Evolution de la règlementation des dispositifs médicaux et impact sur le circuit hospitalier

Comparée à l'industrie du médicament, celle du dispositif médical est relativement jeune. Elle a rapidement évolué grâce aux innovations successives et à l'ouverture du marché européen. Il a alors fallu créer puis adapter la règlementation afin d'encadrer l'ensemble des dispositifs répondant à la définition d'un dispositif médical (DM). Ce travail a eu pour objectif de définir le DM et de rappeler l'évolution de la règlementation, afin de présenter la proposition de règlement européen parue en septembre 2012.Les changements annoncés concernent majoritairement le monde industriel en impactant principalement les organismes notifiés. Nous nous sommes ensuite concentrés sur le circuit hospitalier des dispositifs médicaux stériles. Certains éléments de la proposition tels que l'apparition de l'IUD et de sa lecture électronique, l'annonce du développement de la base de données européenne EUDAMED et l'augmentation des études cliniques, peuvent modifier ce circuit hospitalier. Enfin nous avons évalué le niveau d'impact de ces changements à travers la réalisation d'un état des lieux du circuit des DMS au sein des établissements de santé de la région Auvergne. Nous avons ainsi pu montrer que l'impact du règlement européen sera ressenti tardivement et probablement différemment selon les établissements en fonction de leur degré d'informatisation et de leurs outils informatiques entre autres.CLERMONT FD-BCIU-Santé (631132104) / SudocLYON1-BU Santé (693882101) / SudocSudocFranceF

Lewis Acid Catalyzed Room-Temperature Michaelis–Arbuzov Rearrangement

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Monitoring cementless femoral stem insertion by impact

International audienceThe primary stability of the femoral stem (FS) implant determines the surgical success of cementless 15 hip arthroplasty. During the insertion, a compromise must be found for the number and energy of 16 impacts that should be sufficiently large to obtain an adapted primary stability of the FS and not too high 17 to decrease fracture risk. The aim of this study is to determine whether a hammer instrumented with a 18 force sensor can be used to monitor the insertion of FS. 19 Cementless FS of different sizes were impacted in four artificial femurs with an instrumented hammer, 20 leading to 72 configurations. The impact number when the surgeon empirically felt that the FS was fully 21 inserted was noted Nsurg. The insertion depth E was assessed using video motion tracking and the impact 22 number Nvid corresponding to the end of the insertion was estimated. For each impact, two indicators 23 noted I and D were determined based on the analysis of the variation of the force as a function of time. 24 The pull-out force F was significantly correlated with the indicator I (R² =0.67). The variation of D was 25 analyzed using a threshold to determine an impact number Nd, which is shown to be closely related to 26 Nsurg and Nvid, with an average difference of around 0.2. This approach allows to determine i) the moment 27 when the surgeon should stop the impaction procedure in order to obtain an optimal insertion of the FS 28 and ii) the FS implant primary stability. This study paves the way towards the development of a decision 29 support system to assist the surgeon in hip arthroplasty

Finite element model of the impaction of a press-fitted acetabular cup

International audiencePress-fit surgical procedures aim at providing primary stability to acetabular cup (AC) implants. Impact analysis constitutes a powerful approach to retrieve the AC implant insertion properties. The aim of this numerical study was to investigate the dynamic interaction occurring between the hammer, the ancillary and bone tissue during the impact and to assess the potential of impact analysis to retrieve AC implant insertion conditions. A dynamic two-dimensional axisymmetric model was developed to simulate the impaction of the AC implant into bone tissue assuming friction at the bone–implant interface and large deformations. Different values of interference fit (from 0.5 to 2 mm) and impact velocities (from 1 to 2 m.s−1) were considered. For each configuration, the variation of the force applied between the hammer and the ancillary was analyzed and an indicator I was determined based on the impact momentum of the signal. The simulated results are compared to the experiments. The value of the polar gap decreases with the impact velocity and increases with the interference fit. The bone–implant contact area was significantly correlated with the resonance frequency (R 2 = 0.94) and the indicator (R 2 = 0.95). The results show the potential of impact analyses to retrieve the bone–implant contact properties

