Real Decreto 601/2019 sobre justificación y optimización: aspectos prácticos / Royal Decree 601/2019 on justification and optimization: Practical aspects

El Real Decreto 601/2019 de 18 de octubre es fruto de la transposición parcial al ordenamiento jurídico español de la Directiva EURATOM 59/2013. Este Real Decreto recoge los mandatos de la Directiva relacionados con la necesidad de justificar y optimizar la exposición médica, incluida la de personas asintomáticas, la propuesta de requisitos más estrictos en cuanto a la información que debe proporcionarse al paciente, el registro y la notificación de las dosis de los procedimientos médico-radiológicos, el uso de niveles de referencia para diagnóstico y la disponibilidad de dispositivos indicadores de dosis. El artículo revisa los aspectos más relevantes y novedades relacionadas con los principios de justificación, optimización, control de dosis y las obligaciones derivadas del derecho a la información y el consentimiento. El Real Decreto considera fundamental que exista un alto nivel de competencia, y una nueva enumeración de responsabilidades y funciones de los radiólogos, las cuales se detallan y analizan.(AU)

The Royal Decree 601/2019 of 18th october is the result of the partial transposition into the Spanish legal system of the EURATOM Directive 59/2013. This Royal Decree includes the mandates of the Directive related to the need to justify and optimize medical exposure, including that of asymptomatic people, proposal of stricter requirements regarding the information that must be provided to the patient, registration and notification of the doses of medical-radiological procedures, use of reference levels for diagnosis and the availability of dose-indicating devices. The article reviews the most relevant aspects and novelties related to the principles of justification, optimization, dose control and the obligations derived from the right to information and consent. This Royal Decree considers essential for radiologists to develop a high level of competence and a new list of responsibilities and functions, which are detailed and analysed in this article.(AU)

Radiotherapy and pregnancy.

We present the updated recommendations of the French society for radiation oncology on radiotherapy and pregnancy. The occurrence of cancer during pregnancy is a rare event (approximately 1 in 1000 pregnancies). The risks for the embryo or the foetus depend on the gestational age at the time of irradiation. The main risks are malformations with microcephaly and mental retardation. There is also a risk of radiation-induced cancer in the unborn child. In the case of only supradiaphragmatic irradiation, radiotherapy can be performed most often in pregnant women without risk to the foetus. On the other hand, in the case of an indication for subdiaphragmatic irradiation, therapeutic termination of the pregnancy should be proposed. In all cases, when radiotherapy is chosen, a phantom estimation of the dose delivered to the foetus, confirmed by in vivo measurement, is recommended. Conformational radiotherapy is the preferred technique because of the lower dose delivered to the foetus (except in tumour locations where other techniques such as IMRT are recommended).

The new radiation protection framework since 2019 - Implementation in Germany and comparison of some aspects in seven European countries. / Das neue Strahlenschutzrecht ab 2019 ­ Umsetzung in Deutschland und Vergleich einzelner Aspekte in 7 europäischen Ländern.

