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Copyright of Actualités Pharmaceutiques is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Les dispositifs médicaux forment un groupe très hétérogène, allant du scalpel à l'appareil d'imagerie par résonance magnétique, en passant par le pansement, du plus simple au plus technologique. Avec les médicaments et les cosmétiques, ce sont les principaux produits de santé utilisés dans le monde. Les services qu'ils rendent ont conduit les pouvoirs publics à les rembourser. Medical devices form a very heterogeneous group of objects. In this group we can find items ranging from the scalpel, through the bandage – from the simplest to the most technological – to the scanner or MRI. Together with medicinal products and cosmetic products, they are one of the most important health products used worldwide. In addition, the services they provide have led government to reimburse them. [ABSTRACT FROM AUTHOR]

Les certificats médicaux ont une place régulière en consultation de médecine générale. Depuis 2011, l'absence de fondement réglementaire de certains certificats a été mis en lumière, émanant notamment de services publics. L'objectif de cette étude était de rechercher sur quels textes réglementaires reposaient les certificats médicaux requis par une administration municipale, 8 ans après la circulaire de rationalisation de 2011 ? Étude qualitative par observation et analyse critique de certificats par mini-revues de littérature suivant les principaux critères de qualité PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). La première étape a consisté en le recensement exhaustif des certificats médicaux prévus par la municipalité, pour les administrés ou les employés de la ville. La provenance de l'un des services municipaux était le seul critère d'inclusion. La deuxième étape a consisté en l'analyse des certificats demandés d'après la réglementation en vigueur au moyen de moteurs de recherche classés par niveau en tenant compte en priorité de leur valeur réglementaire. Les équations de recherche ont été construites par un procédé inductif au fur et à mesure du recueil des certificats. Quarante-deux certificats ont été recueillis et analysés. Vingt-sept répondaient à la réglementation en vigueur dont deux (hors du champ des soins primaires) respectaient le contenu. Aucun support réglementaire n'a été retrouvé pour les 15 autres certificats. Le flou réglementaire autour des accidents sportifs, ou encore l'abus d'autorité, sont des éléments d'explication de ces certificats sans support réglementaire existant ou respecté. Le médecin généraliste est mis dans une position difficile et ambivalente. Un engagement institutionnel important est à envisager pour la rationalisation des certificats médicaux, en particulier par la formation médicale, l'éducation en santé des usagers et la mise en application de la loi. Medical certificates have a regular place in general medicine consultation. Since 2011, the french law has highlighted the absence of regulatory support of certain certificates, in particular of public services. The objective of this study was to find out which regulatory texts were based on the medical certificates required by a municipal administration, 8 years after the 2011 rationalization circular? Qualitative study by observation and critical analysis of certificates by literature reviews according to the main PRISMA quality criteria (Preferred Reporting Items for Systematic Reviews and Meta-Analyzes). The first step consisted of the exhaustive collection of the medical certificates provided by the municipality, for the citizens or the employees of the city. The origin of one of the municipal services was the only criterion for inclusion. The second stage consisted in analyzing the certificates according to the law by using databases classified depending on their level, taking their regulatory value into account as a priority. The research equations were constructed with an inductive process as the certificates were collected. Forty-two certificates were collected and analyzed. Twenty-seven had regulatory support, two of which (not concerned in general medicine) complied with its content. No regulatory support was found for the 15 other certificates. The regulatory vagueness around sports accidents, or even the abuse of authority, are explanations for these certificates without existing or respected regulatory support. The general practitioner is put in a difficult and ambivalent position. A major institutional commitment should be considered for the rationalization of medical certificates, in particular through medical education, health education for users and law enforcement. [ABSTRACT FROM AUTHOR]

Radiotherapy alone or in association with systemic treatment plays a major role in the treatment of head and neck tumours, either as a primary treatment or as a postoperative modality. The management of these tumours is multidisciplinary, requiring particular care at every treatment step. We present the update of the recommendations of the French Society of Radiation Oncology on the radiotherapy of head and neck tumours from the imaging work-up needed for optimal selection of treatment volume, to optimization of the dose distribution and delivery. [ABSTRACT FROM AUTHOR]

The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France. [ABSTRACT FROM AUTHOR]

We present an update of the French society of oncological radiotherapy recommendation regarding indication, doses, and technique of radiotherapy for intrathoracic metastases. The recommendations for delineation of the target volumes and critical organs are detailed. [ABSTRACT FROM AUTHOR]

