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IAEA International Atomic Energy Agency
Regional Workshop on the
International Basic Safety Standards
Session 3b: Justification in Medical Exposures
16-19 October 2012, Kiev, Ukraine
John Le Heron
Radiation Protection of Patients Unit
Division for Radiation, Transport and Waste Safety
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IAEA
Justification of medical exposures
- Evolution of ICRP recommendations
Should be dealt with in the same way as justification of any
other practice
But adds that each procedure is subject to a separate decision,
so that there is an opportunity to apply a further, case-by-case,
justification for each procedure. Notes that this may be important
for complex investigations and for therapy.
1990 – ICRP 60
2007 – ICRP 103
– ICRP 105
1996 – ICRP 73
2011 – New BSS
A more complex approach - 3 levels
•Justification of a practice
•Generic justification of a defined procedure
•Justification of a procedure for an individual patient
ICRP 73 approach is maintained – medical exposure of
patients calls for a different and more detailed approach
to the process of justification
1996 – BSS 115
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IAEA
New BSS – Justification
• Follows ICRP recommendations
• Assigns responsibilities
• General requirement (as in BSS 115)
• Level II (for radiological procedures) • Health authority,
professional bodies
• Health screening programmes • Health authority, professional
bodies
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IAEA
Justification for an individual patient - level 3
• What needs to be considered? • Appropriateness of the
request
• Use of relevant national or international guidelines
• Urgency of the procedure
• Characteristics of the exposure
• Characteristics of the individual patient
• Relevant information from previous radiological procedures
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IAEA
Who does the justifying at level 3?
• 2 roles identified in the new BSS • Radiological medical
practitioner
• Referring medical practitioner
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Who? – Respective roles and issues
Referring medical
practitioner • Clinical context, medical
history
• Defensive medicine
Radiological medical
practitioner • Knowledge about procedure –
benefits, risks, limitations
• Financial conflict of interest
“Request for consultation”
versus “instruction to perform”
Referral guidelines / criteria of appropriateness
..shall be carried out through consultation between the
radiological
medical practitioner and the referring medical practitioner,
….
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IAEA
Asymptomatic individuals – intended early
detection of disease
• “Cutting-edge” research versus “entrepreneurial” medicine
• Self-presenting patients
• New BSS • Referring medical practitioner/Radiological
medical
practitioner
• Professional body guidelines
• Individual informed re benefits, risks and limitations
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Biomedical research
• Justification of medical exposures that occur in the context
of biomedical
research
• Helsinki Declaration
• Guidelines of the Council for International Organizations of
Medical Sciences
• Recommendations of the ICRP
• Ethics committee approval
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IAEA
Issues in implementing the BSS
- Justification of medical exposures – (1)
• Awareness of radiation risks and hence the actual need for
justification
• Regulations may require justification
• But little is actually happening
• “Lip service” only
• Regulatory body needs to promote awareness
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IAEA
Issues in implementing the BSS
- Justification of medical exposures – (2)
• Appropriateness • Joint responsibility
• The referrer (referring medical practitioner)
• The radiological medical practitioner
• Development and use of appropriateness criteria
• Professional bodies
• Availability of relevant information from the patient’s
previous radiological procedures
• The regulatory body as a facilitator
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IAEA
Issues in implementing the BSS
- Justification of medical exposures – (3)
• Audit • What can the regulatory body do in this area?
• Medical domain versus radiation protection
• What should the regulatory body look for during its
inspections?
• Regulatory body needs specialized/trained staff in this
area?
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Issues in implementing the BSS
- Justification of medical exposures – (4)
• Asymptomatic individuals • “Worried well”
• Pressures from advertising, media
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IAEA
Issues in implementing the BSS
- Justification of medical exposures – (5)
• Biomedical research projects
• RBs need to ensure there is a system in place so that ethics
committees are able to make a
decision on the “justification of the use of
radiation” in the proposed project
• Dose & risk assessment
• Application of dose constraints
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IAEA
