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[Impact of the European Medical Device Regulation on the availability of medical devices: Scoping review and two-year analysis on the risk for patients in the cardiovascular field].
Ann Pharm Fr
January 2025
Service Pharmacie, Hôpital Européen Georges Pompidou, AP-HP, 20 rue Leblanc, 75015, Paris, France; Université Paris-Saclay, GRADES, Faculté de Pharmacie, 17 Avenue des Sciences, 91190, France. Electronic address:
The implementation of the Medical Devices Regulation (MDR) 2017/745/EU leaves manufacturers facing new requirements to certify their medical devices (MDs). Our objective is to accurately assess the impact of regulation on the availability of cardiovascular MDs in healthcare facilities. High-risk cardiovascular MDs appear to be heavily impacted by the regulation, with reclassification leading to mandatory clinical investigations.
View Article and Find Full Text PDFSubstitutes for Industrial Trans Fats in Packaged Foods: A Scoping Review.
Nutr Rev
January 2025
Postgraduate Program in Nutrition, Health Sciences Center, Federal University of Santa Catarina, Florianópolis 88040-370, Brazil.
The World Health Organization recommended the global elimination of industrial trans fats by 2023, leading to a decrease in their use in packaged foods. Nevertheless, a gap remains in the scientific literature regarding the ingredients adopted as substitutes by the food industry. This study aimed to map evidence on substitutes for industrial trans fats in packaged foods, discussing their possible designation in the ingredients lists.
View Article and Find Full Text PDFPain and Physical Function are common core domains across 40 core outcome sets of musculoskeletal conditions: A systematic review.
J Clin Epidemiol
January 2025
Discipline of Physiotherapy, Graduate School of Health, The University of Technology Sydney, New South Wales, Australia.
Objective: To determine common domains across existing musculoskeletal COSs. Secondary aims were to assess the development quality of existing musculoskeletal COSs and whether development quality and patient participation was associated with domain selection.
Study Design And Setting: A systematic review of musculoskeletal COSs.
Parental Attitudes, Motivators and Barriers Toward Children's Vaccination in Poland: A Scoping Review.
Vaccines (Basel)
January 2025
Department of Family and Geriatric Nursing, Faculty of Health Sciences, Medical University of Lublin, Staszica 6 Str., PL-20-081 Lublin, Poland.
Background: Vaccination is one of the most effective ways of protecting individuals against serious infectious diseases and their fatal consequences.
Objectives: The aim of this scoping review was to synthesize data on parental attitudes toward vaccination and identify factors influencing the motivators and barriers to children's vaccination based on Polish studies.
Methods: The scoping review process and reporting were based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScRs) checklist.
[Drug safety and mandatory reporting].
Schmerz
January 2025
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.
The spontaneous reporting system for cases of suspected side effects is a central instrument for detecting possible side effects after a pharmaceutical preparation has received marketing authorization. It provides important information (signals) on the occurrence of rare, previously unknown side effects, on increases in the frequency of known side effects that may also be due to quality defects, or on changes in the type or severity of known side effects. In recent decades, this system has made a significant contribution to the identification of drug-related risks that only arise upon widespread use following approval and to the introduction of appropriate measures to minimize risk.
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