[Construction of a methodology for clinical evaluation of medical devices using simulation tools and illustration through three studies].

Introduction: European regulations have recently moved towards more stringent requirements for demonstrating the safety and performance of medical devices (MDs).

Objective: To apply an innovative testing method using medical simulation to the evaluation of three medical devices at different stages of their life cycle.

Method: The methodology for evaluating DMs using simulation is based on seven stages: definition of the context, training, construction of a scenario to test the DM, validation of the scenario, realization of the scenario, evaluation of the scenario by the players and validation and exploitation of the results.

[Implementing an operating room pharmacy satellite in an university hospital].

Objectives: An operating room pharmaceutical unit centralizes medical devices and drugs for various surgical specialities. The aim of this work is to present the methodology used in our establishment to set up the operating room pharmaceutical unit.

Methods: This approach involved the formation of multi-professional working groups.

An ethically guided preclinical device for phenotyping H production in laboratory rodents.

Background: Dihydrogen (H) is produced endogenously by the intestinal microbiota through the fermentation of diet carbohydrates. Over the past few years, numerous studies have demonstrated the significant therapeutic potential of H in various pathophysiological contexts, making the characterization of its production in laboratory species of major preclinical importance.

Methods: This study proposes an innovative solution to accurately monitor H production in free-moving rodents while respecting animal welfare standards.

Hydrogen inhalation: in vivo rat genotoxicity tests.

Preclinical and clinical studies have shown that molecular hydrogen (H) has anti-oxidant, anti-inflammatory, and anti-apoptotic properties. Safety data are available in the literature and acute toxicity has been tested in isolated cells and laboratory animals. We have evaluates the genotoxicity of H in vivo in rats after 72 h exposure, following the International Council for Harmonization guidelines ICH S2 (R1).