Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

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

Research output: Contribution to journalJournal articleResearchpeer-review

DOI

  1. Recurrent injection-site reactions after incorrect subcutaneous administration of a COVID-19 vaccine

    Research output: Contribution to journalLetterResearchpeer-review

  2. Metronidazole for Hidradenitis Suppurativa: future potential treatment applications

    Research output: Contribution to journalLetterResearchpeer-review

  3. Atopic dermatitis among children and adolescents in the Arctic region - a systematic review and meta-analysis

    Research output: Contribution to journalReviewResearchpeer-review

  4. An approach for the transition from systemic immunosuppressants to dupilumab

    Research output: Contribution to journalLetterResearchpeer-review

  1. Incidence rates of occupational contact dermatitis in Denmark between 2007 and 2018 - A population-based study

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Aluminium contact allergy without vaccination granulomas: A systematic review and meta-analysis

    Research output: Contribution to journalReviewResearchpeer-review

  3. Nickel release from metallic earrings: A survey of the Danish market and validation of the nickel spot test

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Memory T helper cells identify patients with nickel, cobalt, and chromium metal allergy

    Research output: Contribution to journalJournal articleResearchpeer-review

  • ESCD, EECDRG, EADV Contact Dermatitis Task Force, EAACI
View graph of relations

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.

Original languageEnglish
JournalJournal of the European Academy of Dermatology and Venereology : JEADV
Volume35
Issue number7
Pages (from-to)1444-1448
Number of pages5
ISSN0926-9959
DOIs
Publication statusPublished - Jul 2021

    Research areas

  • Bandages, Dermatitis, Allergic Contact, Disclosure, Humans

ID: 66835444