[Introduction of Health technology assessment at hospital]. / Mise en place de l'évaluation des technologies de santé en milieu hospitalier.

INTRODUCTION: The Medical Devices Committee (CODIMS) of the Assistance publique-Hôpitaux de Paris (AP-HP) is responsible for deciding whether innovative and costly sterile medical devices (SMD) should be adopted for the AP-HP network and for issuing recommendations on their proper use. The aim of this study was to qualify retrospectively the level of evidence of clinical studies used for the device evaluations by the CODIMS in 2012 and 2013 and to analyze the relationship between levels of evidence and decisions. MATERIAL AND METHOD: Executive summaries written in 2012 and 2013 about studied SMD was analyzed and the level of evidence of clinical studies used was qualified in high/low levels of evidence according to the scale of Sackett et al. Then, levels of evidence were correlated to decisions published by the CODIMS. RESULTS: Sixty-one files of SMD (72.1% of implantable MD) have been evaluated (225 clinical studies). Among them, only 28% of clinical studies had a high level of evidence (and 28.6% of MD at-risk) and 18% did not have any clinical studies. The CODIMS delivered an unfavourable opinion for 16 SMD: only 28 clinicals studies were available for evaluation. Among these, only 6 studies had a high level of evidence. DISCUSSION ET CONCLUSION: The amount and level of evidence of clinical studies is naturally correlated to admittance of SMD. These findings suggest that the clinical evidence used to demonstrate safety and efficacy for high-risk medical devices is based on clinical studies with poor quality data, making more difficult the evaluation of SMD in hospital. The development of a multi-criteria tool to help decision-making would improve the process of SMD evaluation by the CODIMS.

Impact of high-energy nuclear data on radioprotection in spallation sources.

The high-energy programme of the HINDAS European project has provided a large amount of experimental data and led to a better understanding of the spallation reaction mechanism and the development of more reliable spallation models. These data, or the new models, which have been implemented into high-energy transport codes, can be now used to predict with a larger confidence or, at least with a known uncertainty, some important quantities for the design of spallation sources. In this paper, examples concerning the residue production in a Pb-Bi target and the high-energy neutrons escaping the target are presented. In the first case, the activity and the amount of radioactive volatile elements that can be released, in case of a containment failure, are calculated and the level of confidence of the calculation is assessed. The second example shows that the models correctly predict the high-energy tail of the neutron spectrum, which is important for radioprotection in the facility.

Isotopic dependence of the nuclear caloric curve.

The A/Z dependence of projectile fragmentation at relativistic energies has been studied with the ALADIN forward spectrometer at SIS. A stable beam of (124)Sn and radioactive beams of (124)La and (107)Sn at 600 MeV per nucleon have been used in order to explore a wide range of isotopic compositions. Chemical freeze-out temperatures are found to be nearly invariant with respect to the A/Z of the produced spectator sources, consistent with predictions for expanded systems. Small Coulomb effects (DeltaT approximately 0.6 MeV) appear for residue production near the onset of multifragmentation.

Coincidence measurement of residues and light particles in the reaction 56Fe+p at 1 GeV per nucleon with the spallation reactions setup SPALADIN.

The spallation of 56Fe in collisions with hydrogen at 1A GeV has been studied in inverse kinematics with the large-aperture setup SPALADIN at GSI. Coincidences of residues with low-center-of-mass kinetic energy light particles and fragments have been measured allowing the decomposition of the total reaction cross section into the different possible deexcitation channels. Detailed information on the evolution of these deexcitation channels with excitation energy has also been obtained. The comparison of the data with predictions of several deexcitation models coupled to the INCL4 intranuclear cascade model shows that only GEMINI can reasonably account for the bulk of collected results, indicating that in a light system with no compression and little angular momentum, multifragmentation might not be necessary to explain the data.

Cross sections of spallation residues produced in 1A GeV 208Pb on proton reactions.

Spallation residues produced in 1 GeV per nucleon 208Pb on proton reactions have been studied using the Fragment Separator facility at GSI. Isotopic production cross sections of elements from 61Pm to 82Pb have been measured down to 0.1 mb with a high accuracy. The recoil kinetic energies of the produced fragments were also determined. The obtained cross sections agree with most of the few existing gamma-spectroscopic data. The data are compared with different intranuclear-cascade and evaporation-fission models. Drastic deviations were found for a standard code used in technical applications.

Measurement of a complete set of nuclides, cross sections, and kinetic energies in spallation of 238U 1A GeV with protons.

Spallation residues and fission fragments from 1A GeV 238U projectiles irradiating a liquid hydrogen target were investigated by using the fragment separator at GSI for magnetic selection of reaction products including ray-tracing, energy-loss and time-of-flight techniques. The longitudinal-momentum spectra of identified fragments were analyzed, and evaporation residues and fission fragments could be separated. For 1385 nuclides, production cross sections down to values of 10 microb with a mean accuracy of 15%, velocities in the uranium rest frame and kinetic energies were determined. In the reaction all elements from uranium to nitrogen were found, each with a large number of isotopes.