Reference Values in Diagnostic Radiology Application and Impact by xeg10270

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									                     SENTINEL
(SAFETY AND EFFICACY FOR NEW TECHNIQUES AND
    IMAGING USING NEW EQUIPMENT TO SUPPORT

               EUROPEAN LEGISLATION   )

22 Partners
17 member states
3 accession states
        Background EU

•   Health care equates to 8.4% of
    GDP
•   Radiology is 10% of revenue
    expenditure
•   Radiology equipment is 15% of
    capital expenditure
•   In the UK this equates to
    15,000,000,000 euros
     Background SENTINEL
        European Union

•   Population 457,000,000
•   180,000,000 radiology
    examinations per year
•   Population exposure 220,000
    man Sv
           Background
            SENTINEL

•   90% of all patient examinations
•   60% of collective dose
•   50% of man-made sources of
    radiation
          Background
        SENTINEL EU CA

•   Public concern about radiation
    in general
•   Public want safe X-ray
    examinations
•   Are all examinations justified
     Technology Driven
   Revolution in Radiology

Introduction of new technology (computing)
  and imaging devices (digital) in radiology
  and nuclear medicine. These must be safe
Main Objectives SENTINEL

•   Address efficacy and safety
    issues in all digital diagnostic
    examinations and nuclear
    medicine
•   Particular emphasis on high
    dose procedures and sensitive
    groups
    Objectives SENTINEL

•   Establish physical and clinical
    image quality criteria and link
    the two
•   Establish reference levels for
    new procedures, particularly for
    interventional radiology and
    cardiology
    Objectives SENTINEL

•   Develop good practice
    guidelines for new digital
    imaging equipment and
    procedures
•   Develop training courses and
    supporting material
•   Identify ethical concerns
    Functional Performance
        and Standards

•   Investigate image quality
    indices and referral criteria
•   Equipment performance surveys
•   IEC/CEN/CENELEC
           Efficacy and Safety
        Cardiology and Interventional
                 Radiology

•   Develop functional performance standards
•   Patient dose surveys
•   Optimisation studies
•   Use of DICOM (digital imaging and communications in
    medicine) header for surveys and QA
          DICOM Header

•   DICOM header contains information
    on the procedure and dosimetry
•   Accurate dosimetry requires extra
    calculations and calibration.
•   Important differences between the
    different modalities and different X-
    ray systems.
            Use of DICOM
               Header

•   On-line patient dosimetry requires
    significant interaction with the
    industry to clarify the data contained
    in the header
•   Transfer of this information to data
    bases still not fully solved
•   Dosimetry survey performed by a PC
    linked to the hospital RIS/PACS
    system
•   IEC developing a dosimetry standard
    following SENTINEL request
DICOM HEADER
  (contains useful
information for QA,
 audit and patient    Siemens Axiom FD important DICOM tags
     dosimetry)       (0018,0040) : Cine Rate               : 30
                      (0018,0060) : KVP                  : 97
                      (0018,1030) : Protocol Name               : Reg
                      (0018,1110) : Distance Source to Detector : 947
                      (0018,1111) : Distance Source to Patient : 798
                      (0018,1150) : Exposure Time                : 786
                      (0018,1151) : X-ray Tube Current             : 271
                      (0018,1154) : Average Pulse Width              : 6.5
                      (0018,115E) : Image Area Dose Product             : 1839
                      (0018,1162) : Intensifier Size          : 160
                      (0018,1190) : Focal Spot(s)             : 0.4
                      (0018,1510) : Positioner Primary Angle           :0
                      (0018,1511) : Positioner Secondary Angle : 0
                      (0018,1702) : Collimator Left Vertical Edge : 0
                      (0018,1704) : Collimator Right Vertical Edge: 1023
                      (0018,1706) : Collimator Upper Horizontal Ed: 0
                      (0018,1708) : Collimator Lower Horizontal Ed: 1023
  Computed radiography (CR)                                     Digital radiography with flat detector (DR)


(0008,0020) : Study Date               : 04/12/2003                   Relevant DICOM tags GE Chest flat panel
(0008,0022) : Acquisition Date            : 04/12/2003       (0008,0020) : Study Date               : 27/01/03
(0008,0060) : Modality               : CR
(0008,0070) : Manufacturer               : AGFA
                                                             (0008,0030) : Study Time                : 10:31:12
                                                             (0008,0033) : Image Time                 : 10:32:43
(0008,0080) : Institution Name          : HCSC               (0008,0068) : Presentation Intent Type : FOR
(0008,1010) : Station Name             : ADCC2               PRESENTATION
                                                             (0008,103E) : Series Description           : TORAX
(0008,103E) : Series Description       : lumbar AP
(0010,1010) : Patient's Age         : 020Y                   (0010,0020) : Patient ID             : 795607
(0018,0015) : Body Part Examined          : LSPINE           (0010,0040) : Patient's Sex             :F
(0018,1004) : Plate ID           : U13-35                    (0010,1010) : Patient's Age             : 085Y
(0018,1401) : Acquisition Device Processing : 60025Ia712Ra
                                                             (0018,0015) : Body Part Examined               :
(0018,1403) : Cassette Size          : 35CMX43CM             (0018,0060) : KVP                  : 125
(0018,1404) : Exposures on Plate         : 342               (0018,1150) : Exposure Time                :5
                                                             (0018,1151) : X-ray Tube Current             : 250
(0018,5101) : View Position          : AP                    (0018,1153) : Exposure in uAs              : 1400
(0018,6000) : Sensitivity         : 4.00000000E+02
(0019,1010) : Image processing parameters :
                                                             (0018,115E) : Image Area Dose Product              : 0.83557
 MENU=60025 CC=0 MC=3.00 EC=0.00 LR=2.00 NR=4.00             (0018,1190) : Focal Spot(s)             : 0.6
(0019,1013) : Sensitometry name         : NK5                (0018,1405) : Relative X-ray Exposure           : 61
                                                             (0018,7060) : Exposure Control Mode              : AUTOMATIC
(0019,1015) : Dose monitoring list        : 1.54
                                                             (0018,7062) : Exposure Control Mode Descript:
(0020,0013) : Image Number              :1
(0020,1002) : Images in Acquisition        :1                AEC_left_and_right_cells
(0028,0010) : Rows                 : 3730                    (0028,0010) : Rows                  : 2022
(0028,0011) : Columns                : 3062                  (0028,0011) : Columns                  : 2022
(0028,0100) : Bits Allocated          : 16                   (0028,0100) : Bits Allocated           : 16
(0028,0101) : Bits Stored            : 12                    (0028,0101) : Bits Stored             : 14
(0028,0102) : High Bit             : 11
                              2. DICOM header
                               information is
                                  extracted




