Part 6

Part 6 Medical ExposureProtection of the PatientIAEA Training Material on Radiation Protection in Nuclear Medicine

Part 6. Medical Exposure

Nuclear Medicine

Part 6. Medical Exposure*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


Nuclear Medicine

Part 6. Medical Exposure*ContentsIntroductionResponsibilitiesJustificationOptimization of examinationGuidance levels of activityDose constraintsExamination of children, pregnant women and lactating womenRecordsLocal rules


Module 6.1. IntroductionIAEA Training Material on Radiation Protection in Nuclear Medicine

Part 6. Medical ExposureProtection of the Patient


Nuclear Medicine

Part 6. Medical Exposure*

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


Nuclear Medicine



Nuclear Medicine



Nuclear Medicine

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


Nuclear Medicine

Part 6. Medical Exposure*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??


Nuclear Medicine


Medical Exposure versus Occupational


Nuclear Medicine

Part 6. Medical Exposure*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.?????


Nuclear Medicine

Part 6. Medical Exposure*Medical Exposure versus Occupational Exposure


Nuclear Medicine

Part 6. Medical Exposure*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.???????


Nuclear Medicine

Part 6. Medical Exposure*Medical Exposure (BSS: Interim Edition) 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


Module 6.2. ResponsibilitiesIAEA Training Material on Radiation Protection in Nuclear Medicine



Nuclear Medicine

Part 6. Medical Exposure*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.Responsibilities: BSS (2011)


Nuclear Medicine

Part 6. Medical Exposure*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 patients 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.Responsibilities: BSS (2011) contd.


Nuclear Medicine

Part 6. Medical Exposure*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 3.1543.160 and the optimization of protection and safety, in cooperation with the medical physicist and the medical radiation technologist as required in paras 3.1613.176;(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 BSSResponsibilities: BSS (2011) contd.


Nuclear Medicine

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.



Nuclear Medicine



Nuclear Medicine

Part 6. Medical Exposure*RequestExamination or treatmentBiomedical researchTreatmentExaminationAdministration ofradiopharmaceuticalPatient identificationand informationChild ?Lactating woman ?Pregnant woman ?Safe preparation ofprescribed radio-pharmaceutical andactivityDose constraintsMethodQuality of equip-mentCorrect use of equipmentDose constraints to comforters and visitorsAccidental medical exposureFACTORS AFFECTINGMEDICAL EXPOSUREWho is responsible?


Nuclear Medicine

Part 6. Medical Exposure*Justificationof medical exposureOptimization of medical exposurethrough well educated personnel with clearly defined responsibilities

NM specialistQualified expertNM technologistNurseEngineerRadiopharmacistReferring physicianNuclear Medicine DepartmentLicensee/Hospital managementOptimization of medical exposurethroughorganization and resourcesRESPONSIBILITY STRUCTURE


Nuclear Medicine

Part 6. Medical Exposure*Referring PhysicianPrescribe and justify diagnostic procedures and therapy in writing in co-operation with the nuclear medicine specialist


Nuclear Medicine

Part 6. Medical Exposure*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.


Nuclear Medicine

Part 6. Medical Exposure*Nuclear Medicine StaffIndividuals 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 physiciansQualified experts in nuclear medicine physics (medical physicists)Other health professionals in nuclear medicine (radiopharmacists, nuclear medicine technologists, nurses,)Radiation Protection Officer


Nuclear Medicine

Part 6. Medical Exposure*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.Personal Authorization


Nuclear Medicine

Part 6. Medical Exposure*Ensure overall patient protection and safety;provide consultation and clinical evaluation of patientsensure 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; andprovide evaluation of any radiation incident and accident from medical point of view.Nuclear Medicine Specialist


Nuclear Medicine

Part 6. Medical Exposure*Medical Physicist Participate in continuing review of the nuclear medicine practices 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.


Nuclear Medicine

Part 6. Medical Exposure*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.


Module 6.3. JustificationIAEA Training Material on Radiation Protection in Nuclear Medicine



Nuclear Medicine

Part 6. Medical Exposure*JustificationAlthough Nuclear Medicine is a justified diagnostic toola case-by-case justification shall be applied.

This is the responsibility of the referring physician inco-operation with the nuclear medicine specialist and other specialists in diagnostic imaging, taking relevant guidelines into account.


Nuclear Medicine

Part 6. Medical Exposure*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.

