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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., Results: Our evaluation methodology enabled us to assess three DMs at different stages of their development: a respiratory protection device at the initial stage (prototype definition), a respiratory protection mask (prototype optimization) and bottle adapters (post-marketing)., Conclusion: Simulation is a valuable tool for evaluating DM. The proposed methodology enables it to be used and adapted to different contexts. It responds to the specificities of clinical evaluation of this class of products, and helps to better anticipate certain risks., (Copyright © 2024 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

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. The needs of operating theatres were defined based on an analysis of healthcare product consumption and stock inventories. Material sheets were defined for each procedure. On the basis of simulations, material supply arrangements were selected, specifying material flows, equipment, workstations and information systems., Results: Over 3200 healthcare product references were identified and 862 equipment files were created. Local stocks have been limited to medical trolleys for nursing staff. Emergency operating packs have been deployed for unforeseen operations. Cabinets have been dedicated to transporting re-sterilizable medical devices, and carts have been purchased for programmed operating packs. The equipment is made available by logistics agents and pharmacy assistants under pharmaceutical responsibility., Conclusions: This innovative approach is a model for facilities desiring to centralize and secure the logistics of healthcare products in the operating room. Ongoing adjustments will be required to meet new operating rooms needs., (Copyright © 2024 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has triggered a serious global health crisis, resulting in millions of reported deaths since its initial identification in China in November 2019. The global disparities in immunization access emphasize the urgent need for ongoing research into therapeutic interventions. This study focuses on the potential use of molecular dihydrogen (H2) inhalation as an adjunctive treatment for COVID-19. H2 therapy shows promise in inhibiting intracellular signaling pathways associated with inflammation, particularly when administered early in conjunction with nasal oxygen therapy. This phase I study, characterized by an open-label, prospective, monocentric, and single ascending-dose design, seeks to assess the safety and tolerability of the procedure in individuals with confirmed SARS-CoV-2 infection. Employing a 3 + 3 design, the study includes three exposure durations (target durations): 1 day (D1), 3 days (D2), and 6 days (D3). We concluded that the maximum tolerated duration is at least 3 days. Every patient showed clinical improvement and excellent tolerance to H2 therapy. To the best of our knowledge, this phase I clinical trial is the first to establish the safety of inhaling a mixture of H2 (3.6%) and N2 (96.4%) in hospitalized COVID-19 patients. The original device and method employed ensure the absence of explosion risk. The encouraging outcomes observed in the 12 patients included in the study justify further exploration through larger, controlled clinical trials., Clinical Trials: This study is registered with ClinicalTrials.gov as NCT04633980., Competing Interests: The authors declare no conflict of interest.

Background: Dihydrogen (H 2 ) 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 2 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 2 production in free-moving rodents while respecting animal welfare standards. The developed device consisted of a wire rodent cage placed inside an airtight chamber in which the air quality was maintained, and the H 2 concentration was continuously analyzed. After the airtightness and efficiency of the systems used to control and maintain air quality in the chamber were checked, tests were carried out on rats and mice with different metabolic phenotypes, over 12 min to 1-h experiments and repeatedly. H 2 production rates (HPR) were obtained using an easy calculation algorithm based on a first-order moving average., Results: HPR in hyperphagic Zucker rats was found to be twice as high as in control Wistar rats, respectively, 2.64 and 1.27 nmol.s -1 per animal. In addition, the ingestion of inulin, a dietary fiber, stimulated H 2 production in mice. HPRs were 0.46 nmol.s -1 for animals under control diet and 1.99 nmol.s -1 for animals under inulin diet., Conclusions: The proposed device coupled with our algorithm enables fine analysis of the metabolic phenotype of laboratory rats or mice with regard to their endogenous H 2 production., (© 2024 The Author(s). Animal Models and Experimental Medicine published by John Wiley & Sons Australia, Ltd on behalf of The Chinese Association for Laboratory Animal Sciences.)

Background . Due to its antioxidant, anti-inflammatory, anti-apoptosis, and anti-fatigue properties, molecular hydrogen (H 2 ) is potentially a novel therapeutic nutrient for patients with coronavirus acute disease 2019 (COVID-19). We determined the efficacy and safety profile of hydrogen-rich water (HRW) to reduce the risk of COVID-19 progression. Methods : We also conducted a phase 3, triple-blind, randomised, placebo-controlled trial to evaluate treatment with HRW initiated within 5 days after the onset of signs or symptoms in primary care patients with mild-to-moderate, laboratory-confirmed COVID-19. Participants were randomised to receive HRW or placebo twice daily for 21 days. The incidence of clinical worsening and adverse events were the primary endpoints. Results : A total of 675 participants were followed up to day 30. HRW was not superior to placebo in preventing clinical worsening at day 14: in H 2 group, 46.1% in the H 2 group, 43.5% in the placebo group, hazard ratio 1.09, 90% confidence interval [0.90-1.31]. One death was reported at day 30 in the H 2 group and two in the placebo group at day 30. Adverse events were reported in 91 (27%) and 89 (26.2%) participants, respectively. Conclusions : HRW taken twice daily from the onset of COVID-19 symptoms for 21 days did not reduce clinical worsening.

Preclinical and clinical studies have shown that molecular hydrogen (H 2 ) 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 2 in vivo in rats after 72 h exposure, following the International Council for Harmonization guidelines ICH S2 (R1). The study was conducted on three groups of male Wistar rats: a negative control group, a positive control group receiving methyl methanesulfonate, and a H 2 -treated group receiving a 3.1% H 2 gas mixture for 72 h. Alkaline comet, formamidopyrimidine DNA glycosylase (Fpg)-modified comet and bone marrow micronucleus assays were performed. H 2 exposure increased neither comet-tail DNA intensity (DNA damage) nor frequency of "hedgehogs" in blood, liver, lungs, or bronchoalveolar lavage fluid. No increase in Fpg-sensitive sites in lungs, no induction of micronucleus formation, and no imbalance of immature erythrocyte to total erythrocyte ratio (IME%) was observed in rats exposed to H 2 . The ICH S2 (R1) test-battery revealed no in vivo genotoxicity in Wistar rats after 72 h inhalation of a mixture containing 3.1% H 2 ., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Tacrolimus is the cornerstone of the therapeutic immunosuppressive strategy in liver transplantation. The inter-individual and intra-individual variability of its trough blood concentrations is a surrogated biomarker of allograft rejection. Here we described two cases of patients with liver transplant who exhibited increases of tacrolimus blood trough concentration adjusted on the dose while experiencing acute inflammatory episodes. These case reports highlight the inhibitory effect of acute inflammation on tacrolimus metabolism and show that it accounts for the longitudinal intra-individual variability of tacrolimus blood concentrations, beyond drug-drug interaction and observance., (© 2020 The British Pharmacological Society.)