FDA Perspective on Radiation Dose Monitoring

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					FDA Perspective on Radiation
     Dose Monitoring

         ACR Dose Monitoring Forum

         Donald L. Miller, M.D. FACR
             Acting Chief, Diagnostic Devices Branch
   Division of Mammography Quality and Radiation Programs
           Center for Devices and Radiological Health
                  Food and Drug Administration
Nothing to Disclose
         21 USC 360ii

FDA has authority to:
Plan, conduct, coordinate, and support
research, development, training and
operational activities to minimize the
emissions of and the exposure of people
to, unnecessary electronic product

 National dose registry
National reference levels
  FDA Dose Reduction Initiative
• The healthcare professional community, in
  collaboration with FDA, should continue efforts to
  develop DRLs for CT, fluoroscopy, and nuclear
  medicine procedures locally and also through a
  national radiation dose registry.
• Requirements for CT and fluoroscopic device
  capability to record radiation dose information for
  use in patient medical records or a radiation
  dose registry.
• Provide patients with tools to track their personal
  medical imaging history.

         Initiative to Reduce Unnecessary Radiation Exposure from
                        Medical Imaging. February 2010
Diagnostic Reference Levels
• QA/QI tool for controlling radiation dose
• Designed to reduce the risk of
  stochastic effects
• Indicator of radiation dose for a specific
  procedure for an average-sized patient
• Guidance for what is achievable with
  good practice
• Not regulatory; not dose limits
• Do not apply to individual patients
Imaging Modalities

 •   CT
 •   Fluoroscopy
 •   Radiography
 •   Nuclear medicine
Uses For a Radiation Dose Registry

         •   Justification
         •   Optimization
         •   Risk Assessment
         •   Research
• Goal: optimize radiation dose
• Registry purpose: develop reference levels
• Sample: examinations from a number of
  patients at a sample of facilities
• Necessary data:
  – Facility identifiers
  – Radiation dose data
  – Patient age and weight
• PHI not needed
              FDA’s Role
• Provide expertise in
  – Development of diagnostic reference levels
  – Radiation dose reporting
• Work with manufacturers and end-users to
  standardize dose reporting
• Work with Federal agencies and NGOs to
  support registry development efforts
• Help develop educational material on use
  of DRLs
Standardization: Role of Manufacturers
  • Dose reporting
    – Incorporate RDSR capabilities into new and
      existing equipment.
    – Ensure compliance with DICOM by
      adherence to IHE Radiation Exposure
      Monitoring (REM) profile
  • Naming conventions
    – Facilitate adoption of naming conventions by
      using standard terminology in the default
      protocol names.
Standardization: Role of End-Users
• Standard terminology for procedure
  – RadLex playbook: detailed standard names,
    allowing differentiation of body regions, use of
    contrast, etc.
  – Current efforts (e.g. RadLex, LOINC) need to
    be further developed and harmonized
  – Institutions should incorporate standard
    terminologies into naming conventions
Registry/Reference Level Development

     • Identification of data sources
       – Within the Federal government
       – Outside the Federal government
     • Promotion of registry development
     • NEXT
• Nationwide Evaluation of X-Ray Trends
• Since 1973; collaborative with CRCPD
• National surveys of representative
  samples of U.S. clinical facilities
• Comprehensive data on radiation
  exposure and QA practices for selected
  imaging examinations
• Includes image quality evaluations
    NEXT Data in Action
• NCRP report on reference levels (in
  draft stage)
• NCRP Report No. 160 on U.S.
  population exposure (2009)
• CRCPD patient exposure and dose
  guide (2003)
Existing Federal Data Sources

  • FDA
    – NEXT
  • NIH
    – NCI oncology databases
Planned/Proposed Federal Databases
 • VA
   – Registry under development
 • DoD
   – In exploratory stage
   – DoD/VA EHR platforms to merge in the next
     few years
 • IHS
   – Extremely interested
   – Most facilities use VA EHR platform (VistA)
     Non-Federal Data Sources
• ACR Dose Index Registry (DIR)
  – Component of National Radiology Data Registry
  – Started full operation May, 2011
  – CT only; DR in development
• Society of Interventional Radiology
  – Registry, still in planning stages
• ACC National Cardiovascular Data Registry
  – 1,400 facilities participate (of 1,800 in the US)
  – Data on almost 2,000,000 PCI procedures
  – Most dose data are fluoro time only
   Proposed Guiding Principles
• Aggregated data should be publicly and
  freely available
• Raw data should be accessible to
• Registry participants should include all
  facilities where medical imaging using
  ionizing radiation is performed (e.g., medical
  offices, dental offices, chiropractors)
 Proposed Guiding Principles

• Facilities should be able to participate at
  no or minimal cost
• Reference levels are a QA/QI tool
  Not dose limits
  Not a regulatory or enforcement tool

• Who will host the registry?
  – Design, setup, storage
  – Federal? Non-Federal?
• Who will operate the registry?
  – Storage, analysis, data dissemination
• Who will fund the registry?
     Thank you



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