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

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@article{3573b2a1348444748b0d1fb68d4ff5f1,
title = "Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices",
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.CONCLUSION: There is an urgent need for full and accurate labelling of the chemical composition of MD in contact with the human body.",
keywords = "Bandages, Dermatitis, Allergic Contact, Disclosure, Humans",
author = "A Herman and W Uter and T Rustemeyer and M Matura and K Aalto-Korte and {Duus Johansen}, J and M Gon{\c c}alo and White, {I R} and A Balato and {Gim{\'e}nez Arnau}, {A M} and K Brockow and Mortz, {C G} and V Mahler and A Goossens and {ESCD, EECDRG, EADV Contact Dermatitis Task Force, EAACI}",
note = "{\textcopyright} 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.",
year = "2021",
month = jul,
doi = "10.1111/jdv.17238",
language = "English",
volume = "35",
pages = "1444--1448",
journal = "Journal of the European Academy of Dermatology and Venereology",
issn = "0926-9959",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "7",

}

RIS

TY - JOUR

T1 - Position statement

T2 - The need for EU legislation to require disclosure and labelling of the composition of medical devices

AU - Herman, A

AU - Uter, W

AU - Rustemeyer, T

AU - Matura, M

AU - Aalto-Korte, K

AU - Duus Johansen, J

AU - Gonçalo, M

AU - White, I R

AU - Balato, A

AU - Giménez Arnau, A M

AU - Brockow, K

AU - Mortz, C G

AU - Mahler, V

AU - Goossens, A

AU - ESCD, EECDRG, EADV Contact Dermatitis Task Force, EAACI

N1 - © 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.

PY - 2021/7

Y1 - 2021/7

N2 - 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.

AB - 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.

KW - Bandages

KW - Dermatitis, Allergic Contact

KW - Disclosure

KW - Humans

UR - http://www.scopus.com/inward/record.url?scp=85105778768&partnerID=8YFLogxK

U2 - 10.1111/jdv.17238

DO - 10.1111/jdv.17238

M3 - Journal article

C2 - 33955077

VL - 35

SP - 1444

EP - 1448

JO - Journal of the European Academy of Dermatology and Venereology

JF - Journal of the European Academy of Dermatology and Venereology

SN - 0926-9959

IS - 7

ER -

ID: 66835444