USE OF RADIATION IN NUCLEAR MEDICINE

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USE OF RADIATION IN NUCLEAR MEDICINE

  1. 1. This Guide is valid as of 2 May 2003 until further notice. Helsinki 2005 ISSN 0789-4716 ISBN 951-712- 952-1 (pdf) ISBN 951-712- 953-X (html) GUIDE ST 6.3 / 18 MARCH 2003 USE OF RADIATION IN NUCLEAR MEDICINE STUK• SÄTEILYTURVAKESKUS STRÅLSÄKERHETSCENTRALEN RADIATION AND NUCLEAR SAFETY AUTHORITY Osoite/Address • Laippatie 4, 00880 Helsinki Postiosoite / Postal address • PL / P.O.Box 14, FIN-00881 Helsinki, FINLAND Puh./Tel. (09) 759 881, +358 9 759 881 • Fax (09) 759 88 500, +358 9 759 88 500 • www.stuk.fi 1 GENERAL 3 2 DEFINITIONS 3 3 SAFETY LICENSE REQUIRED FOR NUCLEAR MEDICINE ACTIVITIES 3 4 OPTIMISATION OF TREATMENTS AND EXAMINATIONS AND RADIATION PROTECTION OF THE PATIENT 3 5 USE OF REFERENCE LEVELS FOR NUCLEAR MEDICINE EXAMINATIONS 4 5.1 How to determine the mean activities to be administered to patients? 4 5.2 Approaches when the mean activities obtained differ from the reference levels 4 5.3 Recording of results 4 6 WRITTEN INSTRUCTIONS TO BE AVAILABLE FOR EXAMINATIONS AND TREATMENT 5 7 INSTRUCTIONS FOR QUALITY ASSURANCE 5 7.1 The quality system 5 7.2 Quality assurance programme 5 7.3 Quality requirements for equipment 6 7.4 Quality assurance of radiopharmaceuticals 6 7.5 Records for quality assurance 6 8 CLINICAL AUDITS 6 9 SCIENTIFIC RESEARCH 6
  2. 2. S T U K GUIDE ST 6.3 / 18 MARCH 2003 Authorization Under section 70, paragraph 2, of the Radiation Act (592/1991), STUK – Radiation and Nuclear Safety Authority (Finland) issues general instructions, known as Radiation Safety Guides (ST Guides), concerning the use of radiation and operations involving radiation. The Radiation Act stipulates that the party running a radiation practice is responsible for the safety of the operations. The responsible party is obliged to ensure that the level of safety specified in the ST Guides is attained and maintained. Translation. Original text in Finnish. 10 SPECIAL PROTECTION DURING PREGNANCY AND BREAST-FEEDING 7 10.1 Nuclear medicine examination 7 10.2 Radionuclide therapy 7 10.3 Protection of the child during breast-feeding 8 11 RADIATION PROTECTION OF THE PATIENT’S FAMILY MEMBERS, AND MEMBERS OF THE PUBLIC AFTER NUCLEAR MEDICINE EXAMINATION AND RADIONUCLIDE THERAPY 8 11.1 Dose constraints 8 11.2 Radiation protection instructions to be provided both orally and in writing 8 12 HOW TO RECORD AND REPORT INFORMATION ON NUCLEAR MEDICINE PROCEDURES? 9 13 ABNORMAL EVENTS IN THE USE OF RADIATION 9 13.1 Dealing with abnormal events 9 13.2 Abnormal events to be notified without delay 9 14 BIBLIOGRAPHY 10 APPENDIX A RECORDING OF DATA WHEN DETERMINING THE MEAN ACTIVITIES OF RADIOPHARMACEUTICALS TO BE ADMINISTERED TO PATIENTS APPENDIX B ACCEPTANCE CRITERIA FOR GAMMA CAMERAS AND ACTIVITY METERS APPENDIX C RECOMMENDATIONS ON THE DURATION OF INTERRUPTION OR CESSATION OF BREAST-FEEDING APPENDIX D PATIENT LEAVING HOSPITAL AFTER RADIONUCLIDE THERAPY
  3. 3. GUIDE ST 6.3 / 18 MARCH 2003 S T U K 3 1 General The basic provisions governing the medical use of radiation are set out in chapter 10 of the Radiation Act (521/1991, amendment 1142/1998). Section 41 of the Radiation Act is the authorising provision for the Decree of the Ministry of Social Affairs and Health on the medical use of radiation (no. 423 of 2000, hereinafter referred to as the MSAH Decree). The Decree contains provisions governing the grounds for procedures involving exposure to radiation and the instructions to be followed when performing such procedures. This ST Guide presents the essential radiation safety requirements for nuclear medicine. These requirements also apply to procedures performed on healthy persons and patients participating in scientific research. The requirements also apply to the radiation exposure of persons who voluntarily and otherwise than as part of their occupation assist a person who is subject to a procedure involving exposure to radiation. Other instructions pertaining to radiation safety are listed below: • The training and qualification requirements for workers involved in nuclear medicine activity are prescribed in chapter 5 of the MSAH Decree. • Requirements for radiation protection training in health care are set out in Guide ST 1.7. • The radiation safety requirements for laboratory and patient premises are set out in Guide ST 6.1. • Radiation safety requirements on the handling of radioactive wastes and discharges into the environment are set out in Guide ST 6.2. • Requirements on the use of sealed sources in radiotherapy are set out in Guide ST 2.1. 