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The European Council Directive 93/42/EEC concerning medical devices (14 June 1993) assigns new responsibilities and imposes technical requirements both to the manufacturer and user of medical devices. In this paper the general outlines of the directive are discussed with a particular emphasis on the risk classification of products, the compliance and evaluation process and the CE-marking regulations. Furthermore, some practical implications are highlighted for devices and tools relevant to the field of nuclear medicine such as radiation detectors, gamma- and PET-cameras and software.  相似文献   

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Paez  D.  Gnanasegaran  G.  Fanti  S.  Bomanji  J.  Hacker  M.  Sathekge  M.  Bom  H. S.  Cerci  J. J.  Chiti  A.  Herrmann  K.  Scott  A. M.  Czernin  J.  El-Haj  N.  Estrada  E.  Pellet  O.  Orellana  P.  Giammarile  F.  Abdel-Wahab  M. 《European journal of nuclear medicine and molecular imaging》2020,47(7):1615-1619
European Journal of Nuclear Medicine and Molecular Imaging -  相似文献   

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BACKGROUND: Nuclear medicine in Australia has encountered significant change over the past 30 years, with a move to privately owned practices, technological advances and the transfer of education of the nuclear medicine technologist (NMT) from technical college apprenticeships to university degrees. Currently, shortages of nuclear medicine technologists are reported in some states of Australia. It is not known whether changes in NMT practice or the type of centre in which an NMT works have an influence on retention of staff. AIM: The primary objective of this survey was to establish a profile of NMT practice in Australia, with the aim of producing baseline data that could be used in further research to establish levels of retention and job satisfaction. METHODS: Chief technologists in three states of Australia were invited to respond to a written questionnaire. The questionnaire included data about staffing levels, imaging modalities, procedures performed, and movement of staff. Findings presented will relate to the profile of practice data only. RESULTS: Forty-eight (54%) chief technologists responded to the questionnaire with 73% working in privately owned practices. The majority of centres employ up to two full-time equivalent nuclear medicine technologists and have two gamma cameras and one full-time equivalent nuclear medicine physician. Most centres perform a limited range of studies with bone scans predominating. More than half the centres make some use of a centralized radiopharmacy service. CONCLUSION: Further research is required to determine how these changes may impact on workplace satisfaction and in turn, on retention.  相似文献   

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The radiation incident at Chernobyl, USSR, on April 26, 1986 was first detected in Sweden on April 29, when increased radioactivity was observed at a nuclear facility in that country. Subsequently, higher levels of radioactivity were observed in most of Eastern Europe and then in Western Europe. Increased radioactivity was eventually noted in the United States beginning about May 5. The three-day interval between the incident and its discovery outside the USSR caused great apprehension. This chain of events indicates the very important role for the nuclear medicine physician, the medical physicist and their colleagues. It is likely that this medical specialty area is staffed by personnel who are best qualified to interpret these findings and to determine the necessary course of action both for patients and the general public. The nuclear medicine specialist can provide valuable input in estimating the radiation dose impact resulting from such an incident. This estimate may be accomplished either by combining measured activity levels with the physiological and physical factors involved; or by actual in vivo counting and quantitation of radioactivity in individuals exposed to radionuclides. From the measured activities in air, water and food, and assumed intakes for various age groups, doses can be estimated both for inhalation and ingestion of radionuclides. In vivo measurements of radionuclides can be performed with conventional instrumentation used routinely in nuclear medicine laboratories.  相似文献   

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Image registration: an essential tool for nuclear medicine   总被引:5,自引:5,他引:0  
There is increasing interest in being able to automatically register medical images from either the same or different modalities. Registered images are proving useful in a range of applications, not only providing more correlative information to aid in diagnosis, but also assisting with the planning and monitoring of therapy, both surgery and radiotherapy. The practising nuclear medicine specialist is faced with a dilemma in choosing an appropriate method since the literature in the field is extensive, with conflicting evidence as to what methods are optimal. Although most barriers to implementing registration in routine practice have been removed, there remains a lack of commercial, validated software. The alternative is to install a dual-modality instrument. The objective of this review is to present a general overview of medical image registration with emphasis on the application and issues relevant to nuclear medicine.  相似文献   

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Weir M 《Medicine and law》2006,25(4):673-685
The regulatory structure for complementary and alternative medicine worldwide reflects an orthodox medicine perspective that seeks to exclude complementary and alternative medicine from the health sector. This results in a regulatory structure that does not adequately protect those consumers who choose complementary and alternative medicine as their form of health care. This article discusses the historical reasons for the current regulatory structures and suggests it is time to provide consumers of complementary and alternative medicine with statutory regulation under a minimalist regime to provide quality markers for the training and ethics of complementary and alternative medicine practitioners.  相似文献   

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The explosive expansion of knowledge in immunology in recent decades has already affected the research and practice of nuclear medicine in several ways. New hematopoietic cells have been isolated and their functions discovered, including hematopoietic stem cells and dendritic cells (DCs). Many new humeral factors have been found that have potent effects on cells, including cytokines, growth factors, and specialized proteins. Radiolabeled compounds are needed to follow the pharmacodynamics of the humeral factors and to follow the migration of mobile cells in animals and humans. In this article, only DCs, cytokines, and growth factors used clinically are discussed. DCs are essential for defense against infectious diseases. Autologous DCs cultured for a week and pulsed with tumor antigens have already proved highly immunogenic compared with other methods for activating cytotoxic T cells, and preliminary studies suggest that DCs are more potent for tumor cell killing than monoclonal antibodies. DCs, unfortunately, also play an important role in causing certain human diseases. In allograft transplants, residual donor DCs are responsible for the cellular rejection; if they could be eliminated, rejection could be prevented. These cells are also detrimental in rheumatoid arthritis, other autoimmune diseases, asthma, and chronic obstructive pulmonary disease. Cytokines such as interleukin-2 and such growth factors as granulocyte-macrophage colony-stimulating factor and granulocyte colony-stimulating factor, administered to patients with malignancies to alleviate the leukopenia of chemotherapy agents, frequently alter the tissue distribution of radiopharmaceuticals; these alterations may be confused with disease.  相似文献   

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