Justification :BSS (2011)


Nuclear Medicine

Part 6. Medical Exposure*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 patients 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.

Justification: BSS (2011) Contd


Nuclear Medicine

Part 6. Medical Exposure*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.

Justification: BSS (2011) contd..


Nuclear Medicine

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.



Module 6.4. Optimization of ExaminationIAEA Training Material on Radiation Protection in Nuclear Medicine



Nuclear Medicine

Part 6. Medical Exposure*Otimization ofPatient ExaminationDiagnostic Objective Medical Exposure


Nuclear Medicine

Part 6. Medical Exposure*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.Optimization of Medical Exposure in Nuclear Medicine


Nuclear Medicine

Part 6. Medical Exposure*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.


Nuclear Medicine

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*


Nuclear Medicine

Part 6. Medical Exposure*Optimization of Medical ExposureAdministeredactivityRadiation riskQuality ofequipment etcEffectivedoseImage qualityRadionuclideBiokineticsPatient


Nuclear Medicine

Part 6. Medical Exposure*RadiopharmaceuticalsUse only radiopharmaceuticals from an authorizedmanufacturer!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


Nuclear Medicine

Part 6. Medical Exposure*RadiopharmaceuticalsIf 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-99m0.36 mSv/MBq0.011 mSv/MBq20 MBq 7.2 mSv200 MBq 2.2 mSvT1/2 = 2.8 daysT1/2 = 6 hours


Nuclear Medicine

Part 6. Medical Exposure*Radiopharmaceuticals Tl-201 Tc-99m25 mSv 8 mSv


Nuclear Medicine

Part 6. Medical Exposure*Optimization of Image QualityImage quality depends on: Administered activityTechnical factors - equipment used - acquisition protocol - image processing & evaluation - noise - spatial resolution - scatterPatient factors - size - age - disease - movement


Nuclear Medicine

Part 6. Medical Exposure*Optimization of Administered ActivityIn general, doses should be maintained as low as reasonableachievable but high enough to obtain the desired diagnosticinformation. This means that exposures above clinically acceptable maximum doses must be avoided as well as doses below clinically acceptable minimum doses


Nuclear Medicine

Part 6. Medical Exposure*Optimization of Administered ActivityValue of diagnostic informationAdministered activityThere is a threshold belowwhich no useful informationcan be expected

Above this threshold thediagnostic quality increasessteeply with the administeredactivity

Once an acceptable level hasbeen reached further increaseof activity will not improvethe result

(ICRP 52)


Nuclear Medicine

Part 6. Medical Exposure*Administered Activity to ChildrenOptimization is Necessary!Administered activity to children referred to DMSA scan in Swedish hospitals


Nuclear Medicine

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


Diagr1

1

5

10

42

Kidney dose (mGy)

KIDNEY FUNCTION (100 MBq Tc99m-DTPA)

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normalpartialtotal

0.00500.010.40

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10

42

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Kidney dose (mGy)

KIDNEY FUNCTION (DTPA)

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Nuclear Medicine

Part 6. Medical Exposure*OptimizationBlocking agents for thyroidHydration and frequent voiding of the urinary bladderLaxativesCatheterisation to empty the bladder???Cholecystokinin (fatty meal) for gallbladder emptying(ii) use of methods for blocking the uptake in organs not under study and for accelerated excretion when applicable;


Nuclear Medicine

Part 6. Medical Exposure*Tc-99m-MAG3, Two different first voiding times, girl 7 years


Blad1

Time between injection and first void

Organ30 min2 hours2h/30min

Bladder wall (mGy/MBq)0.070.152.1

Gall bladder wall0.0990.011.0

Kidneys0.00780.00811.0

Liver0.00180.0021.1

Red marrow0.00180.00221.2

Ovaries0.0050.00861.7

Testes0.00450.00821.8

Effective dose (mSv/MBq)0.00620.0111.8

(Eleonor Westergren)

Blad2

Blad3

Nuclear Medicine

Part 6. Medical Exposure*Optimization(iii) appropriate image acquisition and processing;Equipment used:Single head/dual head cameraCollimator used


Nuclear Medicine

Part 6. Medical Exposure*Aquisition Protocol Static? Tomographic? Dynamic?


