The International Atomic Energy Agency action plan on radiation protection of patients and staff in interventional procedures: Achieving change in practice.

INTRODUCTION: The International Atomic Energy Agency (IAEA) organized the 3rd international conference on radiation protection (RP) of patients in December 2017. This paper presents the conclusions on the interventional procedures (IP) session. MATERIAL AND METHODS: The IAEA conference was conducted as a series of plenary sessions followed by various thematic sessions. "Radiation protection of patients and staff in interventional procedures" session keynote speakers presented information on: 1) Risk management of skin injuries, 2) Occupational radiation risks and 3) RP for paediatric patients. Then, a summary of the session-related papers was presented by a rapporteur, followed by an open question-and-answer discussion. RESULTS: Sixty-seven percent (67%) of papers came from Europe. Forty-four percent (44%) were patient studies, 44% were occupational and 12% were combined studies. Occupational studies were mostly on eye lens dosimetry. The rest were on scattered radiation measurements and dose tracking. The majority of patient studies related to patient exposure with only one study on paediatric patients. Automatic patient dose reporting is considered as a first step for dose optimization. Despite efforts, paediatric IP radiation dose data are still scarce. The keynote speakers outlined recent achievements but also challenges in the field. Forecasting technology, task-specific targeted education from educators familiar with the clinical situation, more accurate estimation of lens doses and improved identification of high-risk professional groups are some of the areas they focused on. CONCLUSIONS: Manufacturers play an important role in making patients safer. Low dose technologies are still expensive and manufacturers should make these affordable in less resourced countries. Automatic patient dose reporting and real-time skin dose map are important for dose optimization. Clinical audit and better QA processes together with more studies on the impact of lens opacities in clinical practice and on paediatric patients are needed.

The mandate and work of ICRP Committee 3 on radiological protection in medicine.

The mandate of Committee 3 of the International Commission on Radiological Protection (ICRP) is concerned with the protection of persons and unborn children when ionising radiation is used in medical diagnosis, therapy, and biomedical research. Protection in veterinary medicine has been newly added to the mandate. Committee 3 develops recommendations and guidance in these areas. The most recent documents published by ICRP that relate to radiological protection in medicine are 'Radiological protection in cone beam computed tomography' (ICRP Publication 129) and 'Radiological protection in ion beam radiotherapy' (ICRP Publication 127). A report in cooperation with ICRP Committee 2 entitled 'Radiation dose to patients from radiopharmaceuticals: a compendium of current information related to frequently used substances' (ICRP Publication 128) has also been published. 'Diagnostic reference levels in medical imaging' (ICRP Publication 135), published in 2017, provides specific advice on the setting and use of diagnostic reference levels for diagnostic and interventional radiology, digital imaging, computed tomography, nuclear medicine, paediatrics, and multi-modality procedures. 'Occupational radiological protection in interventional procedures' was published in March 2018 as ICRP Publication 139. A document on radiological protection in therapy with radiopharmaceuticals is likely to be published in 2018. Work is in progress on several other topics, including appropriate use of effective dose in collaboration with the other ICRP committees, guidance for occupational radiological protection in brachytherapy, justification in medical imaging, and radiation doses to patients from radiopharmaceuticals (an update to ICRP Publication 128). Committee 3 is also considering the development of guidance on radiological protection in medicine related to individual radiosusceptibility, in collaboration with ICRP Committee 1.

ICRP Publication 135: Diagnostic Reference Levels in Medical Imaging.