Copyright of Actualités Pharmaceutiques is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Les patients se tournent couramment vers des produits à base de plantes ou de substances naturelles pour rester en bonne santé. Le nouveau cadre réglementaire européen sur les dispositifs médicaux, toujours plus exigeant en termes de qualité et de sécurité, apporte des précisions sur l'utilisation de ceux qui sont composés de substances complexes, notamment d'origine naturelle, dans un contexte thérapeutique allopathique. Patients commonly turn to herbal products or natural substances to stay healthy. The new European regulatory framework for medical devices, which is increasingly demanding in terms of quality and safety, provides clarification on the use of products based on complex substances, particularly those of natural origin, in an allopathic therapeutic context. [ABSTRACT FROM AUTHOR]

En France, la recherche clinique sur les personnes humaines est encadrée sur le plan réglementaire par la loi Jardé dont les décrets d'application ont été publiés en novembre 2016. L'autorisation d'un comité de protection des personnes est obligatoire pour les recherches interventionnelles et non interventionnelles. Les études sur données provenant des dossiers patients dans le cadre du soin, souvent utilisées pour les travaux de thèse ou de publication, ne sont pas considérées comme des recherches sur les personnes humaines. Ces données médicales sont des données à caractère personnel. La commission nationale de l'informatique et des libertés a également un rôle réglementaire important au cours des recherches cliniques afin de garantir le respect de la réglementation sur les données personnelles. Nous détaillons dans cet article les différents types de recherches, les différentes instances réglementaires et la conduite à tenir en pratique pour effectuer un travail de recherche. In France, clinical research involving human beings is regulated by the Jardé's law since November 2016. The law distinguishes interventional and non-interventional studies. Both need to be authorized by a Persons Protection Committee. Studies performed on medical data collected during standard clinical care are not considered as studies involving human beings. Medical data are personal data. French Data Protection Authority National has an important role, guarantying the respect of regulation on personal data. We summarize in this article the different types of studies and the role of regulatory authorities. [ABSTRACT FROM AUTHOR]

Résumé En France, les études de santé sont réglementées au niveau national. La formation pharmaceutique a fait l'objet de nombreux décrets et arrêtés fixant les différentes modifications induites par les réformes successives. Summary In France, healthcare studies are regulated on a national level. Pharmacy degrees are subjected to numerous decrees and laws setting out the different modifications brought about by successive reforms. The process to adapt this degree course is far from finished. [ABSTRACT FROM AUTHOR]

Résumé Les huiles essentielles (HE) sont de plus en plus utilisées par les patients. Or, elles sont présentes dans une grande diversité de produits et sans contrôle d'accès particulier, malgré une toxicité importante. Il est important de comprendre quel est le statut de l'HE, qu'elle soit vendue seule ou incorporée dans un produit, la sécurité du patient-consommateur en dépend. Summary More and more patients are using essential oils. However, there is a wide diversity of products and there is no specific control regarding their access, despite significant levels of toxicity. It is important to understand the status of the essential oil, whether it is sold alone or incorporated into a product, the safety guarantees of he patient-consumer depends on it. [ABSTRACT FROM AUTHOR]

Résumé Le don volontaire et non rémunéré est préconisé par toutes les instances internationales – OMS/Conseil de l’Europe/ISBT/EBA – car il représente la meilleure façon de tendre vers l’autosuffisance en produits sanguins de toutes natures, tout en assurant un niveau de qualité et de sécurité optimal tant pour les patients que pour les donneurs. Encore minoritaire, notamment dans les pays en voie de développement, il tend à se développer. Toutefois, l’objectif fixé par l’OMS d’atteindre 100 % de dons volontaires et non rémunérés en 2020 semble très ambitieux, notamment pour la collecte de plasma destiné à l’industrie du fractionnement. L’évaluation des directives européennes portant sur le don d’éléments issus du corps humain devrait permettre une proche harmonisation des pratiques des différents États membres. The voluntary and unpaid blood donation is recommended by all international authorities (WHO, Council of Europe, ISBT, EBA), because it represents the best way of aiming towards self-sufficiency in blood products of all kinds, while preserving an optimal level of quality and safety for recipients as for donors. Still infrequent in many developing countries it tends to develop. However, the objective assigned by the WHO to reach 100% of unpaid and voluntary blood donations in 2020 appears ambitious, in particular for the collection of plasma intended to the splitting industry. The close evaluation of European directives concerning the donation of human body elements should allow harmonization of practices by Member States. [ABSTRACT FROM AUTHOR]

