Engineering Laboratories (T.O.W.), In Vitro Diagnostics and Radiological Health (J.G.D.), and Device Evaluation (M.J.S.), U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993.
authors.forename: Mitchell J
authors.initials: MJ
authors.lastname: Shein
mesh_terms: D006801:Humans; D008279:Magnetic Resonance Imaging / Q000295:instrumentation*; D059346:Magnets; D061214:Patient Safety; D019736:Prostheses and Implants; D012015:Reference Standards; D014481:United States