Monitoring cementless femoral stem insertion by impact

International audienceThe primary stability of the femoral stem (FS) implant determines the surgical success of cementless 15 hip arthroplasty. During the insertion, a compromise must be found for the number and energy of 16 impacts that should be sufficiently large to obtain an adapted primary stability of the FS and not too high 17 to decrease fracture risk. The aim of this study is to determine whether a hammer instrumented with a 18 force sensor can be used to monitor the insertion of FS. 19 Cementless FS of different sizes were impacted in four artificial femurs with an instrumented hammer, 20 leading to 72 configurations. The impact number when the surgeon empirically felt that the FS was fully 21 inserted was noted Nsurg. The insertion depth E was assessed using video motion tracking and the impact 22 number Nvid corresponding to the end of the insertion was estimated. For each impact, two indicators 23 noted I and D were determined based on the analysis of the variation of the force as a function of time. 24 The pull-out force F was significantly correlated with the indicator I (R² =0.67). The variation of D was 25 analyzed using a threshold to determine an impact number Nd, which is shown to be closely related to 26 Nsurg and Nvid, with an average difference of around 0.2. This approach allows to determine i) the moment 27 when the surgeon should stop the impaction procedure in order to obtain an optimal insertion of the FS 28 and ii) the FS implant primary stability. This study paves the way towards the development of a decision 29 support system to assist the surgeon in hip arthroplasty

Multimodal Evaluation of the Spatiotemporal Variations of Periprosthetic Bone Properties

International audienceTitanium implants are widely used in dental and orthopedic surgery. However, implant failures still occur because of a lack of implant stability. The biomechanical properties of bone tissue located around the implant need to be assessed to better understand the osseointegration phenomena and anticipate implant failure. The aim of this study was to explore the spatio-temporal variation of the microscopic elastic properties of newly formed bone tissue close to an implant. Eight coin-shaped Ti6Al4V implants were inserted into rabbit tibiae for 7 and 13 weeks using an in vivo model allowing the distinction between mature and newly formed bone in a standardized configuration. Nanoindentation and micro-Brillouin scattering measurements were carried out in similar locations to measure the indentation modulus and the wave velocity, from which relative variations of bone mass density were extracted.The indentation modulus, the wave velocity and mass density were found to be higher i) in newly formed bone tissue located close to the implant surface, compared to mature cortical bone tissue, and ii) after longer healing time, consistently with an increased mineralization. Within the bone chamber, the spatial distribution of elastic properties was more heterogeneous for shorter healing durations. After 7 weeks of healing, bone tissue in the bone chamber close to the implant surface was 12.3 % denser than bone tissue further away. Bone tissue close to the chamber edge was 16.8 % denser than in its center. These results suggest a bone spreading pathway along tissue maturation, which is confirmed by histology and consistent with contact osteogenesis phenomena

Looking forward : a glance into the future of organic chemistry

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Alchimies futures : Compte rendu de l'expérience ESYOP

International audience“Organic Chemistry, where now?” This article reports the outcome of the first edition of ESYOP, a symposium devoted to the future of organic chemistry. The collective answer proposed to the above question has been elaborated by thirty-year-old French-speaking researchers. The challenges reported may be structured in three interdependent themes: quest for simplicity, nature as a guide, design of molecular structures capable of autonomy and adaptability. In the future, organic chemistry may be a science devoted to the synthesis of ‘intelligent' molecular systems inspired by Nature by using the simplest means.« Quelle chimie organique demain ? » Cet article présente les conclusions de la première édition des entretiens de synthèse organique et de prospective (ESYOP), dont l'objectif était d'apporter une réponse collective à cette question fondamentale. Les défis mis en évidence par une trentaine de jeunes chercheurs francophones de la génération 30-39 ans peuvent se regrouper suivant trois thèmes interdépendants : la conquête du simple, la nature comme guide et la conception d'édifices moléculaires capables d'autonomie et d'adaptabilité. Le visage de la chimie organique de demain sera peut-être celui d'une science cherchant à construire avec une grande économie de moyens des systèmes moléculaires inspirés de la nature et dotés d'une forme d'intelligence