IAEA Training Material on Radiation Protection in Nuclear Medicine

Part 8

Radiation Protection in Radionuclide Therapy

Objective
To be able to apply the principle of optimization of radiation protection to therapeutic procedures including design, operational consideration, quality control and clinical dosimetry.

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Contents
q q q q q

Basic requirements Administration of therapy The radioactive patient. Dose constraints The hospitalized patient Emergency procedures

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IAEA Training Material on Radiation Protection in Nuclear Medicine

Part 8 Optimization of Protection in Medical Exposure

Module 8.1 Basic Requirements

Justification of Medical Exposure (BSS: Interim Edition, 2011)
“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.” Use WHO guidelines
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Responsibilities (BSS: Interim Edition)
”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.”

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Dosimetry (BSS: Interim Edition)
“3.167. Registrants and licensees shall ensure that dosimetry of patients is performed and documented by or under the supervision of a medical physicist, using calibrated dosimeters and following internationally accepted or nationally accepted protocols, including dosimetry to determine the following:
s s

….. (c) For therapeutic medical exposures, absorbed doses to the tissues or organs for individual patients, as determined to be relevant by the radiological medical practitioner.”
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Medical Physicist
A qualified medical physicist should be responsible for measurement of radionuclide activity, identification of radionuclides and internal radiation dosimetry

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Absorbed Dose-Administered Activity I-131
Example of method to calculate administered activity from Prescribed absorbed dose to the thyroid
Thyroid mass (g) Prescibed dose (Gy) 30 100

Uptake measurements
Time (h) 0 2 24 48 144 Standard (cpm) 21736 18286 17165 13171 Patient (cpm) 5521 12338 10565 5754 Bg (cpm) 100 100 100 100 Uptake (%) 73,5 25,1 67,3 61,3 43,3

Activity (MBq)= 23.4*mass(g)*dose (Gy) uptake at t=0 (%)*Teff (d)

Effective half-life (d): Activity to administer (MBq):

4,0 240

Berg GEB et al, J Nucl Med 1996; 37:228-232
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Uptake Measurement

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Gamma Camera Examination

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Gamma Camera Examination

Used to determine the size of the organ

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Factors Affecting Safety in Radionuclide Therapy
Safe handling of radionuclides
• • • • • • • • •

ordering receipt and unpacking storage dispensing internal transports radioactive waste Identification pregnancy breastfeeding

Patient preparation The radioactive patient and dose constraints The hospitalized patient
•instructions to nursing staff •visitors instructions •discharge of the patient •decommissioning of hospital ward •radioactive waste

Safe administration

Emergency procedures

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Ordering, Receipt & Unpacking
•The hospital routines for ordering radionuclides should be followed. •When ordering, be sure the delivery service knows where in the hospital to deliver the material. •Make sure that the package is expected and that no unauthorized person will open it upon arrival. •Before unpacking, check the package. In case of damage, contact your RPO.

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Storage of I-131
•The radionuclide should be stored in a controlled area, according to national regulations and local rules. •The radionuclide should always be stored in a lead container and preferably in a fridge to prevent evaporation •To reach an acceptable external dose rate, a thickness of 1-4 cm lead is generally required.

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Dispensing
• Protective clothing • Lead shields (bench top shield, vial shield, syringe shield) • Keep the vial in the fume hood and on a tray with lips, lined with plastic backed absorbent pads. • Handle the vial with forceps or similar long handled instruments. • Cover the vial with lead after use. • Check the activity • Fill in the necessary records

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Internal Transport
If the administration of radiopharmaceutical to the patient takes place far from the dispensing room, use a transport container with absorbent pads. Make sure that a warning sign is on the container together with patient name, activity and date. Travel by the most direct route avoiding more heavily occupied areas

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Radioactive Waste
Shall be collected, segregated and disposed of according to national regulations and local rules.

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IAEA Training Material on Radiation Protection in Nuclear Medicine

Part 8 Optimization of Protection in Medical Exposure

Module 8.2 Administration of Therapy

Precautions Before Administration
• • •

Be prepared for an emergency situation. Careful identification of the patient (hospital routines shall be followed). Questions to the patient:
-Pregnant? -Breastfeeding? -Incontinent? -Nausea? -Living conditions? -Type of work? -Public transportation back home?