2 Definitions The following terms used in this Guide shall have the following meanings: nuclear medicine A medical speciality in which radioactive substances are used as unsealed sources in the form of radiopharmaceuticals to diagnose and treat illnesses and for scientific research. radiopharmaceutical A radioactive medicinal product reference level A predetermined activity level in nuclear medicine examinations, that is not presumed to be exceeded in a procedure performed according to the standards of good practice upon a person of normal size quality assurance programme The document referred to in section 18 of the MSAH Decree including written specifications of quality assurance activities in the medical use of radiation. 3 Safety license required for nuclear medicine activities For nuclear medicine activities the party running a radiation practice (hereafter the responsible party) shall have the safety license referred to in section 16 of the Radiation Act (592/1991). The description of organisation required by section 18 of the Radiation Act must specify the assignment of responsibilities with respect to radiation safety. The radiation user’s organisation is governed by Guide ST 1.4. 4 Optimisation of treatments and examinations and radiation protection of the patient Nuclear medicine examination must be performed in a manner that achieves the objective set for the examination while minimising the exposure of the examinee to radiation. The dose in radionuclide therapy must be planned individually for each patient so that the radiation dose to target tissue or organ is sufficient to bring about the desired effect. At the same time the dose to non-target tissues must be as low as reasonable achievable.
  4. 4. S T U K GUIDE ST 6.3 / 18 MARCH 2003 4 The referral must clearly state indication of the examination or treatment and other necessary information enabling the examination or treatment to be performed in an optimal manner. The activity of a radiopharmaceutical must be measured with an activity meter before it is administered to the patient. The activity of the radiopharmaceutical, the radionuclide, and the chemical form of the radiopharmaceutical or the abbreviation generally used for it must be entered in the patient’s medical record. Where alternative radiopharmaceuticals may be used, the radiopharmaceutical selected must, where possible, be the radiopharmaceutical that minimises the radiation dose to the patient. Available measures must be used to reduce the radiation dose to the patient in diagnostic and therapeutic nuclear medicine procedures. These measures include preventing radioactive substances from accumulating in organs that are not being examined and accelerating excretion of radioactive substances. Patients treated with unsealed radioactive substances shall be accommodated in hospital in a manner that minimises the radiation exposure of workers, other patients and visitors. 5 Use of reference levels for nuclear medicine examinations Reference levels referred to in section 16 of the MSAH Decree shall be introduced by the responsible party to nuclear medicine examinations. The use of reference levels is prescribed in section 17 of the MSAH Decree. The Radiation and Nuclear Safety Authority (STUK) has issued reference levels for the most common nuclear medicine examinations in decision no. 596/310/00 (8 December 2000), and these are revised as necessary. 