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Module 1.12 Planned Exposure Situations Medical Exposure (GSR part 3)

Module 1.12 Planned Exposure Situations Medical Exposure (GSR part 3). “ IAEA REGIONAL WORKSHOP ON SCHOOL FOR DRAFTING REGULATIONS ON RADIATION SAFETY ” International Atomic Energy Agency, Vienna, Austria, 3 - 14 November 2014. Julius Žiliukas. Content.

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Module 1.12 Planned Exposure Situations Medical Exposure (GSR part 3)

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  1. Module 1.12Planned Exposure SituationsMedical Exposure(GSR part 3) “IAEA REGIONAL WORKSHOP ON SCHOOL FOR DRAFTING REGULATIONS ON RADIATION SAFETY” International Atomic Energy Agency, Vienna, Austria, 3 - 14 November 2014 Julius Žiliukas

  2. Content • Responsibilities of government specific to medical exposure • Responsibilities of the regulatory body specific to medical exposure • Responsibilities of registrants and licensees specific to medical exposure • Justification of medical exposures • Optimization of protection and safety Planned Exposure Situations. Medical Exposure

  3. Content • Pregnant or breast-feeding women • Release of patients after radionuclide therapy • Unintended and accidental medical exposures • Reviews and records Planned Exposure Situations. Medical Exposure

  4. Introduction Planned Exposure Situations. Medical exposure

  5. Introduction Planned Exposure Situations. Medical Exposure

  6. Introduction Planned Exposure Situations.Medical Exposure

  7. Introduction Planned Exposure Situations. Medical exposure

  8. Introduction Planned Exposure Situations. Medical Exposure

  9. Introduction Planned Exposure Situations. Medical exposure

  10. General • The requirements in respect of medical exposure in planned exposure situations apply to all medical exposures, including intended, unintended and accidental exposures. • Dose limits do not apply to medical exposures. Planned Exposure Situations. Medical Exposure

  11. Responsibilities of the government specific to medical exposure • The government shall ensure that relevant parties are authorized to assume their roles andresponsibilities and that are established: • diagnostic reference levels, • dose constraints, • criteria and guidelinesfor the release of patients. Planned Exposure Situations. Medical Exposure

  12. Responsibilities of the government specific to medical exposure • The government shall ensure thatthe following are established: • (a) Dose constraints to be fulfilled for: • 1. Exposures of carers and comforters; • 2. Exposures due to diagnostic investigations of volunteers participating in a programme of biomedical research. Planned Exposure Situations. Medical Exposure

  13. Responsibilities of the government specific to medical exposure • The government shall ensure thatthe following are established: • (b) Criteria and guidelines for the release of patients who have undergone therapeutic proceduresusing unsealed sources or patients who still retain implanted sealed sources. Planned Exposure Situations. Medical Exposure

  14. Responsibilities of the regulatory body specific to medical exposure • The regulatory body shall require that health professionals with responsibilities for medicalexposure are specialized in the appropriate area and that they meet the requirements for: • education, • training and • competence in the relevant specialty. Planned Exposure Situations. Medical Exposure

  15. Responsibilities of the regulatory body specific to medical exposure • The regulatory body shall authorizeparticular medical radiation facilityonly if it’s personnel (radiological medical practitioners, medical physicists, medical radiation technologists and any other health professionals): • (a) are specialized in the appropriate area; • (b) meet the respective requirements for education, training and competence in radiationprotection; • (c) are named in a list maintained up to date by the registrant or licensee. Planned Exposure Situations. Medical Exposure

  16. Responsibilities of registrants and licensees specific to medical exposure • Registrants and licensees shall ensure that no patient, whether symptomatic or asymptomatic,undergoes a medical exposure unless: • (a) The radiological procedure has been requested by a referring medical practitioner andinformation on the clinical context has been provided, or it is part of an approved healthscreening programme; Planned Exposure Situations. Medical Exposure

  17. Responsibilities of registrants and licensees specific to medical exposure • Registrants and licensees shall ensure that no patient, whether symptomatic or asymptomatic,undergoes a medical exposure unless: • (b) The medical exposure has been justified through consultation between the radiological medicalpractitioner and the referring medical practitioner, as appropriate, or it is part of an approved health screening programme; Planned Exposure Situations. Medical Exposure

  18. Responsibilities of registrants and licensees specific to medical exposure • Registrants and licensees shall ensure that no patient, whether symptomatic or asymptomatic,undergoes a medical exposure unless: • (c) A radiological medical practitioner has assumed responsibility for protection and safety in theplanning and delivery of the medical exposure; Planned Exposure Situations. Medical Exposure

  19. Responsibilities of registrants and licensees specific to medical exposure • Registrants and licensees shall ensure that no patient, whether symptomatic or asymptomatic,undergoes a medical exposure unless: • (d) The patient or the patient’s legal authorized representative has been informed, as appropriate,of the expected diagnostic or therapeutic benefits of the radiological procedure as well as theradiation risks. Planned Exposure Situations. Medical Exposure

