Modern principles of the radiation protection from sources of ionizing radiation in medicine. Part 2: radiation risks and development of the system of radiation protection

According to the Decree of the President of the Russian Federation №585, 13.10.2018, the main approaches to the provision of the radiation safety of the public of the Russian Federation from the use of the sources of ionizing radiation in medicine are the harmonization of the national legislative documents with the international recommendations and the development of the new and improvement of the existing methods of the assessment of the individual patient doses and corresponding radiation risks. The current study was aimed at the justification of the complex of actions to prevent the unnecessary medical exposure of the Russian population. That required to analyze the existing national and international approaches to the assessment of the radiation risks from medical exposure and the results of the existing epidemiological studies, as well as to assess the risks from the most common and/or high dose X-ray examination (computed tomography, interventional examinations, nuclear medicine) for pediatric and adult patients. It was indicated, that these examinations correspond to the “Low” and “Moderate” radiation risk categories. The level of the lifetime radiation risk of cancer morbidity in the Russian Federation for the computed tomography was estimated as 1 case per 3-30 thousand examinations. The performed analysis of the existing international regulatory and methodical documents indicated the significant differences in the practice of the radiation protection in medicine. International practice is mainly based on the practical application of the principle of justification by using the X-ray examination referral guidelines and various methods of risk communication with patients. Main actions to reduce the patient doses and to improve the diagnostic image quality are performed on the hospital level by medical physicists in collaboration with medical staff and representatives of the vendor. It should be noted that dose limits are not applied to the exposure of healthy individuals from screening X-ray examinations. Based on the results of the comparison of the national and international practices of the radiation protection in medicine, both general and specific (for different X-ray modalities) recommendations for the improvement of the system of the radiation protection of the patients and staff were developed. These recommendations should be implemented on practice in the form of the complex program of the optimization of the radiation protection of the public of the Russian Federation from medical exposure. This program can be developed and implemented through the collaboration of the Federal Service of Surveillance on Consumer Rights Protection and Human Well-being and the Ministry of Healthcare of the Russian Federation.

1. Metz C.E. ROC analysis in medical imaging: a tutorial review of the literature. Radiological physics and technology, 2008, V. 1(1), pp. 2-12.

2. Onischenko G.G., Popova A.Yu., Romanovich I.K., Vodovatov A.V., Bashketova N.S., Istorik O.A., Chipiga L.A., Shatsky I.G., Repin L.V., Biblin A.M. Modern principles of the radiation protection from sources of ionizing radiation in medicine. Part 1: Trends, structure of x-ray diagnostics and doses from medical exposure. Radiatsionnaya Gygiena = Radiation Hygiene, 2019, V. 12(1), pp. 6-24. - Available on: https://doi.org/10.21514/1998-426X-2019-12-1-6-24 (Accessed: 01.04.2019) (In Russian)

3. Verdun F.R., Racine D., Ott J.G., et al. Image quality in CT: From physical measurements to model observers. Physica Medica, 2015, V. 31, pp. 23-843.

4. ICRP Publication 103. The 2007 Recommendations of the International Commission on Radiological Protection: translation from English. Edited by M.F. Kiselev, N.K. Shandala. Moscow, «Alana», 2009, 312 p. (In Russian)

5. Ludewig E., Richter A., Frame M. Diagnostic imaging-evaluating image quality using visual grading characteristic (VGC) analysis. Vet Res Commun., 2010, V. 34, №5, pp. 473-479.

6. International Commission on Radiological Protection. Radiological protection in pediatric diagnostic and interventional radiology. ICRP Publication 121. Ann. ICRP, 2013, V.42(2).

7. European Commission. European Guidelines on Quality Criteria for Diagnostic Radiographic Images. Report EUR 16260. - Luxembourg: Office for Official Publications of the European Communities, 1996, 38 p.

8. International Commission on Radiological Protection. Radiological protection in cardiology. ICRP Publication 120. Ann. ICRP, 2013, V. 42(1).

9. European Commission. European Guidelines on Quality Criteria for Computed Tomography. Report EUR 16262. -Luxembourg: Office for Official Publications of the European Communities, 2000.

10. . Jaschke W., Schmuth M., Trianni A., Bartal G. Radiation-induced skin injuries to patients: what the interventional radiologist needs to know. Cardiovasc Intervent Radiol., 2017, V.40, №8, pp.1131-1140.

11. Walsh C. et al. Quality assurance of computed and digital radiography systems. Pad. Prot. Dos., 2008, V. 129(1-3), pp. 271-275.