5.1 How to determine the mean activities to be administered to patients? The quality assurance programme must include an evaluation of the activities administered to patients in various examinations and a comparison thereof to reference levels. The mean activity is determined for a group of no fewer than ten patients of normal size for each examination at intervals of at least three years. If the activity administered to a patient depends on the weight of the patient, then patients will be selected so that their weights fall in the range 60–80 kilograms. In the event that the same examination may be performed with several equipments, the mean activity will be determined for each equipment separately. If the examination practice or equipment changes in a manner that affects the activity administered to a patient, then the mean activity will be determined again at the earliest opportunity. The mean activity need not be determined for examinations performed fewer than 20 times a year. 5.2 Approaches when the mean activities obtained differ from the reference levels If the mean activity obtained exceeds the reference level, then the reasons for the exceeding must be investigated and steps must be taken where necessary to optimise the examination. If the activities administered to patients fall substantially below the reference levels, then it must be ensured that adequate information is being procured for the purpose of diagnosis. 5.3 Recording of results The measurement results, determined mean values and information on corrective measures must be recorded and archived for at least five years. The measurement results must specify the information presented in Appendix A.
  5. 5. GUIDE ST 6.3 / 18 MARCH 2003 S T U K 5 6 Written instructions to be available for examinations and treatment Written instructions shall be available for nuclear medicine examinations and radionuclide therapies. For the most common examinations and therapeutic procedures, the written instructions shall cover all stages of the examination or therapeutic procedures, including the preparation and processing of radiopharmaceuticals and handling of radioactive wastes. The written instructions shall also include instructions on radiation protection and safety regulations, together with instructions for responding when incidents or accidents occur. 7 Instructions for quality assurance 7.1 The quality system The best way to implement the requirements imposed on responsible parties by radiation legislation is to use a quality system covering all operations. A quality system is a system of organisational structures, procedures, processes and resources required in quality control. The quality system is described in quality documents arranged as an integrated collection that is continually updated (a quality manual or equivalent). 7.2 Quality assurance programme The responsible party shall ensure that quality assurance functions are planned and specified in a written quality assurance programme in the manner prescribed in the MSAH Decree (especially section 18). The responsible party shall supervise the apparatus used in nuclear activity in the manner referred to in section 40 of the Radiation Act (592/1991, amendment 1142/1998), in order to be sure that all devices and instruments are in working order and that their operating instructions and procedures are appropriate. The operating condition of radiological equipment must be checked: • before the equipment is commissioned • at specified intervals according to device- specific instructions • following repairs or servicing • when there is cause to suspect a fault or malfunction. According to section 32 of the MSAH Decree, the quality assurance programme shall set out the principal tasks involved in supervising the operating condition and performance characteristics of radiological equipment. The instructions and responsibilities pertaining to supervision of equipment must be specified for each equipment. Documentation must also exist in respect of each equipment as follows: • inspections and measurements to be performed and the purpose thereof • methods of inspection and measurement • apparatus and instruments to be used • intervals for performing inspections and measurements • acceptability criteria for inspections and measurements (action levels) • measures to be taken when the acceptability criteria are exceeded. The persons performing inspections and measurements (vocational group) must be specified. The inspection and measurement methods must be described in sufficient detail for the inspections and measurements to be repeated on the basis of the quality assurance programme in the manner intended by the person who prepared the programme. According to section 18 of the Decree of the MSAH Decree, the quality assurance programme shall include the principles for preventing errors or damage from which radiation doses may arise unintentionally.
