RESPONSIBILITIES & JUSTIFICATION IN MEDICAL EXPOSURES IAEA BSS WORKSHOP OCTOBER 2013 SOUTH AFRICA

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1 RESPONSIBILITIES & JUSTIFICATION IN MEDICAL EXPOSURES IAEA BSS WORKSHOP OCTOBER 2013 SOUTH AFRICA Susan Nel Department of Health Directorate: Radiation Control South Africa

2 Radcon as National Regulator of all radiation sources - serious staff shortage 10 Inspectors (4 Admin), X-ray section (5), Radio-nuclides (6) X-Ray Total: > Licence holders X-ray generators Medical: X-ray generators (80%) Non-medical: X-ray generators (20%) Radio-nuclides Total: > Authority holders sources Medical Applications: (10%) Industrial Applications (90%)

3 Responsibilities of the Government specific to medical exposure Requirement 34: Par incl The government shall ensure that relevant parties are authorized to assume their roles and responsibilities and that diagnostic reference levels, dose constraints, and criteria and guidelines for the release of patients are established.

4 Responsibilities Government Par Par in accordance with Par relevant parties are authorized to assume roles. Ensure compliance through: - Licences/authorities issued in terms of Hazardous Substance Act (15 of 1973), relevant Regulations (1973 & 1993) & specific conditions, Codes & Guidelines - Prior to licensing - Ensure suitable qualified medical personnel is involved - must be registered HPCSA - Problem - Act & Regulations require to be revised urgently to include all requirements as stipulated in new BSS - Problem areas in Par highlighted in National SAT report submitted to IAEA e.g (i) Government shall ensure effective independence of Regulator (Par 2.16) (ii) Co-ordination between responsible authorities w.r.t. protection and safety for all exposure situations (iii) The government to ensure arrangements are in place for the provision of education and training services required for building and maintaining the competence of persons with responsibilities relating to protection and safety.. No recognized courses currently available (eg RPO, responsible person,licensee)

5 Responsibilities - Government Reference Levels & Dose Constraints Par DRL s - Do not comply - Mr Smit - optimization Par (a)(i) Dose constraints for carers and comforters - Require discussion (ref 3.172) (b) Guidelines for release of patients following therapeutic procedure - Comply Optimization In Medical Exposures IAEA BSS Workshop 5

6 Responsibilities of the Regulator specific to medical exposure Requirement 35 The regulatory body shall require that health professionals with responsibilities for medical exposure are specialized in the appropriate area and that they meet the requirements for education, training and competence in the relevant specialty.

7 Responsibilities Regulator Authorization Par Comply - Licences/authorities issued in terms of Hazardous Substance Act (15 of 1973), relevant Regulations (1973 & 1993) & specific conditions to a : - Specific company, hospital, person, specific source/equipment & specific premises - Prior to authorization - Ensure suitable qualified medical personnel is involved, registered and listed at HPCSA Problem: Post licensing BSS stipulates that government shall ensure that arrangements are in place for the provision of education and training services required for building and maintaining the competence of persons and organizations with responsibilities relating to protection and safety.. (safety culture needs to be created) No recognized courses in protection and safety currently available.

8 Responsibilities of licensees specific to medical exposure Requirement 36 Registrants and licensees shall ensure that no person incurs a medical exposure unless there has been an appropriate referral, responsibility has been assumed for ensuring protection and safety, and the person subject to exposure has been informed as appropriate of the expected benefits and risks.

9 Par Responsibilities Licensees Par (b) The medical exposure has been justified through consultation between the radiological medical practitioner and the referring medical practitioner, as appropriate - Not always done in practice - many unjustified procedures Problem: licensee/referring dr/radiologist/radiographer not aware of what is the dose to patient (d) The patient or the patient s legal authorized representative been informed, as appropriate, of the expected diagnostic or therapeutic benefits of the procedure as well as the radiation risks. - Not practical in diagnostic -? discuss

10 Responsibilities - Licensees Par (exposure part of research - shall be approved by ethics committee) - Comply (Regulator approves - ad hoc basis no specific guidelines) Par (dose to carers) - Require discussion Par (a) Do not comply with all in (next slide) (c),(d),(e) - re. Medical Physicist Mr Smit - optimization

11 Justification of medical exposures Requirement 37: Par Relevant parties shall ensure that medical exposures are justified Par Regulator: Aim - To provide an appropriate standard of protection to all South African citizens against ionizing radiation without unduly limiting the beneficial practice giving rise to radiation exposure do we succeed? not according to BSS. Challenge to Regulator how to control/regulate justification Licensee: No Par Generic justification of a radiological procedure shall be carried out by the health authority in conjunction with appropriate professional bodies, and shall be reviewed from time to time, with account taken of advances in knowledge and technological developments. - Do not comply Par justification of exposure in consultation between the radiological medical practitioner and the referring medical practitioner. Licensee: Complies for pregnant, breastfeeding & paediatric patients - not always for all exposure

12 Justification Par Relevant national & international referral documents shall be taken into account Regulator: Apply for Guidelines - require revision Licensee: Do not comply Par procedures on asymptomatic patients (research, screening program) ad hoc basis Problem areas: CxR at mines (? Benefit outweigh risk) Justification require urgent attention by Regulator and licensee. A Radiation Safety Culture is required by all professionals - should already be addressed during initial training

13 Conclusion IAEA Technical Committee Workshop on Justification of Medical Exposure in Brussels, March 2013 Globally a significant and systematic practice of inappropriate examinations leading to radiation overuse and unnecessary radiation (increase CT & Nucl Med procedures) IAEA- proposed Triple A approach to encourage Member States to adopt, adapt & support - implement Appropriateness criteria; improve Awareness issue of justification and introduce clinical Audits to prioritize justification.

14 Thank you