12. Sodickson A, Baeyens P, Andriole K, et al. Recurrent CT, cumulative radiation exposure, and associated radiation-induced cancer risks from CT of adults. Radiology, 2009, V.251, №1, pp.175-184.

13. AAPM Imaging Physics Committee Task Group 151. Ongoing quality control in digital radiography: Report of AAPM Imaging Physics Committee Task Group 151. Med. Phys., 2015, V. 42(11), pp. 6658-6670.

14. Ivanov V.K., Kashcheev V.V., Chekin S.Yu., Menyaylo A.N., Pryakhin E.A., Tsyb A.F., Mettler F.A. Estimating the lifetime risk of cancer associated with multiple CT scans. J. Radiol. Prot., 2014, V.34, №4, pp. 825-841. - Available on: DOI: 10.1088/0952-4746/34/4/825. (Accessed: 01.04.2019)

15. American College of Radiology. ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiographic and Fluoroscopic Equipment. Reston, VA, 2006, pp. 1139-1142.

16. Kascheev V.V., Pryahin E.A. Medical diagnostic exposure: problems of the radiation safety. A review. Radiation and risk, 2018, V.27, №4, pp. 49-64.

17. Vodovatov A.V. Improvement of radiation safety standards. Part 1. Appropriateness of the limitation of the medical exposure of healthy individuals. Radiatsionnaya Gygiena = Radiation Hygiene, 2018, V. 11(3), pp. 115-124. - Available on: https://doi.org/10.21514/1998-426X-2018-11-3-115-124 (Accessed: 01.04.2019) (In Russian)

18. Pearce M.S., Salotti J.A., Little M.P et al. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet., 2012, V. 380(9840), pp. 499-505.

19. Balonov M., Golikov V., Zvonova I., Chipiga L., Kalnitsky S., Sarycheva S. and Vodovatov A. Patient doses from medical examinations in Russia: 2009-2015. J. Radiol. Prot., V. 38, pp. 121-140. - Available on: DOI: https://doi.org/10.1088/1361-6498/aa9b99 (Accessed: 24.04.2019)

20. Mathews J.D., Forsythe A.V., Brady Z. et. al. Cancer risk in 680 000 people exposed to computed tomography scans in childhood or adolescence: data linkage study of 11 million Australians. BMJ, 2013, V. 346. - Available on: https://doi.org/10.1136/bmj.f2360 (Accessed: 01.04.2019)

21. Vodovatov A.V., Balonov M.I., Golikov V.Yu., Shatsky I.G., Chipiga L.A., Bernhardsson C. Proposals for the establishment of national diagnostic reference levels for radiography for adult patients based on regional dose surveys in Russian Federation. Rad. Prot. Dos., 2017, V. 173(1-3), pp. 223-232.

22. Huang W.Y, Muo C.H., Lin C.Y et al. Paediatric head CT scan and subsequent risk of malignancy and benign brain tumour: a nation-wide population-based cohort study. British Journal of Cancer, 2014, V.110, pp. 2354-2360. - Available on: doi: 10.1038/bjc.2014.103 (Accessed: 01.04.2019)

23. Chipiga L.A., Bernhardsson C. Patient doses in Computed Tomography examinations in two regions of the Russian Federation. Rad. Prot. Dos., 2016, V. 169(1-4), pp. 240-244.

24. Krille L., Dreger S., Schindel R. et al. Risk of cancer incidence before the age of 15 years after exposure to ionising radiation from computed tomography: results from a German cohort study. Radiat Environ Biophys., 2015, V.54, pp.1-12.

25. Chipiga L.A., Zvonova I.A., Ryzhkova D.V., Menkov M.A., Dolgushin M.B. Levels of patients’ exposure and a potential for optimization of the PET diagnostics in the Russian Federation. Radiatsionnaya Gygiena = Radiation Hygiene, 2017, V. 10(4), pp. 31-43. - Available on: https://doi.org/10.21514/1998-426X-2017-10-4-31-43 (Accessed: 01.04.2019) (In Russian)

26. Journy N., Rehel J.L., Ducou Le Pointe H. et al. Are the studies on cancer risk from CT scans biased by indication? Elements of answer from a large-scale cohort study in France. British Journal of Cancer, 2015, V.112, p.185-193. - Available on: doi: 10.1038/bjc.2014.526 (Accessed: 01.04.2019)

27. Onischenko G.G., Romanovich I.K. Current trends of the provision for radiation safety of the population of the Russian Federation. Radiatsionnaya Gygiena = Radiation Hygiene, 2014, V. 7(4), pp. 5-22. (In Russian)

28. Meulepas J.M., Ronckers C.M., Smets A.M.J.B. et al. Radiation Exposure From Pediatric CT Scans and Subsequent Cancer Risk in the Netherlands. J Natl Cancer Inst., 2019, V. 111, №3.

