COMP Report: A survey of radiation safety regulations for medical imaging x-ray equipment in Canada.

X-ray regulations and room design methodology vary widely across Canada. The Canadian Organization of Medical Physicists (COMP) conducted a survey in 2016/2017 to provide a useful snapshot of existing variations in rules and methodologies for human patient medical imaging facilities. Some jurisdictions no longer have radiation safety regulatory requirements and COMP is concerned that lack of regulatory oversight might erode safe practices. Harmonized standards will facilitate oversight that will ensure continued attention is given to public safety and to control workplace exposure. COMP encourages all Canadian jurisdictions to adopt the dose limits and constraints outlined in Health Canada Safety Code 35 with the codicil that the design standards be updated to those outlined in NCRP 147 and BIR 2012.

[The new radiation protection legislation-part 2 : Modifications in radiology regarding approval procedure and special fields including teleradiology]. / Die neue Strahlenschutzgesetzgebung ­ Teil 2 : Änderungen in der Radiologie bezüglich Vorabkontrolle und Sonderbereiche, einschließlich Teleradiologie.

BACKGROUND: The entry of the new Radiation Protection Act and new Radiation Protection Regulation into force in Germany created many changes for radiology with regard to the old Radiation Protection Regulation and X­ray Regulation. OBJECTIVES: The substantial modifications in radiology regarding the areas of approval and notification procedures, teleradiology, screening, research and radon in the workplace are summarized. METHOD: Changes in the new Radiation Protection Act and Regulation compared to the old Radiation Protection Regulation and X­ray Regulation were evaluated. Thereby, the focus was on areas beyond the workflow in clinical routine. RESULTS AND CONCLUSION: The requirements for the approval and notification procedure have increased. For example, proof must be provided that a medical physics expert can be consulted. The establishment of deadlines for the process by the responsible authorities may accelerate the procedure and create planning certainty.

[The new radiation protection legislation-part 1 : Modifications in radiology for the workflow in clinical routine]. / Die neue Strahlenschutzgesetzgebung ­ Teil 1 : Änderungen für die arbeitstägliche Routine in der Radiologie.

BACKGROUND: On 31 December 2018, the new Radiation Protection Regulation came into effect in Germany and made the new Radiation Protection Act more concrete. The old Radiation Protection Regulation and X­ray Regulation have thereby been replaced. OBJECTIVES: The substantial modifications regarding the practical daily routine in radiology are summarized. METHODS: Modifications and innovations of the New Radiation Protection Act and Regulation compared to the old Radiation Protection Regulation and X­ray Regulation and accordances were evaluated. Thereby the main focus was in the relevance for workflow in clinical routine. RESULTS AND CONCLUSION: The new legislation contains a number of regulations that provide crucial tools for implementation of radiation protection, quality assurance, and dose optimization. However, this also requires additional time and personnel.

The new lens dose limit: implication for occupational radiation protection.

AIM AND OBJECTIVES: The aim of this article was to explore the implications of the new Euratom dose limit for occupational radiation protection in the context of medical occupational radiation exposures. The European Directive 2013/59/Euratom takes into account the new recommendations on reduction in the dose limit for the lens of the eye for planned occupational exposures released in 2012 by the International Commission on Radiological Protection (ICRP 118). MATERIALS AND METHODS: Different dose-monitoring procedures and devices were considered. Occupational eye lens doses reported by previous studies were analyzed, mainly considering workers involved in interventional procedures with X-rays. The current status of eye lens radiation protection and the main methods for dose reduction were investigated. RESULTS: The analysis showed that the workers, potentially exceeding the new limit, are clinical staff performing interventional procedures with a relatively high X-ray dose. Regarding radiological protection issues, the considered literature reports that the proper use of personal protective equipment may reduce the eye lens absorbed dose. CONCLUSION: The evaluation of the occupational eye lens dose is essential to establish which method of personal dose monitoring should be preferred. Furthermore, education and training about the right use of personal protective equipment are important for medical staff working with ionizing radiation.

Protecting sensitive patient groups from imaging using ionizing radiation: effects during pregnancy, in fetal life and childhood.

