[en] The extent of the radiation exposure of patients has increased dramatically in recent times. The major part of the exposure now arises from practices that barely existed two decades ago. In some countries, the population dose from medical exposures now rivals that from the natural background. For practitioners and regulators, it is evident that this innovation has been driven both by the imaging industry and by an ever increasing array of new applications generated and validated in the clinical environment. Because of these increases, the radiation protection of patients has assumed much greater importance. The doses involved are large compared with those from occupational exposures. Much work has been done to optimize these doses, and much of what is required is well understood. However, more remains to be done to ensure that routine day to day practice throughout the world is well optimized. The other cornerstone of the radiation protection of patients is the justification of exposures as recommended by the International Commission on Radiological Protection (ICRP) and required by the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (BSS), jointly sponsored by the IAEA and a number of other international organizations. The justification process must ensure that only those who can benefit from medical exposures will receive them. In practice, the benefit must be balanced against the risk. The theory of the radiation protection of the patient relies on this balance being struck in a way that ultimately favours patients and does not expose them to unnecessary risk. With the increase in the dose per examination, the issue of justification has acquired a new urgency to which the IAEA has responded vigorously over the last few years. The IAEA response initially involved two consultations with groups of experts. The first established that there is a prime facie case to be concerned that the implementation of justification is not all it should be. The second established that there is a robust set of tools that can greatly improve justification. These are mature enough to be deployed for clinical use in various parts of the world, although further refinement and nuancing is required. Arising from these initiatives, the IAEA and the European Commission (EC) organized a joint workshop on the justification of medical exposures in Brussels with a view to consolidating these conclusions and broadening the interest groups involved in considering the problem. These proceedings report the work and conclusions of this workshop. Over 40 countries and several international organizations were involved, and concluded that there are major issues to be addressed in the implementation of justification in practice. A concerted global campaign to improve 'awareness, appropriateness and audit' (the three A's campaign) is required, as set out in the conclusions. The campaign will necessarily involve all the key players in the field. The International Action Plan for the Radiological Protection of Patients was approved by the General Conference of the IAEA in 2002, and its implementation has been the subject of a resolution at succeeding General Conferences. Recently, the IAEA Secretariat was encouraged to 'develop further guidance on justification of medical exposures and optimization of protection, taking into account, inter alia, the outcomes of the September 2009 workshop hosted jointly with the European Commission'. These proceedings are prepared and issued in response to this.

[en] I am honoured to welcome you to the workshop on justification of medical exposure in diagnostic imaging, sponsored jointly by the International Atomic Energy Agency and the European Commission, and I would like to thank the European Commission for hosting this workshop here in Brussels. Diagnostic imaging has seen many developments as it has evolved over the years, and in the last 30-40 years the pace of innovation has increased, starting with the introduction of computed tomography in the early 1970s. During the last decade, the rate of change has accelerated even further. Most patient exposure now arises from practices that barely existed two decades ago. These developments are evident in technology such as multi-detector CT scanning. However, this advance is achieved at the cost of a radiation burden to the individual patient and to the community. Contrary to other exposures to ionizing radiation, which have remained constant or decreased over the past decades, medical exposures have increased at a remarkable