Nuclear Medicine

Part 6. Medical Exposure*Acquisition ProtocolStatic imaging- matrix size- number of counts- projections, zoomDynamic imaging- matrix size- time/frame- number of groupsTomographic imaging- 180o or 360o- matrix size- number of angles- time/angle


Nuclear Medicine

Part 6. Medical Exposure*Image Processing & EvaluationStatic- smoothing- image filtering- quantification- applications programmeDynamic- regions of interest (ROI)- time-activity curves- application programmeTomographic- attenuation correction- reconstruction method- image filtering- slices displayed- application programme


Nuclear Medicine

Part 6. Medical Exposure*NoiseRandom variations in the number of counts (N) in a pixel, ROI or in a point in a time-activity curvetrue uptakes may not be seenfalse uptakes may occuruncertainty in quantitative valuesLower noise requires more administered activity or longer acquisition times

Noise SD %


Nuclear Medicine

Part 6. Medical Exposure*Noise1000000 counts 100000 counts


Nuclear Medicine

Part 6. Medical Exposure*Phantom: Different number of counts 50 k 250 k 1000 k


Nuclear Medicine

Part 6. Medical Exposure*Thyroid Scintigraphy,different acquisition times1 min4 min2 min8 min


Nuclear Medicine

Part 6. Medical Exposure*The noise level versus activity levels for an adult, CBFEleonor Westergren


Sheet: Diagr1

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28.3

53.67

89.52

100.16

105.47

191.56

363.91

7.789

5.472

4.362

4.089

3.93

3.242

2.486

283.0

536.7

895.1999999999999

1001.5999999999999

1054.7

1915.6

3639.1000000000004

7.789

5.472

4.362

4.089

3.93

3.242

2.486

%of adult activity 1000 MBq

Activity (MBq)

CV (%)

28.3

283.0

7.789

53.67

536.7

5.472

89.52

895.1999999999999

4.362

100.16

1001.5999999999999

4.089

105.47

1054.7

3.93

191.56

1915.6

3.242

363.91

3639.1000000000004

2.486

Nuclear Medicine

Part 6. Medical Exposure*Spatial ResolutionDescribes how a point source is reproducedsmall details are not seenuptakes seem to be lowerImproved spatial resolution can be achieved by changing to a collimator with higher resolution but:lower sensitivity requires more administered activity or longer acquisition times


Nuclear Medicine

Part 6. Medical Exposure*Appropriate Image Acquisition Close 15 cm Wrong setting of energy window


Nuclear Medicine

Part 6. Medical Exposure*Patient FactorsSizeincreased scatterspatial resolution

Age & Diseaseradiopharmaceutical distributionmovement artifacts


Nuclear Medicine

Part 6. Medical Exposure*Image QualityPatient MovementMovementCorrected


Nuclear Medicine

Part 6. Medical Exposure*Staff and ProceduresWell trained staff with access to manuals and other documentation. Quality control program. Regular maintenance of equipment


Module 6.5. Reference Levels of ActivityIAEA Training Material on Radiation Protection in Nuclear Medicine



Nuclear Medicine

Part 6. Medical Exposure*3.168. Registrants and licensees shall ensure that:(a)Local assessments, on the basis of the measurements required in para. 3.167, are made at approved intervals for those radiological procedures for which diagnostic reference levels have been established (para. 3.147);(b)A review is conducted to determine whether the optimization of protection and safety for patients is adequate, or whether corrective action is required if, for a given radiological procedure:(i) typical doses or activities exceed the relevant diagnostic reference level; or(ii) typical doses or activities fall substantially below the relevant diagnostic reference level and the exposures do not provide useful diagnostic information or do not yield the expected medical benefit to the patient.Diagnostic Reference Levels (BSS)


Nuclear Medicine

Part 6. Medical Exposure*Reference Levels of Activity


Examination

Radionuclide

Chemical form

Guidance level

(MBq)

Effective dose

(mSv)

Bone scan

Tc-99m

phosphonate

600

4.8

Brain scan

Tc-99m

pertechnetate

500

2.7

CBF

Tc-99m

HMPAO

500

5.5

Thyroid imaging

Tc-99m

pertechnetate

200

2.6

Thyroid imaging

I-123

iodide

20

3.4

Parathyroid

Tl-201

chloride

80

18

Lung perfusion

Tc-99m

MAA

100

1.2

Lung ventilation

Tc-99m

aerosol

80

0.6

Lung ventilation

Kr-81m

gas

6000

0.2

Lung ventilation

Xe-133

gas

400

0.4

Liver & spleen

Tc-99m

colloid

80

0.6

Myocardium

Tl-201

chloride

100

23

Myocardium

Tc-99m

isonitriles

600

4.2

Kidneys

Tc-99m

DMSA

160

2.5

Kidneys

Tc-99m

DTPA

350

2.2

Kidneys

I-123

hippuran

20

0.3

Tumours

Ga-67

citrate

300

36

Tumour

I-123

MIBG

400

7.2

Tumour

I-131

MIBG

20

4

Nuclear Medicine

Part 6. Medical Exposure*How to establish:

