INTERNATIONAL RECOMMENDATIONS FOR RADIATION PROTECTION IN DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY

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1 INTERNATIONAL RECOMMENDATIONS FOR RADIATION PROTECTION IN DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY Jenia Vassileva, Ph.D. Radiation Protection Specialist Radiation Protection of Patients Unit Division of Radiation, Waste and Transport Safety International Atomic Energy Agency, Vienna, Austria

International Atomic Energy Agency World's centre for

secure and peaceful use of nuclear technologies Established

Nations Headquarters in Vienna, Austria Winner of Nobel Peace

2 International Atomic Energy Agency World's centre for cooperation in the nuclear field Seeks to promote the safe, secure and peaceful use of nuclear technologies Established in 1957 as an autonomous organization under the United Nations Headquarters in Vienna, Austria Winner of Nobel Peace Prize in Member States Secretariat: 2500 staff from > 125 countries 2

3 Statute of the IAEA The Agency shall seek to accelerate and enlarge the contribution of atomic energy to peace, health and prosperity throughout the world. To establish or adopt standards of safety for protection of health and minimization of danger to life and to provide for the application of these standards

4 Outline Why safety standards for medical applications? International Safety Standards IAEA resources for diagnostic and interventional radiology

5 Global trends The use of radiation in medicine has brought tremendous benefits to the global population

6 Global trends More can be done with radiation in medicine More equipment More complex equipment New technologies and techniques New role of imaging Single slice CT Multi-Detector CT Film Computed & Digital Radiography Hybrid imaging, PET-CT Image-guided interventional procedures PACS, RIS Tomosynthesis, Cone beam CT IMRT, IGRT in radiotherapy, etc Access vary around the world Issues vary around the world

7 Global trends Global increase of radiation use ounscear 2008: worldwide, 4 billion diagnostic, interventional and NM radiological procedures and undertaken annually

$1980: 3 million CTs 2005: 63 million CTs A significant fraction$

8 Global trends Growth of high-dose proceds CT (2->20 msv) Fluoroscopy guided interventions (<1 100 msv) Cardiac NM (- 40 msv) United States 1980: 3 million CTs 2005: 63 million CTs A significant fraction (20-50% in some areas) of radiological examination may be medically inappropriate

9 Global trends Repeated high dose procedures on the same patient Considerable number of individuals subjected to cumulative doses >100 msv Jaffe et al. AJR 2007, 189(5): % of patients had > 10 CT scans Richard and Sodickson. AJR 2009, 192: Multiple CT studies: mean 13.4, maximum 70 Sodickson et al. Radiology 2009, 251: years, patients 33% of patents > 5 CTs 5% of patients > CTs 15% received > 100 msv 5% received > 250 msv De Mauri et al. J Am Soc Nephrol 2011, 22: haemodialysis patients in 3 years 22 pat: msv/y 11 pat: > 50 msv/y 17 (16%): total cumulative dose > 100 msv

CTDI vol values (max/min) Head CT: between 3.3 (>5-10 y) and 18 (<10-15 y) Chest CT: between 6.

10 Global trends Patient doses vary greatly, use of non-optimized protocols IAEA survey of practice in paediatric radiology (40 countries, 126 hospitals, 146 CT facilities) olarge variations between average CTDI vol values (max/min) Head CT: between 3.3 (>5-10 y) and 18 (<10-15 y) Chest CT: between 6.4 (>5-10y) and 22.3 (>10-15y) Abdomen CT: between 6.4 (>10-15y) and 13.4 (>5-10y) oadult protocols often used for children

staff Human errors (improper calibration or improper use) Lack of knowledge or

11 Global trends Tissue reactions (deterministic effects) in diagnostic and interventional radiology Interventional radiology Computed tomography Cataract in staff Human errors (improper calibration or improper use) Lack of knowledge or experience Lack of awareness Lack of resources, support or safety culture 151 CT scans in 65 min

12 Do more good than harm Primum non nocere Radiation saves lives Radiation can cause harm Short-term effects (deterministic) Long-term effects (stochastic) - Carcinogenesis - Hereditary effects - Effects in the embryo/foetus ICRP principles of radiation protection Justification Optimization Dose limits (don t apply to medical exposures)

13 Outline Why standards? International Safety Standards IAEA resources for diagnostic and interventional radiology

14 International Safety Standards IAEA Essential principles (moral obligation) Effects of radiation (UNSCEAR) Recommendations for protection (ICRP) IAEA Essential requirements (legal obligation)

assistance from the IAEA o Used as template for many national regulations Safety Guide on Radiation Protection and Safety in Medical Uses