  6. 6. S T U K GUIDE ST 6.3 / 18 MARCH 2003 6 7.3 Quality requirements for equipment Procedures involving exposure to radiation shall be performed using equipment suited for the said purpose. The Medical Devices Act (1505/1994) also governs equipment used in nuclear activity. Apparatus manufactured after 13 June 1998 must bear the CE marking (Directive 93/42/EEC) referred to in the Act. The said CE marking is a manufacturer’s warranty that the apparatus meets the equipment safety requirements imposed by European Community Directives. Criteria of acceptability denote the minimum equipment performance requirements that are applied as action levels or remedial levels when using the equipment. If the equipment does not meet the criteria, then measures must ultimately be taken to repair the equipment and restore its performance to the acceptable level. If necessary, the equipment must be decommissioned. The equipment may not be used for patient examinations before it has been repaired and found to be fit for use once again. Criteria of acceptability are not limiting values for the optimal performance of the equipment. When procuring new equipment, at acceptance tests and in the course of quality control of equipment at the time of use, responsible parties may apply stricter requirements, which may be based, for example, on the equipment specifications or performance tolerance values proposed in equipment standards. Appendix B sets out the acceptability criteria for gamma cameras intended for planar imaging and SPECT, and activity meters. They are based on European Commission publication Radiation Protection 91, Criteria for acceptability of radiological (including radiotherapy) and nuclear medicine installations. During use equipment must at least meet the criteria of acceptability set out in Appendix B. The responsible party must ensure that any equipment used in nuclear medicine activity has been approved in an acceptance test before it is taken into use. In the acceptance test gamma cameras for planar imaging and SPECT and activity meters must at least conform to the acceptability criteria set out in Appendix B. 7.4 Quality assurance of radiopharmaceuticals The quality assurance operations and acceptability criteria pertaining to radiopharmaceuticals must be set out in the quality documents. The processing and manufacture of radiopharmaceuticals must conform to Good Radiopharmaceutical Practice (GRP). This includes both radiation safety aspects and purity requirements. The quality documents must contain a descrip- tion of the measures ensuring that the right patient receives the correct amount of the right radiopharmaceutical. They must also include a description of the measures to be taken to alleviate the harmful effects of any dosage error that may occur. 7.5 Records for quality assurance Records must be kept of the inspections and measurements involved in quality assurance, specifying that the said inspections and measurements have been made and by whom, the results thereof and the measures taken on account of those results. Records must also be kept of any faults, malfunctions and other incidents occurring in use of the apparatus that disrupt the said use or endanger safety. 8 Clinical audits The obligation of a responsible party to arrange clinical audits is prescribed in section 39c of the Radiation Act (592/1991 amendment 1142/1998) and in chapter 4 of the MSAH Decree. According to the Decree, clinical audits shall be arranged so that it complements self-assessment of activities in an expedient manner. The objective is for the activity to be audited in all essential respects at intervals not exceeding five years. The results of audits and an account of corrective measures taken must be submitted on request to STUK. 9 Scientific research The requirements for scientific research are prescribed in section 6 of the MSAH Decree.
  7. 7. GUIDE ST 6.3 / 18 MARCH 2003 S T U K 7 Implementation of research and the measures to be followed therein are governed by the provisions of the Medical Research Act (488/1999). The European Commission publication Radiation Protection 99, Guidance on medical exposures in medical and biomedical research sets out the risk classes into which research is divided on the basis of the radiation exposure that it causes to persons involved in the research. This risk classification may be applied when assessing the justification for scientific research. The classification is derived from publication 62 of the International Commission on Radiological Protection. Attention shall be paid to the following factors when selecting persons for scientific research involving the exposure of subjects to radioactive substances: • Persons under 18 years of age shall not participate in scientific research unless the subject of the research is the particular problems of this specific age group. Participation of children and young adults in scientific research is generally not justified. If possible, healthy volunteers should be over 50 years of age. • The number of persons participating in the research shall be limited to the smallest possible number required to procure the desired information. The prior radiation exposure of the persons participating in the research must be investigated. • A dose constraint shall be imposed on healthy volunteers. The effective dose applied to healthy volunteers shall not normally exceed 10 mSv per year. • When women of childbearing age participate in research the possibility of pregnancy shall be considered. Pregnant and breast-feeding women may participate in scientific research only when studying particular problems pertaining to pregnancy and when no alternative research methods are available. • If volunteers participating in scientific research are exposed to radiation in their work, then the person performing the research shall ensure that the volunteers understand the significance of the additional risk caused by the research. Category A radiation workers should not normally be accepted as volunteers for scientific research. 