1. Elimination of outliers2. State-of-the practice (good practice)3. State-of-the art (optimal practice)Reference Levels


Nuclear Medicine

Part 6. Medical Exposure*Distribution of Administered ActivitiesNumber of patients

ActivityLog-normal distributionsGuidance levelOptimized?


Nuclear Medicine

Part 6. Medical Exposure*MaxIAEA guidance levelMean and range of mean (Sweden, 1995)Bone scintigraphyOptimized?Activity, MBq


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Module 6.6. Dose Constraints: Volunteers and ComfortersIAEA Training Material on Radiation Protection in Nuclear Medicine



Nuclear Medicine

Part 6. Medical Exposure*Dose Constraints 3.151. Registrants and licensees shall ensure that no individual incurs a medical exposure as part of a 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) as required in para. 3.160 and a radiological medical practitioner has assumed responsibility as specified in para. 3.153(a). Registrants and licensees shall ensure that the requirements specified in para. 3.173 are met for the optimization of protection and safety for persons subject to exposure as part of a programme of biomedical research.


Nuclear Medicine

Part 6. Medical Exposure*Biomedical Researcha To be kept below deterministic thresholds except for therapeutic experiments. ICRP and WHO categorization of risk


Nuclear Medicine

Part 6. Medical Exposure*Research on Pregnant PatientsRadiation research involving pregnant patients should be discouraged


Nuclear Medicine

Part 6. Medical Exposure*Dose Constraints 3.152. Registrants and licensees shall ensure that no individual incurs a medical exposure as a carer or comforter unless he or she has received, and has indicated an understanding of, relevant information on radiation protection and information on the radiation risks prior to providing care and comfort to an individual undergoing a radiological procedure. Registrants and licensees shall ensure that the requirements specified in para. 3.172 are met for the optimization of protection and safety for any procedure in which an individual acts as a carer or comforter.


Nuclear Medicine

Part 6. Medical Exposure*Dose Constraints ..The dose shall be constrained so that it is unlikely that his orher dose will exceed 5 mSv during the period of a patientsdiagnostic examination or treatment. The dose to childrenvisiting patients who have ingested radioactive materials shouldbe similarly constrained to less than 1 mSv


Nuclear Medicine

Part 6. Medical Exposure*NM patient with pregnant family member at homeFor most diagnostic nuclear medicine procedures, the total decay dose at 0.5 meter from the patient ranges from .02-0.25 mGy and at 1 meter from the patient the dose is 0.05-0.10 mGy. This poses no significant risk to pregnant family members.


Module 6.7. Examination of Children, Pregnant and Lactating WomenIAEA Training Material on Radiation Protection in Nuclear Medicine



Nuclear Medicine

Part 6. Medical Exposure*Optimization 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;..(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.


Nuclear Medicine



Nuclear Medicine

Part 6. Medical Exposure*Radiation Risks


Diagr1

155

125

105

7.55

3.55

2.85

2.65

2.35

1.25

0.65

05

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Sida &P

AGE AT EXPOSURE

LIFE-TIME RISK (%/Sv)

Blad1

0155

5125

15105

257.55

353.55

452.85

552.65

652.35

751.25

850.65

9505

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Sida &P

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00

00

00

00

00

00

00

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Nuclear Medicine

Part 6. Medical Exposure*Activity to ChildrenThe amount of activity administered to an adult can for children be reduced by one of the following methods:body weight/70 kgbody surface area/1.73 m2height/174 cm


Nuclear Medicine

Part 6. Medical Exposure*Fraction of the Adult Activity


Nuclear Medicine

Part 6. Medical Exposure*European Association of Nuclear Medicine (EANM)


Diagr2

0.1

0.14

0.19

0.23

0.27

0.32

0.36

0.4

0.44

0.46

0.5

0.53

0.56

0.58

0.62

0.65

0.68

0.71

0.73

0.76

0.78

0.8

0.82

0.85

0.88

0.96

Body Weight (kg)

