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Le règlement européen qui régit la mise sur le marché des dispositifs médicaux (DM) prévoit la mise en place progressive et obligatoire, au sein de l’Union européenne, d’un système d’identification unique (IUD) et d’une base de données européenne (EUDAMED) dans un objectif d’amélioration de la traçabilité et de la transparence du marché. Le déploiement de ces outils va fortement impacter les acteurs du dispositif médical (entreprises, établissements de santé, professionnels de santé, autorités compétentes…). Une analyse de type menaces/opportunités/forces/faiblesses (MOFF) conduite auprès des participants à la table ronde montre une réelle adhésion aux objectifs mais également l’existence de nombreuses interrogations relatives à la mise en place opérationnelle de ces outils. Un état des lieux de l’existant en matière d’outils de traçabilité et de bases de données utilisées en France a ensuite été réalisé pour mesurer les écarts entre les exigences du règlement européen et l’existant. Au final, EUDAMED et le système IUD vont devoir s’intégrer dans un écosystème complexe et peu interopérable. Une première étape essentielle pour faciliter cette intégration sera de multiplier les actions de pédagogie, de sensibilisation et d’information auprès des acteurs concernés. Plusieurs autres recommandations ont été formulées pour accompagner l’implémentation d’EUDAMED et du système IUD en France et permettre, ainsi, que leurs promesses puissent un jour devenir réalité.

The European regulation governing the placing on the market of medical devices (MD) provides for the gradual and mandatory phasing-in, within the European Union, of a unique device identification (UDI) system and a European database (EUDAMED) aimed at improving traceability and transparency of the market. The deployment of these tools will have a significant impact on the stakeholders of the medical device world (companies, health institutions, healthcare professionals, competent authorities, etc.). A strengths/weaknesses/opportunities/threats (SWOT) analysis conducted among the think tank participants shows real support for the objectives but also distinguishes a great deal of issues relating to the implementation of these tools. An inventory of the current traceability tools and databases used in France was then carried out to measure the gaps between the requirements of the European regulation and the current situation revealing that EUDAMED and the UDI system will ultimately have to slot into a complex and poorly interoperable ecosystem. An essential first step to facilitate this integration will be to increase the number of educational, awareness-raising and information initiatives for the stakeholders concerned. Several other recommendations were put forward to support the implementation of EUDAMED and the UDI system in France and thus enable their promises to crystallise in the future.

An 8-year-old girl presented with back and leg pain and left arm and leg paresis. Lumbar puncture was suggestive of lymphocytic meningitis without identified organism. A second lumbar puncture demonstrated a large number of lymphoid B cells, with positive immunohistochemical staining for CD20 and CD25, proving the diagnosis of neurolymphomatosis. Brain and spine MRI demonstrated involvement of cervical and lumbosacral nerve roots. FDG PET/CT showed multiple bone metastases in addition to nerve involvement. Postchemotherapy FDG PET/CT demonstrated complete metabolic response.

Diallyl sulfide (DAS) and diallyl disulfide (DADS) are natural components that could account for the anticarcinogenic properties of garlic, at least in part, through the activation of xenobiotic detoxifying metabolism. The aim of this work was to describe the effect of DAS and DADS on xenobiotic-related gene expressions and to study molecular mechanisms relaying DAS effect. We describe the different effects of DAS and DADS on hepatic CYP2B1/2, CYP3A and epoxide hydrolase (EpH) mRNAs in rats, in terms of activation profile, doses and kinetics. The activation profile varied with the mode of chemical administration, i.e. gastric infusion or intraperitoneal (i.p.) injection. Using gastric infusion, DAS and DADS proved different efficiencies at enhancing the mRNA level of the three drug-metabolizing enzymes. After an i.p. administration, we observed a specific activation of CYP2B1/2 gene by DAS. The DAS-mediated CYP2B1/2 activation occurred at transcriptional level and through an okadaic acid-sensitive pathway. In rat livers, a short sequence (NR1) derived from the CYP2B1/2 promoter was stimulated by DAS and we observed a nuclear accumulation of a DNA–protein complex binding NR1. Because constitutively activated receptor (CAR) is a major transcription factor driving the xenobiotic-induced stimulation of CYP2B1/2 through NR1, the role of CAR as a preferential mediator of DAS effect is discussed.

Flow field flow fractionation (F4) with an on-line multi-angle laser light scattering detector was used to characterize amphiphilic biodegradable water-soluble copolymers poly(methyl glyoxylate -co- potassium glyoxylate). These new products are prepared from hydrophobic poly(methyl glyoxylate) by partial and statistical saponification of methyl ester functions. Conformational shape and degradability of polymers in dilute aqueous solution were investigated as a function of saponification rate (y) ranged from 10 to 100%. Derivatives with high hydrophobe content (y = 10%) forms compact intermolecular aggregates. In contrast, macromolecules of poly(potassium glyoxylate) (y = 100%) are molecularly dispersed in solution because of the presence of numerous electrostatic repulsions. For intermediate compounds (15 ≤ y ≤ 81%), the major part of the sample is represented by a population of single polymer molecules dispersed in solution. The kinetics of degradation of these different copolymers in aqueous solution was found to be a direct function of the macromolecular conformation and the percentage of methyl ester groups on the polymer chains.

Seaweed extracts, because of their physicochemical characteristics and potential nutritional value, could provide a new source of dietary fibre. This study investigated changes in seaweed fibres (physicochemical and fermentative properties) in different digestive sites and their effects on digesta (viscosity and hydration properties). Sixteen pigs were adapted to a test diet supplemented with 5% algal fibre (either Palmaria palmata (PP), a poorly viscous soluble xylan; or Eucheuma cottonii (EC), a partly insoluble carrageenan; or Laminaria digitata (LD), a highly viscous soluble alginate) or 5% cellulose (reference fibre). PP did not modify the characteristics of digesta and was fermented in the caecum (pH 6.1 ± 0.4; short-chain fatty acids measured in digesta, 1409 ± 691 µmol g⁻¹ dry matter). EC and LD were mainly insoluble in the stomach, becoming soluble in the intestine; EC was slightly fermented in the colon, giving a low concentration of short-chain fatty acids (303 ± 122 µmol g⁻¹ dry matter). Supplementation of the diet with alginate (LD) increased 3.5-fold the ileal viscosity of digesta and their hydration capacity in the ileum and colon. Thus the physicochemical properties of pig digesta largely depend on the physicochemical properties of the ingested seaweed fibre, the pH and ionic conditions prevailing in the gut, and their fermentability. © 2000 Society of Chemical Industry