Abstract ­: The International Commission on Radiological Protection (ICRP) first introduced the term 'diagnostic reference level' (DRL) in 1996 in Publication 73. The concept was subsequently developed further, and practical guidance was provided in 2001. The DRL has been proven to be an effective tool that aids in optimisation of protection in the medical exposure of patients for diagnostic and interventional procedures. However, with time, it has become evident that additional advice is needed. There are issues related to definitions of the terms used in previous guidance, determination of the values for DRLs, the appropriate interval for re-evaluating and updating these values, appropriate use of DRLs in clinical practice, methods for practical application of DRLs, and application of the DRL concept to newer imaging technologies. This publication is intended as a further source of information and guidance on these issues. Some terminology has been clarified. In addition, this publication recommends quantities for use as DRLs for various imaging modalities, and provides information on the use of DRLs for interventional procedures and in paediatric imaging. It suggests modifications in the conduct of DRL surveys that take advantage of automated reporting of radiation-dose-related quantities, and highlights the importance of including information on DRLs in training programmes for healthcare workers. The target audience for this publication is national, regional, and local authorities; professional societies; and facilities that use ionising radiation for medical purposes, and responsible staff within these facilities. A full set of the Commission's recommendations is provided.

Lessons from two cases of radiation induced skin injuries in fluoroscopic procedures in Bulgaria.

BACKGROUND: Radiation-induced injuries to patient skin as a result of fluoroscopy guided interventional procedures are infrequently reported, often misdiagnosed and there is a need to learn lessons from every injury. METHODS: This paper describes two cases of radiation induced skin injuries that are, to the best of our knowledge, the first ever reported cases from Bulgaria and possibly from Eastern Europe, and would thus have educational value. RESULTS: The important messages from the skin injuries reported here are: lack of awareness among part of the interventional specialists about the potential for radiation induced skin injury, misdiagnosis after injury happened because of lack of awareness and knowledge among general physicians, dermatologists and surgeons who followed up cases of skin injuries; the lack of system to monitor patients with relatively high exposure; the important role played by the medical physicist in diagnosing the injury and overall in initiating actions; the role of training and informational material displayed in interventional facilities. CONCLUSIONS: For avoidance of skin injuries from interventional procedures it is of utmost importance to implement a system that includes (a) regular monitoring of radiation dose parameters of the procedure; (b) established trigger values for reporting;

Overview of ICRP Committee 3: protection in medicine.

Committee 3 of the International Commission on Radiological Protection (ICRP) develops recommendations and guidance for protection of patients, staff, and the public against radiation exposure when ionising radiation is used for medical diagnosis, therapy, or biomedical research. This paper presents a summary of the work that Committee 3 has accomplished over the past few years, and also describes its current work. The most recent reports published by the Commission that relate to radiological protection in medicine are 'Radiological protection in cone beam computed tomography' (Publication 129), 'Radiation dose to patients from radiopharmaceuticals: a compendium of current information related to frequently used substances' (Publication 128, in cooperation with Committee 2), 'Radiological protection in ion beam radiotherapy' (Publication 127), 'Radiological protection in paediatric diagnostic and interventional radiology' (Publication 121), 'Radiological protection in cardiology' (Publication 120), and 'Radiological protection in fluoroscopically guided procedures outside the imaging department' (Publication 117). A new report on diagnostic reference levels in medical imaging will provide specific advice for interventional radiology, digital imaging, computed tomography, nuclear medicine, paediatrics, and hybrid (multi-modality) imaging procedures, and is expected to be published in 2016. Committee 3 is also working on guidance for occupational radiological protection in brachytherapy, and on guidance on occupational protection issues in interventional procedures, paying particular attention to the 2011 Commission's recommendations on the occupational dose limit for the lens of the eye (Publication 118). Other reports in preparation deal with justification, radiological protection in therapy with radiopharmaceuticals, radiological protection in medicine as related to individual radiosusceptibility, appropriate use of effective dose (in cooperation with other Committees), and guidance for healthcare practitioners on radiological and patient protection. Committee 3 has also suggested specific priorities for research on radiological protection in medicine to the Commission.

Radiological Protection in Cone Beam Computed Tomography (CBCT). ICRP Publication 129.

