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

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• dc.contributor.author Herman, Allen
• dc.contributor.author Uter, Wolfgang
• dc.contributor.author Rustemeyer, Thomas
• dc.contributor.author Matura, M.
• dc.contributor.author Aalto-Korte, Kristiina
• dc.contributor.author Johanssen, Jeanne Duus
• dc.contributor.author Gonçalo, Margarida
• dc.contributor.author White, Ian R.
• dc.contributor.author Balato, Anna
• dc.contributor.author Giménez Arnau, Anna Maria
• dc.contributor.author Brockow, K.
• dc.contributor.author Mortz, C.G.
• dc.contributor.author Mahler, Vera
• dc.contributor.author Goossens, Alain
• dc.contributor.author ESCD
• dc.contributor.author EECDRG
• dc.contributor.author EADV Contact Dermatitis Task Force
• dc.contributor.author EAACI
• dc.date.accessioned 2021-09-30T06:17:55Z
• dc.date.available 2021-09-30T06:17:55Z
• dc.date.issued 2021
• dc.description.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. Objectives: To advocate for full ingredient labelling in the implementation of EU regulation for MD. Methods: This position paper reviews the scientific literature, the current regulatory framework adopted for MD to date, and the likely impact, including some costs data in case of the absence of such labelling. Results: Efforts made by several scientific teams, who are trying to identify the culprit of such adverse effects, either via asking for cooperation from companies, or using costly chemical analyses of MD, can only partly, and with considerable delay, compensate for the absence of meaningful information on the composition of MD; hence, patient management is compromised. Indeed, without knowing the chemical substances present, physicians are unable to inform patients about which substances they should avoid, and which alternative MD may be suitable/tolerated.
• dc.format.mimetype application/pdf
• dc.identifier.citation Herman A, Uter W, Rustemeyer T, Matura M, Aalto-Korte K, Duus Johansen J, Gonçalo M, White IR, Balato A, Giménez Arnau AM, Brockow K, Mortz CG, Mahler V, Goossens A; ESCD, EECDRG, EADV Contact Dermatitis Task Force, EAACI. Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices. J Eur Acad Dermatol Venereol. 2021;35(7):1444-8. DOI: 10.1111/jdv.17238
• dc.identifier.doi http://dx.doi.org/10.1111/jdv.17238
• dc.identifier.issn 0926-9959
• dc.identifier.uri http://hdl.handle.net/10230/48532
• dc.language.iso eng
• dc.publisher Wiley
• dc.relation.ispartof J Eur Acad Dermatol Venereol. 2021;35(7):1444-8
• dc.rights © 2021 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
• dc.title Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion