Organisations & reports
An independent, international organisation that advances for the public benefit the science of radiological protection, in particular by providing recommendations and guidance on all aspects of protection against ionising radiation
Abstract – The central dose quantities used in radiological protection are absorbed dose, equivalent dose, and effective dose. The concept of effective dose was developed by the International Commission on Radiological Protection (ICRP) as a riskadjusted dosimetric quantity for the management of protection against stochastic effects, principally cancer, enabling comparison of estimated doses with dose limits, dose constraints, and reference levels expressed in the same quantity. Its use allows all radiation exposures from external and internal sources to be considered together and summed, relying on the assumptions of a linear non-threshold dose–response relationship, equivalence of acute and chronic exposures at low doses or low dose rates, and equivalence of external and internal exposures. ICRP Publication 103 provides detailed explanation of the purpose and use of effective dose and equivalent dose to individual organs and tissues. This publication provides further guidance on the scientific basis for the control of radiation risks using dose quantities, and discusses occupational, public, and medical applications. It is recognised that best estimates of risk to individuals will use organ/tissue doses and specific dose risk models. Although doses incurred at low levels of exposure may be measured or assessed with reasonable accuracy, the associated risks are increasingly uncertain at lower doses. Bearing in mind the uncertainties associated with risk projection to low doses or low dose rates, it is concluded that effective dose may be considered as an approximate indicator of possible risk, recognising also that lifetime cancer risks vary with age at exposure, sex, and population group. A further conclusion is that equivalent dose is not required as a protection quantity. It will be more appropriate for limits for the avoidance of tissue reactions for the skin, hands and feet, and lens of the eye to be set in terms of absorbed dose rather than equivalent dose.
ICRP, 2021. Use of dose quantities in radiological protection. ICRP Publication 147. Ann. ICRP 50(1).
In recent publications, such as Publications 117 and 120, the Commission provided practical advice for physicians and other healthcare personnel on measures to protect their patients and themselves during interventional procedures. These measures can only be effective if they are encompassed by a framework of radiological protection elements, and by the availability of professionals with responsibilities in radiological protection. This framework includes a radiological protection programme with a strategy for exposure monitoring, protective garments, education and training, and quality assurance of the programme implementation. Professionals with responsibilities in occupational radiological protection for interventional procedures include: medical physicists; radiological protection specialists; personnel working in dosimetry services; clinical applications support personnel from the suppliers and maintenance companies; staff engaged in training, standardisation of equipment, and procedures; staff responsible for occupational health; hospital administrators responsible for providing financial support; and professional bodies and regulators. This publication addresses these elements and these audiences, and provides advice on specific issues, such as assessment of effective dose from dosimeter readings when an apron is worn, estimation of exposure of the lens of the eye (with and without protective eyewear), extremity monitoring, selection and testing of protective garments, and auditing the interventional procedures when occupational doses are unusually high or low (the latter meaning that the dosimeter may not have been worn).
ICRP, 2018. Occupational radiological protection in interventional procedures. ICRP Publication 139. Ann. ICRP 47(2).
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, staff1 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. 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.
ICRP, 2013. Radiological protection in cardiology. ICRP Publication 120. Ann. ICRP 42(1).
This report provides a review of early and late effects of radiation in normal tissues and organs with respect to radiation protection. It was instigated following a recommendation in Publication 103, and it provides updated estimates of ‘practical’ threshold doses for tissue injury defined at the level of 1% incidence. Estimates are given for morbidity and mortality endpoints in all organ systems following acute, fractionated, or chronic exposure. The organ systems comprise the haematopoietic, immune, reproductive, circulatory, respiratory, musculoskeletal, endocrine, and nervous systems; the digestive and urinary tracts; the skin; and the eye.
