Regional Workshop on the International Basic Safety Standards

Transcription

1 Regional Workshop on the International Basic Safety Standards Session 3b: Justification in Medical Exposures October 2012, Kiev, Ukraine John Le Heron Radiation Protection of Patients Unit Division for Radiation, Transport and Waste Safety International Atomic Energy Agency

2 Justification of medical exposures - Evolution of ICRP recommendations 1990 ICRP BSS ICRP 73 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. A more complex approach - 3 levels Justification of a practice Generic justification of a defined procedure Justification of a procedure for an individual patient 2007 ICRP 103 ICRP New BSS ICRP 73 approach is maintained medical exposure of patients calls for a different and more detailed approach to the process of justification

3 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

4 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

5 Who does the justifying at level 3? 2 roles identified in the new BSS Radiological medical practitioner Referring medical practitioner

6 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,.

7 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

8 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

9 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

10 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

11 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?

12 Issues in implementing the BSS - Justification of medical exposures (4) Asymptomatic individuals Worried well Pressures from advertising, media

13 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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