PURPOSE: The implementation of EU Directive 2013/59 EURATOM (EU-BSS) of 2014 led to a reorganization of radiation protection legislation in Germany in the form of a new radiation protection law Strahlenschutzgesetz (StrlSchG) of 2017 and a new radiation protection ordinance Strahlenschutzverordnung (StrlSchV) of 2018. For application of ionizing radiation in medicine these changes affect radiology, nuclear medicine and radiotherapy. A comparison between the old and the new legal system analyses changes that are relevant for diagnostic and interventional radiology. For the important new regulation of unintended exposures, a comparison is made with the implementation of Art. 63 EU-BSS in 7 European countries. MATERIAL AND METHODS: The provisions of the Röntgenverordnung (RöV) and the old Strahlenschutzverordnung (StrlSchV alt), which were valid until 2018, are compared with the new legislation of StrlSchG and StrlSchV for changes in radiation protection for patients, the population and occupational radiation protection of staff members. The occupational dose limit of the eye lens was reduced. The reduction by a factor of 7.5 results in new requirements for radiation protection equipment. New requirements in teleradiology are compared with the previous regulation, as well as the necessary involvement of medical physics experts (MPE) in high dose procedures, such as CT and fluoroscopic interventions. The regulation for unintended exposures of the German StrlSchV are analyzed in terms of their reporting criteria. RESULTS: The principles of medical radiation protection in Germany have not changed as a result of the new radiation protection legislation from 2019 onwards. However, there are a number of changes and new requirements that must be considered and implemented. Important points are e. g. new regulations on teleradiology, early detection of diseases in asymptomatic individuals and reporting of unintended exposure of patients. As all new regulations are no longer found in only one single regulation, both knowledge of the StrlSchG and the StrlSchV are necessary. KEY POINTS: · The EU Directive 2013/59 EURATOM (EU-BSS) was transposed into the new German radiation protection law 2018. · The basic regulations of the RöV and old StrlSchV remain unchanged. · Newly added regulations must be known and implemented in practice. · Many regulations of the EU-BSS are so vaguely formulated that they allow a wide scope for national implementation. CITATION FORMAT: · Loose R, Wucherer M, Walz M et al. The new radiation protection framework since 2019 - Implementation in Germany and comparison of some aspects in seven European countries. Fortschr Röntgenstr 2020; 192: 1036 - 1045.

[The radiolabeled blood cell: Finding a legal qualification]. / La cellule sanguine marquée par un radionucléide : recherche d'une qualification juridique.

Radiolabelling of blood cells is a technique commonly used as a diagnostic tool in nuclear medicine; it has never been legally defined. This lack of legal status is a factor of uncertainty for both patients and health care professionals. The aim of this work was to identify what could be the legal nature of the radiolabelled blood cells by comparing their constitutive elements to the various existing legal categories applicable, according to the law applicable to living organisms as well as the regulations for other health products. The study concludes that, as it stands, the radiolabelled blood cells undoubtedly belong to the category of a drug by function for diagnostic purpose. More precisely, it is compared to a radiopharmaceutical medicinal product resulting from a well characterised manufacturing process. In order to increase visibility and thus the actors' awareness of the constraints arising from this specific status, it is proposed to create a specific legal regime for the radiolabelled blood cells by including in Article L. 5121-1 of the French Public Health Code a new category of health product which could be called: radiopharmaceutical preparation of cellular blood component for diagnostic purposes. The consequence of this proposal will mechanically place the radiolabelled blood cell preparation under the exclusive competences of radiopharmacists practising in an hospital pharmacy. Another important consequence will be that the radiolabelling process of blood cells will have to fulfil the rules of the French good hospital pharmacy practices and good preparation practices, for the benefit of patient protection and safety.

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.

Medical radiological procedures: which information would be chosen for the report?

AIMS AND OBJECTIVES: The aim of this study was to properly define the information regarding patient exposure to Ionizing Radiations in the radiological report, according to the European Directive 2013/59/EURATOM (EU 2013/59 art.58(b)). For this purpose, we evaluated the results from other Member States EU 2013/59 transpositions and from Guidelines recommendation published by International Organizations involved in diagnostic radiology. A practical way for implementing art.58 is also traced. MATERIALS AND METHODS: Dosimetric quantities, such as exposure, absorbed dose and effective dose which may be included in radiological report, were first analyzed; then, in order to define international state of art of Member States EU 2013/59 transposition, a Web research using French, English, Spanish and German key words was performed. RESULTS: EU 2013/59 transposition for 5 Member States was reported. Especially regarding art.58, a European project reports that few European countries (11 of 28) have identified the dose metrics to be used in radiological report. Scientific organizations supporting clinical radiologists and medical physicists have published Guidelines reporting parameters useful to quantify the radiation output and to assess patient dose. CONCLUSIONS: Our research revealed that there is not a shared interpretation of patient exposure information to be included in radiological report. Nevertheless, according to scientific community, authors believe that the exposure is the most appropriate information that could be included in radiological report. Alternatively, but with more expensiveness, a risk index based on effective dose could be used. Moreover, the systematic exposure information recorded could be useful for dose estimates of population from medical exposure.

