FDA Dose-Reduction Initiative: 1 Progress Stanley H. Stern, Ph.D. Stanley.Stern@FDA.HHS

1. FDA Dose-Reduction Initiative:1 Progress Stanley H. Stern, Ph.D. Stanley.Stern@FDA.HHS.gov U.S. Food and Drug Administration Center for Devices and Radiological Health Office of Communications, Education, and Radiation Programs Division of Mammography Quality and Radiation Programs Radiation Programs Branch MITA CT Stakeholders’ Meeting at RSNA, Chicago, November 30, 2010

2. Milestones • Public meeting2 • CT and fluoroscopic device improvements • Integrate dose-mgt QA principles in CMS programs • MIPPA accredit stds:3 free-standing CT, NM, MR imaging facilities • Conditions of participation:4 hospital radiologic services • Promote dose registries, DRLs5,6 • Develop guidance:7 CT8 and pediatric8 • Research:6,9 CT image quality,10,11 dose5,12,13 • CT brain-perfusion dose anomalies: conclusion14 FDA Dose-Reduction Initiative: Progress

3. What is Guidance?7 • Defined by regulation: 21 CFR 10.115(b) • Addresses FDA staff, applicants/sponsors, public • Describes FDA policies for regulated products • Devices: design, production, manufacturing, tests, labeling, promotion • Submissions: processing, content, evaluation, clearance, approval • Compliance: inspection and enforcement • Can be formally identified as a “special control:”15 • Safety and effectiveness issues need to be addressed FDA Dose-Reduction Initiative: Progress

4. Noise Correlations Affect SNR11 highest SNR highest SNR FDA Dose-Reduction Initiative: Progress

5. CT Brain-Perfusion Dose Anomalies: • FDA Safety Investigation: Conclusion14 • Equipment, protocols performed to specifications • Room for improvement • Brain perfusion information and training re protocols • Tabulate mfr-recommended settings, expected CTDIvol, DLP • Describe each parameter set and role in protocol • Explain no need for high-quality image quality in perfusion phase • Explain relationship of peak skin dose to CTDIvol FDA Dose-Reduction Initiative: Progress

6. CT Brain-Perfusion Dose Anomalies: • FDA Safety Investigation: Conclusion14 • Room for improvement (cont.) • Automatic exposure control (AEC): information • Discuss AEC vs. manual modes, with examples • How to/why: select, modify of parameters affecting dose • How to/why: optimize efficacy/dose via build, modify protocols • Pop-up notification at threshold for deterministic injury • User-accessible organization of all dose-related information • Paper copies/pdf files tabulating the specs for all protocols FDA Dose-Reduction Initiative: Progress

7. References and Notes 1. U.S. Food and Drug Administration, Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, announced February 10, 2010, http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199904.htm, updated November 9, 2010. 2. U.S. Food and Drug Administration, Public Meeting: Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging, March 30-31, 2010, http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm201448.htm, updated April 29, 2010. 3. See Section 135 of U.S. Public Law 110-175, Medicare Improvements for Patients and Providers Act of 2008, http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ275.pdf, July 15, 2008. 4. U.S. Centers for Medicare & Medicaid Services, State Operations Manual 100-07 (http://www.cms.gov/Manuals/IOM/itemdetail.asp?filterType=none&filterByDID=-99&sortByDID=1&sortOrder=ascending&itemID=CMS1201984&intNumPerPage=10), Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, Rev. 47, June 5, 2009, http://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf, accessed through http://www.cms.gov/manuals/downloads/som107_Appendicestoc.pdf. FDA Dose-Reduction Initiative: Progress

8. References and Notes (cont.) 5. For example, David C. Spelic of FDA/CDRH is analyzing the raw data obtained from the 2005-6 Nationwide Evaluation of X-ray Trends survey of U.S. CT facilities (http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm202868.htm) to quantify the distributions of operating conditions, procedure workloads, and dose indices, and to develop estimates of diagnostic reference levels (DRLs) associated with particular pediatric CT exams. The estimates are to be published in a forthcoming report of the National Council on Radiation Protection and Measurements. 6. The FDA Critical Path Initiative (http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm) is funding research by Kish Chakrabarti of FDA/CDRH in a broad scientific collaboration to develop DRLs, to characterize peak skin dose (PSD), and to assess methods of image-quality evaluation developed in the CDRH Office of Science and Engineering Laboratories. 7. U.S. Food and Drug Administration, CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff, issued February 9, 2001, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070804.htm, updated October 27, 2009. FDA Dose-Reduction Initiative: Progress

9. References and Notes (cont.) 8. U.S. Food and Drug Administration, Documents the Center for Devices and Radiological Health is Considering for Development (FY11), http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm, updated October 6, 2010. 9. The FDA Office of Women’s Health (http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofWomensHealth/default.htm) is funding Iacovos S. Kyprianou of FDA/CDRH in a broad scientific collaboration on quantification and mitigation of radiation dose and excess cancer risk in women undergoing x-ray computed tomography. 10. C. C. Brunner, S. A. Hurowitz, S. F. Abboud, C. Hoeschen, I. S. Kyprianou, “Noise characterization of computed tomography using the covariance matrix,” SPIE Medical Imaging 2010: Physics of Medical Imaging, E. Samei, N. J. Pelc, Editors, 7622-76224Z [Proc. SPIE (2010)]. 11. C. C. Brunner, B. Renger, C. Hoeschen, and I. S. Kyprianou, “Calculation of the MTF and NPS of CT: a proposal to the IEC.” Part of this work has been accepted for publication in SPIE Medical Imaging 2011: Physics of Medical Imaging, E. Samei, N. J. Pelc, Editors, [Proc. SPIE (2011)], and part of this work is to be submitted for publication in Physics in Medicine and Biology. FDA Dose-Reduction Initiative: Progress

10. References and Notes (cont.) 12. S. F. Abboud, A. S. Badal, S. H. Stern, and I. S. Kyprianou, “Designing a phantom for dose evaluation in multi-slice CT,” SPIE Medical Imaging 2010: Physics of Medical Imaging, E. Samei, N. J. Pelc, Editors, 7622-762232 [Proc. SPIE (2010)]. 13. T. Mills and S. Stern, “Development of a Handbook of Radiation Doses in Organs of Patients Undergoing X-Ray Computed Tomography (CT),” presentations at the 42nd National Conference on Radiation Control, Newport, Rhode Island, April 18-22, 2010, and at the 52nd Annual Meeting of the American Association of Physicists in Medicine, Philadelphia, Pennsylvania, July 18-22, 2010. 14. U.S. Food and Drug Administration, Safety Investigation of CT Brain Perfusion Scans: Update 11/9/2010, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htm, issued November 9, 2010. 15. Per 21 CFR 860.3(c)(2), a class-II medical device is one that is or will be subject to “special controls” because “general controls” (such as establishment registration, medical device listing, good manufacturing practices, and labeling) “alone are insufficient to provide reasonable assurance of its safety and effectiveness and there is sufficient information to establish special controls, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidance documents (including guidance on the submission of clinical data in premarket notification submissions in accordance with section 510(k) of the act), recommendations, and other appropriate actions as the Commissioner deems necessary to provide such assurance.” FDA Dose-Reduction Initiative: Progress