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  1. IAEA Training Material on Radiation Protection in Nuclear Medicine Part 6 Medical Exposure Protection of the Patient

  2. Objective To become familiar with the BSS detailed requirement for medical exposure in nuclear medicine: responsibilities, justification, optimization, guidance level, dose constraints accidental exposure and medical records Part 6. Medical Exposure

  3. Contents • Introduction • Responsibilities • Justification • Optimization of examination • Guidance levels of activity • Dose constraints • Examination of children, pregnant women and lactating women • Records • Local rules Part 6. Medical Exposure

  4. Part 6. Medical ExposureProtection of the Patient IAEA Training Material on Radiation Protection in Nuclear Medicine Module 6.1. Introduction

  5. Medical Exposure(Definition) “Exposure incurred by patients as part of their own medical or dental diagnosis or treatment; by persons, other than those occupationally exposed, knowingly while voluntarily helping in the support and comfort of patients; and by volunteers in a programme of biomedical research involving their exposure.” Part 6. Medical Exposure

  6. Protection of the patient Part 6. Medical Exposure

  7. Protection of comforters and visitors Part 6. Medical Exposure

  8. Protection from What? • Unnecessary examination or treatment (justification) • Unnecessary exposure (optimization) • Inadequate examinations, which can lead to incorrect or incomplete diagnosis (optimization) Part 6. Medical Exposure

  9. Mr. Sharp, I am given to understand that 2 bone scans and a cardiac study done on me have given me 22 mSv whereas 20 mSv is the safe dose. I want to file legal suit against the doctor. What do you feel?? Part 6. Medical Exposure

  10. Medical Exposure versus Occupational Part 6. Medical Exposure

  11. My resident doctor has got 12 mSv in her last badge report as she was wearing the badge while getting her barium study. She wants off from radiation work. ????? Part 6. Medical Exposure

  12. Medical Exposure versus Occupational Exposure Part 6. Medical Exposure

  13. While caring for his spouse Mr. Joseph got 2 mSv. As a member of the public with 1 mSv dose limit, he can not get any radiation dose this year. ??????? Part 6. Medical Exposure

  14. MedicalExposure(BSS: InterimEdition) • Responsibilities • Justification of medical exposure • Optimization of protection for medical exposure • Guidance levels • Dose constraints • Maximum activity for patients in therapy on discharge from hospital • Investigation of accidental medical exposures • Records Part 6. Medical Exposure

  15. Part 6. Medical ExposureProtection of the Patient IAEA Training Material on Radiation Protection in Nuclear Medicine Module 6.2. Responsibilities

  16. Responsibilities: BSS (2011) • “3.149. The regulatory body shall ensure that the authorization for medical exposures to be performed at a particular medical radiation facility allows personnel (radiological medical practitioners, medical physicists, medical radiation technologists and any other health professionals with specific duties in relation to the radiation protection of patients) to take on the responsibilities specified in these Standards only if they: • (a) are specialized in the appropriate area; • (b) meet the respective requirements for education, training and competence in radiation protection, • (c) are named in a list maintained up to date by the registrant or licensee.” Part 6. Medical Exposure

  17. Responsibilities: BSS (2011) contd. • “3.150. Registrants and licensees shall ensure that no patient, whether symptomatic or asymptomatic, undergoes a medical exposure unless: • The radiological procedure has been requested by a referring medical practitioner and information on the clinical context has been provided, or it is part of an approved health screening programme; • (b) The medical exposure has been justified through consultation between the radiological medical practitioner and the referring medical practitioner, as appropriate, or it is part of an approved health screening programme; • (c) A radiological medical practitioner has assumed responsibility for protection and safety in the planning and delivery of the medical exposure; • (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 the radiation risks.” Part 6. Medical Exposure

  18. Responsibilities: BSS (2011) contd. • “3.153. Registrants and licensees shall ensure that: • (a) The radiological medical practitioner performing or overseeing the radiological procedure has assumed responsibility for ensuring overall protection and safety for patients during the planning and delivery of the medical exposure, including the justification of the procedure as required in paras 3.154–3.160 and the optimization of protection and safety, in cooperation with the medical physicist and the medical radiation technologist as required in paras 3.161–3.176; • (b) Radiological medical practitioners, medical physicists, medical radiation technologists and other health professionals with specific duties in relation to protection and safety for patients in a given radiological procedure have the appropriate specialization; • (c) Sufficient medical personnel and paramedical personnel are available as specified by the health authority;” • . *Interim version of revised BSS Part 6. Medical Exposure

