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.

Medical Malpractice Primer for Practicing Interventional Radiologists.

Medical professional liability (MPL), also commonly referred to as medical malpractice, is a costly issue in health care today, accounting for roughly 2.4% of total health care expenditure in the United States. Almost all physicians currently in clinical practice will either be subject to a lawsuit themselves or work with someone who has. Given a lack of formal structured education about MPL in medicine for trainees, this review aims to define and discuss the relevant concepts in MPL as a reference for early career interventionalists to understand the current medicolegal environment and learn best practices to avoid litigation.

New European Regulation for Medical Devices: What Is Changing?

INTRODUCTION: The Medical Devices Regulation (MDR) 2017/745/EU will fully apply from May 2020. Interventional radiologists use medical devices on a daily basis and so must be aware of the impact that this new regulation will have on their daily practice. MATERIALS AND METHODS: In this paper, we describe the major transformation that the MDR brings to the medical devices sector, with a focus on clinical evaluations and clinical investigations. RESULTS: This regulation significantly tightens controls to ensure that devices are safe and effective. In addition, equivalence to already existing devices, which allowed an accelerated access to the market, will now be possible only in some cases. Furthermore, post-marketing clinical follow-up is extended under the MDR and is required for all devices. These new requirements will probably lead to a dramatic increase in the number of clinical investigations and also to a delay in the availability of certain devices on the market. CONCLUSIONS: In the coming years, interventional radiologists are likely to be affected by these changes in their daily practice, in terms of medical device availability and/or in terms of increased involvement in clinical investigations.

Outcomes and associated factors in malpractice litigation involving inferior vena cava filters.

OBJECTIVE: Placement of inferior vena cava (IVC) filters is a controversial focus of medical malpractice. Clinicians currently have little information to guide them regarding key issues and outcomes in litigation. In this retrospective legal case review, we analyzed the factors associated with malpractice actions involving IVC filters. METHODS: The legal databases LexisNexis and Westlaw were searched from 1967 to 2016 for all published legal cases in the United States involving placement of IVC filters. Keywords included "IVC," "inferior vena cava," "filter," and "malpractice." Social Security Disability claims, product liability actions, and hospital employment contract disputes were excluded. RESULTS: There were 310 search results eligible for initial review. After application of exclusion criteria, 29 cases involving medical malpractice were included in final analysis. The majority of excluded cases were insurance disputes and tax revenue cases. Overall, private practitioners were most often sued (11/29 [37.9%]), whereas 24.1% of defendants were academic hospitals (7/29), 20.7% were prisons (6/29), and 17.2% were community hospitals (5/29). The most common specialty named was vascular surgery (8/29), whereas interventional radiologists were named only twice. The most common indications for IVC filter placement were hypercoagulable state (8/29 [29.6%]), recurrent pulmonary embolism (PE; 6/29 [22.2%]), and trauma (5/29 [18.5%]). The most common underlying allegations involved failure to insert IVC filter when indicated (14/29 [48.3%]), intraprocedural negligence (5/29 [17.2%]), and failure to timely remove device (5/29 [17.2%]). Common complications included failure to prevent occurrence of PE (14/29 [48.3%]), device migration (4/29 [13.8%]), and perforation of organs or vasculature (3/29 [10.3%]). Death of the patient occurred in 41.4% of total cases (12/29). In cases in which the patient died, the most common indications for filter placement were trauma (4/12 [33.3%]) and deep venous thrombosis (3/12 [25.0%]), and the most common complication in those patients who died was the failure to prevent a subsequent PE (9/12 [75.0%]). Available verdicts favored defendants (13/14 [92.9%]). In cases with defense verdicts, the most common indications for filter placement similarly were trauma (4/13 [30.8%]) and deep venous thrombosis (3/13 [23.1%)], and the most common complication was failure to prevent PE (9/14 [64.3%]). CONCLUSIONS: Analysis of malpractice cases involving IVC filters revealed key factors associated with litigation. Overall, verdicts favored defendants. Private practitioners were most commonly sued, and the most common reasons for bringing suit were failure to insert filter, intraprocedural complications, and failure to remove filter. Deeper awareness of issues related to malpractice litigation can inform clinical practice and improve patient care and safety.

Criterios para la formación y capacitación en Neurorradiología Intervencionista-Neurointervencionismo, acordados por el Grupo Español de Neurorradiología Intervencionista (GENI), la Sociedad Española de Neurorradiología (SENR), el Grupo de Estudio de Enfermedades Cerebrovasculares (GEECV) de la Sociedad Española de Neurología (SEN) y el grupo experto en enfermedades vasculares de la Sociedad Española de Neurocirugía (SENEC). Bases para la obtención de una Acreditación de Centros y Especialistas en Neurorradiología Intervencionista-Neurointervencionismo / Criteria for training and accreditation in Interventional Neuroradiology-Neurointervention, approved by the Spanish Group of Interventional Neuroradiology (GENI), the Spanish Society of Neuroradiology (SENR), the Spanish Group of Cerebrovascular Diseases (GEECV), the Spanish Society of Neurology (SEN), and the vascular disease specialists in the Spanish Society of Neurosurgery (SENEC). Requirements for accreditation in Interventional Neuroradiology-Neurointervention for institutions and specialists