10 Special protection during pregnancy and breast-feeding*) 10.1 Nuclear medicine examination There is no need to avoid pregnancy after most nuclear medicine examinations. Some nuclear medicine examinations may, however, cause a radiation dose to an unborn child exceeding 1 mSv. In such cases the patient is to be urged to avoid pregnancy for a certain period of time. 10.2 Radionuclide therapy When considering radionuclide therapy to a pregnant woman, the dose to the foetus must be estimated. If the treatment cannot be delayed until after confinement, then the dose to the unborn child must be minimised. A female patient is to be urged to avoid pregnancy for a certain period of time following radionuclide therapy. This ensures that the dose caused to the unborn child does not exceed 1 mSv if pregnancy begins at this time. Spermatozoa may also be damaged through radionuclide therapy. For this reason, male patients are to be advised not to father children for a period of four months following 32P, 89Sr and 131I (activity up to 800 MBq) treatment. The four month period is recommended as it exceeds the life span of spermatozoa. *) European Commission. Radiation protection 100. Guidance for protection of unborn children and infants irradiated due to parental medical exposure.
  8. 8. S T U K GUIDE ST 6.3 / 18 MARCH 2003 8 10.3 Protection of the child during breast-feeding Children should not be breast-fed after nuclear medicine examination until the dose to the child can be estimated to be smaller than 1 mSv. Before the procedure is performed, breast-feeding women shall be advised of the anticipated interruption in breast-feeding. The recommended lengths of interruption in breast-feeding following various nuclear medicine examinations are set out in Appendix C. Breast-feeding must generally be stopped altogether after radionuclide therapy. 11 Radiation protection of the patient’s family members, and members of the public after nuclear medicine examination and radionuclide therapy 11.1 Dose constraints Section 10 of the MSAH Decree prescribes that dose constraints are to be used as necessary to limit the radiation exposure of voluntary assistants. STUK is authorised to issue guidance on the use of dose constraints. A patient to whom a radioactive substance has been administered may be treated as an out- patient, or an in-patient may be discharged only after the radiation exposure caused to family members and other persons by the residual activity in the patient has become insignificant. The following dose constraints will be applied in such cases*): Family members of the patient Children (including unborn children) 1 mSv Adults (under 60 years of age) 3 mSv Adults (60 years of age and older) 15 mSv Other persons (members of the public)**) 0.3 mSv If it is possible that the dose constraints of family members and others will be exceeded, then the patient must remain in hospital until the residual activity in the patient has fallen by a sufficient amount. Before a patient is discharged following 131I therapy it must be verified that the residual activity in the patient does not exceed 800 MBq. 11.2 Radiation protection instructions to be provided both orally and in writing Section 11 of the MSAH Decree provides that before a patient is discharged, the patient and any person attending thereto shall be furnished with proper protection instructions, which shall also be provided in writing. Before the patient, administered radiopharma- ceutical for the treatment, is discharged and any person attending thereto shall be furnished with instructions on how to act so as to prevent unnecessary exposure to radiation of persons coming into contact with the patient. The instructions must be provided both orally and in writing, and in a form that the patient understands. The fact that instructions have been given must be entered in the patient’s medical record. The instructions should include at least the following details: • the name and address of the patient • the name, address and telephone number of the hospital • a person to contact if problems arise • the radiopharmaceutical administered to the patient and its activity • the date of administering • practical instructions for limiting the radiation exposure of persons coming into contact with the patient • the length of time for which the instructions must be followed. The publication Radiation Protection 97, Radiation Protection following Iodine-131 therapy *) European Commission publication. Radiation Protection 97. Radiation Protection following Iodine-131 therapy (ex- posures due to out-patients or discharged in-patients). **) The exposure of other persons is subject to the dose limit for the members of the public, which is 1 mSv per year. As the dose may be caused by other radiation sources, the dose constraint for exposure due to a single radiation source is 0.3 mSv.