29. Onischenko G.G., Popova A.Yu., Romanovich I.K., Barkovsky A.N., Kormanovskaya T.A., Shevkun I.G. Radiation-hygienic passportization and USIDC-information basis for management decision making for radiation safety of the population of the Russian Federation Report 2: Characteristics of the sources and exposure doses of the population of the RF. Radiatsionnaya Gygiena = Radiation Hygiene, 2017, V. 10(3), pp. 18-35. - Available on: https://doi.org/10.21514/1998-426X-2017-10-3-18-35 (Accessed: 01.04.2019) (In Russian)

30. Bernier M.O. et al. Cohort Profile: the EPI-CT study: A European pooled epidemiological study to quantify the risk of radiation-induced cancer from pediatric CT. International Journal of Epidemiology, 2018, pp.1-10. - Available on: doi: 10.1093/ije/dyy231 (Accessed: 01.04.2019)

31. Shore R.E. et al. Implications of recent epidemiological studies for the linear nonthreshold model and radiation protection. Journal of radiological protection, 2018, Vol. 38, pp. 1217-1233.

32. Walsh L. et al. Risks from CT scans - what do recent studies tell us? Journal of radiological protection, 2014, Vol. 34, E1-E5.

33. Boice J.D. Radiation epidemiology and recent paediatric computed tomography studies. Annals of ICRP, 2015, Vol. 44, pp. 236-248.

34. International Atomic Energy Agency. Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards. GSR Part 3. Vienna: IAEA, 2015, 518 p. (in Russian)

35. International Atomic Energy Agency. Radiation Protection and Safety in Medical Uses of Ionizing Radiation. Specific Safety Guide №SSG-46. - Vienna: IAEA, 2018, 340 p.

36. International Commission on Radiological Protection. Radiation Protection in Medicine. ICRP Publication 105. Russian translation under M. Balonov. Saint-Petersburg, NIIRG, 2011,66 p. (in Russian)

37. ICRP Publications: - Available on: http://www.icrp.org/page.asp?id=5 (Accessed: 24.04.2019)

38. United Nations Scientific Committee on the Effects of Atomic Radiation. UNSCEAR 2008 Report to the General Assembly with Scientific Annexes. Sources and Effects of Ionizing Radiation - V.I - Annex A. Medical radiation exposures. NY: United Nations, 2010, 143 p.

39. International Commission on Radiological Protection. Radiological Protection in Ion Beam Radiotherapy. ICRP Publication 127.Ann. ICRP, 2014, V.43, №4.

40. International Commission on Radiological Protection. Preventing Accidental Exposures from New External Beam Radiation Therapy Technologies. ICRP Publication 112. Ann. ICRP, 2009, V.39, №4.

41. Loreti G., Delis H., Healy B. et al. IAEA education and training activities in medical physics. Medical physics international Journal, 2015, V.3, №2, pp. 81-86.

42. Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom: -Available on: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02013L0059-20140117&from=EN (Accessed: 24.04.2019)

43. Overview of EU radiation protection legislation. - Available on: https://ec.europa.eu/energy/en/overview-eu-radiation-protection-legislation (Accessed: 24.04.2019)

44. Digital Imaging and Communication in Medicine. - Available on: https://www.dicomstandard.org/current/ (Accessed: 24.04.2019)

45. NEMA Medical Imaging Standards. - Available on: htt-ps://www.nema.org/Standards/Pages/All-Standards-by-Product.aspx?ProductId=6c490050-e74a-4366-bca5-f7e-40fa714f6 (Accessed: 24.04.2019)

46. iRefer. Making the best use of clinical radiology. - Available on: https://www.irefer.org.uk/ (Accessed: 24.04.2019)

47. Appropriateness criteria. - Available on: https://acsearch.acr.org/list (Accessed: 24.04.2019)

48. European Commission. Radiation Protection №178. Referral Guidelines for Medical Imaging Availability and Use in the European Union. -Luxembourg: Publications Office of the European Union, 2014, 52 p.