Particular attention is paid to circulatory disease and cataracts because of recent evidence of higher incidences of injury than expected after lower doses; hence, threshold doses appear to be lower than previously considered. This is largely because of the increasing incidences with increasing times after exposure. In the context of protection, it is the threshold doses for very long follow-up times that are the most relevant for workers and the public; for example, the atomic bomb survivors with 40–50 years of follow-up. Radiotherapy data generally apply for shorter follow-up times because of competing causes of death in cancer patients, and hence the risks of radiation-induced circulatory disease at those earlier times are lower.
A variety of biological response modifiers have been used to help reduce late reactions in many tissues. These include antioxidants, radical scavengers, inhibitors of apoptosis, anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, growth factors, and cytokines. In many cases, these give dose modification factors of 1.1–1.2, and in a few cases 1.5–2, indicating the potential for increasing threshold doses in known exposure cases. In contrast, there are agents that enhance radiation responses, notably other cytotoxic agents such as antimetabolites, alkylating agents, anti-angiogenic drugs, and antibiotics, as well as genetic and comorbidity factors.
Most tissues show a sparing effect of dose fractionation, so that total doses for a given endpoint are higher if the dose is fractionated rather than when given as a single dose. However, for reactions manifesting very late after low total doses, particularly for cataracts and circulatory disease, it appears that the rate of dose delivery does not modify the low incidence. This implies that the injury in these cases and at these low dose levels is caused by single-hit irreparable-type events. For these two tissues, a threshold dose of 0.5 Gy is proposed herein for practical purposes, irrespective of the rate of dose delivery, and future studies may elucidate this judgement further.
ICRP, 2012 ICRP Statement on Tissue Reactions / Early and Late Effects of Radiation in Normal Tissues and Organs – Threshold Doses for Tissue Reactions in a Radiation Protection Context. ICRP Publication 118. Ann. ICRP 41(1/2).
An increasing number of medical specialists are using fluoroscopy outside imaging departments, but there has been general neglect of radiological protection coverage of fluoroscopy machines used outside imaging departments. Lack of radiological protection training of those working with fluoroscopy outside imaging departments can increase the radiation risk to workers and patients. Procedures such as endovascular aneurysm repair, renal angioplasty, iliac angioplasty, ureteric stent placement, therapeutic endoscopic retrograde cholangio-pancreatography, and bile duct stenting and drainage have the potential to impart skin doses exceeding 1 Gy. Although tissue reactions among patients and workers from fluoroscopy procedures have, to date, only been reported in interventional radiology and cardiology, the level of fluoroscopy use outside imaging departments creates potential for such injuries.
A brief account of the health effects of ionising radiation and protection principles is presented in Section 2. Section 3 deals with general aspects of the protection of workers and patients that are common to all, whereas specific aspects are covered in Section 4 for vascular surgery, urology, orthopaedic surgery, obstetrics and gynaecology, gastroenterology and hepatobiliary system, and anaesthetics and pain management. Although sentinel lymph node biopsy involves the use of radio-isotopic methods rather than fluoroscopy, performance of this procedure in operating theatres is covered in this report as it is unlikely that this topic will be addressed in another ICRP publication in coming years. Information on radiation dose levels to patients and workers, and dose management is presented for each speciality.
Issues connected with pregnant patients and pregnant workers are covered in Section 5. Although ICRP has recently published a report on training, specific needs for the target groups in terms of orientation of training, competency of those who conduct and assess specialists, and guidelines on the curriculum are provided in Section 6.
This report emphasises that patient dose monitoring is essential whenever fluoroscopy is used.
It is recommended that manufacturers should develop systems to indicate patient dose indices with the possibility of producing patient dose reports that can be transferred to the hospital network, and shielding screens that can be effectively used for the protection of workers using fluoroscopy machines in operating theatres without hindering the clinical task.
ICRP, 2010. Radiological Protection in Fluoroscopically Guided Procedures outside the Imaging Department. ICRP Publication 117, Ann. ICRP 40(6)
IRPA is the international voice of the radiation protection profession. It is an association of radiation protection professionals joining through national and regional radiation protection societies. We promote the worldwide enhancement of professional competence, radiation protection culture, and practice by providing benchmarks of good practice, and encouraging the application of the highest standards of professional conduct, skills, and knowledge for the benefit of individuals and society.
The term fluoroscopically guided interventional procedure describes a clinical practice in medicine, where fluoroscopic systems are used to conduct diagnostic procedures or provide image guidance for therapeutic interventional procedures performed via percutaneous or other access routes [1]. These procedures are increasingly used in pediatric patients as minimally invasive procedures that can replace more complex surgical options, especially in pediatric interventional cardiology [2].
Fluoroscopically guided interventional procedures may involve high radiation doses to patients [3]. Special attention must be paid to pediatric patients undergoing these procedures in comparison with adult patients, as children are potentially at greater risk of radiation-induced stochastic effects due to a higher radiation sensitivity of their tissues [4,5], and they have a longer lifespan in which long-term carcinogenic effects can develop [3].
Due to the above concerns, it must be a priority to avoid unnecessarily high doses to pediatric patients, applying the principles of radiological protection system, in particular in the strategies that allow radiological safety to be optimized during these procedures [5], despite the fact that modern X-ray systems come with more options to reduce doses to patients and operators, thanks to their new detectors, automatic dose management programs, etc. The basic aim of the optimization of radiological protection during a fluoroscopically guided interventional procedure is to adjust imaging parameters and institute protective measures in such a way that the required image is obtained with the lowest possible radiation dose, and net benefit is maximized [6]. Some examples of optimization strategies might be: quality assurance programs, characterization of dose and image quality of X-ray systems [7,8], quality control tests of X-ray systems, the analysis of patient dose metrics, establishment of diagnostic reference levels (DRLs) classified by
ranges of weight and age, among others. Some possible concrete actions for optimization might be: reducing the radiation dose to the minimum needed (“ALARA” principle), reducing the field to the strictly necessary part of the body, avoiding unnecessary double planes, using a low-dose-rate fluoroscopy mode when possible, minimizing fluoroscopy time, using fluoroscopy only to guide devices if absolutely necessary and observe motion, using the last-image-hold image for review when possible, instead of using fluoroscopy, minimizing the number of cine series, reducing the number of personnel present in the
fluoroscopically guided interventional laboratory to the minimum needed, posing careful indications, considering non-radiating alternatives if possible, etc.
This special issue will mainly show the outcomes achieved in the OPRIPALC (Optimization of Protection in Pediatric Interventional Radiology in Latin America and the Caribbean) program [9], although also articles that are framed within the optimization strategies for other types of fluoroscopically guided pediatric procedures may be accepted.
OPRIPALC was conceived as a joint response of the Pan American Health Organization and the World Health Organization, in cooperation with the International Atomic Energy Agency, to support their member states in Latin America and the Caribbean in ensuring that radiation exposures of pediatric patients are appropriate for the respective Children fluoroscopically guided interventional procedures [10,11]. To our knowledge, this initiative
is unique worldwide.
This special issue will present articles to share the evolution, advancements, and
challenges of the OPRIPALC program. Likewise, as one of the main products of this international initiative, an article on good practices for the optimization of protection and safety in fluoroscopically guided interventional paediatric procedures will be prepared. Furthermore, two systematic reviews on ranges of pediatric radiation dose indices in interventional cardiology procedures and the image quality metrics used to characterize X-ray equipment and optimize fluoroscopically guided interventional procedures will be presented. In addition, the use of DRLs will be part of this effort, showing the experience and results accumulated by the countries participating in OPRIPALC. Finally, the uses of automatic dose management systems, their advantages, and disadvantages will be discussed.
Ubeda C. New Optimization Strategies on Radiation Protection in Fluoroscopy-Guided Interventional Procedures in Pediatrics. Children (Basel). 2023; 10.