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.

Benchmark of different assessment methods for non-sinusoidal magnetic field exposure in the context of European Directive 2013/35/EU.

For the assessment of non-sinusoidal magnetic fields the European EMF Directive 2013/35/EU specified the Weighted Peak Method in Time Domain (WPM-TD) as the reference method. However, also other scientifically validated methods are allowed, provided that they lead to approximately equivalent and comparable results. In the non-binding guide for practical implementation of 2013/35/EU three methods alternative to the WPM-TD are described, i.e. the Weighted Peak Method in Frequency Domain (WPM-FD), the Multiple Frequency Rule (MFR), and an alternative Time Domain Assessment Method (TDAM). In this paper the results of a benchmark comparison of these assessment methods, based on 12 different time domain signals of magnetic induction, measured close to real devices and nine additional generic waveforms, are presented. The results demonstrated that assessments obtained with WPM-TD and WPM-FD can be considered approximately equivalent (maximum deviation 3.4 dB). The MFR systematically overestimates exposure, due to its inherently conservative definitions. In contrast, the TDAM significantly and systematically underestimates exposure up to a factor of 22 (26.8 dB) for the considered waveforms. The main reasons for this exposure underestimation by the TDAM are the introduction of an inappropriate time averaging, and the fact that the characteristic time parameter τ p,min, describing the minimum duration of all field changes dB/dt of the waveform is derived independently from the extent of the field change in the definitions of the TDAM. Consequently, we recommend not to use the TDAM as presently published in the non-binding guide to 2013/35/EU, as its application would be in contradiction with the underlying aim of 2013/35/EU, i.e. a harmonised level of occupational safety with respect to exposure to electromagnetic fields.

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.

Informe sobre la radio-exposición en el personal quirúrgico de Ortopedia y Traumatología: Principios, marco legal y análisis situacional en la Argentina / Report on the radiation exposure in Orthopedic and Traumatology surgical staff. Principles, legal framework, and situational analysis in Argentina

La cirugía ortopédica ha avanzado mucho en estos años y, con ello, el uso de la intensificación de imágenes en el quirófano. El objetivo de este informe es revisar los principios biológicos de la radiación, el marco legal actual y hacer una breve reseña sobre la situación actual en la Argentina.

Orthopedic surgery has significantly advanced in the past years along with image intensifier fluoroscopy in the operating room. The purpose of this report is to review biological principles of radiation, as well as the current legal framework and to outline the present situation in Argentina.

[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.

Artificial Optical Radiation photobiological hazards in arc welding.

Occupational Health and Safety (OHS) is associated with crucial social, economic, cultural and technical issues. A highly specialized OHS sector deals with the photobiological hazards from artificial optical radiation (AOR), which is divided into visible light, UV and IR emitted during various activities and which is legally covered by European Directive 2006/25/EC. Among the enormous amount of sources emitting AOR, the most important non-coherent ones to consider for health effects to the whole optical range, are arcs created during metal welding. This survey presents the effort to assess the complicated exposure limits of the Directive in the controlled environment of a welding laboratory. Sensors covering the UV and blue light range were set to measure typical welding procedures reproduced in the laboratory. Initial results, apart from apparently justifying the use of Personal Protective Equipment (PPE) due to even subsecond overexposures measured, also set the basis to evaluate PPE's properties and support an integrated risk assessment of the complex welding environment. These results can also improve workers' and employer's information and training about radiation hazards, which is a crucial OHS demand.

Outdoor Exposure to Solar Ultraviolet Radiation and Legislation in Brazil.

