Medical imaging radiation protection culture: an FDA perspective

1
Medical imaging radiation protection culture an
FDA perspective

• Thalia T. Mills, Ph.D.
• thalia.mills_at_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 others 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).

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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

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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

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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.

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Notes and References

• ACR motto (also used in FDAs 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/Radiati
  on-EmittingProducts/RadiationSafety/RadiationDoseR
  eduction/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/W
  orkshopsConferences/ucm201448.htm. Submissions to
  the public docket are available at
  http//www.regulations.gov/!docketDetailDFDA-20
  10-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/DeviceRegulation
  andGuidance/Overview/MedicalDeviceUserFeeandModern
  izationActMDUFMA/ucm109196.htm, updated October
  6, 2010.
• FDA, Safety Investigation of CT Brain Perfusion
  Scans Update 11/9/2010, http//www.fda.gov/Medica
  lDevices/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/Radi
  ationSafety/RadiationDoseReduction/ucm232551.htm.

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• National Electrical Manufacturers Association,
  Computed Tomography Dose Check, NEMA Standards
  Publication XR 25-2010, http//www.nema.org/stds/x
  r25.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?dbname110_cong_public_law
  sdocidfpubl275.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/CentersOffic
  es/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)

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• 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 Womens Health
  (http//www.fda.gov/AboutFDA/CentersOffices/OC/Off
  iceofWomensHealth/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.

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• One of the primary components of FDAs 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_presentatio
  ns_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/itemdet
  ail.asp?itemIDCMS1222075.
• 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/struc
  ture/default.asp?committee_codeWGCTNP. The
  working group has posted CT brain perfusion
  protocols (available for download by AAPM
  members) https//www.aapm.org/pubs/CTProtocols/de
  fault.asp.