The objective of this publication is to provide guidance on radiological protection in the new technology of cone beam computed tomography (CBCT). Publications 87 and 102 dealt with patient dose management in computed tomography (CT) and multi-detector CT. The new applications of CBCT and the associated radiological protection issues are substantially different from those of conventional CT. The perception that CBCT involves lower doses was only true in initial applications. CBCT is now used widely by specialists who have little or no training in radiological protection. This publication provides recommendations on radiation dose management directed at different stakeholders, and covers principles of radiological protection, training, and quality assurance aspects. Advice on appropriate use of CBCT needs to be made widely available. Advice on optimisation of protection when using CBCT equipment needs to be strengthened, particularly with respect to the use of newer features of the equipment. Manufacturers should standardise radiation dose displays on CBCT equipment to assist users in optimisation of protection and comparisons of performance. Additional challenges to radiological protection are introduced when CBCT-capable equipment is used for both fluoroscopy and tomography during the same procedure. Standardised methods need to be established for tracking and reporting of patient radiation doses from these procedures. The recommendations provided in this publication may evolve in the future as CBCT equipment and applications evolve. As with previous ICRP publications, the Commission hopes that imaging professionals, medical physicists, and manufacturers will use the guidelines and recommendations provided in this publication for implementation of the Commission's principle of optimisation of protection of patients and medical workers, with the objective of keeping exposures as low as reasonably achievable, taking into account economic and societal factors, and consistent with achieving the necessary medical outcomes.

A study to establish international diagnostic reference levels for paediatric computed tomography.

The article reports results from the largest international dose survey in paediatric computed tomography (CT) in 32 countries and proposes international diagnostic reference levels (DRLs) in terms of computed tomography dose index (CTDI vol) and dose length product (DLP). It also assesses whether mean or median values of individual facilities should be used. A total of 6115 individual patient data were recorded among four age groups: <1 y, >1-5 y, >5-10 y and >10-15 y. CTDIw, CTDI vol and DLP from the CT console were recorded in dedicated forms together with patient data and technical parameters. Statistical analysis was performed, and international DRLs were established at rounded 75th percentile values of distribution of median values from all CT facilities. The study presents evidence in favour of using median rather than mean of patient dose indices as the representative of typical local dose in a facility, and for establishing DRLs as third quartile of median values. International DRLs were established for paediatric CT examinations for routine head, chest and abdomen in the four age groups. DRLs for CTDI vol are similar to the reference values from other published reports, with some differences for chest and abdomen CT. Higher variations were observed between DLP values, based on a survey of whole multi-phase exams. It may be noted that other studies in literature were based on single phase only. DRLs reported in this article can be used in countries without sufficient medical physics support to identify non-optimised practice. Recommendations to improve the accuracy and importance of future surveys are provided.

Patient grouping for dose surveys and establishment of diagnostic reference levels in paediatric computed tomography.

There has been confusion in literature on whether paediatric patients should be grouped according to age, weight or other parameters when dealing with dose surveys. The present work aims to suggest a pragmatic approach to achieve reasonable accuracy for performing patient dose surveys in countries with limited resources. The analysis is based on a subset of data collected within the IAEA survey of paediatric computed tomography (CT) doses, involving 82 CT facilities from 32 countries in Asia, Europe, Africa and Latin America. Data for 6115 patients were collected, in 34.5 % of which data for weight were available. The present study suggests that using four age groups, <1, >1-5, >5-10 and >10-15 y, is realistic and pragmatic for dose surveys in less resourced countries and for the establishment of DRLs. To ensure relevant accuracy of results, data for >30 patients in a particular age group should be collected if patient weight is not known. If a smaller sample is used, patient weight should be recorded and the median weight in the sample should be within 5-10 % from the median weight of the sample for which the DRLs were established. Comparison of results from different surveys should always be performed with caution, taking into consideration the way of grouping of paediatric patients. Dose results can be corrected for differences in patient weight/age group.

Radiation effects and risks: overview and a new risk perception index.

