Woods Terry O, Delfino Jana G, Shein Mitchell J
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.
Radiology. 2016 Jun;279(3):906-9. doi: 10.1148/radiol.2015151108. Epub 2015 Nov 23.
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.
美国食品药品监督管理局（FDA）持续致力于实现安全目标。对于使用磁共振（MR）条件性设备的患者，当MR条件性标签清晰易懂且能被明确解读和应用时，即可实现安全。FDA支持美国放射学会（ACR）MR安全小组委员会在其特别报告中列出的标准化的三个方面：（a）与MR系统相关的空间梯度磁场的术语和报告标准化；（b）植入物和设备的铁磁性测试结果报告标准化；（c）射频功率沉积指南和术语的标准化、一致性和清晰度。虽然FDA与ACR MR安全小组委员会一致认为患者安全是首要关注点，但作者在几个重要问题上与该小组委员会存在分歧，并对该小组委员会的四项建议逐一做出回应。（©）RSNA，2015年。