Verbal and written individual instructions to the patient.

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Pregnancy (BSS: Interim Edition)
q

“3.175. 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, so that this information can be considered in the justification for the radiological procedure (para. 3.154 and 3.156) and in the optimization of protection and safety (para. 3.165).”

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Radioiodine Therapy and Pregnancy
Radioiodine easily crosses the placenta and therapeutic doses can pose significant problems for the fetus, particularly permanent hypothyroidism.

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Radioiodine Therapy
As a rule, a pregnant woman should not be treated with a radioactive substance unless the therapy is required to save her life: in that extremely rare event, the potential absorbed dose and risk to the fetus should be estimated and conveyed to the patient and the referring physician. Considerations may include terminating the pregnancy.

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Radioiodine Therapy
In women, thyroid carcinoma comprises over 80% of cancer of the head and neck diagnosed between the ages of 15-45 years. Thyroid cancers are relatively unaggressive compared to most other cancers. As a result both surgical and radio-iodine treatment are often delayed until after pregnancy. In general, if any therapy is to be performed during pregnancy, it will be surgery during the second or third trimester.

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Inadvertent Administration of Therapy Dose
Menstrual history is often not adequate to ensure that a patient is not pregnant. In most developed countries, it is common practice to obtain a pregnancy test prior to highdose 131 I scanning or therapy for women of childbearing age unless there is a clear history of prior tubal ligation or hysterectomy precluding pregnancy. In spite of the above, it still happens that pregnant women are treated, either because of false histories or because the pregnancy is at such an early stage that the pregnancy test is not yet positive.

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Becoming Pregnant after Irradiation
• ICRP has recommended that a woman not become pregnant until the potential fetal dose from remaining radionuclides is less than 1 mGy.

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Pregnancy after Therapy
Radiopharmaceutical Au-198 colloid I-131 iodide (thyroid ca) I-131 iodide (thyrotoxicosis) I-131 MIBG P-32 phosphate Sr-89 chloride Y-90 colloid (arthritic joints) Y-90 colloid (malignancy) All activities up to (MBq) 10000 5000 800 5000 200 150 400 4000 Avoid pregnancy (months) 2 4 4 4 3 24 0 1

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Breast Feeding (BSS: Interim Edition)
q

“3.176. Registrants and licensees shall ensure that there are arrangements in place for establishing that a female patient is not breast-feeding before the performance of any radiological procedure involving the administration of a radiopharmaceutical that could result in a significant dose to an infant being breast-fed, so that this information can be considered in the justification for the radiological procedure (para. 3.154 and 3.156) and in the optimization of protection and safety (para. 3.165).”

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Breast Feeding

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Patient Information Needed:
•Nausea -intravenous administration to be considered? •Living conditions -number of people in house? -children? -separate room? •Type of work-working close to other people? -working with children? -pregnant coworkers? •Public transport -time?

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Administration of Therapy: Calibration of Sources (BSS)
“3.166. In accordance with para. 3.153(d) and (e), the medical physicist shall ensure that: s (a) All sources giving rise to medical exposure are calibrated in terms of appropriate quantities using internationally accepted or nationally accepted protocols; 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.”
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Safe Administration
• • •

I-131 should be administered in a controlled area (hot lab or the patient’s hospital bedroom). A plastic bag for contaminated items should be available as well as paper tissues. The patient is asked to sit at a table covered with adsorbent pads and the floor beneath the patient should also be covered by adsorbent pads. If the I-131 is administered in capsules they should be transferred to the patient mouth by tipping from a small shielded (>1 cm Pb) container. I-131 administered in an oral solution (50 ml) should be sucked up through a straw from the shielded vial by the patient. The vial should be flushed with water several times. The patient should drink several glasses of water to clean the mouth.

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Safe Administration

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Safe Administration
Procedure for intravenous administration:
• • • • •

Dispense the radionuclide into a shielded syringe Put the radionuclide in an infusion bottle Line the bottle to the patient using an intravenous catheter Keep the patient in bed until the bottle is empty Remove the bottle and the catheter and dispose of them as radioactive waste

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IAEA Training Material on Radiation Protection in Nuclear Medicine

Part 8 Optimization of Protection in Medical Exposure

Module 8.3 The Radioactive Patient: Dose Constraints

Shall the Patient be Hospitalized?