In 2012 IRPA established a Task Group to identify key issues in the implementation of the revised eye dose limit. The TG reported its conclusions in 2013. In January 2015, IRPA asked the Task Group to review progress with the implementation of the recommendations from the earlier report and to collate current practitioner experience. The TG defined and promoted a survey with reference to: i) the best applied methods for monitoring dose to the lens; ii) the updated and optimized methods used to reduce dose to the eye; iii) the ongoing path towards implementation in the different countries at a legislative level.
The results of the survey on the view of the professionals of the IRPA Associate Societies (ASs) on the new limit to the lens of the eye and on the wider issue of tissue reactions is presented in the IRPA document ‘Report of Task Group on the impact of the Eye Lens Dose Limits’. At the same time the TG was working towards the development of practical recommendations about when and how eye lens dose should be monitored and of guidance on use of protective tools depending on the exposure levels.
The draft of the ‘IRPA guidance on implementation of eye dose monitoring and eye protection of workers’ was presented at the IRPA14 International Congress held in Cape Town, then it was sent for comments to all the IRPA ASs.
After the revision the document was approved by the IRPA Executive Council on 31 January 2017.
The purpose of “IRPA Guiding Principles for Establishing a Radiation Protection Culture” is to capture the opinion and standpoint of radiation protection (RP) professionals on the essential components of a radiation protection culture. Developed in an inclusive and consultative approach involving all the stakeholders, this document aims at both fostering a belief in the success of cultural approaches and providing guidance to help equip radiation protection professionals to promote a successful RP culture in their organisation and workplace. It should help RP practitioners in establishing their own practical guidelines and recommendations, commensurate with their own specific issues and should be owned at the highest management level in organizations.
The IAEA is the world’s centre for cooperation in the nuclear field and seeks to promote the safe, secure and peaceful use of nuclear technologies.
Description
This Safety Report explains how the concepts of attribution of health effects and inference of risks can be taken into account in the application of IAEA safety standards, so as to implement them more effectively. In particular, this publication demonstrates explicitly what the relevant provisions of the safety standards are for high and moderate levels of exposure where health effects might be able to be attributed to the exposure, and for low and very low levels of exposure where risks can only be inferred. This Safety Report also aims to support more effective communication by clarifying the proper use of certain concepts detailed in the safety standards and plain language explanations of the concepts of attribution of effects and inference of risk are provided.
Keywords
Attribution of Radiation Health Effects, Inference of Radiation Risks, Considerations for Application of the IAEA Safety Standards, Health Aspects, Safety Measures, Safety Regulations, UNSCEAR 2012, Past Radiation Exposures, Estimation of Health Effects, Health Risks, Basis of the Safety Standards, Development and Use, Fundamental Safety Principles, Practical Application, Risk Related Concepts, Different Categories of Exposure, Public, Occupational and Medical Exposure, Implications of the Concepts of Attribution of Health Effects, Inference of Risk for Communication, Data on Actual Effects, Plain Language Explanation, Inference to Support Public Communication, Review
Attribution of Radiation Health Effects and Inference of Radiation Risks: Considerations for Application of the IAEA Safety Standards. Vienna: INTERNATIONAL ATOMIC ENERGY AGENCY, 2023.
Highlights
- Manufacturers play an important role in making patients safer.
- Automatic patient dose (skin dose maps) reporting are essential for optimization.
- More studies on the impact of lens opacities in clinical practice.
- Paediatric patient dose data in interventional procedures are scarce.
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.
Materials 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.
Tsapaki, V., Balter, S., Cousins, C., Holmberg, O., Miller, D., Miranda, P., … Vano, E. (2018). The International Atomic Energy Agency action plan on radiation protection of patients and staff in interventional procedures: Achieving change in practice. Physica Medica, 52, 56–64. https://doi.org/10.1016/j.ejmp.2018.06.634
The purpose of the current publication is to provide advice on the implications for occupational radiation protection of the new dose limit for the lens of the eye and to allow comment on detailed recommendations that may be incorporated into the safety guides.
