1. Planned Exposure Situations Medical Exposure – Part 3 (GSR Part 3)
2016 School on Drafting Regulations. Radiation Safety Stream. IAEA Regional Workshop Vienna, Austria 8 – 19 August 2016
Module 1.5
Planned Exposure Situations
Medical Exposure – Part 3
(GSR Part 3)
Simone Kodlulovich Renha

2. Contents Requirement 39: Pregnant or breast-feeding female patients
Requirement 40: Release of patients after radionuclide therapy
Requirement 41: Unintended and accidental medical exposures
Requirement 42: Reviews and records

3. Req. 39: Pregnant or breast-feeding female patients
Req. 39: Pregnant or breast-feeding female patients. Registrants and licensees shall ensure that:
There are arrangements in place for appropriate radiation protection in cases where a female patient:
is or might be pregnant or
is breast-feeding.

4. Req. 39: Pregnant or breast-feeding female patients
Req. 39: Pregnant or breast-feeding female patients. Registrants and licensees shall ensure that:
Signs
is breast-feeding:
in case of radiopharmaceutical administration
is or might be pregnant
Communication
Patient notify
In appropriate languages
Public areas:
waiting rooms and cubicles
3.175

6. Pregnant women and breast-feeding women

7. Req. 39: Pregnant or breast-feeding female patients
Req. 39: Pregnant or breast-feeding female patients. Registrants and licensees shall ensure that:
There are procedures in place for ascertaining the pregnancy status of a female patient of reproductive capacity before the performance of any radiological procedure that could result in a significant dose to the embryo or fetus. This information can be considered in the justification for the radiological procedure and in the optimization of protection and safety
3.176, and 3.156,

8. Registrants and licensees: Female patient is or might be pregnant?
Procedures:
Patients who are to undergo x-ray examination of the abdomen, pelvis, lower spine, etc, should be asked whether they are pregnant or if there is a possibility that they might be pregnant. ?
Embarazada
If yes, the responsible medical practitioner should determine if the examination can be safely deferred.
If no, standard protective measures should nevertheless be applied x

9. Registrants and licensees: Female patient is or might be pregnant?
Confirmation of the pregnancy status before the radiological procedure
Justification: radiologist and medical referee should decide if the procedure should be done and consider alternative imaging modalities
Optimization of protection and safety:
Shielding if possible and adjust the technical factors
pregnancy status ?
Embarazada
reproductive capacity
3.176, 3.155, 3.156, 3.166)

10. Flow diagram shows the recommended imaging algorithm for urolithiasis evaluations in pregnant women.
Verify first the possibility of alternative exams
that do not use ionizing radiation
Figure 4.  Flow diagram shows the recommended imaging algorithm for urolithiasis evaluations in pregnant women.
McCollough C H et al. Radiographics 2007;27:

11. Female patient pregnant: NM diagnostic procedures
NM examination in pregnancy is permitted.
Pregnancy need not be considered a contradiction for NM procedures, in particular diagnostic ones involving short lived radionuclides, provided there are strong clinical justifications and effort has been made to explore alternatives involving non-ionizing radiation.
IAEA -RPOP

12. Female patient pregnant, NM diagnostic procedures: Actions and precautions
Since radionuclides in maternal tissues contribute to foetal dose: maternal hydration and frequent voiding, can reduce the foetal dose after the administration of a number of radiopharmaceuticals.
Irradiation of the foetus results from: placental transfer and distribution of radiopharmaceuticals in the foetal tissues; from external irradiation from radioactivity in the mother's organs and tissues. Physical, chemical, and biological properties of the radiopharmaceuticals are the critical factors in possible placental transfer.
Using smaller administered activities and longer imaging times can reduce the absorbed dose to the foetus. This is feasible if the patient is not too sick and is able to remain still. Occasionally, the sequence of examinations and choice of radiopharmaceutical can be adjusted to reduce radiation dose.