49. ESR iGuide. Clinical Decision Support. - Available on: https://www.myesr.org/esriguide (Accessed: 24.04.2019)

50. Huber T.C., Krishnaraj A., Patrie J., Gaskin C.M. Impact of a Commercially Available Clinical Decision Support Program on Provider Ordering Habits. Journal of the American College of Radiology, V. 15, Issue 7, pp. 951 - 957.

51. Raja A.S. et al. Effect of Computerized Clinical Decision Support on the Use and Yield of CT Pulmonary Angiography in the Emergency Department. Radiology, V. 262, Number 2, pp. 468-474.

52. Lacson R. et al. Assessing strength of evidence of appropriate use criteria for diagnostic imaging examinations. Journal of the American Medical Informatics Association, 2016, V. 23, №3, pp. 649-653.

53. World health organization. Communicating radiation risks in pediatric imaging. Information to support healthcare discussions about benefit and risk. Geneva, 2016, 90 p.

54. International Commission on Radiological Protection. Ethical foundations of the system of radiological protection. ICRP Publication 138. Ann. ICRP, 2018, V. 47, №1.

55. Repin L.V., Biblin A.M., Vishnyakova N.M. Problems of risk communication related to the provision of the radiation safety. Basic concepts and definitions. Radiatsionnaya Gygiena = Radiation Hygiene, 2018, V. 11(3), pp. 83-91. - Available on: https://doi.org/10.21514/1998-426X-2018-11-3-83-91(Accessed: 1.04.2019) (In Russian)

56. Frush D. P Radiation, Risks, and ... a Rational Approach in Diagnostic Imaging: What the Radiology Team Should Know. Journal of Radiology Nursing, 2017, V. 36, pp. 10-14.

57. Ahmed H. et al. Communicating risk. British Medical Journal, 2012, V. 344, pp. 1-7.

58. Fagerlin A., Zikmund-Fisher B.J. and Ubel P.A. Helping Patients Decide: Ten Steps to Better Risk Communication. J Natl Cancer Inst., 2011, V. 103, pp. 1436-1443.

59. Picano E. Informed consent and communication of risk from radiological and nuclear medicine examinations: how to escape from a communication inferno. BMJ, 2004, V. 329, pp. 849-851.

60. Brook O. et al. Measuring and improving the patient experience in radiology. Abdom Radiol., 2016. - Available on: DOI: 10.1007/s00261-016-0960-z (Accessed: 24.04.2019)

61. Kastraie N. et al. Optimizing Communication With Parents on Benefits and Radiation Risks in Pediatric Imaging. J Am Coll Radiol., 2018, V. 15, pp. 809-817.

62. Jarvinen H., Vassileva J., Samei E., Wallace A, Vano E. and Rehani M., Patient dose monitoring and the use of diagnostic reference levels for the optimization of protection in medical imaging: current status and challenges worldwide. Journal of Medical Imaging, 2017, V. 4, №3.

63. Martin C.J. The Importance of Radiation Quality for Optimisation in Radiology. Biomedical Imaging and Intervention Journal, 2007, V. 3.2, pp. 38.

64. Vodovatov A.V. Practical implementation of the diagnostic reference levels concept for the common radiographic examinations. Radiatsionnaya Gygiena = Radiation Hygiene, 2017, V. 10(1), pp. 47-55. - Available on: https://doi.org/10.21514/1998-426X-2017-10-1-47-55 (Accessed: 01.04.2019 (In Russian)

65. European Commission. Radiation protection № 180 part 1/2. Medical Radiation Exposure of the European Population. Luxembourg, 2014, 181 p.

66. Hart D., Hilier M.C., Shrimpton PC. Doses to Patients from Radiographic and Fluoroscopic X-ray Imaging Procedures in the UK - 2010 Review. HpA-CRCE-034. Health Protection Agency, 2012, 87 p.

67. Region-wide dose monitoring increases patient safety. -Available on: https://sectra.com/medical/case/region-wide-dose-monitoring-increases-patient-safety/ (Accessed: 24.04.2019)

68. Sectra DoseTrack. - Available on: https://sectra.com/medi-cal/product/sectra-dosetrack/ (Accessed: 13.11.2018)

69. Aavik A., Allik T., Nazarenko S., Paats A. National PACS Programme in Estonia - Results and Successes. Health Management, 2007, V. 7, №2. - Available on: https://health-management.org/c/imaging/issuearticle/national-pacs-programme-in-estonia-results-and-successes (Accessed: 13.11.2018)

70. Nation-wide PACS system in Estonia. - Available on: http://mug.ee/ehealth/presentations/Andrus_Paats.pdf (Accessed: 13.11.2018)

71. Mattsson S. Need for individual cancer risk estimates in X-ray and nuclear medicine imaging. Pad. Prot. Dos., 2016, V. 169(1-4), pp. 11-16.