rate. It is of interest to note that in the 1990s, a patient had to remain in a CT gantry for a period of 10 minutes for a chest CT, whereas now it takes a few seconds to scan the entire chest. This may give the impression that the radiation dose in CT is small, which is not the case. A typical chest CT can impart a radiation dose equivalent to hundreds of chest radiographs. However, the radiation dose to individual patients and the population can be reduced significantly through careful application of optimization and justification of medical exposures. Over the last 20 years, much successful work has been devoted to developing and consolidating approaches to optimization. Less effort has been committed to justification and the limited amount applied has not yet been as successful. We should recognize that the use of ionizing radiation in medicine has brought tremendous health benefits to the global population, even though these benefits are not evenly distributed around the world. We should also take note of the very rapid growth of medical radiation technology, increasing access for patients every year. But we must always remember that the use of ionizing radiation has an associated risk. There are many advocates for the first two points, for example 'big industry' and 'big medicine', but perhaps a shortage of serious well considered advocates for the balanced management of the risks involved. In many cases, regulatory oversight of medical exposure is lacking, even in highly developed countries, and the sharing of experience among practitioners needs to be further developed. This technology is now increasingly reaching developing countries with less developed infrastructure, making the issues even more crucial. Joint efforts by the IAEA, along with WHO, the EC and other organizations within the framework of the International Action Plan for the Radiological Protection of Patients is a good example of cooperation for the benefit of patients. This Action Plan has been in effect since 2002, and has enabled coordination of international efforts and the provision of guidance on the radiation protection of patients. We should remember that medical exposure is a massive global activity and that every day, throughout the world, radiation is used in an estimated more than ten million diagnostic procedures and one hundred thousand nuclear medicine procedures, while more than twenty thousand radiotherapy courses are started. For those of you who might not be aware of the work of the IAEA, I would like to share some fundamental facts. The IAEA is part of the United Nations family of organizations, functioning under its own statute as an autonomous international organization in a working relationship with the United Nations. The UN recognizes the IAEA as the agency responsible for international activities concerned with the peaceful uses of atomic energy, which includes the application of ionizing radiation in medicine. We are working closely with other United Nations Organizations on this issue and I would like to highlight our close cooperation with the World Health Organization. Three main pillars underpin the IAEA's mission: the first is safety and security; the second is science and technology; and the third is safeguards and verification. Within the first two pillars, in safety/security and in science/technology, we carry out our work relating to the use of radiation in medicine. The IAEA helps countries to mobilize peaceful applications of nuclear science and technology, for example through providing Member States with equipment, training and expertise to help fight cancer, and the IAEA also helps countries to upgrade safety and security in nuclear science and technology in order to protect people and the environment from harmful radiation exposure, for example through our programme on radiation safety. A core element of safety is setting and promoting the application of international safety standards for the management and regulation of activities involving nuclear and radioactive materials. It is a statutory function of the IAEA to establish standards of safety for protection of health and minimization of danger to life and to provide for their use. I would here like to mention the key standards in this area: the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources. This is known as the International BSS, and marks the culmination of efforts that have continued over the past several decades towards the harmonization of radiation protection and safety standards internationally.

