IAEA International Atomic Energy Agency

Regional Workshop on the

International Basic Safety Standards

Session 3a: Responsibilities in

Medical Exposures

17-20 April 2012, Kuala Lumpur, Malaysia

John Le Heron

Radiation Protection of Patients Unit

Division for Radiation, Transport and Waste Safety

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Medical exposures – current usage

Every year, throughout the world, ionizing radiation is used in*:

• 4.000.000.000 diagnostic procedures

• 35.000.000 nuclear medicine procedures

• 8.000.000 radiotherapy treatment courses

* An expanding activity worldwide

Diagnostic procedure Nuclear medicine procedure Radiotherapy procedure

These bring huge

benefit to healthcare

*UNSCEAR 2008

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Increasing use of radiation in medicine

• More machines, etc

• New technologies and techniques

• New roles

• Increasing complexity in the planning & delivery of the radiation

Single slice CT → Multi-Detector CT

Film → Computed & Digital Radiography

Hybrid imaging, PET-CT

Image-guided interventional procedures

Virtual procedures

E.g. Changes in the role of imaging:

First “port of call”

A move towards “screening”, in all its guises

E.g. IMRT, IGRT, etc.

More can be done with radiation in medicine

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• The BSS & Medical exposures

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Scope of Medical Exposures section

• Planned exposure situations (ICRP)

• Medical exposures • As intended, but also

• Unintended and accidental exposures

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Definition of medical exposure

• Slight change from BSS 115

• Includes health screening programmes, implicitly • Explicit in requirements

• Does not include medico-legal, etc • Covered elsewhere in the new BSS

Medical exposure: Exposure incurred:

•by patients for the purpose of medical or dental diagnosis or treatment;

•by carers and comforters;

•by volunteers in a programme of biomedical research involving their

exposure.

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Responsibilities

• An area identified in the review of the BSS as needing improvement

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Responsibilities

Government (in addition to Section 2):

to ensure, as a result of consultation between

Health Authorities, professional bodies and the

Regulatory Body, that:

• DRLs are established

• Dose constraints are established for

• Carers and comforters

• Volunteers in biomedical research

• Criteria and guidelines are established for the release of patients after radionuclide therapy

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Responsibilities

• Regulatory Body • Authorization allows persons to take on the

responsibilities of the Standards as a:

• Radiological medical practitioner

• Medical physicist

• Medical radiation technologist

• Other health professionals with specific duties in patient radiation protection

• Only if: • Specialized in the appropriate area

• Meet the respective education, training and competence requirements in radiation protection

• Named in an up-to-date list maintained by the licensee

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Education, training and competence

• Crucial to radiation protection in medical exposure • Radiological medical practitioner

• Medical physicist

• Medical radiation technologist

• Radiopharmacist

• All definitions have a similar format: • A health professional, with specialist education and training in …….,

competent to …… .

• Explanatory note to each definition: • Competence of persons is normally assessed by the Member State

by having a formal mechanism for registration, accreditation or certification of ….

• Member States that have yet to develop such a mechanism need to assess …. based either on international accreditation standards or standards from another country ….

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Responsibilities

• Licensees to ensure that there is no medical exposure unless: Patient Volunteer in biomedical

research

Carer or comforter

Appropriate referral Programme approved by

ethics committee

Carer or comforter has

received, and

understood, information

on radiation protection

and on risks

Justified

Radiological medical

practitioner has assumed

responsibility for

protection & safety

Radiological medical

practitioner has assumed

responsibility for

protection & safety, and

dose constraints are

applied

Dose constraints are

applied

Patient informed of

expected benefits & risks

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The new BSS & the medical physicist

• The MP has a mandated role in: • Therapeutic uses of radiation:

• The requirements for calibration, dosimetry and QA, including the acceptance and commissioning of medical radiological equipment

• Are fulfilled by or under the supervision of a medical physicist

• Diagnostic uses & image-guided interventional procedures • The requirements for imaging, calibration, dosimetry and QA,

including the acceptance and commissioning of medical

radiological equipment

• Are fulfilled by or under the oversight of or with the documented advice of a medical physicist

• Whose degree of involvement is determined by the complexity of the radiological procedures and the associated radiation

risks

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Responsibilities – issues for Government

• Establishing DRLs

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Responsibilities – issues for the RB

• Key persons • Crucial roles for radiation protection

• Need to be able to assess whether a given person is acceptable or not for their intended role

• Specialization

• Radiation protection training

The doctors: • Radiologists, Nuclear Medicine

Physicians, Radiation Oncologists

• OK??

• Cardiologists and other specialists?

Medical physicists • Radiotherapy

• Diagnostic radiology

• Image-guided interventional procedures

• Nuclear medicine??

Medical radiation technologists • Radiotherapy

• Diagnostic radiology

• Image-guided interventional procedures

• Nuclear medicine??

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Responsibilities - issues

• Ensuring appropriate persons for the roles:

• Are there parallel strategies that can be used to bring about change?

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Parallel strategies?

• Administrative pressure

• Avoiding risk (litigation)

• Financial pressure

• Re-imbursement only if performed by appropriate persons

• Quality pressure

• ISO accreditation