Can the patient leave? Any restrictions?
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Dose Constraints (BSS: Interim Edition)
“3.172. Registrants and licensees shall ensure that relevant dose constraints (para. 3.148(a) (i)) are used in the optimization of protection and safety in any procedure in which an individual acts as a carer or comforter.”

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Dose Limitation for Comforters and Visitors of Patients
..The dose shall be constrained so that it is unlikely that his or her dose will exceed 5 mSv during the period of a patient’s diagnostic examination or treatment. The dose to children visiting patients who have ingested radioactive materials should be similarly constrained to less than 1 mSv

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Exposures From Patient
Contamination saliva perspiration breath urine External

0.5

0.1

0.06

0.03 mSv/h

1000 MBq I-131 0
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0.5
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2m
39

Biodistribution of I-131

(MIRD)
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Excretion of I-131

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Contamination
Administered activity: 1000 MBq I-131

Excretion

Concentration

Contamination utensils 2 kBq surfaces 10 Bq/cm2 air 1 Bq/l toilet 2 kBq/cm2

Saliva <2 MBq/g Perspiration <20 Bq/cm2 Breathing 100 Bq/l Urine < 500 kBq/ml

Generally larger than the derived limits for contamination given by ICRP (publ 57)
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Exposures from Patient
6 μSv /h* GBq , 0 m

Sm-153

26

9

3μSv/h* GBq

0 3 μSv /h* GBq , 0 m

0,5

1m

Activity concentration in urine: 0.3 MBq/ml*GBq
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External Exposure from Patient Sm-153
Dose rate at 0.5 m
10

Mean dose rate (µSv/h*GBq)

8

6

4

2

0 0 1 2 3 4 5

Time after injection (h)

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Restrictions
Patient with Iodine-131
Activity of I-131 administered (MBq) 30-200 200-400 400-600 600-800 Behaviour restriction Period of restrictions (d) Stay at least 1 metre away from all members 5 9 12 14
of the household except for very brief periods (a few minutes every day) Restrict close contact (“cuddling” with all members of the household to less than 15 minutes per day, and sleep separately from them Sleep separately from “comforters and cares”

15 -

21 -

25 4 -

27 8 1

Avoid prolonged close contact (more than 3 hours at <1 metre) with other adults NOTE THAT: The restriction times in the first two rows run concurrently e.g. for 30 -200MBq category, a child should only be cuddled for brief periods for 5 days, then cuddling must be restricted to 15 min per day for a further 10 days. The dose constraint for the th row is 5 mSv ird The fourth row only covers on single event whereas the other ategories assume daily contact. c

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Restrictions
Patient with Iodine-131

Public travel allowed per day Activity 1:st w 2:nd w (MBq) (h) (h) 200 3,5 24 400 1,5 14 600 1 9 800 0,5 7

Off work (d) 0 3 6 8

Sleep apart from partner pregn. no (d) (d) 15 1 20 8 24 11 26 13

Restricted close contact with children <2 y 2-5 y 5-11 y (d) (d) (d) 15 11 5 21 16 11 25 20 14 27 22 16

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Therapy Patient
The dose to a family member staying at a distance of 0.5 meters from the patient until the radioactivity totally decays (about 10 weeks) is about 1.3 mGy from a hyperthyroid patient and 6.8 mGy from a thyroid cancer patient. These patients must also be careful not to transfer radio-iodine contamination to family members by direct contact or through indirect means

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Measurements
25 patients who received 220-600 MBq I-131

Husband/wife Children

220-3100 μSv 110- 700 μSv

No correlation between administered activity and doses to members of the family.

University Hospital, Gothenburg, Sweden
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Therapy Patient I-131
The patient should be kept at least 2h, and if possible one day in the hospital. In the case of cancer treatment, the patient should generally be hospitalized for several days. In all cases, the dose rate at 1 m from the patient should be down to an acceptable level established by the RPC.