Fraction of adult activity

Blad1

30.1

40.14

60.19

80.23

100.27

120.32

140.36

160.4

180.44

200.46

220.5

240.53

260.56

280.58

300.62

320.65

340.68

360.71

380.73

400.76

420.78

440.8

460.82

480.85

500.88

600.96

Blad1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Body Weight (kg)

Fraction of adult activity

Blad2

Blad3

Nuclear Medicine

Part 6. Medical Exposure*...noting the special requirements for

Local rules for administered activities to children should be available. Recommendations from international professional organizations should be followed.Children


Nuclear Medicine

Part 6. Medical Exposure*Pregnancy


Nuclear Medicine

Part 6. Medical Exposure*Example of justified use of CT in a pregnant female who was in a motor vehicle accident


Nuclear Medicine

Part 6. Medical Exposure*3 minute CT exam and taken to the operating room. She and the child survived


Nuclear Medicine

Part 6. Medical Exposure*IntroductionThousands of pregnant women are exposed to ionizing radiation each yearLack of knowledge is responsible for great anxiety and probably unnecessary termination of pregnanciesFor most patients, radiation exposure is medically appropriate and the radiation risk is minimal


Nuclear Medicine

Part 6. Medical Exposure*In some circumstances, the exposure is inappropriate and the unborn child may be at increased risk.Prenatal doses from most properly done diagnostic procedures present no measurably increased risk of prenatal death, malformation, mental impairment.Higher doses such as those from therapeutic procedures can result in significant fetal harm.


Nuclear Medicine

Part 6. Medical Exposure*An example of media nonsense


Nuclear Medicine

Part 6. Medical Exposure*Pregnant Women3.175. 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 in the optimization of protection and safety (para. 3.165).


Nuclear Medicine

Part 6. Medical Exposure*Situation AnalysisNumber of females getting exposed every week without knowing that they are pregnant: Inadvertent radiation exposure of early conceptusPlanned Exposures: patients needing nuclear medicine examinations or even therapy while pregnantAccidental exposure in pregnancyOccupational exposures in pregnancyExposure of female of reproductive capacity


Nuclear Medicine

Part 6. Medical Exposure*How Sensitive is Early Conceptus?Threshold dosedeterministic effects 100 - 200 mSv

Mental retardation40 % /Sv

Cancer and leukemiabefore 10 years of age 2 % /Svlifetime15 % /Sv

Hereditary effects 1 % /Sv


Nuclear Medicine

Part 6. Medical Exposure*Irradiation of Fetus Results from:Placental transferdistribution of activity in fetal organsnot much data availableI-131 as iodide Tc-99m pertechnetate

External radiation from activity present in the mothers organs and tissuesradiopharmaceuticals eliminated via the kidneys


Nuclear Medicine

Part 6. Medical Exposure*Absorbed Dose to the FetusExamination Activity Dose to fetus (MBq) (mSv)Bone (Tc99m) 600 4Brain (CBF) 500 4Lung (Tc99m-MAA) 160 0.4Kidneys (MAG3) 100 2Tumour or abscess (Ga-67 citrate) 300 28Heart (Tc99m-MIBI) 300 5Heart (Tl-201) 100 10Thyroid (Tc99m) 100 1Thyroid (I-131) 100 7Kidney clearance (Cr-51-EDTA) 4 0.02(Data from Russell, Stabin et al Radiation dose to the embryo/fetus from radiopharmaceuticals Draft, 1997


Nuclear Medicine

Part 6. Medical Exposure*Absorbed Dose to the Fetus(Data from Russell, Stabin et al Radiation dose to the embryo/fetus from radiopharmaceuticals Draft, 1997


Doser embryo

ExaminationmGy/MBqActivityDose to fetus

(MBq)(mGy)