13. Considerations may include terminating the pregnancy.
Female patient pregnant: NM diagnostic procedures: NM radionuclides therapy
Pregnant woman should not be treated with a radioactive substance unless the radionuclide therapy is required to save her life: in that extremely rare event, the potential absorbed dose and risk to the foetus should be estimated and conveyed to the patient and the referring physician.
Considerations may include terminating the pregnancy.
IAEA RPOP

14. Female patient pregnant: NM radionuclides therapy
Radioiodine therapy is essentially contra-indicated in pregnant patients.
If radioiodine treatment of thyroid carcinoma is to be performed, it should be delayed until after delivery.
And the physician should also be aware that radioiodine is excreted in breast milk and breast-feeding should be stopped completely after a therapeutic dose. If this is not done the infant may become permanently hypothyroid or be at high risk for subsequent thyroid cancer.
IAEA RPOP

15. Req. 39: Pregnant or breast-feeding female patients
Req. 39: Pregnant or breast-feeding female patients. Registrants and licensees shall ensure arrangements for:
Female patient is not currently breast-feeding before the performance of any radiological procedure involving the administration of a radiopharmaceutical that could result in a significant dose to a breastfed infant, so that this information can be considered in the justification for the radiological procedure and in the optimization of protection and safety.
3.177, 3.155, 3.157, 3.166)

16. Can a patient who is breastfeeding a baby continue to do so?
Depends on: radiopharmaceutical and activity.
Before administering a radiopharmaceutical, an inquiry should be made and consideration should be given as to whether:
the test could reasonably be delayed until after the mother has ceased breastfeeding; and
the most appropriate choice of radiopharmaceutical has been made bearing in mind the secretion of activity in breast milk.
To minimize potential irradiation of a breastfed child, advisory notices should be posted within the NM department asking patients to inform the staff if they are breastfeeding.
This image shows the uptake of pertechnetate in the breast of a lactating women scheduled for a thyroid scan. The activity in the breasts is about 50% of the administered. The thyroid has an uptake of 1-2%.
Gamma camera image of a lactating woman who received 99mTc-pertechnetate for a thyroid examination

17. Pregnant women and breast-feeding women
breast feeding is to be totally avoided after 131I administration for therapeutic purpose!!!!!!!
Guidelines from ICRP 84: recommended periods of interruption for breastfeeding as examples of good practice
3 weeks
12 h
4 hours
after 125I radiopharmaceuticals except labelled hippurate, and after 22Na, 67Ga and 201Tl;
after iodine-labelled hippurates and 99mTc compounds,
except labelled red blood cells, -phosphonates and -DTPA;
after 99mTc compounds labelled red blood cells, -phosphonates and -DTPA;

18. Female patient pregnant, NM diagnostic procedures: Actions and precautions
If more than one radiopharmaceutical can be used for a procedure, consider: the physical, chemical and biological properties of each radiopharmaceutical so as to minimize the organ doses to the relevant tissues and other risks to the patient while at the same time providing the desired diagnostic information.
The user also has the obligation to use only licensed producers of radiopharmaceuticals, who can guarantee that the production is according to good manufacturing practice and complies with relevant international standards.
Left: Tl-201 myocardial scan (25 mSv)
Right: Tc-99m compound scan (8 mSv)..

19. Req. 40: Release of patients after radionuclide therapy
Registrants and licensees shall ensure that there are arrangements in place to ensure appropriate radiation protection for members of the public and for family members before a patient is released following radionuclide therapy.
The radiological medical practitioner shall ensure that no patient who has undergone a therapeutic radiological procedure with a sealed source or an unsealed source is discharged from a medical radiation facility until it has been established by either a medical physicist or the facility’s radiation protection officer that:

20. Req. 40: Release of patients after radionuclide therapy
(a) The activity of radionuclides in the patient is such that doses that could be received by members of the public and family members would be in compliance with the requirements set by the relevant authorities (b) The patient or the legal guardian of the patient is provided with: (i) Written instructions for keeping doses to persons in contact with or in the vicinity of the patient as low as reasonably achievable and for avoiding the spread of contamination; (ii) Information on the radiation risks.
3.149(b)

