Medical imaging radiation protection culture: an FDA perspective

1. Medical imaging radiation protection culture: an FDA perspective Thalia T. Mills, Ph.D. thalia.mills@fda.hhs.gov U.S. Food and Drug Administration Center for Devices and Radiological Health Office of Communication, Education, and Radiation Programs Division of Mammography Quality and Radiation Programs IRPA Radiation Protection Culture Workshop February 10, 2011

2. End goal: right exam, right time, right dose1 Integrate radiation protection into: • device design (provide necessary tools) • facility training and QA practices (Image Gently message: RP should be as basic as hand washing.) Keys to success: • Understand each other’s roles and responsibilities in reducing unnecessary radiation exposure. • Coordinate efforts and develop consensus approaches. Be as inclusive as possible. • Combine regulation, education, and automation (e.g. CT Dose Check for optimization/safety; decision support systems for justification).

3. Dose Reduction Initiative2: Activities Dose Optimization/Radiation Safety • Medical imaging device improvements • Public meeting3: CT and fluoroscopy device improvements • Guidance4: CT and Pediatric (covers x-ray imaging) • Conclusion to CT brain perfusion safety investigation5: letter to MITA6 • Industry initiatives including: MITA/NEMA CT Dose-Check standard7; implementation of DICOM Dose Structured Report • Facility QA and training • Integrate dose-management QA principles in CMS guidelines8 • Collaborations to provide better training materials • Metrics9-13:promotion of DRL development/dose registries; research in image quality and dose Justification • Awareness:Image Wisely/FDA Patient Medical Imaging Record Card14 • Appropriate use15

4. Automation, regulation, education: an example • Automation: CT Dose-Check Standard • Regulation • Work with manufacturers to implement this tool (regulated by FDA). • Work with facilities to incorporate dose-management into QA practices (facilities regulated by CMS and states). • Education • AAPM writing recommendations on how to use CT Dose Check • Recommendations for CT Dose Check “notification values” incorporate ACR dose registry data (research/quality metrics in use)

5. Successful partnerships: examples • Alliance for Radiation Safety in Pediatric Imaging/Image Gently • One-stop shop for FDA interaction with industry and professional organizations: ACR, SPR, AAPM, ASRT, MITA, others • FDA participation in workshops and workgroups; co-author of paper16 • FDA contract for Alliance to develop technologist training materials (awarded Aug. 2010) • AAPM Working Group on Standardization of CT Nomenclature and Protocols17 • Reps from: AAPM, ACR, ASRT, MITA, 5 CT vendors, FDA, DICOM, RadLex • Protocol recommendations • Dictionary to translate between vendor-specific terms and standard lexicons • CT Dose Check: recommendations on use • Review of vendor instructions for use for AEC

6. Conclusion • FDA recognizes that its ability to address medical radiation exposure issues is limited in scope to the regulation of medical device manufacturers regarding equipment standards. • Therefore we are partnering with other federal agencies (CMS) and states, which have authority over facilities. • We are also expanding our longstanding radiological health program outreach and research efforts to improve communication and safe use.

7. Notes and References • ACR motto (also used in FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging). • FDA, White Paper: Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, February 2010: http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199994.htm • Public Meeting: Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging, March 30-31, 2010. Transcripts available at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm201448.htm. Submissions to the public docket are available at: http://www.regulations.gov/#!docketDetail;D=FDA-2010-N-0080. • 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. • FDA, Safety Investigation of CT Brain Perfusion Scans: Update 11/9/2010, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htm, issued November 9, 2010. • FDA, Letter to the Medical Imaging Technology Alliance Regarding CT Recommendations, 11/8/2010, http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm232551.htm.