Résumé Les différentes affaires sanitaires qui ont eu lieu en France depuis une quarantaine d’années ont influencé la réglementation des produits cosmétiques. L’influence la plus évidente est celle de « L’affaire du talc Morhange » qui a initié leur réglementation. Par la suite, « L’Affaire du sang contaminé », par le biais de la création de l’Afssaps, a donné aux produits cosmétiques une autorité de tutelle et les fait désormais classer comme des produits de santé. Enfin, plus récemment « L’Affaire Médiator » a entraîné, entre autres, une prise de conscience de la notion de conflits d’intérêt dans le domaine des produits de santé, donc des produits cosmétiques. The various health scandals which have happened in France over the past 40 years have influenced the regulation of cosmetic products. The most obvious influence is the “Talc Morhange Scandal” which triggered their regulation. Then, “the Infected Blood Scandal”, through the creation of Afssaps, provided a regulatory authority for cosmetics products and from then onwards, they were classed as health products. Lastly, one of the effects of the more recent “Médiator scandal” was to bring about an awareness concerning the notion of conflicts of interests in the field of health products, therefore including cosmetic products. [ABSTRACT FROM AUTHOR]

Résumé Compléments alimentaires et produits nutraceutiques soulèvent une problématique d’interface entre les aliments et les médicaments. Maîtriser les définitions est nécessaire. Au-delà de l’évolution de la réglementation des plantes médicinales, le périmètre du monopole pharmaceutique est remis en question. La notion d’homéostasie constitue une piste pour distinguer les effets physiologiques des effets pharmacologiques et permettre au pharmacien de conseiller à meilleur escient. Summary Dietary supplements and nutraceutical products highlight the issue of the interface between food and medicines. Awareness of the various definitions is necessary. Beyond the evolutions in the regulation of medicinal plants, the boundaries of the pharmaceutical monopoly are challenged. The notion of homeostasis is a potential means of distinguishing between the physiological and pharmacological effects and enabling the pharmacist to provide the best advice possible. [ABSTRACT FROM AUTHOR]

Résumé Le soin et la recherche du bien-être par les plantes sont une tendance à laquelle les pharmacies n’échappent pas. La réglementation concernant les produits à base de plantes a beaucoup évolué ces dix dernières années. Le pharmacien doit veiller à référencer des produits efficaces et sûrs. Summary Offering effective and safe phytotherapy solutions. Using plants for health and wellbeing is a trend which pharmacies cannot escape. Regulations concerning plant-based products have evolved significantly over the last ten years. Pharmacists must ensure the products they stock are effective and safe. [ABSTRACT FROM AUTHOR]

La transfusion est actuellement encadrée par des règles et des références scientifiques extrêmement rassurantes. Les acteurs intervenant à ces différentes étapes doivent connaître les exigences relatives à sa pratique au risque de voir leur responsabilité engagée, ou celle de l'établissement où ils travaillent, en cas de dommage occasionné au patient du fait de l'absence de leur respect. La loi no 03-94 relative au don, au prélèvement et à l'utilisation du sang et les textes pris pour son application nécessitent une mise au point des exigences législatives et réglementaires qui encadrent la transfusion au Maroc. Elle encourage le don de sang anonyme, volontaire et bénévole et elle prévoit une série de dispositions pour la sélection des candidats au don du sang, la collecte, la qualification biologique du don, la préparation, la conservation, la délivrance du sang et de ses composantes ainsi que pour l'hémovigilance. Cet article mettra le point sur la réglementation marocaine relative à l'ensemble du processus transfusionnel de la prescription jusqu'au suivi du receveur en se limitant à l'utilisation des produits sanguins labiles. Il a pour objectif d'identifier les principales exigences réglementaires afin d'adapter le même niveau des connaissances des personnels et de les maîtriser malgré un environnement difficile et dans le respect des droits des patients au regard des bénéfices et des conséquences de l'acte transfusionnel. [ABSTRACT FROM AUTHOR]