Introducción: El desarrollo de las técnicas endovasculares ha colocado a la Neurorradiología Intervencionista-Neurointervencionismo (NRI-NI) como una alternativa de primera elección para el tratamiento de gran parte de las enfermedades vasculares del sistema nervioso central. Al no disponer de programas formativos en NRI-NI normalizados, las sociedades científicas de los países desarrollados han creado estándares de formación y acreditación para la práctica segura de estos procedimientos. Desarrollo: En España, estamos a la espera del desarrollo legislativo de las Áreas de Capacitación Específicas que establecerán el modelo formativo oficial para los especialistas que deseen formarse en NRI-NI. Hasta que llegue ese momento, se hace pertinente disponer de unos estándares que definan los mínimos deseables para el periodo formativo en NRI-NI al que puedan acceder especialistas no solo de la Radiología, sino también de la Neurocirugía, y la Neurología, así como los requisitos exigibles a los hospitales que realizan esta actividad y quieran impartir dicha formación. Conclusiones: Para poner en práctica la acreditación de centros formativos y la acreditación de los centros formadores y especialistas formados en NRI-NI, el Grupo Español de Neurorradiología Intervencionista (GENI), la Sociedad Española de Neurorradiología (SENR), el Grupo de Estudio de Enfermedades Cerebrovasculares (GEECV) de la Sociedad Española de Neurología (SEN) y el grupo experto en enfermedades vasculares de la Sociedad Española de Neurocirugía (SENEC), han aprobado el contenido de este documento de consenso y crearán un comité acreditador

Background: The development of endovascular techniques has put Interventional Neuroradiology (INR) as the first-option treatment in the majority of vascular diseases of the central nervous system. Scientific societies in developed countries have created standard procedures for training and accreditation for a safe practice in these procedures. Discussion: In Spain, we are waiting for the development of the legislation on the accreditation for specialists which will establish the official formative model to achieve an accreditation in INR. Until this moment comes, it is necessary to establish standards that define desirable minimums for the formative period in INR. Radiology specialists as well as neurologists and neurosurgeons will have access to INR accreditation. Specific requirements for the hospitals that wish to offer this technique and training should also be defined. Conclusion: The Spanish Group of Interventional Neuroradiology (GENI), the Spanish Society of Neuroradiology (SENR), the Spanish Group of Cerebrovascular Diseases (GEECV), the Spanish Society of Neurology (SEN) and the Spanish Society of Neurosurgery (SENEC) have approved the content of this document and will create a committee in order to put into practice the accreditation of formative centres and INR specialists

Medical Liability and Patient Law in Germany: Main Features with Particular Focus on Treatments in the Field of Interventional Radiology.

UNLABELLED: On February 26th, 2013 the patient law became effective in Germany. Goal of the lawmakers was a most authoritative case law for liability of malpractice and to improve enforcement of the rights of the patients. The following article contains several examples detailing legal situation. By no means should these discourage those persons who treat patients. Rather should they be sensitized to to various aspects of this increasingly important field of law. To identify relevant sources according to judicial standard research was conducted including first- and second selection. Goal was the identification of jurisdiction, literature and other various analyses that all deal with liability of malpractice and patient law within the field of Interventional Radiology--with particular focus on transarterial chemoembolization of the liver and related procedures. In summary, 89 different sources were included and analyzed. The individual who treats a patient is liable for an error in treatment if it causes injury to life, the body or the patient's health. Independent of the error in treatment the individual providing medical care is liable for mistakes made in the context of obtaining informed consent. Prerequisite is the presence of an error made when obtaining informed consent and its causality for the patient's consent for the treatment. Without an effective consent the treatment is considered illegal whether it was free of treatment error or not. The new patient law does not cause material change of the German liablity of malpractice law. KEY POINTS: •On February 26th, 2013 the new patient law came into effect. Materially, there was no fundamental remodeling of the German liability for medical malpractice. •Regarding a physician's liability for medical malpractice two different elements of an offence come into consideration: for one the liability for malpractice and, in turn, liability for errors made during medical consultation in the process of obtaining informed consent. •Forensic practice shows that patients frequently enforce both offences concurrently.

The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research.

The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty.

[Interventional radiology: current problems and new directions]. / Radiología intervencionista. Problemas actuales y nuevos caminos.

In recent years, vascular and interventional radiology has become one of the fastest growing diagnostic and therapeutic specialties. This growth has been based on a fundamental concept: performing minimally invasive procedures under imaging guidance. This attractive combination has led to the interest of professionals from other clinical specialties outside radiology in performing this type of intervention. The future of vascular and interventional radiology, although uncertain, must be linked to clinical practice and multidisciplinary teamwork.