  9. 9. GUIDE ST 6.3 / 18 MARCH 2003 S T U K 9 (exposures due to out-patients or discharged in- patients) includes a model of the instructions to be provided to a patient following 131I therapy. The length of time for which the instructions must be followed will depend on the residual activity in the patient and on the dose rate that this causes. Appendix D presents a recommendation on the duration of restrictions on the behaviour of the patient after 131I therapy. If a patient plans to travel abroad immediately after radionuclide therapy, then the patient must be given a certificate of treatment as a radiation measurement may be made at the national frontier. The activity of a radiopharmaceutical ad- ministered to a patient in nuclear medicine examination is generally so small that no health precautions or restrictions on the behaviour of the patient are necessary. After nuclear medicine examination no instructions on the behaviour of the patient in order to limit radiation exposure of persons coming into contact with the patient are generally necessary. Nuclear medicine examinations in which 30 MBq or more of 131I is administered to the patient, or where there is a reason to assume that the dose constraints referred to in item 11.1 could be exceeded, form an exception to this. 12 How to record and report information on nuclear medicine procedures? Recording of information on procedures is prescribed in section 43 of the MSAH Decree. The procedure must be entered in the patient’s medical record. If the procedure was performed in a substantially different manner than usual, then this must also be entered in the patient’s medical record. The written instructions pertaining to performance of the procedure shall be archived so that the radiation dose to the patient can be assessed at a later date where necessary. It shall be possible to ascertain at a later date from the archived documents the practice that was followed at the time of the procedure. The responsible party shall submit to STUK information of the number of nuclear medicine examinations (including scientific investigations) and therapeutic procedures, the radiopharmaceuticals used, and the mean activities used in various examinations and therapeutic procedures in the manner separately notified by STUK. At the same time an account of the equipment used in nuclear medicine examinations and therapeutic procedures (imaging devices, activity meters and other apparatus) shall also be provided. 13 Abnormal events in the use of radiation 13.1 Dealing with abnormal events When an abnormal event occurs, available measures must be taken to reduce the radiation dose to the patient, the radiation dose received by the patient must be estimated, the reasons for the abnormal event must be investigated, and action must be taken to prevent such events from recurring. 13.2 Abnormal events to be notified without delay Reporting of abnormal events pertaining to the use of radiation is prescribed in section 17 of the Radiation Decree (1512/1991). STUK must be immediately notified of any abnormal event or other unusual observation or information of substantial significance for radiation safety. The report of an abnormal event must specify: • the name and contact details of the person submitting the report • the time and place of the event • a description of the event • details of any persons placed in hazardous situations and of the radiation doses that these persons sustained • immediate measures taken on account of the event • initial evaluations of the reasons for the event. The report must be submitted in writing
  10. 10. S T U K GUIDE ST 6.3 / 18 MARCH 2003 10 immediately when the event has come to light. The initial report may also be submitted by telephone, but must later be confirmed in writing. Reporting of hazardous situations to the National Agency for Medicines is prescribed in the Medical Devices Act (1505/1994). 14 Bibliography 1 European Commission. Criteria for acceptability of radiological (including radiotherapy) and nuclear medicine installations. Radiation protection 91. Luxembourg: Office for official Publications of the European Communities; 1997*). 2 European Commission. Radiation Protection following iodine-131 therapy (Exposures due to out-patients and discharged in-patients). Radiation protection 97. Luxembourg: Office for official Publications of the European Communities; 1998. 3 European Commission. Guidance on medical exposures in medical and biomedical research. Radiation protection 99. Luxembourg: Office for official Publications of the European Communities; 1998. 4 European Commission. Guidance for protection of unborn children and infants irradiated due to parental medical exposure. Radiation protection 100. Luxembourg: Office for official Publications of the European Communities; 1998. 