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Patient Survey
Typical Graph of the Exposure Rate at 1 m from the Patient Administered with of 5.5 GBq I-131
14 12 10 8 6 4 2 0 1 2 3 4 5

Exposure Rate (mR/hr)

Days of Isolation

Abdalla Al-Haj
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Guidance level for maximum activity for patients in therapy on discharge from hospital

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Hospitalization or Not?
I-131 1100 MBq
stay in hospital stay in hospital or discharged with individual restrictions

600 MBq

discharged with individual restrictions

150 MBq
discharged, general restrictions

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Instructions to Out-patients
• • • • • •

No eating and drinking during the first hour after treatment. During the following two days you should drink more than usual. Use only a WC and flush 2-3 times. Keep the toilet and the floor clean. Wash your hands frequently and take a shower every day. Avoid close contact with members of the family, children and pregnant women according to the time table attached Avoid solid waste

Contact the Nuclear medicine department in case of problems or questions. Phone: …………

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Avoiding Solid Waste
Sensitive detectors at sanitary landfills and solid waste transfer and processing sites have identified contaminated articles from nuclear medicine patients.

• • • • •

Do not use paper plates or disposable cups or flatware. Use regular dishes, glasses and utensils. Wash them in the sink or dishwasher. Tissues and paper napkins should go in the toilet, not the garbage. Food residues should be avoided during the first week (apple cores, chicken bones etc). Articles contaminated with body fluids that cannot be washed clean or disposed of in the toilet should be stored for decay.

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IAEA Training Material on Radiation Protection in Nuclear Medicine

Part 8 Optimization of Protection in Medical Exposure

Module 8.4 The Hospitalized Patient

Hospitalized Patient

• • • • •

separate room with toilet and shower patient instructions (verbal and written) local rules for nursing the patient local rules for visitors local rules for decontamination local rules for emergency situations

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Room for Iodine Therapy (controlled area)
• only one patient in the room • easily cleanable surfaces and utensils • extra lead shields • door closed • warning sign outside • restrictions for visitors • decontamination equipment

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Isolation Ward

Bed shield is positioned Bed shield is positioned

Areas are covered with plastic Areas are covered with plastic backed absorbent material. backed absorbent material.

King Faisal Specialist Hospital and Research Center, Riyadh
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Warning Signs
Radiation sign posted on door and on Patient Chart

King Faisal Specialist Hospital and Research Center, Riyadh
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Patient Instructions
• • • • • • •

Stay in the room. Drink as much as possible. Eat lemon slices. Use only the private toilet and flush 3 times. (Men should sit down to avoid splashing.) Wash hands well in soapy water after using toilet. Wear footwear when leaving the bed. In event of vomiting or incontinence notify the nurse immediately.

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Instructions to Nursing Staff
• • •

Reduce time spent with patient by planning ahead and working efficiently. Work as far from patient as possible. Practice preventative measures against contamination. -wear impermeable protection gloves -wear shoe covers -wear a protective gown Remove protection clothing before leaving the room.

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Visitors Warning Card
The patient you are about to visit has received a therapeutic dose of radioactive iodine. It is in your own best interest to protect yourself as much as possible from receiving more radiation than is necessary. To assist you in meeting that end we offer the following recommendations:
• • • • • • •

Visitors are discouraged for a 48 hour period after the patient receives the treatment. Pregnant women and children under the age of 18 are not permitted to visit. You should keep your visit short (<30 min). Keep a reasonable distance (e.g. 2 m) away from the patient. Do not kiss the patient. Do not eat, drink or smoke in the patient’s room Do not touch the toilet or sink in the patient’s room If you have any questions, please ask the nursing staff.
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Discharge of Patient
The patient may leave the hospital when his/her radiation level has dropped below the equivalent activity level specified by the Regulatory Authority or the dose constraints specified by the local RPC. E.g. 20 μSv/h which corresponds to an activity of about 500 MBq The patient should be instructed about the general precautions for out-patients

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Discharge of Patient
T ypical Graph Showing the Percentage of I-131that is Retained in the Body of a Patient Adm inistered with 5.5 GBq
100 90 80

Percentage of I-131 in Body

70 60 50 40 30 20 10 0 1 2 3 4 5

Day of Isolation

Abdalla Al-Haj
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Discharge of Patient
Graph Showing the Number of Patients (5GBq) and the Number of Days of Isolation (Year 2000 Statistics)
160

142 (75%)
140 120 100 80 60 40

Number of Patients

(16%)
31

(4%)
20 0

8

(5%)
10 3 4 5

0 1 2

Number of Days of Isolation

Abdalla Al-Haj
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Decontamination
The RPO should supervise the removal of contaminated waste, the decontamination of the room and equipment and should make a documented final survey of the room. Monitoring and decontamination must be done prior to entry of nursing and housekeeping staff to prepare the room for the next patient. When survey and decontamination procedures are complete, the RPO will remove the radiation warning sign and notify the nursing and housekeeping staff that the room is now clear for general use.