Résumé L’allergie alimentaire est un problème de santé publique de prévalence croissante. L’alimentation moderne se caractérise par l’augmentation de la consommation d’aliments complexes et la mondialisation. Les consommateurs allergiques sont dépendants de l’accessibilité, la précision et la qualité de l’information concernant les aliments qu’ils achètent. Les nouvelles règles européennes en matière d’information du consommateur allergique sont présentées. L’obligation d’information s’applique à 14 ingrédients allergéniques (céréales contenant du gluten, crustacés, œufs, poissons, arachide, soja, lait, fruits à coques, sésame, céleri, moutarde, sulfites, lupin et mollusques) et à leurs produits dérivés que ce soit sur les produits pré-emballés, vendus en vrac ou délivrés en restauration. La liste des allergènes à étiquetage obligatoire doit être périodiquement actualisée sur la base des informations scientifiques et cliniques liées à l’émergence de nouveaux allergènes. La maîtrise du risque repose sur la méthode HACCP appliquée au risque allergique. Elle justifie la détermination des seuils de réactivité allergénique pour évaluer la plus petite dose réactogène et la dose sans effet et développer des méthodes analytiques pour détecter l’allergène dans les aliments. L’attention est attirée sur l’absence d’harmonisation de la réglementation internationale sur l’étiquetage des allergènes, le sentiment d’insécurité du consommateur allergique lié à l’incertitude de l’étiquetage. La nécessité d’une réflexion éthique pour une information juste, équitable et permettant l’autonomie des consommateurs allergiques est soulignée. L’avènement de l’information numérique est prometteuse et s’inscrit dans la conception de sites alliant toutes les parties prenantes : association de patients allergiques, professionnels de santé et de l’alimentation, décideurs et législateurs. Food allergy is a public health problem of increasing prevalence. Modern food is characterized by complexity and globalisation. Allergic consumers are relying on accessibility, accuracy and quality of information concerning purchased food. The new European rules concerning allergic consumers’ information are presented. Mandatory labelling concerns 14 allergens (cereals with gluten, crustaceans, eggs, fish, peanut, soy, milk, nuts, sesame, celery, mustard, sulphites, lupine and molluscs) and derivatives as well as for pre-packaged products, food sold in bulk and served in restaurant. Lists of mandatory allergens must be periodically actualised on the basis of scientific and clinical knowledge concerning new food allergens. The control of allergic risk is based on HACCP method. Reactogenic thresholds have to be assessed in order to determine the lowest reactogenic dose and the dose without effect. Analytic methods have to be developed for the detection of allergens in food. Attention is drawn to the absence of harmonisation of international regulations concerning allergen labelling, the feeling of insecurity of allergic consumers due to the uncertainty of allergen labelling. The need of an ethical reflexion for an accurate and equitable information allowing autonomy of allergic consumers is underlined. The advent of digital information is promising. The conception of web sites built by all stakeholders (patients, health and food professionals, politic makers and legislators) is encouraged. [ABSTRACT FROM AUTHOR]

Supermarkets require considerable amount of electricity and gas for refrigeration and maintenance of comfortable retail environment conditions. They are also responsible for a large amount of both direct and indirect CO 2 emissions. Nowadays advanced refrigeration systems for supermarkets can reduce both annual energy consumption and total equivalent warming impact. One of these advanced solutions is the water-loop self-contained refrigeration system, where the thermal power of each cabinet is rejected to a fluid-loop, refrigerated either by a dry-cooler or by a central chiller. In this study the performances of a real water-loop self-contained plant are analyzed to establish whether the activation of the water-loop chiller is energy effective or not varying the external air temperature. The activation strategy of the chiller is a crucial issue, which dramatically affects the energy performances of the whole system. [ABSTRACT FROM AUTHOR]

Résumé Le tabagisme est la première cause évitable de morbidité et de mortalité. On estime qu’il y a eu environ 14 millions de fumeurs en France en 2012 et que le tabac est responsable de 70 000 décès par an. Toute intervention qui réduit efficacement l’incidence et la prévalence du tabagisme est à considérer pour prolonger l’espérance de vie. La cigarette électronique (cig.e.) est un phénomène de société, mais elle est aussi un produit qui délivre des substances pharmacologiquement actives et qui concerne aujourd’hui plusieurs millions de personnes en France. De ce fait, il est devenu indispensable pour la pratique clinique, d’avoir un certain niveau de connaissances sur les cig.e. La très grande majorité des cig.e. contient de la nicotine ; c’est un système électronique de délivrance de nicotine (SEDEN) ( electronic nicotine delivery system [ENDS]). Il est vraisemblable que les SEDEN, produits de consommation et non produits de santé, délivrent la nicotine avec une bonne biodisponibilité et peuvent contribuer, s’ils sont utilisés largement, à la réduction de la prévalence du tabagisme. Cependant, en l’absence de réglementation, à ce jour, le rapport bénéfice/risque des SEDEN comme aide à l’arrêt de la consommation tabagique et leur profil d’effets indésirables ne peuvent pas être évalués. C’est une responsabilité de santé publique de promouvoir l’acquisition des connaissances fondées sur les preuves pour connaître leur rapport bénéfice/risque. Smoking is the first avoidable cause of morbidity and mortality. It is estimated that there were around 14 million smokers in France in 2012 and that smoking results in 70,000 deaths per year. All types of interventions reducing with efficacy the incidence and prevalence of smoking are to consider in prolonging life expectancy. Electronic cigarettes (e.cig.) are a social phenomenon but they also are a system delivering pharmacologically active substances; their use concerns today several millions of individuals in France. By this fact, it became important for clinical practitioners to acquire some knowledge about e. cig. Most of the e.cig. contains nicotine, thus, e.cig. are now called in the medical literature as electronic nicotine delivery system (ENDS). It is highly plausible that ENDS, which are, as of today, consumer products and not health products, deliver nicotine with a good bioavailability and could, if largely used, help to reduce smoking prevalence. However, because of current lack of regulations, as of today, the risk/benefit ratio of ENDS as an aid to help smokers quit and their adverse effect profile cannot be established. It is of public health responsibility to promote evidence based knowledge about e.cig. to know with confidence their risk/benefit ratio. [ABSTRACT FROM AUTHOR]