  20. Responsibilities of registrants and licensees specific to medical exposure • Registrants and licensees shall ensure that no individual incurs a medical exposure as part ofa programme of biomedical research unless the exposure has been approved by an ethics committee(or other institutional body that has been assigned similar functions by the relevant authority) and a radiological medical practitioner takes responsibility. Planned Exposure Situations. Medical Exposure

  21. Responsibilities of registrants and licensees specific to medical exposure • Registrants and licensees shall ensure that no individual receives a medical exposure as a careeror comforter unless he or she has received, and has indicated an understanding of, relevant informationon radiation protection and information on the radiation risks prior to providing care and comfort to anindividual undergoing a radiological procedure. Planned Exposure Situations. Medical Exposure

  22. Responsibilities of registrants and licensees specific to medical exposure • Registrants and licensees shall ensure that: • (a) The radiological medical practitioner performing or supervising the radiological procedure hasassumed responsibility for ensuring overall protection and safety for patients during theplanning and delivery of the medical exposure, including the justification of the procedure and the optimization of protection and safety, in cooperationwith the medical physicist and the medical radiation technologist; Planned Exposure Situations. Medical Exposure

  23. Responsibilities of registrants and licensees specific to medical exposure • Registrants and licensees shall ensure that: • (b) Radiological medical practitioners, medical physicists, medical radiation technologists andother health professionals with specific duties in relation to protection and safety for patients ina given radiological procedure have the appropriate specialization; Planned Exposure Situations. Medical Exposure

  24. Responsibilities of registrants and licensees specific to medical exposure • Registrants and licensees shall ensure that: • (c) Sufficient medical personnel and paramedical personnel are available as specified by the health authority; Planned Exposure Situations. Medical Exposure

  25. Responsibilities of registrants and licensees specific to medical exposure • Registrants and licensees shall ensure that: • (d) For therapeutic uses of radiation, the requirements for calibration,dosimetry and quality assurance, including the acceptance and commissioning of medicalradiological equipment, are fulfilled byor under the supervision of a medical physicist; Planned Exposure Situations. Medical Exposure

  26. Responsibilities of registrants and licensees specific to medical exposure • Registrants and licensees shall ensure that: • (e) For diagnostic radiological procedures and image guided interventional procedures, therequirements for medical imaging, calibration, dosimetry and qualityassurance, including the acceptance and commissioning of medical radiological equipment are fulfilled by or underthe oversight of or with the documented advice of a medical physicist, whose degree ofinvolvement is determined by the complexity of the radiological procedures and the associated radiation risks. Planned Exposure Situations. Medical Exposure

  27. Justification of medical exposures • Medical exposures shall be justified by weighing the expected diagnostic or therapeuticbenefits that they yield against the radiation detriment that they might cause, with account taken ofthe benefits and the risks of available alternative techniques that do not involve medical exposure. Planned Exposure Situations. Medical Exposure

  28. Justification of medical exposures • Generic justification of a radiological procedure shall be carried out by the health authorityin conjunction with appropriate professional bodies, and shall be reviewed from time to time, withaccount taken of advances in knowledge and technological developments. Planned Exposure Situations. Medical Exposure

  29. Justification of medical exposures • The justification of medical exposure for an individual patient shall be carried out throughconsultation between the radiological medical practitioner and the referring medical practitioner with account taken, in particular for patients who are pregnant or breast-feeding orpaediatric Planned Exposure Situations. Medical Exposure

  30. Justification of medical exposures Planned Exposure Situations. Generic safety requirements

  31. Justification of medical exposures • Any radiological procedure on an asymptomatic individual that is intended to be performedfor the early detection of disease, but not as part of an approved health screening programme, shallrequire specific justification for that individual by the radiological medical practitioner and thereferring medical practitioner, in accordance with the guidelines of relevant professional bodies or thehealth authority. Planned Exposure Situations. Medical Exposure

  32. Optimization of protection and safety • Registrants and licensees and radiological medical practitioners shall ensure that protection andsafety is optimized for eachmedical exposure. Planned Exposure Situations. Medical Exposure

  33. Optimization of protection and safety Design considerations: • Registrants and licensees, in cooperation with suppliers, shall ensure that medicalradiological equipment, and software that could influence the delivery of medical exposure is usedonly if it conforms to the applicable standards of the International Electrotechnical Commission andthe International Organization for Standardization or to national standards adopted by the regulatory body. Planned Exposure Situations. Medical Exposure

  34. Optimization of protection and safety Operational considerations: • For diagnostic radiological procedures and image guided interventional procedures, theradiological medical practitionershall ensure that the following are used: • (a) Appropriate medical radiological equipment and software and also, for nuclear medicine, appropriate radiopharmaceuticals; Planned Exposure Situations. Medical Exposure

  35. Optimization of protection and safety Operational considerations: • For diagnostic radiological procedures and image guided interventional procedures, theradiological medical practitionershall ensure that the following are used: • (b) Appropriate techniques and parameters to deliver a medical exposure of the patient that is theminimum necessary to fulfil the clinical purpose of the procedure. Planned Exposure Situations. Medical Exposure