5 European Commission.Guidance on diagnostic reference levels (DRLs) for medical exposures. Radiation protection 109. Luxembourg: Office for official Publications of the European Communities; 1999. 6 International Commission on Radiological Protection. Protection of the Patient in Nuclear Medicine. ICRP Publication 52. Oxford: Pergamon Press; 1987. 7 International Commission on Radiological Protection. Radiological Protection in Bio- medical Research and Addendum 1 to Publication 53 – Radiation Dose to Patients from Radiopharmaceuticals. ICRP Publication 62. Oxford: Pergamon Press; 1993. 8 International Commission on Radiological Protection. Radiation Dose to Patients from Radiopharmaceuticals, Addendum to ICRP 53, also includes Addendum 1 to ICRP Publication 72. ICRP Publication 80. Oxford: Pergamon Press; 1998. 9 Documents of the NRPB. Guidelines on Patient Dose to Promote the Optimisation of Protection for Diagnostic Medical Exposure. Report of an Advisory Group on Ionising Radiation 1999; 10 (1). 10 NEMANU1-2001.PerformanceMeasurements of Scintillation Cameras. NEMA National Electrical Manufacturers’ Association; 2001. 11 NEMA NU 2-2001. Performance Measure- ments of Positron Emission Tomographs. NEMA National Electrical Manufacturers’ Association; 2001. 12 Hart GC, Smith AH ed. Quality Standards in Nuclear medicine. Report 65. IPSM–The Institute of Physical Sciences in Medicine; 1992. 13 Radiopharmacy. Preparation and control of radiopharmaceuticals in hospitals. Nordic guidelines. NLN Publication no 26. Uppsala: Nordiska Läkemedelsnämnden; 1989. 14 Working Party of the Radiation Protection Committee of the British Institute of Radio- logy, including representatives of the Health and Safety Executive, the Department of Health, the Environment Agency and the National Radiological Protection Board. Patients leaving hospital after administration of radioactive substances. The British Journal of Radiology 1999; 72: 121–125. *) European Union radiation protection publications are available on the Internet at www.europa.eu.int/comm/ environment/radprot or from the Academic Bookstore, Keskuskatu 1, 00100 Helsinki, tel. (09) 121 4418, www. akateeminen.com
  11. 11. GUIDE ST 6.3 / 18 MARCH 2003 S T U K 11 APPENDIX A RECORDING OF DATA WHEN DETERMINING THE MEAN ACTIVITIES OF RADIOPHARMACEUTICALS TO BE ADMINISTERED TO PATIENTS Examination Type of examination Apparatus Gamma camera • Manufacturer and type • Number of gamma camera heads • Collimator type • Imaging type (planar, SPECT, etc.) • Sensitivity (cps/MBq) Uptake measurements • Manufacturer and type of detector • Sensitivity (cps/MBq) Activity meter • Manufacturer and type • Accuracy (%) Date Radiopharmaceutical • Radionuclide and chemical form • Mean activity administered to the patients • Average time between administering activity and beginning imaging • Average imaging time • Weight of patients (when this affects the activity administered) • Other factors affecting the mean activity administered to the patient For each patient • Activity of the radiopharmaceutical administered to the patient • Weight of the patient • Time between administering activity and beginning imaging • Imaging time
  12. 12. S T U K GUIDE ST 6.3 / 18 MARCH 2003 12 APPENDIX B ACCEPTANCE CRITERIA FOR GAMMA CAMERAS AND ACTIVITY METERS*) Gamma camera (high resolution collimator – 99mTc) Uniformity Variation should be less than ± 10% within used field. Test to be performed both with and without the collimator at a specified energy window (E ± 10%). Sensitivity Sensitivity (ability to detect the gamma rays emitted from a radioactive source in cps/MBq) should not deviate by more than ± 20% from the baseline value. Centre of rotation (SPECT) The deviation in centre of rotation should be stable within limits of 0.5 pixels. Multi-headed camera Sensitivity Sensitivity differences between any of the heads should be less than ± 10%. Geometry Pixel by pixel correspondence of opposed views should be within 0.5 pixels (when matrix size is 64 x 64). Activity meter (dose calibrator) Linearity Linearity should be better than ± 5% over the range of activities used. Reproducibility Reproducibility should be better than ± 5%. Accuracy Accuracy should be better than ± 10% when measuring activities exceeding 3.7 MBq**). Definitions of terms: base line value; parameter reference value Value obtained for this parameter in the initial constancy test performed immediately after the status test, or where described in a corresponding special standard, the mean value of values obtained in a series of initial constancy tests, immediately after a status test. *) European Commission. Radiation protection 91.Criteria for acceptability of radiological (including radiotherapy) and nu- clear medicine installations. **) The activity meter accuracy requirement differs from the recommendation issued in the Radiation Protection 91 publica- tion.