Résumé Les modalités de la prise en charge des dispositifs de perfusion à domicile ont récemment été modifiées. Cette nouvelle réglementation permet de mieux encadrer les facturations du pharmacien d’officine, d’assurer un suivi renforcé des prestations et de limiter les dépenses de santé. Summary The guidelines for the management of home infusion devices have recently been modified. They aim to improve the regulation of community pharmacists’ billing, ensure greater monitoring of services and limit health care spending. [ABSTRACT FROM AUTHOR]

Résumé Les indications des traitements délivrés en conditions stéréotaxiques connaissent, à l’heure actuelle, un développement considérable devant l’émergence de nouvelles indications. Les conditions de réalisation de ces traitements sont multiples. L’étape initiale est essentielle, elle concerne la validité de l’indication au regard du niveau de preuve grâce auquel elle est proposée en réunion de concertation multidisciplinaire. Ces techniques émergentes ne bénéficient pas d’évaluation à long terme pouvant être considérée comme définitives pour les traitements extracrâniens, d’une part, de leur efficacité et, d’autre part, des seuils de tolérance des tissus sains. C’est dire la priorité qui doit être offerte aux patients de bénéficier des études cliniques prospectives, indépendantes, validées par un conseil scientifique indépendant, encadrées dans un programme d’assurance de qualité pertinent et multicentrique qui favorise la connaissance et la sélection des indications. La Société française de radiothérapie oncologique (SFRO) prépare dans son guide des procédures la description des conditions de réalisation de ces traitements et elle collabore avec tous les acteurs institutionnels à la rédaction de guide de pratique qui permettront d’offrir le cadre estimé prérequis indispensable à tous, patients et professionnels de la radiothérapie. Indications of treatment by stereotactic body radiotherapy are dramatically increasing due to new potential indications. The conditions associated with the treatment delivery are multiple. The first step of the process is crucial. It is related to the validation of the indication proposed during the multidisciplinary meeting as regard the evidence-based proof of the concept. These emerging techniques mainly extracranial stereotactic body irradiation do not benefit from long-term evaluation in terms of efficiency as well as normal tissue late toxicities. Priority should be given to prospective independent clinical trials, validated by an independent scientific committee, performed under a relevant and well dedicated multicentric quality assurance program aiming to improve knowledge and selection of indications. The SFRO is still working with others professionals on the definition of the conditions for the implementation of such treatments and actively collaborates with the authorities to define the appropriate conditions to preserve the quality of the treatment delivery under these specific conditions. [ABSTRACT FROM AUTHOR]

In order to answer statutory requirements and to anticipate the future needs and standards, the EFS is committed, since a few years, in a process of harmonization of its metrology function. In particular, the institution has opted for the skills development by internalizing the metrological traceability of the main critical quantities (temperature, volumetric) measurements. The development of metrology so resulted in a significant increase in calibration and testing activities. Methods are homogenized and improved through accreditations. The investment strategies are based on more and more demanding specifications. The performance of the equipments is better known and mastered. Technical expertise and maturity of the national metrology function today are assets to review in more informed ways the appropriateness of the applied periodicities. Analysis of numerous information and data in the calibration and testing reports could be pooled and operated on behalf of the unique establishment. The objective of this article is to illustrate these reflections with a few examples from of a feedback of the EFS Pyrénées Méditerranée. The analysis of some methods of qualification, the exploitation of the historical metrology in order to quantify the risk of non-compliance, and to adapt the control strategy, analysis of the criticality of an instrument in a measurement process, risk analyses are tools that deserve to be more widely exploited for that discipline wins in efficiency at the national level. [ABSTRACT FROM AUTHOR]