The total ozone column of 265 ± 11 Dobson Units in the tropical-equatorial zones and 283 ± 16 Dobson Units in the subtropics of Brazil are among the lowest on Earth, and as a result, the prevalence of skin cancer due to solar ultraviolet radiation is among the highest. Daily erythemal doses in Brazil can be over 7,500 J m. Erythemal dose rates on cloudless days of winter and summer are typically about 0.147 W m and 0.332 W m, respectively. However, radiation enhancement events yielded by clouds have been reported with erythemal dose rates of 0.486 W m. Daily doses of the diffuse component of erythemal radiation have been determined with values of 5,053 J m and diffuse erythemal dose rates of 0.312 W m. Unfortunately, Brazilians still behave in ways that lead to overexposure to the sun. The annual personal ultraviolet radiation ambient dose among Brazilian youths can be about 5.3%. Skin cancer in Brazil is prevalent, with annual rates of 31.6% (non-melanoma) and 1.0% (melanoma). Governmental and non-governmental initiatives have been taken to increase public awareness of photoprotection behaviors. Resolution #56 by the Agência Nacional de Vigilância Sanitária has banned tanning devices in Brazil. In addition, Projects of Law (PL), like PL 3730/2004, propose that the Sistema Único de Saúde should distribute sunscreen to members of the public, while PL 4027/2012 proposes that employers should provide outdoor workers with sunscreen during professional outdoor activities. Similar laws have already been passed in some municipalities. These are presented and discussed in this study.

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.

Health Risks From Low Doses and Low Dose-Rates of Ionizing Radiation. Session 5: Future of Radiation Protection Regulations.

The system of radiological protection is a prospective approach to protection of individuals in all exposure situations. It must be applied equitably across all age groups and all populations. This is a very different circumstance from dose assessment for a particular individual where the unique characteristics of the individual and the exposure can be taken into account. Notwithstanding the ongoing discussions on the possible shape of the dose response at low doses and dose rates, the prospective system of protection has therefore historically used a linear assumption as a pragmatic, prudent and protective approach. These radiation protection criteria are not intended to be a demarcation between "safe" and "unsafe" and are the product of a risk-informed judgement that includes inputs from science, ethics, and experience. There are significant implications for different dose response relationships. A linear model allows for equal treatment of an exposure, irrespective of the previously accumulated exposure. In contrast, other models would predict different implications. Great care is therefore needed in separating the thinking around risk assessment from risk management, and prospective protection for all age groups and genders from retrospective assessment for a particular individual. In the United States, the prospective regulatory structure functions effectively because of assumptions that facilitate independent treatment of different types of exposures, and which provide pragmatic and prudent protection. While the a linear assumption may, in fact, not be consistent with the biological reality, the implications of a different regulatory model must be considered carefully.

Ionising radiation exposure in patients with circular frame treatment of distal tibial fractures.

Total radiation exposure accumulated during circular frame treatment of distal tibial fractures was quantified in 47 patients treated by a single surgeon from February 2007 until Oct 2010. The radiation exposures for all relevant radiology procedures for the distal tibial injury were included to estimate the radiation risk to the patient. The median time of treatment in the frame was 169 days (range 105-368 days). Patients underwent a median of 13 sets of plain radiographs; at least one intra operative exposure and 16 patients underwent CT scanning. The median total effective dose per patient from time of injury to discharge was 0.025mSv (interquartile range 0.013-0.162 and minimum to maximum 0.01-0.53). The only variable shown to be an independent predictor of cumulative radiation dose on multivariate analysis was the use of CT scanning. This was associated with a 13-fold increase in overall exposure. Radiation exposure during treatment of distal tibial fractures with a circular frame in this group was well within accepted safe limits. The fact that use of CT was the only significant predictor of overall exposure serves as a reminder to individually assess the risk and utility of radiological investigations on an individual basis. This is consistent with the UK legal requirements for justification of all X-ray imaging, as set out in the Ionising Radiation (Medical Exposure) Regulations 2000 [1].