  13. 13. GUIDE ST 6.3 / 18 MARCH 2003 S T U K 13 APPENDIX B Status tests Tests carried out to establish the functional status of equipment at given time. Accuracy Correspondence between the observed value of a quantity and the true value. The percentage of difference between measured value (m) and true value (t) is calculated as follows: 100 x (m-t)/t. Reproducibility Variation in observed values usually for a set of measurements made at different times. Measurements are often performed after a certain period of time. Cf. precision. Precision Variation in observed values usually for a set of measurements made at about the same time.
  14. 14. S T U K GUIDE ST 6.3 / 18 MARCH 2003 14 APPENDIX C RECOMMENDATIONS ON THE DURATION OF INTERRUPTION OR CESSATION OF BREAST-FEEDING*) Length of interruption of breast-feeding following nuclear medicine examination or radionuclide therapy, so that the radiation dose to the child does not exceed 1 mSv. I No interruption usually needed 51Cr EDTA 99mTc DMSA 99mTc DTPA 99mTc diphosphonates 99mTc glucoheptonate 99mTc gluconate 99mTc HMPAO 99mTc MIBI 99mTc tetrophosmin 99mTc sulphur colloid II No interruption needed unless activity applied is higher than stated 99mTc MAG3 (100 MBq) 111I labelled leukocytes (20 MBq) 201Tl chloride (80 MBq) III Length of interruption 99mTc MAA (100 MBq) 12 hours 99mTc pertechnetate (80 MBq) 24 hours 99mTc pertechnetate (800 MBq) 48 hours IV Length of interruption determined on the basis of activity concentration measured in breast milk and biological half-life 99mTc labelled erythrocytes 99mTc aerosol (Technegas) 99mTc MAG3 (> 100 MBq) 99mTc microspheres 99mTc pyrophosphate 123I iodide 123I MIBG 123I hippurate V Breast-feeding must usually be ceased following radionuclide therapy *) These instructions are based on the publication Radiation Protection 100. Guidance for protection of unborn children and infants irradiated due to parental medical exposures.
  15. 15. GUIDE ST 6.3 / 18 MARCH 2003 S T U K 15 APPENDIX D PATIENT LEAVING HOSPITAL AFTER RADIONUCLIDE THERAPY Duration of patient behaviour restrictions after 131I therapy. The patient may be discharged on receipt of radiation protection instructions after the residual 131I activity in the patient no longer exceeds 800 MBq. Patient may use public transport for journeys of about one hour. Autopsy may be performed without radiation protection measures after the residual 131I activity in the patient no longer exceeds 600 MBq. When using beta emitting radionuclides, such as 32P, 89Sr and 90Y, no radiation protection measures are necessary after the residual activity in the patient no longer exceeds 200 MBq. Residual 131 I activity in patient 30–400 (MBq) 400–600 (MBq) 600–800 (MBq) Restriction to be observed after 131 I therapy Avoidance of close contact with small chil- dren and pregnant women. 9 days 12 days 14 days Avoidance of sustained (over 3 hours) close contact with small children and pregnant women. 21 days 25 days 27 days Avoidance of sleeping in the same bed with an adult. - 4 days 8 days

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