Résumé: Le centre hospitalier d’Ainay-le-Château est l’héritier des ű Colonies familiales Ƈ créées à la fin du xix e siècle par le docteur Auguste Marie. Le but était alors de désencombrer les grandes institutions psychiatriques de leurs patients stabilisés en les envoyant dans un milieu agricole qui leur assurait alors le gîte, le couvert et un gardiennage. Ce mode de prise en charge peut être considéré comme l’héritage historique lointain de l’accueil des malades mentaux chez l’habitant à Geel à la suite du miracle de Sainte Dymphne. La loi du 10 juillet 1989 a posé un cadre juridique et institutionnel, tout en dénommant ce mode de prise en charge Accueil familial thérapeutique (AFT). L’auteur, directeur du centre hospitalier d’Ainay-le-Château, présente l’organisation et le fonctionnement de la structure actuelle (100 lits intra-muros dont 60 de psychiatrie et 40 USLD et 340 lits occupés en AFT ; 190 familles d’accueil et 280 salariés) qui continue d’accueillir des patients de toute la France selon un protocole précis. Il expose le mode d’agrément des accueillants, leurs rétributions et leur statut. L’articulation Patient/FA/Équipe pluridisciplinaire constitue l’essence de la valeur thérapeutique psychiatrique de la prise en charge en AFT. Il insiste sur la tolérance des populations locales et sur le fait qu’un dispositif de grande taille facilite, par la variété des profils d’accueillants, l’adéquation accueillants/accueillis. [ABSTRACT FROM AUTHOR]

Copyright of Actualités Pharmaceutiques is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Revue Francophone des Laboratoires is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Revue Francaise d'Allergologie is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Revue Francophone des Laboratoires is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Summary: Grace to the creativity of surgeons and the introduction of new technologies, second half of the XXth century opened the era of innovations and decisive progress. At the same time, however, is born the feeling of distrust and claiming which has come with the graving and threatening juridiciarisation. The evolution of complex structures of our society joined the ingenuity researchers unlimited makes formal law and the legal framework constantly to adapt oneself to circumstances. In the field of surgery, it''s necessary to make work in integrity the innovation and protection at the patient''s and their dignity. The legal framework that governs today innovation in surgery must still to go further and will precise. Dignity, compelling paradigm for all those who seek to better understand and better protect human starred as impassable limit any search and any experimentation. To make this chapter more alive, we have supplemented it and illustrated by the testimony some of the most fruitful French last years innovative in order to enrich our thinking of the fruit of their large and brilliant experience. [Copyright &y& Elsevier]

Abstract: What is the regulation of clinical research? Which administrative steps must be carried out? Who are the different actors and what are their responsibilities in the management of biomedical research? What are the characteristics of clinical research in nutrition? Which methodology should be used? The objective of this paper is to answer these questions, keeping in mind that the rules are regularly modified, and that the elements described today will not apply tomorrow. Moreover, the law does not always respond to all situations and to all questions. [ABSTRACT FROM AUTHOR]

Copyright of Revue Francaise d'Allergologie is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Revue Francophone des Laboratoires is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of IRBM is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract: The ministerial decree of 12 January 2009 fixing the criteria for the selection of blood donors establishes the list of contraindications for blood donation according to the appendix to the European directive 2004/33/EC. This text regroups the preexisting guidelines and reinforces their regulatory status, which illustrates the importance attributed to the selection of donors within the dispositions ensuring transfusion safety. It introduces more flexibility with respect to the preexisting criteria taking into account the improvement in life expectancy and the continual increase in transfusion requirements. Thus, the rules for donation authorize up to 24 donations annually and one may give whole blood up to six times per year for men and four times for women, up to the age of 70, the risk of anaemia now being well controlled. The medical rules are more flexible in the areas of haemochromatosis, allergies and autoimmune diseases and for the collection of plasma for fractionation. Some expected changes were not approved in certain cases due to the preeminence of the corresponding criteria in the European directive, like for cured cancers, in other cases in view of an analysis of the available epidemiological data or potential risks like for sexual relations between men and the risks linked to prions or emerging agents (transfusion antecedents). These selection criteria will be revised every year, which should permit their adaptation to the current state of knowledge, although the extent of the revisions will be limited by the updating of the European text on which they are based. [Copyright &y& Elsevier]

