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.
Abstract
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
Zusamenfassung
Ziel
Die Umsetzung der EU-Direktive 2013/59 EURATOM (EU-BSS) von 2014 führte in Deutschland zu einer Neuordnung des Strahlenschutzrechts in Form eines neuen Strahlenschutzgesetzes (StrlSchG) von 2017 und einer neuen Strahlenschutzverordnung (StrlSchV) von 2018. Damit ergeben sich bei der Anwendung ionisierender Strahlen in der Medizin Veränderungen, die Radiologie, Nuklearmedizin und Strahlentherapie betreffen. In einem Vergleich zwischen alter und neuer Rechtsordnung werden die für die Radiologie relevanten Veränderungen analysiert. Für die wichtige neue Regelung meldepflichtiger Ereignisse wird ein Vergleich mit der Implementierung von Art. 63 EU-BSS in 7 europäischen Staaten durchgeführt.
Material und Methoden
Die bis 2018 geltenden Regelungen der Röntgenverordnung und alten Strahlenschutzverordnung werden für die in der Radiologie relevanten Regelungen zum Strahlenschutz für Patienten, die Bevölkerung und zum beruflichen Strahlenschutz des Personals mit dem StrlSchG und der StrlSchV verglichen und Veränderungen in ihrer Auswirkung bewertet. Aus der Herabsetzung der beruflichen Augenlinsendosis um den Faktor 7,5 ergeben sich neue Anforderungen an die Strahlenschutzausrüstung. Die neuen Anforderungen in der Teleradiologie werden in ihren Auswirkungen mit den früheren Genehmigungen verglichen, ebenso wie die jetzt notwendige Hinzuziehung von Medizinphysikexperten bei dosisintensiven Verfahren wie CT und fluoroskopische Interventionen. Die in der deutschen StrlSchV getroffenen Regelungen für meldepflichtige Ereignisse werden mit ihren Kriterien zur Meldepflicht diskutiert.
Ergebnisse
Die Grundlagen des medizinischen Strahlenschutzes in Deutschland haben sich durch das neue Strahlenschutzrecht ab 2019 nicht verändert. Es gibt allerdings eine Reihe von Veränderungen und auch neuer Anforderungen, die zu beachten und umzusetzen sind. Wichtige Punkte sind z. B. neue Regelungen zur Teleradiologie, Früherkennung von Krankheiten und Meldekriterien bei unbeabsichtigter zu hoher Exposition von Patienten. Da sich alle neuen Regelungen nicht mehr nur in einer Verordnung finden, sind sowohl Kenntnisse des StrlSchG als auch der StrlSchV notwendig.
Kernaussagen:
Die EU-Direktive 2013/59 EURATOM (EU-BSS) wurde im neuen Deutschen Strahlenschutzrecht 2018 umgesetzt.
Die grundlegenden Regelungen der RöV und alten StrlSchV bleiben erhalten.
Neu hinzugekommene Regelungen müssen bekannt sein und in der Praxis umgesetzt werden.
Viele Regelungen der EU-BSS sind so unscharf formuliert, dass sie einen weiten Spielraum in der nationalen Umsetzung ermöglichen.
Zitierweise
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 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.
Abstract
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.
Citation Format:
• Sommer SA, Geissler R, Stampfl U et al. Medical Liability and Patient Law in Germany: Main Features with Particular Focus on Treatments in the Field of Interventional Radiology. Fortschr Röntgenstr 2016; 188: 353 – 358
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