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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