An international study called RELID (Retrospective Evaluation of Lens Injuries and Dose) was initiated by the IAEA in 2008. RELID has two components namely, evaluation of dose and evaluation of radiation injury.
ACR is the voice of our members, empowering them to serve patients and society by advancing the practice and science of radiological care.
Purpose
To update normative data on fluoroscopy dose indices in the United States for the first time since the Radiation Doses in Interventional Radiology study in the late 1990s.
Materials and Methods
The Dose Index Registry-Fluoroscopy pilot study collected data from March 2018 through December 2019, with 50 fluoroscopes from 10 sites submitting data. Primary radiation dose indices including fluoroscopy time (FT), cumulative air kerma (Ka,r), and kerma area product (PKA) were collected for interventional radiology fluoroscopically guided interventional (FGI) procedures. Clinical facility procedure names were mapped to the American College of Radiology (ACR) common procedure lexicon. Distribution parameters including the 10th, 25th, 50th, 75th, 95th, and 99th percentiles were computed.
Results
Dose indices were collected for 70,377 FGI procedures, with 50,501 ultimately eligible for analysis. Distribution parameters are reported for 100 ACR Common IDs. FT in minutes, Ka,r in mGy, and PKA in Gy-cm2 are reported in this study as (n; median) for select ACR Common IDs: inferior vena cava filter insertion (1,726; FT: 2.9; Ka,r: 55.8; PKA: 14.19); inferior vena cava filter removal (464; FT: 5.7; Ka,r: 178.6; PKA: 34.73); nephrostomy placement (2,037; FT: 4.1; Ka,r: 39.2; PKA: 6.61); percutaneous biliary drainage (952; FT: 12.4; Ka,r: 160.5; PKA: 21.32); gastrostomy placement (1,643; FT: 3.2; Ka,r: 29.1; PKA: 7.29); and transjugular intrahepatic portosystemic shunt placement (327; FT: 34.8; Ka,r: 813.0; PKA: 181.47).
Conclusions
The ACR DIR-Fluoro pilot has provided state-of-the-practice statistics for radiation dose indices from IR FGI procedures. These data can be used to prioritize procedures for radiation optimization, as demonstrated in this work.
Jones AK, Wunderle KA, Fruscello T, et al. Patient Radiation Doses in IR Procedures: The American College of Radiology Dose Index Registry-Fluoroscopy Pilot. J Vasc Interv Radiol. 2023; 34: 544-55.e11.
To transform cardiovascular care and improve heart health
This document has been developed as an Expert Consensus Document by the American College of Cardiology (ACC) in collaboration with the American Society of Nuclear Cardiology, Heart Rhythm Society, Mended Hearts, North American Society for Cardiovascular Imaging, Society for Cardiovascular Angiography and Interventions, Society for Cardiovascular Computed Tomography, and Society of Nuclear Medicine and Molecular Imaging. Expert Consensus Documents are intended to inform practitioners, payers, and other interested parties of the opinion of ACC and document cosponsors concerning evolving areas of clinical practice and/or technologies that are widely available or new to the practice community. Expert Consensus Documents are intended to provide guidance for clinicians in areas where evidence may be limited or new and evolving, or insufficient data exist to fully inform clinical decision making. These documents therefore serve to complement clinical practice guidelines, providing practical guidance for transforming guideline recommendations into clinically actionable information.