  19. Responsibilities: BSS (2011) contd. • “(d) For therapeutic uses of radiation, the requirements of these Standards for calibration, dosimetry and quality assurance, including the acceptance and commissioning of medical radiological equipment, as specified in paras 3.166, 3.167(c), 3.169 and 3.170, are fulfilled by or under the supervision of a medical physicist; • (e) For diagnostic radiological procedures and image guided interventional procedures, the requirements of these Standards for medical imaging, calibration, dosimetry and quality assurance, including the acceptance and commissioning of medical radiological equipment, as specified in paras 3.166, 3.167(a), 3.167(b), 3.168, 3.169 and 3.170, are fulfilled by or under the supervision 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; • (f) Any delegation of responsibilities by a principal party is documented.” Part 6. Medical Exposure

  20. How to apply this in nuclear medicine? Part 6. Medical Exposure

  21. FACTORS AFFECTINGMEDICAL EXPOSURE Request Examination or treatment Biomedical research Patient identification and information Administration of radiopharmaceutical Examination Treatment Child ? Lactating woman ? Pregnant woman ? Safe preparation of prescribed radio- pharmaceutical and activity Dose constraints Method Quality of equip-ment Correct use of equipment Dose constraints to comforters and visitors Accidental medical exposure Who is responsible? Part 6. Medical Exposure

  22. RESPONSIBILITY STRUCTURE Licensee/Hospital management Optimization of medical exposure through organization and resources Nuclear Medicine Department Referring physician Optimization of medical exposure through well educated personnel with clearly defined responsibilities NM specialist Qualified expert NM technologist Nurse Engineer Radiopharmacist Justification of medical exposure Part 6. Medical Exposure

  23. Referring Physician • Prescribe and justify diagnostic procedures and therapy in writing in co-operation with the nuclear medicine specialist Part 6. Medical Exposure

  24. Administrative Manager • Appoint the necessary personnel and ensure the individuals • have the necessary education to perform their duties. • Establish a radiation protection programme and provide the • necessary resources. • Assign clear responsibilities for personnel. • Appoint a Radiation Protection Officer. • Establish a comprehensive QA programme. • Support education and training of personnel. Part 6. Medical Exposure

  25. Nuclear Medicine Staff • Individuals with key positions, i.e., responsibilities for protection and safety and those who could substantially affect protection and safety by virtue of tasks involving operation or manipulation of sources, or equipment which could lead to an accidental exposure should have documented evidence of education and training. The objective is to ensure that only qualified personnel fill such positions. In nuclear medicine, these individuals are: • Nuclear medicine physicians • Qualified experts in nuclear medicine physics (medical physicists) • Other health professionals in nuclear medicine (radiopharmacists, nuclear medicine technologists, nurses,…) • Radiation Protection Officer Part 6. Medical Exposure

  26. Personal Authorization • To obtain the personal authorization, the nuclear medicine staff should comply with the following requirements: • university degree or equivalent relevant to the profession by the competent education authorities as required in the country; • accreditation to exercise the profession granted by the competent authorities or institutions as required in the country; • course on radiation protection for which the contents, the methodology and the teaching institution are approved by the Regulatory Authority. This course may be integrated in the curricula of the professional education; and • on the job training supervised by professionals with authorization by the Regulatory Authority. Part 6. Medical Exposure

  27. Nuclear Medicine Specialist • Ensure overall patient protection and safety; • provide consultation and clinical evaluation of patients • ensure that the exposure of patients be the minimum required to achieve the intended objective; • take into account relevant information from previous examinations in order to avoid unnecessary additional examinations; • take into account the relevant guidance levels for medical exposure; • determine dose prescription for therapy in consultation with the medical physicist; and • provide evaluation of any radiation incident and accident from medical point of view. Part 6. Medical Exposure