1. Images
    are
received
                                4. ALARMS are
                                   displayed
            3. COMPARISON
             with reference
                 values
What Parameters
  are audited
•   Patient entrance dose (entrance air
    kerma).
•   Dose area product (collimation).
•   Radiographic technique (e.g. appropriate
    kVp).
•   Appropriate use of the AEC.
What Parameters
  are audited

•   Flat panel detector temperature.
•   Number of series, number of images per
    series, kV, mA, ms and total number of
    images per procedure.
•   Exposure index and post-processing
    parameters (for CR).
•   Repeated images (retakes).
•   Image quality (basic evaluation).
  A total of 3,506 paediatric patients have
  been selected for the dose evaluations


                0 <1 years  1 < 5 years   5 <10 years   10 < 15 years
                sample size sample size   sample size    sample size    TOTAL sample
Chest without
   bucky           1180         309          143             92             1724
 Chest with
   bucky            0           181          255             363            799
  Abdomen          93           30           69              150            342
   Pelvis          254          128          122             137            641
         Standardisation

•   Direct Input to Industry both through
    Representation and as working
    participants in Standardisation
    Bodies
•   Brings research results directly to
    bear on Equipment Design Process
    and Industry thinking
      Formal Collaboration
           with IEC
•   Acceptance Testing/Commissioning/QA
•   Long term differences and lack of trust
    between industry engineers, end user
    physicists, et al.
•   Criteria for Acceptability of Equipment in
    Europe under MED
•   Major Achievement: Meeting (Oct 2007)
    between SENTINEL and IEC Industry
    representatives agreed to work approach and
    common issues
       Efficacy and Safety in
      Mammography Screening


•   Digital mammography
•   Risk/benefit studies
•   Tissue sampling techniques
 Efficacy and Safety in
Mammography Screening
 Efficacy and Safety in
Mammography Screening
         Defining Aspects of
         Radiation Protection

•   Relatively strong science base
•   Developed mainly outside medicine, but is
    used mainly within medicine
•   Employs arcane impenetrable language
    invented and protected by Physicists
•   Inept in Social and Political Sciences (Note
    EU Medico Legal Survey)
•   Global Industry and Local Health Care
    Provision
          Ethics Issues in
             Radiology
•   Identified a problem for Radiation
    Protection arising from a shift in dominant
    values in society since ICRP 26 and 60
•   Ethicists will not solve the problems for us,
    but help us identify and formulate them
•   Training essential to produce ethically
    sensitive and competent professions.
    Presently weak in this area.
         Examples of Areas

•   Right to Life
•   Right to Bodily Integrity
•   Individual Choice
•   Consent
•   Equality
•   Equity
•   Special Needs
•   Ageism
•   Trust of Authority
•   Trust in Professions
     Some Issues Identified

•   Major Issues around Justification
•   Philosophical assumptions underlying ICRP
    Recommendations need re-examining
•   Pregnancy Issues
•   Medico Legal Issues
•   Population Screening Issues
•   Issues around consent, authorisation, power
    of attorney, personal choice, self referral etc.
•   Non Transparent Language for Discourse,
    particularly Quantities and Units
            Pregnancy

•   Basis for Recommendations
•   Diversity of Practice throughout
    Community
•   Widespread high dose
    procedures need a more
    consistent approach
•   Patient Consent?
           Non Medical
            Exposures

• Exposures not primarily MEDICAL;
  Common Feature is lack of Medical
  Indication. Include:
   • Medico Legal,
   • Security,
   • Evidential
   • Commercial health screening,
   • Art
         Training Guidelines


•   Training needs identified
•   Training syllabus developed
•   Dissemination to member states
    via a series of training courses
              Summary


•   Safer, more effective
    procedures and examinations
    using new technology
•   Greater public acceptance of
    medical uses of radiation
•   Safer, more cost effective
    health care
Radiology Can Be
  Decorative!
---- Or

Threatening
           Is It Safe ?
Is It Justified ?




                          Is It Ethical ?

								
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