  36. Optimization of protection and safety Operational considerations: • For therapeutic radiological procedures, the radiological medical practitioner, in cooperationwith the medical physicist and the medical radiation technologist, shall ensure that for each patient theexposure of volumes other than the planning target volume is kept as low as reasonably achievableconsistent with delivery of the prescribed dose to the planning target volume within the required tolerances. Planned Exposure Situations. Medical Exposure

  37. Optimization of protection and safety Operational considerations: • For therapeutic radiological procedures in which radiopharmaceuticals are administered, theradiological medical practitioner shall ensure that for eachpatient the appropriate radiopharmaceuticalwith the appropriate activity is selected and administeredso that the radioactivity is primarily localized in the organ(s) of interest, while the radioactivity in therest of the body is kept as low as reasonably achievable. Planned Exposure Situations. Medical Exposure

  38. Optimization of protection and safety Operational considerations: • Registrants and licensees shall ensure that the particular aspects of medical exposures areconsidered in the optimization process for: • (a) Paediatric patients subject to medical exposure; • (b) Individuals subject to medical exposure as part of a health screening programme; • (c) Volunteers subject to medical exposure as part of a programme of biomedical research; Planned Exposure Situations. Medical Exposure

  39. Optimization of protection and safety Operational considerations: • Registrants and licensees shall ensure that the particular aspects of medical exposures areconsidered in the optimization process for: • (d) Relatively high doses to the patient; • (e) Exposure of the embryo or fetus, in particular for radiological procedures in which theabdomen or pelvis of the pregnant woman is exposed to the useful radiation beam or couldotherwise receive a significant dose; Planned Exposure Situations. Medical Exposure

  40. Optimization of protection and safety Operational considerations: • Registrants and licensees shall ensure that the particular aspects of medical exposures areconsidered in the optimization process for: • (f) Exposure of a breast-fed infant as a result of a female patient undergoing a radiological procedure with radiopharmaceuticals. Planned Exposure Situations. Medical Exposure

  41. Optimization of protection and safety Calibration: • The medical physicist shall ensure that: • (a) All sources giving rise to medical exposure are calibrated in terms of appropriate quantitiesusing internationally accepted or nationally accepted protocols; • (b) Calibrations are carried out at the time of commissioning a unit prior to clinical use, after anymaintenance procedure that could affect the dosimetry and at intervals approved by theregulatory body; Planned Exposure Situations. Medical Exposure

  42. Optimization of protection and safety Calibration: Planned Exposure Situations. Medical Exposure

  43. Optimization of protection and safety • Calibration • The medical physicist shall ensure that: • (c) Calibrations of radiotherapy units are subject to independent verification prior to clinical use; • (d) Calibration of all dosimeters used for dosimetry of patients and for the calibration of sources istraceable to a standards dosimetry laboratory. Planned Exposure Situations. Medical Exposure

  44. Optimization of protection and safety Dosimetry of patients: • Registrants and licensees shall ensure that dosimetry of patients is performed anddocumented by or under the supervision of a medical physicist, including dosimetry to determine the following: • (a) For diagnostic medical exposures, typical doses to patients for common radiological procedures; Planned Exposure Situations. Medical Exposure

  45. Optimization of protection and safety Dosimetry of patients • Registrants and licensees shall ensure that dosimetry of patients is performed anddocumented by or under the supervision of a medical physicist, including dosimetry to determine the following: • (b) For image guided interventional procedures, typical doses to patients; Planned Exposure Situations. Medical Exposure

  46. Optimization of protection and safety • Dosimetry of patients • Registrants and licensees shall ensure that dosimetry of patients is performed anddocumented by or under the supervision of a medical physicist, including dosimetry to determine the following: • (c) For therapeutic medical exposures, absorbed doses to the tissues or organs for individualpatients, to be relevant by the radiological medical practitioner. Planned Exposure Situations. Medical Exposure

  47. Optimization of protection and safety Diagnostic reference levels • Registrants and licensees shall ensure that: • (a) Local assessmentsare made atapproved intervals for those radiological procedures for which diagnostic reference levels have been established; Planned Exposure Situations. Medical Exposure

  48. Optimization of protection and safety Chest AP Diagnostic reference levels Hospital Planned Exposure Situations. Medical Exposure

  49. Optimization of protection and safety • Diagnostic reference levels • Registrants and licensees shall ensure that: • (b) A review is conducted to determine whether the optimization of protection and safety forpatients is adequate, or whether corrective action is required if, for a given radiological procedure: • 1. typical doses or activities exceed the relevant diagnostic reference level; or Planned Exposure Situations. Medical Exposure

  50. Optimization of protection and safety • Diagnostic reference levels • Registrants and licensees shall ensure that: • (b) A review is conducted to determine whether the optimization of protection and safety forpatients is adequate, or whether corrective action is required if, for a given radiological procedure: • 2. typical doses or activities fall substantially below the relevant diagnostic reference leveland the exposures do not provide useful diagnostic information or do not yield theexpected medical benefit to the patient. Planned Exposure Situations. Medical Exposure

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