15 International Safety Standards International Basic Safety Standards (GSR Part 3) o Published 2014, replacing the old BSS from 1996 o Co-sponsored by 8 international organizations o Set basic requirements for protection and safety o Mandatory for MS receiving technical assistance from the IAEA o Used as template for many national regulations Safety Guide on Radiation Protection and Safety in Medical Uses of Ionizing Radiation o Provides guidance on fulfilling the BSS requirements in medical settings o Under development, target publication early 2018

16 Medical use of ionizing radiation Diagnostic radiology Interventional radiology Nuclear medicine Radiotherapy

17 Categories of exposure (International BSS) Occupational exposure Workers Public exposure Member of public Medical exposure Patients Carers and comforters Volunteers in a programme of biomedical research Justification Optimization Dose limits Justification Optimization Dose limits Justification Optimization

18 Roles and responsibilities State Government Regulatory body Health authority Professional bodies Medical radiation facility Registrant or licensee/employer Radiological medical practitioner Medical radiation technologist Medical physicist Radiopharmacists, Radiochemists, Dosimetrists, Engineers, IT specialist Ethic committee Radiation protection officer Suppliers of sources, equipment and software Maintenance and servicing organizations Referring medical practitioners Patient

- have the prime responsibility for protection and safety, which cannot be delegated.

19 Responsibilities (International BSS) The principal parties responsible for protection and safety: oregistrants or licensees, or the person or organization responsible for facilities and activities - have the prime responsibility for protection and safety, which cannot be delegated. oemployers, in relation to occupational exposure oradiological medical practitioners, in relation to medical exposure

Responsibilities (International BSS) Key persons with crucial roles for radiation protection o specialized in the appropriate area meet the respective education, training and competence requirements

20 Responsibilities (International BSS) Key persons with crucial roles for radiation protection o specialized in the appropriate area meet the respective education, training and competence requirements o competence is assessed by the Member State by having a formal mechanism for registration, accreditation or certification o Sufficient medical personnel and paramedical personnel available Radiological medical practitioner (radiologist) Medical radiation technologists (radiographer) Medical physicists

21 Radiation Protection Principles JUSTIFICATION OPTIMIZATION

Radiation Protection Principles The expected benefits to individuals and to society outweigh the harm JUSTIFICATION Medical exposure: The diagnostic or therapeutic benefits produced by

22 Radiation Protection Principles The expected benefits to individuals and to society outweigh the harm JUSTIFICATION Medical exposure: The diagnostic or therapeutic benefits produced by exposures are weighed against the radiation detriment they might cause, taking into account the benefits and risks of available alternative techniques that do not involve medical exposure

23 Justification of medical exposures 3 levels of justification (ICRP Publ. 73, 1996) Level 1 General justification The use of radiation in medicine Taken for granted accepted as doing more good than harm Level 2 Generic justification Given radiological procedure Health authority in conjunction with appropriate professional bodies Level 3 Individual justification Medical exposure of individual patient Consultation: the radiological medical practitioner and the referring medical practitioner

the individual patient orelevant information from previous radiological procedures Particular attention to be

24 Justification for an individual patient What needs to be considered? oappropriateness of the request ourgency of the procedure ocharacteristics of the exposure ocharacteristics of the individual patient orelevant information from previous radiological procedures Particular attention to be taken for patients who are pregnant or breast-feeding or are paediatric Relevant national or international referral guidelines shall be taken into account

25 Justification for asymptomatic individuals As part of an approved health screening program The health authority in conjunction with appropriate professional bodies For the early detection of disease, but not part of an approved health screening programme 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 radiological procedure.

Justification of medical exposures Difficulties: omedical domain ocomplex issue, many factors orequires holistic approach orequires cooperation Barriers: olack of awareness oself-referral

26 Justification of medical exposures Difficulties: omedical domain ocomplex issue, many factors orequires holistic approach orequires cooperation Barriers: olack of awareness oself-referral opatient demands ofinancial, social, medico-legal pressures odefensive medicine Stakeholders: o Health authorities o Professional bodies o RP authorities o Insurance o Patients Solutions:

27 Optimization of protection Workers and members of the public: Magnitude of individual doses, the number of individuals subject to exposure and the likelihood of exposure are as low as reasonable achievable (ALARA), economic and social factors being taken into account OPTIMIZATION

28 Medical imaging objective: Effective diagnosis Visualization capability Diagnostic accuracy Image production Image interpretation