Uncertainty provides opportunities for differences in perception, and radiation risks at low level of exposures involved in few computed tomography scans fall in this category. While there is good agreement among national and international organisations on risk probability of cancer, risk perception has barely been dealt with by these organisations. Risk perception is commonly defined as the subjective judgment that people make about the characteristics and severity of a risk. Severity and latency are important factors in perception. There is a need to connect all these. Leaving risk perception purely as a subjective judgement provides opportunities for people to amplifying risk. The author postulates a risk perception index as severity divided by latency that becomes determining factor for risk perception. It is hoped that this index will bring rationality in risk perception.

Looking into future: challenges in radiation protection in medicine.

Radiation protection in medicine is becoming more and more important with increasing wider use of X-rays, documentation of effects besides the potential for long-term carcinogenic effects. With computed tomography (CT) likely to become sub-mSv in coming years, positron emission tomography (PET), single photon emission computed tomography (SPECT) and some of the nuclear medical examination will become focus of attraction as high-dose examinations, even though they are less-frequent ones. Clarity will be needed on radiation effects at levels of radiation doses encountered in a couple of CT scans and if effects are really cumulative. There is challenge to develop radiation metrics that can be used as easily as units of temperature and length and avoidance of multiple meaning of a single dose metric. Other challenges include development of biological indicators of radiation dose, transition from dose to a representative phantom to dose to individual patient, system for tracking of radiation exposure history of patient, avoidance of radiation-induced skin injury in patients and radiation cataract in staff, cutting down inappropriate referrals for radiological examinations, confidence building in patient and patient safety in radiotherapy.

Overview of ICRP Committee 3 'Protection in Medicine'.

According to the 2011-2017 strategic plan, Committee 3 develops recommendations and guidance for protection of patients, staff, and the public against radiation exposure when ionising radiation is used for medical diagnosis, therapy, or biomedical research. This paper presents an overview of the work that Committee 3 has accomplished in recent years and describes its current work. The International Commission on Radiological Protection reports dealing with radiological protection in medicine from 2000 to the present cover topics on education and training in radiological protection; preventing accidental exposures in radiation therapy; doses to patients from radiopharmaceuticals; radiation safety aspects of brachytherapy; release of patients after therapy with unsealed radionuclides; and managing radiation dose in interventional radiology, digital radiology, computed tomography, paediatrics, cardiology, and other medical specialties. Current work deals with radiological protection in ion beam therapy, occupational protection in brachytherapy, justification in imaging, radiological protection in cone-beam computed tomography, occupational protection in interventional procedures, diagnostic reference levels for diagnostic and interventional imaging, and an update of an earlier publication on doses to patients and staff from radiopharmaceuticals. Committee 3 is also involved in preparation of a document on effective dose and its use in medicine.

Radiological protection in computed tomography and cone beam computed tomography.

The International Commission on Radiological Protection (ICRP) has sustained interest in radiological protection in computed tomography (CT), and ICRP Publications 87 and 102 focused on the management of patient doses in CT and multi-detector CT (MDCT) respectively. ICRP forecasted and 'sounded the alarm' on increasing patient doses in CT, and recommended actions for manufacturers and users. One of the approaches was that safety is best achieved when it is built into the machine, rather than left as a matter of choice for users. In view of upcoming challenges posed by newer systems that use cone beam geometry for CT (CBCT), and their widened usage, often by untrained users, a new ICRP task group has been working on radiological protection issues in CBCT. Some of the issues identified by the task group are: lack of standardisation of dosimetry in CBCT; the false belief within the medical and dental community that CBCT is a 'light', low-dose CT whereas mobile CBCT units and newer applications, particularly C-arm CT in interventional procedures, involve higher doses; lack of training in radiological protection among clinical users; and lack of dose information and tracking in many applications. This paper provides a summary of approaches used in CT and MDCT, and preliminary information regarding work just published for radiological protection in CBCT.

IAEA experience in communicating radiation risks through the RPOP website.