Abstract: In medicine, as in oncological radiotherapy, as elsewhere, the precept of quality has no meaning if it is not defined. In France as everywhere radiotherapy has its forces and its weaknesses. As in every country, its future seems assured by its character cost effective as by its capacity to make progress in the triple point of view of its equipment, its professions and its organization. However, the French radiotherapy is in crisis. The professionals saw clearly. For more than 10 years they had recalled the medical authorities to their responsibilities concerning the demographic trends for the radiotherapists and the physicists, the renovation of the equipment, the modernization of the organizations, the promotion of the evaluation of procedures and outcomes and the development of a greater fairness in the financings. But the delay taken, the setting under pressure of the professionals by the State, its services, its agencies and the media following the recent accidents cause numerous perverse effects and worried the staff. The accident of Épinal was the starting fact of an effort of professionalisation of the risk management, but also of a disturbed period favourable with a certain confusion of minds, discouragement and protective behaviors. The risks felt by the professionals then seem especially to come from the authorities and the media. It appears that the topic of quality is at the center of all these speeches. Under this vocable, it is in fact the respect of the procedures related to the requirement of security which is privileged by the State and its representatives. The apparent security seems to override the real quality of the practices. Thus, time came for a clarification of the quality and security concepts, of organizations which contribute to it and for the development of a clear strategy bringing together the interprofessionnal actors. In this context, the implication of the College and especially of the Société française de radiothérapie oncologique is a requirement. [Copyright &y& Elsevier]

Abstract: A series of amendments to the international standards concerning refrigeration and A/C equipment is almost available to provide the additional safety measures required for the design, repair and service of refrigeration and A/C equipment using flammable refrigerants. These amendments will provide the framework to develop future refrigeration technology employing hydrocarbons. This paper reviews the different existing standards and the forthcoming drafts highlighting the maximum charge and room area limits as well as the specific requirements for air-conditioning and refrigerating equipment operating with hydrocarbons. [Copyright &y& Elsevier]

Abstract: Ammonia is widely used as a refrigerant in industrial systems for food refrigeration, distribution warehousing and process cooling. It has more recently been proposed for use in applications such as water chilling for air-conditioning systems but has not yet received widespread acceptance in this field. This review paper assesses the reasons why ammonia is so popular in industrial systems, the reasons why it is deemed less suitable for other applications and the possible benefits at local, national and international levels that might be gained by more general acceptance of ammonia as a refrigerant. The paper also considers other possible applications which might benefit from the use of ammonia as refrigerant. [Copyright &y& Elsevier]

Abstract: For 20 years, the number of patients with home enteral or parenteral nutrition is increasing in France. The improvements in regulatory framework and logistic infrastructure allowed to care more patients at home without altering care quality. Education of patients and their relatives, a reliable relation with home care providers, based on a precise specifications, are essential to maintain quality of home artificial nutrition. The regional expert centres for home nutrition will have to have a major role of coordination, assessment, education of the various partners, under the aegis of the SFNEP. [Copyright &y& Elsevier]

Abstract: European regulations (transcribed into French law) aimed at protecting employees from chemicals toxic to reproduction enable classification and labelling of such substances, if they are liable to cause an alteration of male or female reproductive functions or capacity, or to induce non-hereditary harmful effects on their offspring. Three categories can be used to classify these substances in two areas, namely their impairment of fertility and their effects on development. This classification is rarely based on epidemiological study results, but most often on those of experimental toxicological studies conducted by substance manufacturers. These reproduction toxicological studies are only compulsory above a certain tonnage placed on the market. The high level of this tonnage means that these tests are effectively only conducted on rare occasions. It is reckoned that there is no reproduction experimental data for over 95% of substances newly placed on the market. These products therefore appear to be reproduction non-toxic only because they have not been tested. This is a major fault in the current labelling system, which does not allow non-toxic products to be differentiated from non-tested products. The future EU regulatory framework for Registration, Evaluation and Authorisation of CHemicals (REACH) will only slightly enhance information in this area. It can be estimated that over 80% of chemical products will not be exhaustively tested for reproduction and nearly 75% will not be tested to any degree. [Copyright &y& Elsevier]