29 Medical imaging objective: Effective diagnosis Visualization capability = Image quality depends on: imaging modality; equipment: availability; performance; operation Diagnostic accuracy depends on: knowledge and experience; availability of patient history; availability of other clinical information; diagnostic criteria; viewing conditions

30 Radiation risk Radiation risk depends on: imaging modality; equipment: design; performance; operation; human factor: education and training safety culture

31 Attenuation coefficient Image quality and Patient dose bone muscle fat Photon energy, kev Image Contrast SNR Patient dose

Optimization of protection (BSS) In diagnostic and interventional medical exposure: keeping the exposure of patients to the minimum necessary to achieve the required diagnostic or interventional

32 Optimization of protection (BSS) In diagnostic and interventional medical exposure: keeping the exposure of patients to the minimum necessary to achieve the required diagnostic or interventional objective. Optimisation of protection is not minimisation of dose: Too low a radiation dose could be as bad as too high a radiation dose, in that the consequence could be that the images obtained are not of suitable diagnostic quality. It is of paramount importance that the medical exposure leads to the required outcome.

33 Optimization (Diagnostic imaging) Keeping the exposure of patients to the minimum necessary to achieve the required diagnostic objective. Equipment Design Settings Maintenance Calibration Quality control Operation Protocols Proper operation Patient dosimetry Training

34 Equipment design (International BSS) Medical radiological equipment and software that could influence the delivery of medical exposure shall conform to the applicable standards of the IEC and the ISO or to national standards adopted by the regulatory body.

established tolerance limits. Verification of the appropriate physical and clinical factors used in radiological procedures.

35 QA Programme (International BSS) Measurements of the physical parameters of medical radiological equipment made by, or under the supervision of, a medical physicist Implementation of corrective actions if measured values of the physical parameters above are outside established tolerance limits. Verification of the appropriate physical and clinical factors used in radiological procedures. Maintaining records of relevant procedures and results. Periodic checks of the calibration and conditions of operation of dosimetry equipment and monitoring equipment.

Patient dosimetry and DRLs Diagnostic Reference Level (DRL) is a level used in medical imaging to indicate whether, in routine conditions, the dose to the patient or the amount of

36 Patient dosimetry and DRLs Diagnostic Reference Level (DRL) is a level used in medical imaging to indicate whether, in routine conditions, the dose to the patient or the amount of radiopharmaceuticals administered in a specified radiological procedure for medical imaging is unusually high or unusually low for that procedure Establishment of DRL: responsibility of the Government Based on wide scale surveys

37 Vra_hos_TUR Соф_бол_Sie В.Т_бол_TUR Дуп_бол_Sie_ Sof_hos_SIE_41 Sof_hos_MER Соф_бол_CIS Бур_диа_Met Вра_бол_TU Соф_диа_CH Пло_диа_TU Sof_hos_Pre_14 Соф_бол_TU Sof_hos_PhI_ Sof_hos_MER Бур_бол_SIR Кюс_бол_TU Пло_диа_TU Бот_диа_EDR Sof_amb_TU Sof_hos_EDI_ Sof_hos_EDI_ Кюс_бол_Vil_ Соф_бол_Vil_ Соф_бол_PR Габ_бол_TUR Kе, mgy Patient dosimetry and DRLs Example: National survey in Bulgaria, Chest PA min 0.1 mgy max 1.3 mgy average 0.4 mgy median 0.3 mgy 3th quartile 0.5 mgy 13 times

38 Optimization cycle Facility 1 4. Apply changes 1. Asses typical dose in a X-ray room Facility 2 Facility 3 DRLs 3. Image quality adequate? 2. Compare with DRL Facility 4 Facility 5 Facility 6

39 FBP 150 mas IRIS 150 mas 10 mgy FBP 75 mas IRIS 75 mas 5 mgy FBP 40 mas 2.5 mgy IRIS 40 mas

40 Dose management software Commercial and open source To provide standardized and validated data for transfer to vendor neutral archieves

The protocols are best developed using guidelines from national or international professional bodies, and hence

41 Operational considerations Written protocols Developed, adopted and implemented in each radiology facility Specify operational parameters to be used for common diagnostic radiological procedures. The protocols are best developed using guidelines from national or international professional bodies, and hence reflect current best practices. Take into account patient habitus, especially mass. Size specific written protocols for children, from neonates to teenagers

42 Optimization (summary) Components Equipment design and software Responsibility Manufacturer, Supplier, Licensee Calibration QA and QC Dosimetry of patients and DRLs Protocols (technique and parameters) Records keeping Maintenance, Medical physicist Medical physicist, Radiographer, Radiologist Medical physicist, Radiographer, Radiologist, Radiographer, Radiologist, Medical physicist Licensee, Staff Radiological review (Clinical audit) Radiologist, Medical physicist, Radiographer Dose constraints for carers or comforters Licensee, RPO