The frequency of imaging examinations requiring radiation exposure in children (especially CT) is rapidly increasing. This paper reviews the current evidence in radiation protection in pediatric imaging, focusing on the recent knowledge of the biological risk related to low doses exposure. Even if there are no strictly defined limits for patient radiation exposure, it is recommended to try to keep doses as low as reasonably achievable (the ALARA principle). To achieve ALARA, several techniques to reduce the radiation dose in radiation-sensitive patients groups are reviewed. The most recent recommendations that provide guidance regarding imaging of pregnant women are also summarized, and the risk depending on dose and phase of pregnancy is reported. Finally, the risk-benefit analysis of each examination, and careful communication of this risk to the patient, is emphasized.

Practical recommendations for the application of DE 59/2013.

The changes introduced with Council Directive 2013/59/Euratom will require European Member States adapt their regulations, procedures and equipment to the new high standards of radiation safety. These new requirements will have an impact, in particular, on the radiology community (including medical physics experts) and on industry. Relevant changes include new definitions, a new dose limit for the eye lens, non-medical imaging exposures, procedures in asymptomatic individuals, the use and regular review of diagnostic reference levels (including interventional procedures), dosimetric information in imaging systems and its transfer to the examination report, new requirements on responsibilities, the registry and analysis of accidental or unintended exposure and population dose evaluation (based on age and gender distribution). Furthermore, the Directive emphasises the need for justification of medical exposure (including asymptomatic individuals), introduces requirements concerning patient information and strengthens those for recording and reporting doses from radiological procedures, the use of diagnostic reference levels, the availability of dose-indicating devices and the improved role and support of the medical physics experts in imaging.

A European survey on the regulatory status for the estimation of the effective dose and the equivalent dose to the lens of the eye when radiation protection garments are used.

Following the proposal of the ICRP for the reduction of the dose limit for the lens of the eye, which has been adopted by the International Atomic Energy Agency and the European Council, concerns have been raised about the implementation of proper dose monitoring methods as defined in national regulations, and about the harmonisation between European countries. The European Radiation Dosimetry Group organised a survey at the end of 2017, through a web questionnaire, regarding national dose monitoring regulations. The questions were related to: double dosimetry, algorithms for the estimation of the effective dose, methodology for the determination of the equivalent dose to the lens of the eye and structure of the national dose registry. The results showed that more than 50% of the countries that responded to the survey have legal requirements about the number and the position of dosemeters used for estimation of the effective dose when radiation protection garments are used. However, in only five out of 26 countries are there nationally approved algorithms for the estimation of the effective dose. In 14 out of 26 countries there is a legal requirement to estimate the dose to the lens of the eye. All of the responding countries use some kind of national database for storing individual monitoring data but in only 12 out of 26 countries are the estimated effective dose values stored. The personal dose equivalent at depth 3 mm is stored in the registry of only seven out of 26 countries. From the survey, performed just before the implementation of the European Basic Safety Standards Directive, it is concluded that national occupational exposure frameworks require intensive and immediate work under the coordination of the competent authorities to bring them into line with the latest basic safety standards and achieve harmonisation between European countries.

[The new law on radiation protection as a consequence of the EU safety standard of 2013]. / Das neue Strahlenschutzgesetz als Auswirkung der EU-Grundnormen von 2013.

The transformation of a European guideline (2013/59/Euratom) from 2013 into national law requires adaptation of the national statutory regulations. This year, all areas of protection from ionizing radiation will be subject to the new radiation protection law (StrlSchG). Through this, the German X­ray and Radiation Protection Acts will be combined to form a higher level of authority. The main parts of the StrlSchG will receive a new classification and will be organized according to the exposure scenario: radiation protection in planned exposure scenarios, radiation protection in emergency exposure scenarios, radiation protection in existing exposure scenarios, and the regulation of overall exposure scenarios. The most important or modified regulated points for radiology are concerned with early recognition, where the application of X­ray or nuclear radiation is permitted in principle under certain conditions; the consultation of medical physics experts in all diagnostic investigative procedures involving radiation and applications for radiological intervention that are linked to high doses in the person under investigation; teleradiology, another special case of the application of X­rays in humans that requires approval, now with the "required" technical qualification in radiation protection, formerly with the "full" technical qualification, in addition to research, the simplified approval procedure being substituted with a notification procedure.Furthermore, in contrast to previous regulations, those tasked with radiation protection can contact the regulators directly in the case of conflict, which indicates considerable reinforcement of their authority.The only dose limit that will be considerably reduced is the organ-specific equivalent dose of the eye lens, where the highest value will be reduced from 150 to 20 mSv per year in those who are exposed to radiation professionally.

