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