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Safety assessment of the substance 2,2'-oxydiethylamine for use in plastic food contact materials.
The EFSA Panel on Food Contact Materials assessed the safety of 2,2’-oxydiethylamine, which is intended to be used at up to 14% w/w as a monomer along with adipic acid and caprolactam to make polyamide thin films intended for single use, in contact with all types of food under all conditions of time and temperature. Specific migration of 2,2’-oxydiethylamine was tested from a polyamide film in water and was below the limit of quantification (LOQ) of 0.015 mg/kg. Migration of impurities has been estimated pro-rata. Migrating oligomers were identified and semi-quantified in 10% ethanol, 3% acetic acid and olive oil. Considering the measured migration and the virtual presence at the LOQ of the oligomers below 1000 Da containing the substance, the estimated migration of these oligomers would be 1.042 mg/kg. Genotoxicity studies were performed on the substance and on 1-oxa-4,11,18-triazacycloeicosane-5,10,17-trione and 1-oxa-4,11,18,25-tetraazacycloheptacosane-5,10,17,24-tetraone. (Q)SAR analyses were provided on the oligomers of higher molecular masses. Based on these data, the Panel excluded genotoxicity concerns for the substance and its oligomers. From a 90-day toxicity study on the 1-oxa-4,11,18-triazacycloeicosane-5,10,17-trione, the Panel identified a NOAEL of 1040 mg/kg bw per day. Based on their physico-chemical properties and experimental data, the Panel considered the potential for accumulation in humans of the oligomers containing the substance of no concern. The Panel concluded that the substance is not of safety concern for the consumer if it is used as a comonomer with 99.6% minimum purity at up to 14% w/w to manufacture polyamide films (maximum thickness: 25 μm) and intended to be used in contact with all types of foods, except infant formula and human milk, at all time and temperature conditions. The migrations of the substance and of the oligomers below 1000 Da containing the substance should not exceed 0.05 and 5 mg/kg food, respectively.</p
Multimorbidity healthcare expenditure in Belgium: a 4-year analysis (COMORB study).
BACKGROUND: The complex management of health needs in multimorbid patients, alongside limited cost data, presents challenges in developing cost-effective patient-care pathways. We estimated the costs of managing 171 dyads and 969 triads in Belgium, taking into account the influence of morbidity interactions on costs.
METHODS: We followed a retrospective longitudinal study design, using the linked Belgian Health Interview Survey 2018 and the administrative claim database 2017-2020 hosted by the Intermutualistic Agency. We included people aged 15 and older, who had complete profiles (N = 9753). Applying a system costing perspective, the average annual direct cost per person per dyad/triad was presented in 2022 Euro and comprised mainly direct medical costs. We developed mixed models to analyse the impact of single chronic conditions, dyads and triads on healthcare costs, considering two-/three-way interactions within dyads/triads, key cost determinants and clustering at the household level.
RESULTS: People with multimorbidity constituted nearly half of the study population and their total healthcare cost constituted around three quarters of the healthcare cost of the study population. The most common dyad, arthropathies + dorsopathies, with a 14% prevalence rate, accounted for 11% of the total national health expenditure. The most frequent triad, arthropathies + dorsopathies + hypertension, with a 5% prevalence rate, contributed 5%. The average annual direct costs per person with dyad and triad were €3515 (95% CI 3093-3937) and €4592 (95% CI 3920-5264), respectively. Dyads and triads associated with cancer, diabetes, chronic fatigue, and genitourinary problems incurred the highest costs. In most cases, the cost associated with multimorbidity was lower or not substantially different from the combined cost of the same conditions observed in separate patients.
CONCLUSION: Prevalent morbidity combinations, rather than high-cost ones, made a greater contribution to total national health expenditure. Our study contributes to the sparse evidence on this topic globally and in Europe, with the aim of improving cost-effective care for patients with diverse needs.</p
Implementing the 3RS in quality Control and batch release testing - view from a Belgian OMCL
An interdisciplinary approach: Exploring the five dimensions of the tools deployed by EUVABECO
Impact of primary course COVID-19 vaccination on hospitalizations in Belgium, a Bayesian approach
Emergence of ST131 carrying carbapenemase genes, European Union/European Economic Area, August 2012 to May 2024.
Analysis of 594 isolates of sequence type (ST)131 and its single locus variants carrying carbapenemase genes from 17 European Union/European Economic Area countries revealed acquisition of 18 carbapenemase variants, mainly in ST131 clades A and C. Most frequent were (n = 230) and (n = 224), detected in 14 and 12 countries, respectively. Isolates carrying have increased rapidly since 2021. The increasing detection of carbapenemase genes in the high-risk lineage ST131 is a public health concern.</p
Trends of Clostridioides difficile infections in Belgian hospitals, between 2010 and 2022
Clostridioides difficile infections (CDI) remain one of the more important gastro-intestinal infections in European hospitals, being responsible for 4.9% of all healthcare-associated infections. For this study, we present the latest trends on incidence of CDI in Belgium.
Data for period 2010-2022 was obtained through the national surveillance of CDI in Belgian acute hospitals. Hospitals voluntarily participating should report at least for one semester. Data are collected, validated, and reported through the secured environment of the Healthdata system.
Participation of eligible hospitals has decreased from 82% to 77% between 2010 and 2022, throughout this period the percentage of type and region of the participating hospitals remained comparable. In 2010, 62% of all reported CDI could be categorized ‘hospital-associated’ (HA-CDI), meaning symptoms occurring two days or more after admission. Twelve years later this accounts for 58% of all CDI. Over the study period, the reported CDI labelled as ‘recurrent’ remained around 10%. Between 2015 and 2021, a decrease of annual HA-CDI incidence was observed. In 2022, a significant increase in HA-CDI incidence was reported of 1.31 (95%CI 1.23 – 1.39) to 1.62 (95%CI 1.53 – 1.71), and for all CDI this was from 2.41 (95%CI 2.30 – 2.51) to 2.78 (95%CI 2.66 – 2.89).
HA-CDI are still a burden on hospitals compared to twelve years ago, although recent literature suggest that the importance of community-associated CDI should not be ignored. The COVID-19 pandemic did not seem to increase the burden of CDI in Belgian hospitals, possibly through the focus on infection, prevention and control measures, change in care seeking behaviour and lower use of some antimicrobials. The 2022 increase in incidence might be related to a post-pandemic change in the behaviour mentioned above and should be analysed further.</p
Production et accès aux produits médicaux (Vaccin): Témoignage Sciensano: renforcement (RFDA)
EU Call - Direct grants to Member States’ authorities: Personalised Cancer Medicine (CR-g-24-41)
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For evaluating the relevance and feasibility of belgian participation in EU call.</p