72. Metz C.E. ROC analysis in medical imaging: a tutorial review of the literature. Radiological physics and technology, 2008, V. 1(1), pp. 2-12.

73. Verdun F.R., Racine D., Ott J.G., et al. Image quality in CT: From physical measurements to model observers. Physica Medica, 2015, V. 31, pp. 23-843.

74. Ludewig E., Richter A., Frame M. Diagnostic imaging-evaluating image quality using visual grading characteristic (VGC) analysis. Vet Res Commun., 2010, V. 34, №5, pp. 473-479.

75. European Commission. European Guidelines on Quality Criteria for Diagnostic Radiographic Images. Report EUR 16260. - Luxembourg: Office for Official Publications of the European Communities, 1996, 38 p.

76. European Commission. European Guidelines on Quality Criteria for Computed Tomography. Report EUR 16262. -Luxembourg: Office for Official Publications of the European Communities, 2000.

77. Walsh C. et al. Quality assurance of computed and digital radiography systems. Pad. Prot. Dos., 2008, V. 129(1-3), pp. 271-275.

78. AAPM Imaging Physics Committee Task Group 151. Ongoing quality control in digital radiography: Report of AAPM Imaging Physics Committee Task Group 151. Med. Phys., 2015, V. 42(11), pp. 6658-6670.

79. American College of Radiology. ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiographic and Fluoroscopic Equipment. Reston, VA, 2006, pp. 1139-1142.

80. Vodovatov A.V. Improvement of radiation safety standards. Part 1. Appropriateness of the limitation of the medical exposure of healthy individuals. Radiatsionnaya Gygiena = Radiation Hygiene, 2018, V. 11(3), pp. 115-124. - Available on: https://doi.org/10.21514/1998-426X-2018-11-3-115-124 (Accessed: 01.04.2019) (In Russian)

81. Balonov M., Golikov V., Zvonova I., Chipiga L., Kalnitsky S., Sarycheva S. and Vodovatov A. Patient doses from medical examinations in Russia: 2009-2015. J. Radiol. Prot., V. 38, pp. 121-140. - Available on: DOI: https://doi.org/10.1088/1361-6498/aa9b99 (Accessed: 24.04.2019)

82. Vodovatov A.V., Balonov M.I., Golikov V.Yu., Shatsky I.G., Chipiga L.A., Bernhardsson C. Proposals for the establishment of national diagnostic reference levels for radiography for adult patients based on regional dose surveys in Russian Federation. Rad. Prot. Dos., 2017, V. 173(1-3), pp. 223-232.

83. Chipiga L.A., Bernhardsson C. Patient doses in Computed Tomography examinations in two regions of the Russian Federation. Rad. Prot. Dos., 2016, V. 169(1-4), pp. 240-244.

84. Chipiga L.A., Zvonova I.A., Ryzhkova D.V., Menkov M.A., Dolgushin M.B. Levels of patients’ exposure and a potential for optimization of the PET diagnostics in the Russian Federation. Radiatsionnaya Gygiena = Radiation Hygiene, 2017, V. 10(4), pp. 31-43. - Available on: https://doi.org/10.21514/1998-426X-2017-10-4-31-43 (Accessed: 01.04.2019) (In Russian)

85. Onischenko G.G., Romanovich I.K. Current trends of the provision for radiation safety of the population of the Russian Federation. Radiatsionnaya Gygiena = Radiation Hygiene, 2014, V. 7(4), pp. 5-22. (In Russian)

86. Onischenko G.G., Popova A.Yu., Romanovich I.K., Barkovsky A.N., Kormanovskaya T.A., Shevkun I.G. Radiation-hygienic passportization and USIDC-information basis for management decision making for radiation safety of the population of the Russian Federation Report 2: Characteristics of the sources and exposure doses of the population of the RF. Radiatsionnaya Gygiena = Radiation Hygiene, 2017, V. 10(3), pp. 18-35. - Available on: https://doi.org/10.21514/1998-426X-2017-10-3-18-35 (Accessed: 01.04.2019) (In Russian)