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

  1. Herman, Anne ORCID logo
  2. Uter, Wolfgang ORCID logo
  3. Rustemeyer, Thomas ORCID logo
  4. Matura, Mihaly
  5. Aalto-Korte, Kristiina ORCID logo
  6. Johansen, Jeanne Duus ORCID logo
  7. Gonçalo, Margarida ORCID logo
  8. White, Ian R.
  9. Balato, Anna ORCID logo
  10. Gimenez-Arnau , Ana M ORCID logo
  11. Brockow, Knut ORCID logo
  12. Mortz, Charlotte G.
  13. Mahler, Vera
  14. Goossens, An
  15. European Society of Contact Dermatitis
  16. European Environmental and Contact Dermatitis Research Group
  17. EADV Contact Dermatitis Task Force
  18. European Academy of Allergy and Clinical Immunology

Download
Upload.pdf 265,64KB
WeightNameValue
1000 Titel
  • Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices
1000 Autor/in
  1. Herman, Anne |
  2. Uter, Wolfgang |
  3. Rustemeyer, Thomas |
  4. Matura, Mihaly |
  5. Aalto-Korte, Kristiina |
  6. Johansen, Jeanne Duus |
  7. Gonçalo, Margarida |
  8. White, Ian R. |
  9. Balato, Anna |
  10. Gimenez-Arnau , Ana M |
  11. Brockow, Knut |
  12. Mortz, Charlotte G. |
  13. Mahler, Vera |
  14. Goossens, An |
1000 Mitwirkende/r
  1. European Society of Contact Dermatitis |
  2. European Environmental and Contact Dermatitis Research Group |
  3. EADV Contact Dermatitis Task Force |
  4. European Academy of Allergy and Clinical Immunology |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-05-06
1000 Erschienen in
1000 Quellenangabe
  • 35(7):1444-1448
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1111/jdv.17238 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251888/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • 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. CONCLUSION: There is an urgent need for full and accurate labelling of the chemical composition of MD in contact with the human body.
1000 Sacherschließung
gnd 4437717-4 Arzneimittelüberwachung
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0001-7000-1672|https://orcid.org/0000-0002-4498-3710|https://orcid.org/0000-0001-7580-0684|https://frl.publisso.de/adhoc/uri/TWF0dXJhLCBNaWhhbHk=|https://orcid.org/0000-0002-5595-5512|https://orcid.org/0000-0002-3537-8463|https://orcid.org/0000-0001-6842-1360|https://frl.publisso.de/adhoc/uri/V2hpdGUsIElhbiBSLg==|https://orcid.org/0000-0001-5485-0172|https://orcid.org/0000-0001-5434-7753|https://orcid.org/0000-0002-2775-3681|https://frl.publisso.de/adhoc/uri/TW9ydHosIENoYXJsb3R0ZSBHLg==|https://d-nb.info/gnd/1115010409|https://frl.publisso.de/adhoc/uri/R29vc3NlbnMsIEFu|https://d-nb.info/gnd/10021193-8|https://d-nb.info/gnd/16134177-9|https://frl.publisso.de/adhoc/uri/IEVBRFYgQ29udGFjdCBEZXJtYXRpdGlzIFRhc2sgRm9yY2Ug|https://d-nb.info/gnd/1090666683
1000 Label
1000 Fördernummer
  1. -
1000 Förderprogramm
  1. -
1000 Dateien
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6431895.rdf
1000 Erstellt am 2022-03-01T15:37:25.225+0100
1000 Erstellt von 323
1000 beschreibt frl:6431895
1000 Bearbeitet von 25
1000 Zuletzt bearbeitet 2022-03-15T08:40:03.654+0100
1000 Objekt bearb. Tue Mar 15 08:39:36 CET 2022
1000 Vgl. frl:6431895
1000 Oai Id
  1. oai:frl.publisso.de:frl:6431895 |
1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
1000 Gegenstand von

View source