Bone (Tc99m)0.0066004

Brain (CBF)0.00875004

Lung (Tc99m-MAA)0.00281600.4

Kidneys (MAG3)0.0181002

Tumour or abscess (Ga-67 citrate)0.09330028

Heart (Tc99m-MIBI)0.0153005

Heart (Tl-201)0.09710010

Thyroid (Tc99m)0.0111001

Thyroid (I-131)0.0721007

Kidney clearance (Cr-51-EDTA)40.02

I-131

0.0720.018

0.0680.014

0.230.0055

0.270.0052

I-131 iodide

Tc-99m-MAG3

Pregnancy month

mGy/MBq

Doser 0-9 mn

Gestation ageI-131 iodideTc-99m-MAG3

Early0.0720.018

3 months0.0680.014

6 months0.230.0055

9 months0.270.0052

Blad3

Nuclear Medicine

Part 6. Medical Exposure*Risk of childhood cancer from mothers diagnostic procedure in NMThe risk to an embryo or fetus from absorbing 1 mSv of radiation dose - an increased risk of developing childhood cancer of 6 in 100,000 (3 of which would be fatal)Natural risk of complications of pregnancy or of birth anomalies is approximately 4,000 in 100,000Natural risk of the incidence of childhood cancer 150 in 100,000Fetal doses from diagnostic procedures in NM max. tens of mSv ( 67Ga, 131I)


Nuclear Medicine

Part 6. Medical Exposure*When a female of reproductive age presents for an examination ask:Is she likely to be pregnant? Is period over-due?This should be recorded at appropriate place in the formFemales under 16?Depending upon answerNo possibility of pregnancyProceed with the examinationPrevention of Inadvertent Exposure in Pregnancy


Nuclear Medicine

Part 6. Medical Exposure*If pregnancy is established or likely: Review justificationCan examination be deferred until after deliveryDoes delaying examination involve greater riskIf procedure is to undertaken, the fetal dose should be kept to the minimum consistent with the diagnostic purpose(s)Patient Definitely or Probably Pregnant


Nuclear Medicine

Part 6. Medical Exposure*NoticesA missed period in a regularly menstruating woman should be considered due to pregnancy, until proven otherwiseNotices regarding pregnancy should be posted in patient waiting areas.


Nuclear Medicine

Part 6. Medical Exposure*IF YOU THINK THAT YOU MIGHT BE PREGNANT , NOTIFY STAFF BEFORE TREATMENT


Nuclear Medicine

Part 6. Medical Exposure*Before Examination is PerformedMany patients incorrectly assume that irradiation from a nuclear medicine examination begins when the gamma camera begins imaging,Therefore, before radiopharmaceutical administration, it is necessary to consider as pregnant any woman of reproductive age presenting for a nuclear medicine examination at a time when a menstrual period is overdue or missed, unlessthere is information that precludes pregnancy (e.g., hysterectomy or tubal ligation).If the menstrual cycle is irregular, and a non-technetium or therapeutic radiopharmaceutical is being administered, a pregnancy test may be indicated before proceeding.


Nuclear Medicine

Part 6. Medical Exposure*Informed Consent and UnderstandingThe pregnant patient has a right to know the magnitude and type of potential radiation effects that might result from in-utero exposureCommunication should be related to the level of risk. Verbal communication may be adequate for low dose procedures. If fetal doses are above 1 mGy, usually a more detailed explanation is given


Nuclear Medicine

Part 6. Medical Exposure*If an examination of a pregnant woman is judged to be necessaryChoice of radiopharmaceuticalIs it possible to reduce the administered activity? Prolonged acquisition times?For radiopharmaceuticals eliminated via the kidneys:Partially filled urinary bladder at the time of administrationHydration and frequent voiding


Nuclear Medicine

Part 6. Medical Exposure*During the ExaminationUsing smaller administered activities and longer imaging times can reduce the absorbed dose to the fetus. This is feasible if the patient is not too sick and is able to remain still


Nuclear Medicine

Part 6. Medical Exposure*During the ExaminationThe sequence of the examinations can be adjusted to reduce radiation dose. e.g. a ventilation-perfusion lung scan ordered on a pregnant patient to exclude a pulmonary embolus. Many laboratories will perform the ventilation scan first and then do the perfusion scan.In the specific case of a suspected pulmonary embolus, the perfusion scan can be performed first, and if it is normal, a ventilation scan is not needed at all.


