Department of Dermatology, Cliniques universitaires Saint-Luc, Université catholique de Louvain (UCLouvain), Brussels, Belgium.
Department of Medical Informatics, Biometry and Epidemiology, Univ. Erlangen/Nürnberg, Erlangen, Germany.
J Eur Acad Dermatol Venereol. 2021 Jul;35(7):1444-1448. doi: 10.1111/jdv.17238. Epub 2021 May 6.
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.
To advocate for full ingredient labelling in the implementation of EU regulation for MD.
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.
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.
There is an urgent need for full and accurate labelling of the chemical composition of MD in contact with the human body.
近年来，越来越多的人观察到医疗器械（MD）使用后产生的皮肤反应（例如：连续血糖监测系统、胰岛素泵、伤口敷料、医用手套等），这被认为是一种正在发展的流行疾病。MD 成分标签缺失，以及制造商在接到临床医生对已确定不良反应的个别案例的询问时，频繁不愿披露这些相关信息，严重影响了患者护理。
倡导在实施欧盟 MD 法规时进行全面成分标签。
本立场文件回顾了科学文献、迄今为止采用的 MD 现行监管框架，以及可能的影响，包括在缺乏此类标签的情况下的一些成本数据。
一些科学团队正在努力通过向公司寻求合作或使用昂贵的 MD 化学分析来确定此类不良反应的罪魁祸首，但这只能部分地、且延迟相当长的时间来弥补 MD 成分的重要信息缺失，从而影响患者的管理。事实上，如果不知道存在哪些化学物质，医生就无法告知患者应避免哪些物质，以及哪些替代 MD 可能适合/耐受。
迫切需要对与人体接触的 MD 的化学成分进行全面、准确的标签。