Hirshfeld JW, Ferrari VA, Bengel FM, et al. 2018 ACC/HRS/NASCI/SCAI/SCCT Expert Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular Imaging: Best Practices for Safety and Effectiveness. A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. 2018;71(24):e283-e351
The stimulus to create this document was the recognition that ionizing radiation‐guided cardiovascular procedures are being performed with increasing frequency, leading to greater patient radiation exposure and, potentially, to greater exposure to clinical personnel. While the clinical benefit of these procedures is substantial, there is concern about the implications of medical radiation exposure. ACC leadership concluded that it is important to provide practitioners with an educational resource that assembles and interprets the current radiation knowledge base relevant to cardiovascular procedures. By applying this knowledge base, cardiovascular practitioners will be able to select procedures optimally, and minimize radiation exposure to patients and to clinical personnel.
“Optimal Use of Ionizing Radiation in Cardiovascular Imaging ‐ Best Practices for Safety and Effectiveness” is a comprehensive overview of ionizing radiation use in cardiovascular procedures and is published online. To provide the most value to our members, we divided the print version of this document into 2 focused parts. “Part I: Radiation Physics and Radiation Biology” addresses radiation physics, dosimetry and detrimental biologic effects. “Part II: Radiologic Equipment Operation, Dose‐Sparing Methodologies, Patient and Medical Personnel Protection” covers the basics of operation and radiation delivery for the 3 cardiovascular imaging modalities (x‐ray fluoroscopy, x‐ray computed tomography, and nuclear scintigraphy). For each modality, it includes the determinants of radiation exposure and techniques to minimize exposure to both patients and to medical personnel.
Hirshfeld JW Jr, Ferrari VA, Bengel FM, Bergersen L, Chambers CE, Einstein AJ, Eisenberg MJ, Fogel MA, Gerber TC, Haines DE, Laskey WK, Limacher MC, Nichols KJ, Pryma DA, Raff GL, Rubin GD, Smith D, Stillman AE, Thomas SA, Tsai TT, Wagner LK, Wann LS. 2018 ACC/HRS/NASCI/SCAI/SCCT expert consensus document on optimal use of ionizing radiation in cardiovascular imaging—best practices for safety and effectiveness, part 2: radiologic equipment operation, dose‐sparing methodologies, patient and medical personnel protection: a report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 2018;71.
promotes excellence in invasive and interventional cardiovascular medicine through education and representation, and the advancement of quality standards to enhance patient care
The European Society of Cardiology (ESC) is an independent, non-profit organisation. Our members and decision-makers are busy healthcare professionals who volunteer their time and expertise. The ESC represents more than 95,000 men and women in the field of cardiology from Europe, the Mediterranean Basin and far beyond.
Our mission is to support nurses and allied professionals throughout Europe to deliver the best possible care to patients with cardiovascular disease and their families. We do this through the creation and delivery of a diverse programme of activities, including education, research and mentorship.
Sharing knowledge, experience and practice in cardiovascular interventional medicine.
The Society’s fundamental purpose, reflected in its founding Charters of the 1660s, is to recognise, promote, and support excellence in science and to encourage the development and use of science for the benefit of humanity
Exposure to ionizing radiation is ubiquitous, and it is well established that moderate and high doses cause ill-health and can be lethal. The health effects of low doses or low dose-rates of ionizing radiation are not so clear. This paper describes a project which sets out to summarize, as a restatement, the natural science evidence base concerning the human health effects of exposure to low-level ionizing radiation. A novel feature, compared to other reviews, is that a series of statements are listed and categorized according to the nature and strength of the evidence that underpins them. The purpose of this restatement is to provide a concise entrée into this vibrant field, pointing the interested reader deeper into the literature when more detail is needed. It is not our purpose to reach conclusions on whether the legal limits on radiation exposures are too high, too low or just right. Our aim is to provide an introduction so that non-specialist individuals in this area (be they policy-makers, disputers of policy, health professionals or students) have a straightforward place to start. The summary restatement of the evidence and an extensively annotated bibliography are provided as appendices in the electronic supplementary material.