  28. Medical Physicist • Participate in continuing review of the nuclear medicine practice’s resources (including budget, equipment, and staffing), operations, and policies and procedures; • Develop requirements and specifications for the purchase of appropriate equipment assuring radiation safety; • Plan in conjunction with the nuclear medicine physician the facilities for nuclear medicine practice; • Carry out acceptance testing; • Establish dose calculation procedures in nuclear medicine therapy; • Establish and implement QA procedures in nuclear medicine; • Supervise equipment maintenance; • Investigate and evaluate incidents and accidents. Part 6. Medical Exposure

  29. Nuclear Medicine Technologist • Patient identification; • Patient information; • Information to accompanying persons and staff nursing a patient after a nuclear medicine examination or therapy; • Verifying that the female patient is non-pregnant; • Assure that a mother in lactation is given information about discontinuation of nursing; • Make the calculation of administered activity to a child according to the local rules; • Verify the administered radiopharmaceutical and its activity; • Perform regular quality control of activity meter and other relevant equipment; • Perform regular workplace monitoring; • Correct handling of the equipment and safety accessories; • Inform the RPO in the case of accident or incident; • Inform the Nuclear Medicine Physician in the case of misadministrations; • Participate in education and training of new personnel. Part 6. Medical Exposure

  30. Part 6. Medical ExposureProtection of the Patient IAEA Training Material on Radiation Protection in Nuclear Medicine Module 6.3. Justification

  31. Justification Although Nuclear Medicine is a justified diagnostic tool a case-by-case justification shall be applied. This is the responsibility of the referring physician in co-operation with the nuclear medicine specialist and other specialists in diagnostic imaging, taking relevant guidelines into account. Part 6. Medical Exposure

  32. Justification :BSS (2011) Relevant parties shall ensure that medical exposures are justified: “3.154. Medical exposures shall be justified by weighing the expected diagnostic or therapeutic benefits that they yield against the radiation detriment that they might cause, with account taken of the benefits and the risks of available alternative techniques that do not involve medical exposure. 3.155. 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.” Part 6. Medical Exposure

  33. Justification: BSS (2011) Contd… • “3.156. The justification of medical exposure for an individual patient shall be carried out through consultation between the radiological medical practitioner and the referring medical practitioner, as appropriate, with account taken, in particular for patients who are pregnant or breast-feeding or paediatric, of: • (a) The appropriateness of the request; • (b) The urgency of the procedure; • (c) The characteristics of the medical exposure; • (d) The characteristics of the individual patient; • Relevant information from the patient’s previous radiological procedures. • 3.157. Relevant national or international referral guidelines shall be taken into account for the justification of the medical exposure of an individual patient in a radiological procedure.” Part 6. Medical Exposure

  34. Justification: BSS (2011) contd.. “3.158. Justification for radiological procedures to be performed as part of a health screening programme for asymptomatic populations shall be carried out by the health authority in conjunction with appropriate professional bodies. 3.159. Any radiological procedure on an asymptomatic individual that is intended to be performed for the early detection of disease, but not as part of an approved health screening programme, shall require specific justification for that individual by the radiological medical practitioner and the referring medical practitioner, in accordance with the guidelines of relevant professional bodies or the health authority. As part of this process, the individual shall be informed in advance of the expected benefits, risks and limitations of the procedure.” Part 6. Medical Exposure

  35. Justification: BSS (2011) contd… “ 3.160. The medical exposure of volunteers as part of a programme of biomedical research is deemed to be not justified unless: • (a) It is in accordance with the provisions of the Helsinki Declaration [20] and takes into account the guidelines published by the Council for International Organizations of Medical Sciences [21], together with the recommendations of the ICRP [22]; • (b) It is subject to approval by an ethics committee (or other institutional body that has been assigned similar functions by the relevant authority), subject to any dose constraints that may be specified (as required in paras 3.148(a)(ii) and 3.173), and subject to applicable national regulations and local regulations.” Part 6. Medical Exposure

  36. Part 6. Medical ExposureProtection of the Patient IAEA Training Material on Radiation Protection in Nuclear Medicine Module 6.4. Optimization of Examination