43 Optimization Optimization is a team work Radiologists, technologists and medical physicists must work together for the best result

44 Outline Why standards? International Safety Standards IAEA resources for diagnostic and interventional radiology

45 From standards to practice

implementation Bonn Call to Action (2012) Bonn Conference (2012), organized by the IAEA

46 Radiation Protection in Medicine The International Action Plan (2002) Born in the Málaga Conference (2001) Requested by the IAEA GC (1999) Steering Panel set up to review the implementation Bonn Call to Action (2012) Bonn Conference (2012), organized by the IAEA in cooperation with WHO 10 actions to improve radiation protection in medicine in the next decade

IAEA support to implementation Providing standards Providing guidance Providing training Safety standards Safety reports Technical documents Public website Training material Training courses

47 IAEA support to implementation Providing standards Providing guidance Providing training Safety standards Safety reports Technical documents Public website Training material Training courses E-learning Webinars Fellowships Giving assistance Knowledge exchange Building awareness Involve in projects Providing tools Direct advice Assessments, missions Meetings, workshops Reporting system Public website Scientific publications Information campaigns Press campaigns Posters AAA International campaign Awareness, Appropriateness, Audit

odifferent resources onews olatest events > 800 000 visits / year 100 updates

48 RPOP website http//rpop.iaea.org Current information for ohealth professionals opatients opublic Access to odifferent resources onews olatest events > visits / year 100 updates during 10 years subscribers to the monthly newsletter New design expected soon RPOP survey to understand the user s needs and improve RPOP

IADMR, IOMP, Image Gently) Patient Radiation

49 Specific guidance Specific guidance on implementation of standards (Safety Reports, TechDocs) New under development: Radiation Protection in Dental Radiology (with WHO, FDI, IADMR, IOMP, Image Gently) Patient Radiation Exposure Monitoring in Medical Imaging (with ICRP, WHO, UNSCEAR, IOMP, DICOM WG28)

50 Poster and leaflets Available in over 20 languages at

Protection in Dental Radiology 2690 registrants to date 905

51 Providing training Free training packages in English, Spanish and Russian E-learning Launched end 2016 Newest: Radiation Protection in Dental Radiology 2690 registrants to date 905 certificates completed. Next step: translation to other languages

in English and 2 in Spanish o Over 2300 participants from 90 MS

52 Free webinars on selected topics in radiation protection in medical uses of ionizing radiation o 14 webinars broadcasted: 12 in English and 2 in Spanish o Over 2300 participants from 90 MS o Recorded webinars available for viewing from:

53 Providing training Training courses and workshops Regional training courses National training courses Main target audience: health professionals in hospitals

for peaceful uses to countries Disburses

54 Giving technical assistance Helps to transfer nuclear and related technologies for peaceful uses to countries Disburses more than $70 million worth of equipment, services, and training per year in more than 100 countries and territories through more than 800 on-going projects National projects Regional projects Interregional projects

and the use of DRLs for the optimization of protection in medical

55 Knowledge exchange Technical meetings 2016: Justification of medical exposure and the use of appropriateness criteria Patient dose monitoring and the use of DRLs for the optimization of protection in medical imaging 2017: Preventing Unintended and Accidental Medical Exposures in Radiology

56 International conference December 2017 Objectives: Review developments since the 2012 Bonn conference, especially actions taken in line with the Bonn Call for Action by all relevant parties Harmonize activities between international organizations and other stakeholders Look ahead at new developments impacting on radiation protection in medicine http//rpop.iaea.org

57 International conference December official nominations 70 invited speakers and session chairs/ rapporteurs 300 accepted abstracts for contributed papers Program: o8 Topical sessions o4 Roundtables o3 Lunchtime Breakout Sessions http//rpop.iaea.org

58 We look forward to welcoming you in Vienna! http//rpop.iaea.org

MEASURES TO STRENGTHEN INTERNATIONAL CO-OPERATION IN NUCLEAR, RADIATION, TRANSPORT AND WASTE SAFETY

MEASURES TO STRENGTHEN INTERNATIONAL CO-OPERATION IN NUCLEAR, RADIATION, TRANSPORT AND WASTE SAFETY International Atomic Energy Agency BOARD OF GOVERNORS GENERAL CONFERENCE Item 13 of the Conference s provisional agenda (GC(46)/1) B GC GOV/2002/36-GC(46)/12 31 July 2002 GENERAL Distr. Original: ENGLISH