EnergyEnergy
Georgi SimeonovDirectorate-General for Energy (DG ENER)Unit D4 Radiation ProtectionLuxembourg
Workshop on European Population Doses from Medical Exposure 24-26 April 2012, Athens
EURATOM Legal Basis for
Population Dose Estimates
Expectations from DDM 2
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Contents
.Council Directive 97/43/Euratom
.European Guidance RP 154» Purpose of population dose estimates
» Survey frequency and resources required
» Age/sex distribution
.Euratom RP Legislation Revision
.Commission Expectations from DDM2
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Legal Basis
.Council Directive 97/43/Euratom, a.k.a.
Medical Exposure Directive - MED
.Article 12. Estimates of population doses
"2. Member States shall ensure that the distribution
of individual dose estimates from medical exposure
… is determined for the population and for
relevant reference groups of the population as may
be deemed necessary by the Member State."
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RP 154, 2008
.Purpose of population dose
estimates
.Guidance on
» Assessing frequencies
» Assessing patient doses
» Assessing age/sex
distributions
» Presenting the results
. Use of IT – DICOM, RIS …
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RP 154, Purpose of dose estimates
.Study objectives need to be clearly stated, e.g.:
» Trends in the annual collective dose
» Contributions of different modalities and types of examination
» Relationship frequency / exam dose / collective dose contribution
» Regional variations for particular types of examination
» Compare frequencies and dose between countries
» Medical vs. other sources of population exposure
» Age and sex distribution of patients, particularly for
exams with major contribution to collective dose
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RP 154, Survey Frequency and Resources
.Surveys Frequency» Exam frequency surveys – every 5 years» Patient dose surveys – every 5 years» As close in time as possible
.Required resources
» Lead by two senior scientists» Expertise in radiology, dosimetry, public health, statistics and
project management
» Public health and radiation protection authorities involvement
» Collaboration with professional bodies from start
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RP 154, Age/sex distributions
"The predominant effect of radiation exposures at the levels
encountered in diagnostic radiology is an increased probability of
cancer over the remaining lifespan of the patients, which is
critically dependent on the age and sex distribution
of the exposed population. A thorough assessment of the
population dose from medical x-rays should therefore include
information on the age and sex distribution of the
patients undergoing specific types of x-ray examination,
particularly those making major contributions to the total collective dose."
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RP 154, Age/sex distributions
.Ideally» For major contributors to collective dose (Top 20, etc.)
» Representative nation-specific survey» Five-year age bands for each sex
.If no national data – use 'typical European'
age/sex data
» Based on average in five countries (CH, DK, NL, LU, UK)
» For 'Top 20', 'All CT', 'All angiography', 'All interventional'
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Revision of Legal Basis
.Commission proposal, Sep 2011
» http://ec.europa.eu/energy/nuclear/radiation_protection/
doc/com_2011_0593.pdf
» Grouping together five current Directives, e.g.
• 96/29/Euratom, a.k.a. 'European BSS'
• 97/43/Euratom, Medical Exposure Directive
» Some changes, including in 'Medical' Chapter VII
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Revision of Legal Basis
.Article 63. Estimates of population doses "Member States shall ensure that the distribution of
individual dose estimates from medical exposure is
determined for the population and for relevant
reference groups of the population as may be
deemed necessary by the Member State and shall take
into account the age distribution and the
gender of the exposed population."
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Expectations from DDM 2
.Tender Specifications http://ec.europa.eu/dgs/energy/tenders/doc/2010/s092_137171_invitation.pdf
.Objectives
» collect available data on the doses from
radiodiagnostic procedures in the EU
» facilitate the further implementation of RP 154
.Background national data:
» legal and regulatory framework
» healthcare system data
» national DRLs
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Expectations from DDM 2
.For each DDM 2 country (if available)
» List of 'Top 20' and 'NM top 5'
» Frequency and dose for 'Top 20', 'NM top 5' and total
» Gender and age distribution for 'Top 20' and 'NM top 5'
» Annual collective and the per caput (and, if
available, per exposed patient) dose for:
• each of the 'top 20' and 'NM top 5' exams,
• main groups of procedures - CT, radiography, IR and NM
• total exposure from radiodiagnostic procedures
» Data sources, year, methodologies, uncertainties
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Expectations from DDM 2
.Estimate of the doses from radiodiagnostic
procedures for the EU as a whole
» taking into account the lack of data for specific countries or
examinations and the uncertainties in the available data and
formulating reasonable assumptions for dealing with them
.Trends in the Union and in the individual
member States
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Expectations from DDM 2
.Implementation of Radiation Protection 154
» Objectives
• test the guidelines
• Identify deficiencies and needs for amendment or
further development
» Through
• limited collection of data following RP154
• in a test group of countries (no similar work so far)
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Expectations from DDM 2
.Workshop on European population doses from medical
exposure
» Discuss the results of data collection and test of RP 154
• (Worrying?) trends, comparison with other regions
• Implementation difficulties, ways to overcome them
• Need of further EU action» Further Topics for Discussion
• Use of data – policy making, education,
communication
• Global cooperation in data collection
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THANK YOU FOR YOUR ATTENTION
http://ec.europa.eu/energy/nuclear/radiation_protection/radiation_protection_en.htm