[Radiation protection in medical research : Licensing requirement for the use of radiation and advice for the application procedure]. / Strahlenschutz in der medizinischen Forschung : Genehmigungsbedürftigkeit von Strahlenanwendungen und Hinweise zum Antragsverfahren.

BACKGROUND: In Germany, persons who are to be exposed to radiation for medical research purposes are protected by a licensing requirement. However, there are considerable uncertainties on the part of the applicants as to whether licensing by the competent Federal Office for Radiation Protection is necessary, and regarding the choice of application procedure. AIM: The article provides explanatory notes and practical assistance for applicants and an outlook on the forthcoming new regulations concerning the law on radiation protection of persons in the field of medical research. MATERIALS AND METHODS: Questions and typical mistakes in the application process were identified and evaluated. RESULTS AND DISCUSSION: The qualified physicians involved in a study are responsible for deciding whether a license is required for the intended application of radiation. The decision can be guided by answering the key question whether the study participants would undergo the same exposures regarding type and extent if they had not taken part in the study. When physicians are still unsure about their decision, they can seek the advisory service provided by the professional medical societies. Certain groups of people are particularly protected through the prohibition or restriction of radiation exposure. A simplified licensing procedure is used for a proportion of diagnostic procedures involving radiation when all related requirements are met; otherwise, the regular licensing procedure should be used. The new radiation protection law, which will enter into force on the 31st of december 2018, provides a notification procedure in addition to deadlines for both the notification and the licensing procedures. In the article, the authors consider how eligible studies involving applications of radiation that are legally not admissible at present may be feasible in the future, while still ensuring a high protection level for study participants.

Linear No-Threshold model and standards for protection against radiation.

In response to the three petitions by Carol S. Marcus, Mark L. Miller, and Mohan Doss, dated February 9, February 13, and February 24, 2015, respectively, the Nuclear Regulatory Commission (NRC or the Commission) has announced that it is considering assessing its choice of dose-response model, the Linear No-Threshold (LNT) model, for exposure to ionizing radiation. This comment is designed to assist the Commission in evaluating the merits of a review of the default dose-response model it uses as the basis for the Standards for Protection against Radiation regulations. It extends the petitioners' argument in favor of reexamining the default hypothesis (LNT) and taking consideration of low-dose hormesis for two main reasons: 1) Failure to review the LNT hypothesis may jeopardize the NRC's mission to protect public health and safety; and 2) The National Research Council's guidelines for choosing adequate defaults indicate that the choice of low-dose default model is due for a reevaluation.

History and Organizations for Radiological Protection.

International Commission on Radiological Protection (ICRP), an independent international organization established in 1925, develops, maintains, and elaborates radiological protection standards, legislation, and guidelines. United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) provides scientific evidence. World Health Organization (WHO) and International Atomic Energy Agency (IAEA) utilise the ICRP recommendations to implement radiation protection in practice. Finally, radiation protection agencies in each country adopt the policies, and adapt them to each situation. In Korea, Nuclear Safety and Security Commission is the governmental body for nuclear safety regulation and Korea Institute of Nuclear Safety is a public organization for technical support and R&D in nuclear safety and radiation protection.

[Approval procedures for clinical trials in the field of radiation oncology]. / Genehmigungsverfahren klinischer Studien im Bereich der Radioonkologie.

