Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices

Herman A, Uter W, Rustemeyer T, Matura M, Aalto-Korte K, Duus Johansen J, Goncalo M, White IR, Balato A, Gimenez Arnau AM, Brockow K, Mortz CG, Mahler V, Goossens A (2021)

Publication Type: Journal article

Publication year: 2021

Journal

Journal of the European Academy of Dermatology and Venereology Wiley-Blackwell

DOI: 10.1111/jdv.17238

Abstract

Background In recent years, skin reactions secondary to the use of medical devices (MD), such as allergic contact dermatitis have increasingly been observed (e.g. to continuous blood sugar monitoring systems, insulin pumps, wound dressings, medical gloves, etc.): this is regarded as a developing epidemic. Lack of labelling of the composition of MD, as well as frequent lack of cooperation of manufacturers to disclose this relevant information, even when contacted by the clinician for the individual case of an established adverse reaction, significantly impede patient care.

Authors with CRIS profile

Wolfgang Uter Professur für Epidemiologie Vera Mahler Medizinische Fakultät

Involved external institutions

Finnish Institute of Occupational Health (FIOH) / Työterveyslaitos (TTL) FI Finland (FI) University of Copenhagen DK Denmark (DK) Centro Hospitalar e Universitário de Coimbra (CHUC) PT Portugal (PT) Université Catholique de Louvain (UCL) BE Belgium (BE) Skaraborgs Sjukhus SE Sweden (SE) Università degli Studi di Napoli Federico II IT Italy (IT) Guy's and St Thomas' (NHS Foundation Trust) GB United Kingdom (GB) Amsterdam University Medical Centers (Amsterdam UMC) / Amsterdam Universitair Medische Centra NL Netherlands (NL) Autonomous University of Barcelona (UAB) / Universitat Autònoma de Barcelona ES Spain (ES) Katholieke Universiteit Leuven (KUL) / Catholic University of Leuven BE Belgium (BE) Odense Universitetshospital (OUH) DK Denmark (DK) Technische Universität München (TUM) DE Germany (DE)

How to cite

APA:

Herman, A., Uter, W., Rustemeyer, T., Matura, M., Aalto-Korte, K., Duus Johansen, J.,... Goossens, A. (2021). Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices. Journal of the European Academy of Dermatology and Venereology. https://doi.org/10.1111/jdv.17238

MLA:

Herman, A., et al. "Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices." Journal of the European Academy of Dermatology and Venereology (2021).

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