21. Req. 41: Unintended and accidental medical exposures: Registrants and licensees shall ensure that:
all practicable measures are taken to minimize the likelihood of unintended or accidental medical exposures.
promptly investigate unintended or accidental medical exposures and, if appropriate, shall implement corrective actions.
MODIFIED

22. Req. 41: Unintended and accidental medical exposures:
Registrants and licensees, in accordance with the relevant requirements shall ensure that:
all practicable measures are taken to minimize the likelihood of unintended or accidental medical exposures arising from flaws in design and operational failures of medical radiological equipment, from failures of and errors in software, or as a result of human error.
2.51, 3.41–3.42 and 3.49–3.50

23. Investigation of unintended and accidental medical exposures
Investigation of unintended and accidental medical exposures. Registrants and licensees shall promptly investigate any of the following unintended or accidental medical exposures
medical treatment
DR or image guided interventional procedure
wrong individual
wrong tissue or organ
wrong radiopharmaceutical
Any exposure for diagnostic purposes or from an image guided interventional that is substantially greater than was intended
an activity, a dose or dose fractionation differing substantially from the values prescribed or that could lead to unduly severe secondary effects
Any inadvertent exposure of the embryo or fetus in the course of performing a radiological procedure
Any failure of equipment, software or system, or accident, error, mishap or other unusual occurrence – exposure greater them was intended
MODIFIED

24. Investigation of unintended and accidental medical exposures.
(a) Estimate the doses received and the dose distribution within the patient; (b) Indicate the corrective actions to prevent the recurrence of such an unintended or accidental medical exposure; (c) Implement all the corrective actions that are under their own responsibility; (d) Produce and keep, as soon as possible after the investigation or as otherwise required by the regulatory body, a written record that states the cause of the unintended or accidental medical exposure and includes the information specified in (a)–(c) above, as relevant, and any other information as required by the regulatory body; and for significant unintended or accidental medical exposures or as otherwise required by the regulatory body, submit this written record, as soon as possible, to the regulatory body, and to the relevant health authority if appropriate; (e) Ensure that the appropriate radiological medical practitioner informs the referring medical practitioner and the patient or the patient’s legal authorized representative of the unintended or accidental medical exposure.

25. Req. 42: Reviews and records
Registrants and licensees shall ensure that radiological reviews are performed periodically at medical radiation facilities and that records are maintained.
Registrants and licensees shall ensure that radiological reviews:
are performed periodically by the radiological medical practitioners at the medical radiation facility, in cooperation with the medical radiation technologists and the MP
shall include: an investigation and critical review of the current practical application of the radiation protection principles of justification and optimization for the radiological procedures that are performed in the medical radiation facility.
3.182

26. Reviews and records: Registrants and licensees shall maintain the following personnel records:
(a) Records of any delegation of responsibilities by principal parties; (b) Records of training of personnel in radiation protection.

27. Reviews and records: Registrants and licensees shall maintain
Records of calibration, dosimetry and QA:
Records of the results of the calibrations and periodic checks of the relevant physical and clinical parameters selected during treatment of patients;
Records of dosimetry of patients;
Records of local assessments and reviews made with regard to diagnostic reference levels;
Records associated with the QA programme.

28. Registrants and licensees shall maintain the following records for medical exposure:
DR: information necessary for retrospective assessment of doses, including the number of exposures and the duration of fluoroscopic radiological procedures;
Image guided interventional procedures: information necessary for retrospective assessment of doses, including the duration of the fluoroscopic component and the number of images acquired;
NM: types of radiopharmaceutical administered and their activity;

29. Registrants and licensees shall maintain the following records for medical exposure:
Radiation therapy: a description of the planning target volume, the dose to the centre of the planning target volume, and the maximum and minimum doses delivered to the planning target volume, or equivalent alternative information on doses to the planning target volume, the doses to relevant organs as selected by the radiological medical practitioner, the dose fractionation, and the overall treatment time;

30. Registrants and licensees shall maintain the following records for medical exposure:
Exposure records for volunteers subject to medical exposure as part of a programme of biomedical research;
Reports on investigations of unintended and accidental medical exposures.

31. Thank you!
Thank you!