[en] In Canada, the increase in CT utilization has led to substantially increased population radiation exposure. It is believed that a centralized electronic registry of all previous medical radiation exposure would allow better justification of imaging orders and better assessment of the benefits versus the radiation risk of contemplated examinations. Hence, the Radiation Protection Bureau of Health Canada has proposed the development of a Patient Radiation Dose Registry. Government funded projects towards this development are already underway.

[en] Full text: The core principles of radiation protection are those of justification, optimization and limitation of exposures. In general these aim at the health protection of workers and members of the public by avoiding exposure to ionizing radiation through the prohibition of frivolous or unjustified uses of radiation or radioactive substances, the optimization of protective measures and restrictions on individual dose. The application of these principles to medical exposures is not straightforward. Indeed, rather than avoiding exposures, the medical practice implies the deliberate exposure of individuals. In the case of diagnostic imaging, exposure of a patient should be commensurate to the desired quality of the image. The deliberate exposure of an individual is justified only if there is a direct benefit to this individual, for instance the benefit of proper diagnosis and imaging for further health care or treatment of a patient, or a significant benefit to public health in the case of mass health screening or for the purpose or research, which indirectly may be to the benefit of the exposed individual as well, or if there is overwhelming societal benefit as may be the case for security screening. This special feature of medical exposures results in the application of the principle of justification at three levels: · At the first level, the use of radiation in medicine is accepted as doing more good than harm to a patient and is therefore taken for granted and not dealt with in regulations; · At the second level, the justification of using ionizing radiation for specific medical purposes is dealt with, requiring justification of new types of practices involving medical exposure before being generally adopted; · Finally, justification of each individual exposure is required, taking into account the specific objective of the exposure and the characteristics of the individual. The second and third levels of justification were laid down in specific EU legislation: Directive 84/466, as updated in 97/43 and which is now being updated again as part of a major revision and recast of the Basic Safety Standards. While these directives were promptly and correctly transposed in national law, the implementation and enforcement of the principle by national authorities has proven to be difficult, particularly in the two following areas: · The third level of justification is a matter to be decided upon by health professionals, be it the prescriber or the radiological practitioner, and the impact of the regulatory authority is very limited; · The Directive requires steps to be taken to avoid the unnecessary proliferation of medical equipment. The latter point reflects societal reality. Despite the responsibility of health professionals to apply only individually justified exposures, if the, often expensive, equipment is available it is likely to be used more often. Unfortunately, while it is obvious that different national health policies and health security regimes have an impact on the frequency of medical exposures, there seems to be little room for authorities to use this requirement of the Directive to change undesirable trends. These deficiencies rightly receive new attention in view of the technological revolution, which in particular diagnostic imaging has experienced over the last decades. Earlier technological developments, such as image intensification for fluoroscopic examinations and the introduction of photographic film allowed for a reduction in exposures while preserving image diagnostic quality. Digital imaging and computerized tomography meant a revolution in the processing and quality of imaging, but did not reduce exposure to patients. On the contrary, doses can be very high, and while in many cases these may be justified by the quality of the image and the subsequent treatment, the proliferation of CT equipment and its possible overuse have caused a significant increase in overall population exposure, medical exposures now approaching those of the natural background. In view of these developments, the IAEA initiative to launch this series of workshops on justification of medical exposure in diagnostic imaging was important and timely. The EC is very pleased to host the present workshop here in Brussels and is grateful for this opportunity to involve EU stakeholders more closely, in particular our medical working party of the Article 31 Group of Experts. I also welcome the representation of WHO in this workshop, WHO being obviously a major actor in the development of health policies. This workshop will be an outstanding event which I am sure will look into the fundamental aspects of the principle of justification as well as into specific aspects such as radiological imaging for asymptomatic patients, children and pregnant women, into the further development of tools such as referral guidelines, the clinical audit, into the role of professional societies, etc.; all matters in which the Commission is very active as well, both in my unit, the RP unit of DG TREN, as well as in the research programme of our colleagues in DG RTD. The workshop is also timely with regard to the ongoing revision of international standards. The EC is deeply involved in these in order to ensure full coherence between the international standards and the EURATOM standards, in view of our eventual co-sponsorship of international standards. This workshop is of course only one of many initiatives in the medical area, and it is only one of the areas of cooperation between the EC, the IAEA and WHO. The EC plans the adoption of a communication next year elaborating our long term policy in this area. No doubt this communication will receive fair media attention and raise the awareness of stakeholders. The results of this workshop will of course be reflected in this communication.

[en] Medico-legal procedures are defined in the EC Medical Exposure Directive (MED) as 'procedures performed for insurance or legal purposes without a medical indication'. The European Commission started a process in 2005, the revision and recast of the Basic Safety Standards, in which the definition of non-medical imaging exposure is proposed to be, 'Any deliberate exposure of humans for imaging purposes where the primary motivation for making the exposure is not related to the health and well being of the individual exposed.' Issues around this type of exposure are explored in the paper. (author)

[en] The paper reflects on the current trend among radiologists to move away from what is regarded as a paternalistic attitude existing among practitioners and to place more emphasis on the rights of individual patients with regard to the issue of justification. The ethical discussion addresses the autonomy and rights of the patient, as well as the question of consent on his or her part. (author)

[en] The most important contributing factor to the higher cost of health care in the United States of America is the overutilization of services, including a growth in medical imaging that reflects advancements in imaging technologies and their contribution to improved detection and diagnosis of disease and injury. A fraction of imaging studies, perhaps as much as one-third, may be inappropriate. Several approaches to addressing overutilization of medical imaging procedures are being explored, including the development of appropriateness criteria and referral guidelines for imaging procedures. This can help in the selection of procedures judged to be in the best interests of patient care, and requires improved communication and cooperation among practitioners. (author)

[en] Media coverage about the risk associated with medical radiation exposures is increasing, and if not appropriately addressed could result in a drastic loss of public faith in the health benefits from the use of ionizing radiation in medicine. This paper explains from a journalistic perspective why the issue of radiological justification meets the criteria of a newsworthy topic, and outlines how to engage the news media in an outreach programme to achieve a new and better informed relationship between patients and those who deliver radiation in medicine. (author)