The authors report here their successful experience of communicating information to health professionals, patients and the public on benefits and risks of ionising radiation in medical applications. The approaches used have been based on giving importance to clinical benefits against risks, as well as safety in use against risk of use. Communicating brief messages against catchy questions with positive and pragmatic approach resulted in making website on radiation protection of patients (RPOP) as the top website of the world in this area. Credibility of information has been maintained. The results show immense outreach in 213 countries/territories.

Eye dose assessment and management: overview.

Some publications have shown that Hp(0.07) or even Hp(10) can be used as good operational quantities for X-rays in view of difficulties with Hp(3). With increasing awareness, there is tendency to use whatever dosimeter is available with correction factor to estimate eye lens dose. The best position for an eye lens dosimeter has been reported to be at the side of the head nearest to the radiation source, close to the eye. Recent studies have reported eye doses with cone beam CT (CBCT) both for patients and staff, and there are many papers reporting eye lens doses to staff in nuclear medicine. To minimise the dose to eyes, the user can take advantage of a feature of CBCT of projections acquired over an angular span of 180° plus cone angle of the X-ray tube and with tube under scan arcs.

Tracking of examination and dose: overview.

This paper reviews the developments in tracking of patient exposures and dose after the earlier paper published in the same journal in 2011. A global survey in which 76 countries responded indicated strong interest in programme and another survey among referring physicians showed vast majority (71.7 %) of physicians expressing that awareness of previous history of CT scans would always or mostly lead them to a better decision on referring patients for CT scans. A sizable number of countries have system of assigning permanent ID to individuals and nearly half of them use this ID in medical records. This can easily permit tracking of exposures. Templates for tracking at different levels of health care have been provided, and experience from a country where tracking is routinely practised has been published.

Eye dosimetry in interventional radiology and cardiology: current challenges and practical considerations.

Interventional radiology and cardiology are areas with high potential for risk to eye lens. Accurate assessment of eye dose is one of the most important aspects of correlating doses with observed lens opacities among workers in interventional suites and ascertaining compliance with regulatory limits. The purpose of this paper is to review current approaches and opportunities in eye dosimetry and assess challenges in particular in accuracy and practicality. The possible approaches include practical dosimetry using passive dosemeters or active dosemeters with obvious advantage of active dosimetry. When neither of these is available, other approaches are based on either retrospective dose assessment using scatter radiation dose levels or correlations between patient dose indices and eye doses to the operators. In spite of all uncertainties and variations, estimation of eye dose from patient dose can be accepted as a compromise. Future challenges include development of practical methods for regular monitoring of individual eye doses and development of better techniques to estimate eye dose from measurements at some reference points.

Impact of the X-ray system setting on patient dose and image quality; a case study with two interventional cardiology systems.

This study investigates the influence of the initial X-ray system setting on patient doses and image quality in interventional cardiology procedures. Two dedicated interventional cardiology systems were studied: a system with image intensifier (II) and a flat detector (FD) system. Entrance surface air kerma (ESAK) rates in fluoroscopy and ESAK per frame in the acquisition mode were measured on the surface of a PMMA phantom for the field of views (FOV) of 23 and 17 cm (II system) and 25 and 20 cm (FD system). Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) were estimated using DICOM images obtained during the measurements. System performances were compared using a figure of merit combining SNR and ESAK. The influence of system setting on patient doses was investigated analysing the information for air kerma area product (KAP) and cumulative dose (CD) at the patient entrance reference point, for a sample of coronary angiography examinations. ESAK rates in fluoroscopy modes were a factor of 2 higher in the FD system for the similar FOVs, resulting in a factor of 1.9 higher median values of KAP and CD for patients with FD system than for the II system. SNR and CNR for the FD system were better than the equivalent FOVs with II. The resulting FOM was better for the FD system in both FOVs. Potential for optimisation was suggested by adjusting system settings.

ICRP publication 121: radiological protection in paediatric diagnostic and interventional radiology.