Nuclear Medicine

Part 6. Medical Exposure*During the Examination (contd.)There will be much smaller fetal dose with Xenon-133If one does ventilation scans using 99mTc-DTPA aerosol, this will be absorbed and excreted via the kidneys, and while in the bladder it will contribute to fetal dose


Nuclear Medicine

Part 6. Medical Exposure*Dose reduction after procedure has been performed Can the dose be reduced after the procedure has been performed?Yes, by accelerating voiding, bladder doseNot possible in radiology and RT


Nuclear Medicine

Part 6. Medical Exposure*Termination of PregnancyTermination of pregnancy at fetal doses of less than 100 mGy is NOT justified based upon radiation riskAt fetal doses in excess of 100 mGy, there can be fetal damage, the magnitude and type of which is a function of dose and stage of pregnancyIn these cases decisions should be based upon individual circumstances


Nuclear Medicine

Part 6. Medical Exposure*Becoming Pregnant after IrradiationICRP has recommended that a woman not become pregnant until the potential fetal dose from remaining radionuclides is less than 1 mGy. This is not usually a consideration except for radiopharmaceuticals labelled with 59Fe (for metabolism studies) or 75Se (for adrenal imaging). As a result of the long physical half-lives of these radionuclides and their long residence times in the body, it is recommended that pregnancy be avoided for 6 and 12 months respectively.


Nuclear Medicine



Nuclear Medicine

Part 6. Medical Exposure*Mothers in Lactation


Nuclear Medicine

Part 6. Medical Exposure*Optimization: Breast Feeding3.176. 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).


Nuclear Medicine

Part 6. Medical Exposure*Irradiation of breastfed child results from:Activity in milkExternal radiation from the motherPossible contamination


Nuclear Medicine

Part 6. Medical Exposure*Recommendations for Cessation of Breast Feeding Tc-99m PYP 740 no Tc-99m RBC's in vivo labelling 740 yes 12 hr Tc-99m RBC's in vitro labelling 740 no Tc-99m Sulphur Colloid 444 no Tc-99m DTPA Aerosol 37 no Tc-99m WBC's 185 yes 48 hr Tc-99m MAG3 370 no


Nuclear Medicine

Part 6. Medical Exposure*Recommendations for Cessation of Breast Feeding no I-131 OIH 11.1 no Tl-201 111 yes 96 hr Xe-133 gas no


Nuclear Medicine

Part 6. Medical Exposure*IF YOU ARE BREAST-FEEDING, PLEASE NOTIFY THE STAFF


Module 6.8. RecordsIAEA Training Material on Radiation Protection in Nuclear Medicine



Nuclear Medicine

Part 6. Medical Exposure*3.182. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following personnel records:(a)Records of any delegation of responsibilities by principal parties (as required in para. 3.153(f));Records of training of personnel in radiation protection (as required in para. 3.149(b)).

3.183. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following records of calibration, dosimetry and quality assurance:(a)Records of the results of the calibrations and periodic checks of the relevant physical and clinical parameters selected during treatment of patients;(b)Records of dosimetry of patients, as required in para. 3.167;(c)Records of local assessments and reviews made with regard to diagnostic reference levels, as required in para. 3.168;(d)Records associated with the quality assurance programme, as required in para. 3.170(d).Records


Nuclear Medicine

Part 6. Medical Exposure*Records3.184. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following records for medical exposure:.(c)For nuclear medicine, the types of radiopharmaceutical administered and their activity;.(e)Exposure records for volunteers subject to medical exposure as part of a programme of biomedical research;(f)Reports on investigations of unintended and accidental medical exposures (as required in para. 3.180(d).


Nuclear Medicine

Part 6. Medical Exposure*Records and Documents:Medical ExposuresAdministered radiopharmaceutical and activity (each patient)Route of administration (each patient)Incident and accident investigation reportsAbsorbed doses to patientsCalibration certificate (activity meter)Quality control of equipment (gamma camera & activity meter)Maintenance and repair workAudits and reviews of radiation safety programmeTraining provided:initialrefresher


Module 6.9. Local RulesIAEA Training Material on Radiation Protection in Nuclear Medicine



Nuclear Medicine

Part 6. Medical Exposure*Local Rules:Medical ExposuresActivity to adults in nuclear medicine examinationsActivity to children in nuclear medicine examinationsRules for pregnant womenRules for lactating womenPreparation and dispensation of radiopharmaceuticalsProcedure manual, activity meterPatient identification and informationAdministration of radiopharmaceuticalsProcedure manual, gamma camera examinationsProcedures in case of misadministrationsProcedures in case of accidentsRecords


Nuclear Medicine

Part 6. Medical Exposure*Local RulesActivity to AdultsPregnant womenRadiopharmaceuticals MisadministrationChildren & Young peopleLactating womenActivity measurement ExaminationDepartment of Nuclear MedicineRadiation Protection ManualPROTECTION OF THE PATIENTPatient IdentificationProceedure Manuals


Nuclear Medicine

Part 6. Medical Exposure*Questions?