  37. Otimization ofPatient Examination Diagnostic Objective Medical Exposure Part 6. Medical Exposure

  38. Optimization of Medical Exposure in Nuclear Medicine “3.162. For diagnostic radiological procedures and image guided interventional procedures, the radiological medical practitioner, in cooperation with the medical radiation technologist and the medical physicist, and if appropriate with the radiopharmacist or radiochemist , shall ensure that the following are used: • (a) Appropriate medical radiological equipment and software and also, for nuclear medicine, appropriate radiopharmaceuticals; • (b) Appropriate techniques and parameters to deliver a medical exposure of the patient that is the minimum necessary to fulfil the clinical purpose of the procedure, with account taken of relevant norms of acceptable image quality established by relevant professional bodies and relevant diagnostic reference levels established in accordance with paras 3.147 and 3.168.” Part 6. Medical Exposure

  39. Optimization contd... “3.163. For therapeutic radiological procedures, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, shall ensure that for each patient the exposure of volumes other than the planning target volume is kept as low as reasonably achievable consistent with delivery of the prescribed dose to the planning target volume within the required tolerances. 3.164. For therapeutic radiological procedures in which radiopharmaceuticals are administered, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, and if appropriate with the radiopharmacist or radiochemist, shall ensure that for each patient the appropriate radiopharmaceutical with the appropriate activity is selected and administered so that the radioactivity is primarily localized in the organ(s) of interest, while the radioactivity in the rest of the body is kept as low as reasonably achievable.” Part 6. Medical Exposure

  40. Optimization contd... “3.165. Registrants and licensees shall ensure that the particular aspects of medical exposures are considered 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; • (d) Relatively high doses to the patient; • (e) Exposure of the embryo or fetus, in particular for radiological procedures in which the abdomen or pelvis of the pregnant woman is exposed to the useful radiation beam or could otherwise receive a significant dose; • (f) Exposure of a breast-fed infant as a result of a female patient undergoing a radiological procedure with radiopharmaceuticals. Part 6. Medical Exposure

  41. Optimization of Medical Exposure Radionuclide Biokinetics Patient Administered activity Effective dose Quality of equipment etc Radiation risk Image quality Part 6. Medical Exposure

  42. Radiopharmaceuticals • Considering that, according to the BSS, the activities listed below also require authorization, regulatory authorities may require the licensee of a nuclear medicine practice to contract any of the following services only to enterprises authorized by the Regulatory Authority: • production, import, distribution, sale or transfer of radioactive sources • personal monitoring • installation, maintenance of nuclear medicine equipment • disposal of radioactive sources Use only radiopharmaceuticals from an authorized manufacturer! Part 6. Medical Exposure

  43. Radiopharmaceuticals If more than one radiopharmaceutical can be used for a procedure consideration should be given to physical, chemical and biological properties. Example: Leucocytes labelled with In-111Tc-99m 0.36 mSv/MBq 0.011 mSv/MBq 20 MBq 7.2 mSv 200 MBq  2.2 mSv T1/2 = 2.8 days T1/2 = 6 hours Part 6. Medical Exposure

  44. Radiopharmaceuticals Tl-201 Tc-99m 25 mSv 8 mSv Part 6. Medical Exposure

  45. Optimization of Image Quality Image quality depends on: • Administered activity • Technical factors - equipment used - acquisition protocol - image processing & evaluation - noise - spatial resolution - scatter • Patient factors - size - age - disease - movement Part 6. Medical Exposure

  46. Optimization of Administered Activity In general, doses should be maintained as low as reasonable achievable but high enough to obtain the desired diagnostic information. This means that exposures above clinically acceptable maximum doses must be avoided as well as doses below clinically acceptable minimum doses Part 6. Medical Exposure

  47. Optimization of Administered Activity Value of diagnostic information There is a threshold below which no useful information can be expected Above this threshold the diagnostic quality increases steeply with the administered activity Once an acceptable level has been reached further increase of activity will not improve the result (ICRP 52) Administered activity Part 6. Medical Exposure

  48. Administered Activity to Children Optimization is Necessary! Administered activity to children referred to DMSA scan in Swedish hospitals Part 6. Medical Exposure

  49. …..noting the special requirements for patients with impairment of Organ Function normal partially obstructed totally obstructed function outflow outflow Part 6. Medical Exposure

  50. Optimization • (ii) use of methods for blocking the uptake in organs not under study and for accelerated excretion when applicable; • Blocking agents for thyroid • Hydration and frequent voiding of the urinary bladder • Laxatives • Catheterisation to empty the bladder??? • Cholecystokinin (fatty meal) for gallbladder emptying Part 6. Medical Exposure