BACKGROUND AND PURPOSE: Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt für Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for "medical care (Heilkunde)" versus "medical research" frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided. METHODS: A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS. RESULTS: Differentiating between "Heilkunde" which does not need to be approved by the BfS and "medical research" is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) ("fachkundiger Arzt" according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial. The decision-making by the "fachkundigem Arzt" may be supported on request by an opinion given by the DEGRO Expert Committee for clinical trials. CONCLUSION: An important aim for promoting clinical research and patient care in radiation oncology is to further professionalize planning and implementation of clinical trials in this field. Correct assessment, at an early stage, whether a trial needs to be approved by the BfS may reduce unnecessary costs and reduce the time needed for the approval procedure for those trials which need to be assessed by the BfS.

[Data protection, radiation protection and copyright: Problems of transferring results in assessment practice]. / Datenschutz, Strahlenschutz und Urheberrecht: Probleme der Befundübermittlung in der Begutachtungspraxis.

In Germany, the medical assessor is subject to the law on contracts for work and services ("Werksvertragsrecht"). When a medical expert assesses a subject on behalf of a third party, there is no contractual relationship between them. In the field of private insurance law and in social insurance law, the medical expert is faced with various procedural requirements. Failing to meet these legal requirements often makes the assessment difficult or even impossible. The transfer of radiographs to the medical assessor is dealt with in the German X-ray regulations ("Röntgenverordnung"). The assessor, who is without doubt an examining doctor, has the right to have the radiographs temporarily made available (§ 28 et al.). Passing on the radiographs is all the more appropriate if by doing so additional X-ray examinations can be avoided. The right of access to medical data in the social security law, apart from X-ray regulations, is regulated by German Civil Code (BGB) § 810 and German Basic Law section 1 paragraph 1 in connection with section 2 paragraph 1 ("§ 810 BGB; Art. 1 Abs. 1, Art. 2 Abs. 1 GG"). In the absence of third party interest worthy of protection, the right of access to assessment records has to be granted to the subject, who will then authorize the examining medical expert to exercise this right. In private insurance law, only the private health insurance has its regulation concerning obtaining information about treatment or the access to medical assessments. In other types of insurance the medical assessor's right of access to medical examination data and/or the basis for medical findings can only be derived from secondary obligations as part of the insurance contract or directly from general constitutional personal rights.

Radionuclides in drinking water: the recent legislative requirements of the European Union.

In November 2013, a new EURATOM Directive was issued on the protection of public health from the radionuclide content in drinking water. After introducing the contents of the Directive, the paper analyses the hypotheses about drinking water ingestion adopted in documents of international and national organizations and the data obtained from national/regional surveys. Starting from the Directive's parametric value for the Indicative Dose, some examples of derived activity concentrations of radionuclides in drinking water are reported for some age classes and three exposure situations, namely, (i) artificial radionuclides due to routine water release from nuclear power facilities, (ii) artificial radionuclides from nuclear medicine procedures, and (iii) naturally occurring radionuclides in drinking water or resulting from existing or past NORM industrial activities.

Radiation safety during remediation of the SevRAO facilities: 10 years of regulatory experience.

In compliance with the fundamentals of the government's policy in the field of nuclear and radiation safety approved by the President of the Russian Federation, Russia has developed a national program for decommissioning of its nuclear legacy. Under this program, the State Atomic Energy Corporation 'Rosatom' is carrying out remediation of a Site for Temporary Storage of spent nuclear fuel (SNF) and radioactive waste (RW) at Andreeva Bay located in Northwest Russia. The short term plan includes implementation of the most critical stage of remediation, which involves the recovery of SNF from what have historically been poorly maintained storage facilities. SNF and RW are stored in non-standard conditions in tanks designed in some cases for other purposes. It is planned to transport recovered SNF to PA 'Mayak' in the southern Urals. This article analyses the current state of the radiation safety supervision of workers and the public in terms of the regulatory preparedness to implement effective supervision of radiation safety during radiation-hazardous operations. It presents the results of long-term radiation monitoring, which serve as informative indicators of the effectiveness of the site remediation and describes the evolving radiation situation. The state of radiation protection and health care service support for emergency preparedness is characterized by the need to further study the issues of the regulator-operator interactions to prevent and mitigate consequences of a radiological accident at the facility. Having in mind the continuing intensification of practical management activities related to SNF and RW in the whole of northwest Russia, it is reasonable to coordinate the activities of the supervision bodies within a strategic master plan. Arrangements for this master plan are discussed, including a proposed programme of actions to enhance the regulatory supervision in order to support accelerated mitigation of threats related to the nuclear legacy in the area.