Abstract: Hygiene and food safety in hospital are regulated under the Directive of the French Ministry of Health of September 29th, 1997, and, as of January 1st, 2006, under the European Regulation 852/2004/EC of the European Parliament and Council, related to food hygiene. These two regulations have endorsed the HACCP system, which is nowadays considered at the international level as the best reference system for prevention of food borne risks. The French Food Safety Agency published in October 2005 recommendations for preparation and handling of powdered infant formulae. Launched in 2002, the Committees on Diet and Nutrition are devoted to improve in every hospital the nutritional management of patients and the quality of diet and nutrition, to answer properly unresolved questions related to diet or nutrition, and to improve continuing education of staff. [Copyright &y& Elsevier]

Copyright of EMC-Toxicologie--Pathologie is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract: In 2004, three new important laws were passed concerning radiotherapy services. The first two concerns the internal and external quality control of linear accelerators and the last concerns the role of the medical physicist, whose presence was made mandatory during the whole length of the treatments. These laws, which aim to improve the quality and the security of treatments, represent an increase in price that we have calculated, and which prevents them being implemented, as a joint study realised by the SFRO and the SFPM has shown. The cost of quality in radiotherapy requires investment in material and manpower and improvement in availability of the accelerators which entails a complete reorganisation of the services. Cost analysis is included. The difficulties in implementing these laws have also been evaluated and this evaluation already enables us to propose certain elements enabling us to go forward to globally improve the quality and security in radiotherapy. [Copyright &y& Elsevier]

Abstract: Breast implant surgery is now regulated by health laws, which stopped concerns and debates about the safety of the implants in the 90''. After a 6 years ban, silicone gel-filled implants have been allowed by the Afssaps (a national health agency) in 2001, for use in France. The comeback of the silicone gel implants has been a breakthrough in the breast implant market. Goals of the study. – Our goal was to assess breast implant use in France, from 1995 til 2004, a time of deep turmoil for breast implant surgery due to new regulations. Methods. – All manufacturers have been requested to participate in the study and send their confidential data regarding the number and type of implants sold yearly, from 1995 to 2004. Results. – Breast implant sales rose by 53% in 2001, and increase by +383% from 1995 to 2004. The total number of breast implants sold in 2004 reached about 61 800. Following the lift on their ban, silicon gel-filled implants became immediately first-choice implants (they represented 72% in 2001 and more than 97% of all implants sold in 2004); saline filled implants are now rarely used. Textured envelopes are more often used (they represented 73 to 97% between 1995 and 2004), and smooth envelopes represented about 15%. Conclusion. – Health agencies in France and Europe would benefit from a better knowledge of the use and follow-up of breast implants. These are plastic surgeon'' or scientific society'' responsibilities. A national breast implant registry may be a useful tool to gather information, to improve long-term follow-up and to provide better care to women concerned themselves with breast implant surgery. [Copyright &y& Elsevier]

Abstract: Too much a long time the manufacture of the breast implants does not have the object of a specific regulation. This lack led partly to the prohibition of the implants filled with silicone in 1995. It took 10 years for the European Union to create and to set up a standard EC specific to the breast prosthesis. It''s the history of these steps as well on the level of Europe as has the French scale as we report you. Initially classified as implantable devices of IIb level, the breast implants were reclassified on level III in 1993, the highest level of requirement of CE marking. In accordance with the recommendations of the group of experts named by the Afssaps, the technical standard IN ISO 14630:1997, fixing the mechanical properties of the prosthesis, is in the course of revaluation since 2004. According to Council Directive 93/42/EEC of the June 14th 1993, the French government instituted a materiovigilance specific to the breast implants. All these evolutions allow, now a serene use of the breast implants. [Copyright &y& Elsevier]

Copyright of IBS, Immuno-analyse & Biologie Specialisee is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract: The publication of the Circular DGS/DHO/Afssaps No 2003-582 of the December 15 2003 relating to the administration of blood and blood components, means that an update of statutory requirements is needed. This article presents the overall process from the writing of prescriptions to the care and monitoring of the transfused patient. An update and a critical analysis of regulations currently in force are presented for each step as well as a description of the main adverse events. [Copyright &y& Elsevier]

Abstract: This work presents the procedure applied by our hospital to assess the quality and security of intra operative autotransfusion. The suitability of the three following variables has to be constantly assessed: performance of the machines to concentrate and wash collected blood, bacterial contamination of processed blood and rate of adverse events. We note that the procedure is applied with participation of medical and nursing staff. Since its setting-up, we note an amelioration of suitable variables. [Copyright &y& Elsevier]

Copyright of EMC-Toxicologie--Pathologie is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Revue Francaise des Laboratoires is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of EMC-Dentisterie is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)