8. National Electrical Manufacturers Association, Computed Tomography Dose Check, NEMA Standards Publication XR 25-2010, http://www.nema.org/stds/xr25.cfm. • FDA partnership with the Centers for Medicare and Medicaid Services (CMS) to enhance accreditation and participation criteria for freestanding advanced medical imaging facilities (AMIFs) and hospitals is still in progress: • FDA collaborated with CMS to incorporate standards for operator qualifications and facility quality control (QC) into CMS guidelines for AMIFs. These guidelines seek to define initial and continuing training requirements for operators in AMIFs, while encouraging them to adopt QC practices that emphasize establishment of procedures to assess appropriateness of imaging procedures, optimization of exam protocols and monitor quality indicators. CMS guidelines for AMIFs are expected to be implemented under authority of the Medicare Improvements for Patients and Providers Act (MIPPA). (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.) • Guidelines for Medicare-participating hospitals are currently undergoing revision to ensure that, consistent with the current regulatory requirements, they reflect up-to-date standards for the safe delivery of medical imaging services. • Foundation NIH convened a Radiation Medical Imaging Database Roundtable (10/19/2010) to discuss promotion/development of dose registries and adverse event reporting systems. • FDA/CRCPD Nationwide Evaluation of X-ray Trends surveys (http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm202868.htm) provide estimates of diagnostic reference levels (DRLs). The estimates based on the 2005-2006 CT survey are to be published in a forthcoming report of the National Council on Radiation Protection and Measurements. (FDA staff on NEXT project: Dave Spelic and Mike Hilohi)

9. The FDA Critical Path Initiative (http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm) is funding Kish Chakrabarti in a broad scientific collaboration to develop DRLs, to characterize peak skin dose (PSD) with radiochromic film, organ dose with tissue equivalent phantom and OSLD; and to assess methods of image-quality evaluation developed in the CDRH Office of Science and Engineering Laboratories. • The FDA Office of Women’s Health (http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofWomensHealth/default.htm) is funding Iacovos 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. Research on better image quality metrics is an important part of this project. • 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. • The Image Wisely/FDA Patient Medical Imaging Record Card can be downloaded here: http://www.imagewisely.org/Patients.aspx.

10. One of the primary components of FDA’s dose reduction initiative is to “recommend that the healthcare professional community continue to develop and adopt criteria for appropriate use of CT, fluoroscopy, and nuclear medicine procedures.” A number of efforts are underway to encourage appropriate use of medical imaging: • NCRP workshop and forthcoming white paper (Computed Tomography in Emergency Medicine: Ensuring Appropriate Use; workshop Bethesda; Sept. 23-24, 2009; FDA/Stan Stern presented; workshop summary downloadable at http://www.ncrponline.org/PDFs/2009/CT_presentations_9-09.pdf) • IAEA Technical Meeting on Justification of Radiation Exposure in Diagnostic Imaging (Vienna; Oct. 2010; FDA/Thalia Mills presented): The purpose of this workshop was to start a report for the IAEA to inform its planned international campaign on justification of radiation exposure in diagnostic imaging. • WHO Consultation on Referral Guidelines for Appropriate Use of Radiation Imaging (March 1-3 2010). Effort to harmonize appropriate use guidelines. • Centers for Medicare and Medicaid Services (CMS) is conducting a Medical Imaging Demonstration that will assess the impact of decision support systems that implement appropriateness criteria (e.g. ACR AUC) on appropriate utilization of advanced imaging services. This 2-year demonstration is authorized by the Medicare Improvements for Patients and Providers Act of 2008. Additional information at: http://www.cms.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS1222075. • Goske, M. J., E. Charkot, T. Herrmann, S. John, T. T. Mills, G. Morrison, and S. N. Smith, 2011, “Image Gently: Challenges for Radiologic Technologists When Performing Digital Radiography in Children,” accepted by Pediatric Radiology. This paper includes a list of recommendations for manufacturers from the radiologic technologist community. • AAPM Working Group on Standardization of CT Nomenclature and Protocols (includes participants from AAPM, ASRT, ACR, MITA, FDA, 5 CT vendors, RadLex, and DICOM): https://www.aapm.org/org/structure/default.asp?committee_code=WGCTNP. The working group has posted CT brain perfusion protocols (available for download by AAPM members): https://www.aapm.org/pubs/CTProtocols/default.asp.