For radiation protection purposes, it has generally been assumed that there is a threshold of dose below which no non-cancer effects arise (Hildebrandt, 2010). Recent epidemiological studies and studies on radiation-induced cataracts in animals (Ainsbury, 2009; Shore, 2010) suggested that the dose threshold for the loss of eye lens function could be lower than previously considered or that there may be no dose threshold at all. Consequently, the ICRP report 118 (ICRP, 2012) revised an absorbed dose threshold to the eye lens of 0.5 Gy for cataracts instead of 2 Gy previously recommended. Although new dose thresholds and occupational dose limits have been set for radiation-induced cataract, the relationship between radiation dose and radiation effect is not clear in the low dose region.
The reduction of the occupational dose limit for the eye lens to 20 mSv per year will have implications for interventional cardiologists – the targeted population in this study – and for other health care professionals, as previous studies have shown that this dose limit can easily be exceeded for medical staff. Moreover, previous studies have already suggested an increased risk of lens opacities for this group [Vaño, 2010 and 2013; Ciraj-Bjelac, 2010; Jacob, 2013], but they have been unable to establish a dose-response relationship. This study will focus on establishing solid epidemiological evidence with strong dose estimation by producing the largest study on lens opacities in medical personnel so far, with more subjects than in all previous studies with interventional cardiologists combined. Further improvements will be based on proper eye lens dosimetry and state-of-the-art ophthalmological examinations providing objective and quantitative assessment of radiation induced lens opacities.
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EU strategy, its role in setting priorities, and its implementation through EU policy
Executive Summary
Article 7 of the Council Directive 97/43/Euratom (the Medical Exposure Directive, MED), June 30, 1997, on the protection of individuals against the dangers of ionising radiation in relation to medical exposure, lays down requirements for radiation protection education and training. The European Commission realised that certain aspects of this article required some clarification and orientation for Member States and in 2000 published the ‘Radiation Protection Report 116: Guidelines on education and training in radiation protection for medical exposures’. These guidelines contain some specific recommendations for the application of the Directive and it has served the Member States well. However, the rapid technological development of the past decade and the constant growth of ionising radiation use in medicine have necessitated an update of this document. Furthermore, Radiation Protection Report 116 does not provide learning outcomes compatible with the European qualifications framework and does not include requirements and guidance adequate for new specialists using ionising radiation, in particular those outside imaging departments.
The present guidelines are an update of Radiation Protection Report 116, which take into account the recent technological advances, the education and training requirements of the Euratom Basic Safety Standards Directive, the European qualifications framework and includes new specialists using ionising radiation. Radiation protection education and training starts at the entry level to medical, dental and other healthcare professional schools. The revised Euratom Basic Safety Standards Directive states that ‘Member States shall ensure that practitioners and the individuals involved in the practical aspects of medical radiological procedures have adequate education, information and theoretical and practical training for the purposes of medical radiological practices, as well as relevant competence in radiation protection. For this purpose Member States shall ensure that appropriate curricula are established and shall recognise the corresponding diplomas, certificates or formal qualifications. Individuals undergoing relevant training programmes may participate in practical aspects of medical radiological procedures.
Member States shall ensure that continuing education and training after qualification is provided, and, in the special case of the clinical use of new techniques, training is provided on these techniques and the relevant radiation protection requirements. Member States shall encourage the introduction of a course on radiation protection in the basic curriculum of medical and dental schools’. Radiation protection courses for medical and dental students should include knowledge needed by a referring physician, i.e. basic knowledge on patient radiation protection such as biological effects of radiation, justification of exposures, risk-benefit analysis, typical doses for each type of examination etc. In addition, knowledge of the advantages and disadvantages of the use of ionising radiation in medicine, including basic information about radioactive waste and its safe management, should be part of radiation protection education and training for medical students. Learning outcomes for referrers are described in chapter three. Radiation protection courses in dental schools should cover the same basic aspects as medical schools, mentioned above, as well as specific training for the safe operation of diagnostic X-ray equipment. These include the principles of X-ray tube operation, radiographic imaging, image processing, quality assurance programmes, occupational dose control and patient dose control etc. The core radiation protection learning outcomes described in chapter two at European qualifications framework level three are sufficient for health professionals who are not 6 radiation workers or referrers, e.g. nurses without referring duties.