Nuclear Medicine

Part 6. Medical Exposure*DisccussionIncrease the activity for elderly patients and patients with pain to reduce the examination time?

Increase the activity for all patients in order to increase the throughput of patients? Increase the activity for paediatric patients in order to avoid sedation or general anaesthesia? Increase the activity to cancer patients who are nevertheless going to receive radiotherapy?


Nuclear Medicine

Part 6. Medical Exposure*DiscussionA patient is referred to a bone scan. It is obvious from the information on the request that this is the wrong type of examination to get the right diagnosis. The examination is done anyway. Who is responsible for this non justified exposure?


Nuclear Medicine

Part 6. Medical Exposure*DiscussionDiscuss how to handle the problem when it is necessary to to examine or treat a woman who is pregnant.


Nuclear Medicine

Part 6. Medical Exposure*Where to Get More InformationOther sessionsPart 7 Optimization of protection in Nuclear Medicine ExaminationsPart 8 Optimization of protection in Nuclear Medicine therapyPart 11 Potential exposure and accidental medical exposureFurther readingsIAEA Basic Safety Standards: Interim Edition (2011)IAEA Safety Guide on Radiological Protection for Medical ExposureIAEA Model regulations on radiation safety in nuclear medicine WHO. Manual on Radiation Protection in Hospitals and General Practices. Volume 4: Nuclear MedicineICRP publication 84Practical sessionSimulated inspection


Nuclear Medicine

Part 6. Medical Exposure*Local Rules 1ADULTSNote: For not listed examinations consult the nuclear medicine specialistDepartment of Nuclear MedicineRadiation Protection ManualPROTECTION OF THE PATIENT

ExaminationRadiopharmaceuticalActivity (MBq)Bone scanTc99m DPD400ThyroidTc99m-pertechnetate100KidneyTc99m-MAG375


Nuclear Medicine

Part 6. Medical Exposure*Local Rules 2CHILDREN & YOUNG PEOPLENote: For not listed examinations consult the nuclear medicine specialistDepartment of Nuclear MedicineRadiation Protection ManualPROTECTION OF THE PATIENT

ExaminationRadiopharmaceuticalActivity (MBq)Age 0-14 Age 15-18Bone scanTc99m DPD BW x 3 BW x 6ThyroidTc99m-pertechnetate BW x 0.5 BW x 1KidneyTc99m-MAG3 BW x 0.5 BW x 1


Nuclear Medicine

Part 6. Medical Exposure*Local Rules 3PREGNANT WOMENIf a female patient is pregnant or think that she might be, the responsible physician shall always make a decision whether the examination shall be done or shall be postponed either until after delivery or to the latter half of the pregnancy, carefully considering the use of other diagnostic methods.

If there is uncertainty concerning pregnancy, either because the period is known to be overdue or for other reasons, the woman shall be treated as pregnant until otherwise proved.

The administered activity shall be in proportion to body weight using 70% of the normal adult activity for the required examinationDepartment of Nuclear MedicineRadiation Protection ManualPROTECTION OF THE PATIENT


Nuclear Medicine

Part 6. Medical Exposure*Local Rules 4LACTATING WOMENNo counseling of breastfeeding for the following radiopharmaceuticals:51Cr-EDTA, 99mTc-DMSA, 99mTc-DTPA, 99mTc-MDP, 99mTc-glycoheptonate99mTc-HMPAO, 99mTc-MIBI, 99mTc-colloids, 99mTc-MAG3(10 mSv, then the anticipated outcome of the project should be of substantial benefit to SocietyPart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicineShould a radioactive patient (diagnostics, therapy) be placed together with other patients?Part 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicineThis image is a simplification of the information given in ICRP 60Part 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicineThis image shows that the activity to a child will depend on the method used for calculation. Using body height will generally result in higher values than using body weightPart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicineExplanation or/and additional information

Instructions for the lecturer/trainer

Part 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicinePart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicineThis image shows examples of local rules. Note that You can click on the different buttonsPart 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicineThese are some provocative questions. They should be used to discuss about the necessity to apply some flexibility in the administered activity.Part 6. Medical exposurePart 6. Medical exposureRadiation protection in nuclear medicine

Part 6

Documents

Transcript of Part 6