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Specific Regulation Release of Patients after Diagnostic or Therapeutic Procedures with Radionuclides, or with Implanted Brachytherapy Radiation Sources

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Section 1

Section 2

Section 3

Brachytherapy

Brachytherapy is a form of a local radiation therapy where a sealed radiation source (seed, ribbon, or capsule) is placed permanently or temporarily inside the patient body, in or next to the tumour.

Brachytherapy implant

A sealed radiation source which is implanted into a tissue for brachytherapy purposes.

Carers and Comforters

Persons who willingly and voluntarily help (other than in their occupation) in the care, support and comfort of patients undergoing radiological procedures for medical diagnosis or medical treatment.

Dose constraint

A prospective and radiation source related value of individual dose that is used in planned exposure situations as a parameter for the optimization of protection and safety for the source, and that serves as a boundary in defining the range of options in optimization.

Most exposed person

The person who is not considered as carer or comforter and is expected to be most exposed to radiation due to its presence close to a released patient.

Patient (For the purposes of this specific regulation)

An individual who has undergone a diagnostic or therapeutic procedure with radionuclides, or the implantation of brachytherapy sources.

Radioactivity Concentration

The activity per unit mass or volume of the material, in which the radionuclides are essentially uniformly distributed.

Radiological procedure

A medical imaging procedure or therapeutic procedure, that involves ionizing radiation, such as a procedure in diagnostic radiology, nuclear medicine or radiation therapy, or a planning procedure, image guided interventional procedure or other interventional procedure involving radiation delivered by a radiation generator, a device containing a sealed source or an unsealed source, or by means of a radiopharmaceutical administered to a patient.

Radionuclide therapy

The administration of radionuclide to a patient for therapeutic purposes.

Radiopharmaceutical

Biologically active molecules labelled by radionuclides applied in nuclear medicine diagnostic and therapeutic procedures.

Release of patients

The authorization given to patients to leave a medical facility or a biomedical research facility after the administration of radionuclides or the implantation of brachytherapy sources for diagnostic, therapeutic or biomedical research purposes.

Retained Body Activity (RBA)

The fraction of the radionuclide activity administered to a patient for diagnostic or therapeutic purposes that remains in the whole body at a given time.

Third person

A person who might be exposed to radiation due to its presence close to a released patient without being a carer or comforter, of this patient.

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Section 4

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7. The authorized person shall ensure that before any decision about the release of patients the following parameters have been discussed with them (or their caregiver):

a. The type of post-diagnosis/therapy accommodation/destination (e.g., family home, single home, hotel, etc.);

b. Their travel plan (e.g., private car, taxi, train, border crossing, boats, public transportation);

c. Their preference to travel alone or with other individuals.

d. The household members (infant, pregnant woman, children, etc.);

e. Their ability to delay returning to work; and

f. Their ability to keep a distance from others (household members, children, pregnant woman).

8. The authorized person shall provide patients with appropriate instructions, as indicatively presented in Appendix III to ensure that the dose constraints of Appendix IV will not be exceeded.

9. The authorized person shall ensure that patients have formally confirmed by signing a proof document before their release that they have acknowledged the following:

a. The provision of instructions as indicatively presented in Appendix III.

b. The period after their release during which the instructions under a) shall be followed, as indicatively presented in Appendix V.

c. The receipt of a clear explanation of the procedure.

d. The provision of information on the consequences of failure to follow the instructions.

e. The provision of information of the need to limit exposure to others, especially to young children and pregnant women, and on how long they must exercise special care.

f. The possibility to trigger the alarm of radiation detectors at airports, train stations, border patrol checkpoints, interior highway checkpoints, and other areas where there is a radiation detection system, and the need to present the information card in this case.

g. The provision of an information card as defined in article 7.

10. The authorized person shall ensure that released patients, have been provided with an information card including, at least, the information presented in Appendix VI.

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