[en] Ladies and Gentlemen, I am very delighted to be with you this afternoon on the occasion of the closing session of this very interesting seminar. First of all, I would like to express my thanks to all organizations involved in the preparation and conduct of this meeting and especially to the International Atomic Energy Agency, in particular Ms. Renate Czarwinski, and also to our services in the European Commission in charge of this matter, under the responsibility of Mr. A. Janssens, the Head of the Unit for Radiation Protection. I would like to present to you some comments regarding the global nuclear context and then, more specifically, regarding medical exposure. Today the world is going through important changes in the use of nuclear energy and ionizing radiation. We see more and more a new interest in the development of nuclear energy everywhere in the world, including in the European Union - this is the case not only in France or Finland but also today in the United Kingdom, in Italy, in Sweden and in the great majority of the new Member States from Central and Eastern Europe. We also note the rapid developments regarding the use of ionizing radiation in medicine. All these changes have the potential to contribute to a better life for European citizens, providing a cleaner environment, sustainable economic development and improved health care. However, developments in the nuclear arena also create safety and non-proliferation challenges that need to be tackled on national, regional and international levels. We have seen in the context of the last G8 summit new proposals, in particular the proposal from the new President of the United States of America to organize a Global Summit on nuclear security in Washington in April next year. We will also have in 2010, in the context of the United Nations, a review of the Non-Proliferation Treaty. And we, as Europeans, have a special responsibility because we have the largest number of nuclear power plants (over 140 in operation today), and we have the lead on more advanced technologies regarding modern reactors, but also on the nuclear enrichment process and on reprocessing. In this context, it was possible in the last couple of years, first of all, to elaborate a new Directive on Nuclear Safety, adopted at the end of June this year under the Czech presidency and, importantly, with the full support of the 27 Member States and a very large majority at the European Parliament. For the first time we will introduce legally binding provisions regarding nuclear safety in Europe. We will give legal force to the main international standard, that of the Safety Fundamentals of the International Atomic Energy Agency, and also to the obligations of the International Convention on Nuclear Safety. We will also strongly reinforce the independence and resources of the national regulatory authorities. This will be important not only for us, as Europeans, but also in order to provide a good example for the rest of the world. We have also decided to present to the Council and the Parliament a new Communication on nonproliferation. This is extremely important, particularly in the context I mentioned before regarding the preparation of the Global Summit on Nuclear Security. There we will have a common responsibility to facilitate a new common position regarding those countries not respecting key provisions of the Non-Proliferation Treaty and refusing access of the International Atomic Energy Agency inspectors to some nuclear plants. We will also have to work out a position on those parties deciding to leave the Non-Proliferation Treaty, as was the case with the Democratic People's Republic of North Korea. Accordingly, I think that now there is a new clear understanding at the top level in many countries - in particular in the United States of America and in Europe but also in Japan, China and the Russian Federation - regarding the need to increase strongly international cooperation in this sector. We will develop cooperation with our partners including, as a first priority, the signing of bilateral agreements with the Russian Federation, Australia, Canada and all our other key partners. We also take part in the revision of the International Basic Safety Standards for radiation protection, in which the European Commission envisages becoming a cosponsoring organization. We are in parallel working on the update of the EURATOM radiation protection legislation with the aim of ensuring coherence with international standards; the Commission proposal for revising and recasting the EURATOM Basic Safety Standards should be finalized by the end of 2010. The European Union is at this moment in a process of important transition from the current Commission to the new one. President Barroso just presented his views regarding the priorities of the Commission for the next five years. The new Commission could take office at the beginning of next year. Also, after the Irish referendum planned for 2nd of October, we could have the new treaty coming into force and providing us with more possibilities to act, including in the field of energy. Ladies and Gentlemen, Be assured that nuclear energy, including radiation medicine, will remain at the top of our priorities - because of the importance of public health as well as our global quality of life. As it was clearly indicated during the IAEA General Conference in Vienna in September last year, medical applications of ionizing radiation have gone through a revolutionary development over the past decade. Today, every year, throughout the world, ionizing radiation is used in four billion diagnostic procedures, in thirty five million nuclear medicine procedures and in eight million radiotherapy treatment courses, and it keeps expanding, affecting a growing portion of the global population.

[en] This paper reviews justification issues in relation to medical exposures involving women of child-bearing age. One of the most common radiation protection issues in relation to the use of ionizing radiation concerns the management of the pregnant patient. Instinctively, one might want to avoid the use of radiation with a patient who is or might be pregnant. The perception of risk seems to be heightened by the fact that both the hazard and the unborn infant are unseen and the situation may be perceived to be less amenable to control. The problem can be even more difficult when the female is not sure or does not know whether she is pregnant. In such situations, a risk based approach is appropriate. In evaluating risks and benefits, two individuals need to be considered as part of the justification process and the risks and benefits to both must be balanced. This adds a level of complexity to the problem that requires a well considered approach. (author)