Healthcare professionals who are classified as radiation workers require further knowledge, skills and competence and at higher European qualifications framework levels. These guidelines have been divided into sections according to the roles of the healthcare professionals in question, and each section includes, in table format, learning outcomes in terms of knowledge, skills and competence. Recommendations at the required European qualifications framework level in radiation protection upon entry to the particular profession and the type of continuous professional development in radiation protection required for the particular profession are also given.
ORAMED, Optimization of RAdiation protection for MEDical staff is a collaborative project funded in 2008 within the 7th EU Framework Programme, Euratom Programme for Nuclear Research and training.
ORAMED aims at the development of methodologies for better assessing and reducing exposures to medical staff for procedures resulting in potentially large doses or complex radiation fields, such as interventional radiology, nuclear medicine and new developments. We want to concert our efforts to improve and consolidate not only research in this area but also to foster technological transfer and to ensure a good dissemination of our findings.
A consortium of 12 partners from 9 European countries, including research institutes, metrology laboratories, regulator bodies, hospitals and manufacturers, is in charge of the development of the Project, with the collaboration of several hospitals and professional organizations.
The Organization for Occupational Radiation Safety in Interventional Fluoroscopy (ORSIF) raises awareness of the health risks of occupational ionizing radiation exposures and associated musculoskeletal risks occurring in interventional fluoroscopy laboratories.
ORSIF develops support for medical professionals and hospitals for new and better ways to create the safest possible work environment for those dedicated to the wellness of others. ORSIF is composed of members from industry and will expand to include physicians and staff from interventional fluoroscopy labs and will partner with other physician associations, academic institutions, labor groups, and government bodies.
In February 2015, the Organization for Occupational Radiation Safety in Interventional Fluoroscopy (ORSIF) released a white paper detailing the scientific data on the health consequences for medical professionals faced with chronic exposure to low-dose ionizing radiation. The adverse health effects include brain tumors, premature development of cataracts, and thyroid disease, among others. In addition, because of the need to wear personal protective equipment (PPE) to reduce exposure to scatter radiation, many exposed workers (physicians, nurses, and technicians) sustain orthopedic injuries.Since the issuance of ORSIF’s report, there has been growing awareness of occupational hazards—and interest in reducing the risks that interventionalists face—as evidenced by the increase in the number of
scientific publications on these topics. In 2015, there were approximately 45 scientific manuscripts (studies, surveys, and editorials) on occupational hazards or methods to reduce operator exposure to scatter radiation, more than double the number published in 2014.
This supplement summarizes new clinical data on the health consequences of chronic radiation exposure, presents findings from new physician surveys on the musculoskeletal impact of PPE, and provides an overview of various methods being investigated to enhance radiation protection for interventionalists.
The Organization for Occupational Radiation Safety in Interventional Fluoroscopy (ORSIF) raises awareness of the health risks of occupational ionizing radiation exposures and associated musculoskeletal risks occurring in interventional fluoroscopy laboratories. ORSIF develops support for medical professionals and hospitals for new and better ways to create the safest possible work environment for those dedicated to the wellness of others. ORSIF is composed of members from industry and will expand to include physicians and staff from interventional fluoroscopy labs and will partner with other physician associations, academic institutions, labor groups, and government bodies.
The EPA is responsible for preventing and detecting environmental crimes, informing the public of environmental enforcement, and setting and monitoring standards of air pollution, water pollution, hazardous wastes and chemicals.
This guidance provides general principles and specifies the numerical primary guides for limiting worker exposure. It applies to all workers who are exposed to radiation in the course of their work, either as employees of institutions and companies subject to Federal regulation or as Federal employees.