Comparison of state dental radiography safety regulations.

The aim of this study was to compare and provide an overview of state policies on occupational exposure, dosimetry, collimation, patient protection, and the use of portable handheld X-ray machines in dentistry. State government webpages containing radiation protection rules and regulations were scanned. The contents were compared against current federal regulations established by the Nuclear Regulatory Commission (NRC) and the US Food and Drug Administration (FDA). They were further evaluated in light of current recommendations from the National Council on Radiation Protection & Measurements (NCRP) and the American Dental Association (ADA). Most states' regulations mirror the exposure limits set forth by the NRC and FDA. Nonregulatory recommendations regarding use of dental radiography are periodically put forth by the NCRP and the ADA. State and federal agencies often follow recommendations from these scientific organizations when creating regulations. Clinicians must be aware of their state's radiation protection rules, as variations among states exist. In addition, recommendations published by organizations such as the NCRP and the ADA, while not legally binding, contribute significantly to the reduction of radiation risks for operators and patients alike.

[Diagnostic imaging and radiation hazards]. / Imagerie diagnostique et risques d'irradiation.

For the last 20 years, the exposure of the population to medical radiation has been increased by 600%, mainly due to the extension of new imaging modalities such as CT or interventional radiology. The risk for radio-induced hazards is especially marked for children, because of the high sensivity of tissues to radiation especially during the first decade of the life. Two main ways allow to better control and reduce the mean effective dose per patient in diagnostic imaging: the introduction of recent technical improvement (i.e. low dose CT scans using iterative reconstruction algorithms, low dose technique for pediatric spine), and the substitution to non-radiating techniques such as ultrasound and MRI. The French National institute of Radioprotection and Nuclear Safety periodically publishes dose reference levels for conventional films and CT examinations, for both adults and pediatric patients. A close relationship between clinicians and radiologists remains essential for a better appreciation of the risk/benefit ratio of each individual examination using X-Rays.

[Oral and maxillofacial radiology: laws and regulations]. / Tandheelkundige radiologie: wet- en regelgeving.

Since the discovery of X-rays, medical imaging has been one of its most important applications. In the course of years, understanding of the potentially harmful effects of radiation on tissue has substantially increased as a result of experience and scientific studies. This has led to the International Commission on Radiological Protection (ICRP), the organisation that is now regarded as the most authoritative in the field of information on radiation and radiation protection. In most countries the law governing radiation is based on the 3 principles of the ICRP: justification, ALARA and dosage limits. For the Dutch situation, these are the Nuclear Energy Act (Kernenergiewet) and the Radiation Protection Decree (Besluit stralingsbescherming). The Practice Guidelines on Radiology are available for the practical implementation of the regulations. By working according to the Practice Guidelines, the dentist satisfies the legal regulations, but, more importantly, he can apply X-ray diagnostics in a manner that is safe for him, the dental team, the patients and all other visitors of the practice.

CT exposure in adult and paediatric patients: a review of the mechanisms of damage, relative dose and consequent possible risks.

An increase has been observed not only in the absolute number of CT examinations but also in the length of coverage and number of scanning phases, with the result that exposure to ionising radiation from CT is becoming an increasingly serious problem. The extent of the problem is not entirely known and cannot be adequately addressed without proper knowledge of all the phases that leads to the effective dose calculation. In light of the growing awareness of the issue of ionising radiation dose and the possible risk for the individual and the population, there is a need for radiologists, medical physicists and radiographers to play an active role in dose management. In this review, the authors try to delineate the problem in a consequential and multifaceted way: radiation-patient interaction, possible mechanisms of damage, main CT dose units, risk and its quantification in the population, with the aim of optimising the acquisition dose without diagnostic drawbacks. For an "up-to-date" use of CT, radiologists must know the dose concerns for the single patient and population, and use the CT apparatus with the best dose care; substitute CT with other diagnostic techniques when possible, especially in children; reduce the number/extension of scans and phases, and the dose in single scans and single examinations.