Paediatric patients have a higher average risk of developing cancer compared with adults receiving the same dose. The longer life expectancy in children allows more time for any harmful effects of radiation to manifest, and developing organs and tissues are more sensitive to the effects of radiation. This publication aims to provide guiding principles of radiological protection for referring clinicians and clinical staff performing diagnostic imaging and interventional procedures for paediatric patients. It begins with a brief description of the basic concepts of radiological protection, followed by the general aspects of radiological protection, including principles of justification and optimisation. Guidelines and suggestions for radiological protection in specific modalities - radiography and fluoroscopy, interventional radiology, and computed tomography - are subsequently covered in depth. The report concludes with a summary and recommendations. The importance of rigorous justification of radiological procedures is emphasised for every procedure involving ionising radiation, and the use of imaging modalities that are non-ionising should always be considered. The basic aim of optimisation of radiological protection is to adjust imaging parameters and institute protective measures such that the required image is obtained with the lowest possible dose of radiation, and that net benefit is maximised to maintain sufficient quality for diagnostic interpretation. Special consideration should be given to the availability of dose reduction measures when purchasing new imaging equipment for paediatric use. One of the unique aspects of paediatric imaging is with regards to the wide range in patient size (and weight), therefore requiring special attention to optimisation and modification of equipment, technique, and imaging parameters. Examples of good radiographic and fluoroscopic technique include attention to patient positioning, field size and adequate collimation, use of protective shielding, optimisation of exposure factors, use of pulsed fluoroscopy, limiting fluoroscopy time, etc. Major paediatric interventional procedures should be performed by experienced paediatric interventional operators, and a second, specific level of training in radiological protection is desirable (in some countries, this is mandatory). For computed tomography, dose reduction should be optimised by the adjustment of scan parameters (such as mA, kVp, and pitch) according to patient weight or age, region scanned, and study indication (e.g. images with greater noise should be accepted if they are of sufficient diagnostic quality). Other strategies include restricting multiphase examination protocols, avoiding overlapping of scan regions, and only scanning the area in question. Up-to-date dose reduction technology such as tube current modulation, organ-based dose modulation, auto kV technology, and iterative reconstruction should be utilised when appropriate. It is anticipated that this publication will assist institutions in encouraging the standardisation of procedures, and that it may help increase awareness and ultimately improve practices for the benefit of patients.

ICRP PUBLICATION 120: Radiological protection in cardiology.

Cardiac nuclear medicine, cardiac computed tomography (CT), interventional cardiology procedures, and electrophysiology procedures are increasing in number and account for an important share of patient radiation exposure in medicine. Complex percutaneous coronary interventions and cardiac electrophysiology procedures are associated with high radiation doses. These procedures can result in patient skin doses that are high enough to cause radiation injury and an increased risk of cancer. Treatment of congenital heart disease in children is of particular concern. Additionally, staff(1) in cardiac catheterisation laboratories may receive high doses of radiation if radiological protection tools are not used properly. The Commission provided recommendations for radiological protection during fluoroscopically guided interventions in Publication 85, for radiological protection in CT in Publications 87 and 102, and for training in radiological protection in Publication 113 (ICRP, 2000b,c, 2007a, 2009). This report is focused specifically on cardiology, and brings together information relevant to cardiology from the Commission's published documents. There is emphasis on those imaging procedures and interventions specific to cardiology. The material and recommendations in the current document have been updated to reflect the most recent recommendations of the Commission. This report provides guidance to assist the cardiologist with justification procedures and optimisation of protection in cardiac CT studies, cardiac nuclear medicine studies, and fluoroscopically guided cardiac interventions. It includes discussions of the biological effects of radiation, principles of radiological protection, protection of staff during fluoroscopically guided interventions, radiological protection training, and establishment of a quality assurance programme for cardiac imaging and intervention. As tissue injury, principally skin injury, is a risk for fluoroscopically guided interventions, particular attention is devoted to clinical examples of radiation-related skin injuries from cardiac interventions, methods to reduce patient radiation dose, training recommendations, and quality assurance programmes for interventional fluoroscopy.