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Monitoring
Furniture and telephone sets are surveyed. Areas suspected to be contaminated are surveyed.

King Faisal Specialist Hospital and Research Center, Riyadh
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Monitoring
Are or ite a m Toilet Washroom floor Sink and Faucets Shower Bed Arm chair Bedroom floor TV/Telephone Bedside table Doorknobs Lam switches p Initial (Bq/cm2) Afte cle r aning (Bq/cm2)

Derived limit: 3 Bq/cm2 METHODS • wipe testing • direct surveying

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Ready for a New Patient

A “Radiation Safe” sign is posted at the door after decontamination and clearing of room

King Faisal Specialist Hospital and Research Center, Riyadh
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Radioactive Waste

Faeces, urine and other liquids should be disposed of via the toilet. Contaminated clothing, linen, food items etc which can not go into the toilet should be stored in a separate plastic bag labeled ’RADIOACTIVE’, and should be removed daily to the designated radioactive waste storage facility. Disposable cutlery and dishes should be used. If not, they should be washed in the patient’s room and reused by the patient.

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Radioactive Waste

All patient radioactive wastes are placed in a plastic bag and the bag is properly tagged.

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IAEA Training Material on Radiation Protection in Nuclear Medicine

Part 8 Optimization of Protection in Medical Exposure

Module 8.5 Emergency Procedures: Death of Patient

HELP!

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Safety Assessment Contingency Plan
A safety assessment will reveal the possible situations where emergency actions have to be taken: •Loss or damage of radioactive material •Spillage of radioactive material •Fire •Medical emergencies •... A detailed contingency plan covering actions to be taken in any foreseeable accident should be available.
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Death of Patient
In the event of death of a patient who has recently received a therapeutic dose of a radionuclide care has to be taken to ensure that personnel receive as low a dose as possible at all stages prior to the burial or cremation.
Activity (MBq)
R adio nu clide I-131 Y-90 colloid A u-198 colloid P-32 S r-89 B urial 400 2000 400 2000 2000 C rem ation 400 70 100 30 200

(UK)

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Death of Patient
Precautions that should be given are depending on the residual activity and the expert advice provided by the RPO and may involve the following: • preparation for burial or cremation should be controlled by a competent person, • relatives should be prevented from coming into close contact with the body, • people should not be allowed to linger in the presence of the coffin, • all personnel involved in handling the corpse should be instructed by the RPO and monitored if appropriate, • all objects, clothes, documents etc that might have been in contact with the deceased must be tested for contamination, • it may be expedient to wrap the cadaver in waterproof material immediately after death to prevent spread of contaminated body fluids, • embalming of cadavers should, if possible, be avoided, • autopsy of highly radioactive cadavers should be restricted to the absolute minimum
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Questions?

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Discussion
Discuss the advantages/disadvantages of giving the patient a standard activity of I-131 in a capsule or giving a carefully calculated activity based on a prescribed dose to the thyroid.

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Discussion
1. Who should prescribe a thyroid treatment with I-131? 2. Who should perform the treatment?

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Discussion
Define some emergency situations or other hazardous events that can occur in an isolation ward and how to handle the situations.

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Where to Get More Information
qOther
s

sessions

Part 6 Medical exposure s Part 5 Occupational exposure s Part 4 Design

qFurther
s

readings

IAEA, International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources Safety Series No.115, Interim Edition (2011) s IPEM, Medical and Dental Guidance Notes. A good practice guide to implement ionising radiation protection legislation in the clinical environment s IAEA/WHO Manual on Radiation Protection in Hospitals and General Practice, Volume 4, Nuclear Medicine s IAEA, Manual on therapeutic use of iodine-131. Practical Radiation Safety Guide
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