LAUSR

A medical device (MD) is any instrument, equipment, material, or product intended to be used in humans for medical purposes, the main action of which is not obtained by pharmacological or immunological means. Hence, there are a very large number of MDs, ranging from simple contact lenses and sticking plasters to sophisticated pacemakers. They are classified into four categories (I, IIa, IIb, and III) according to their risk level, which is based on several criteria, including indications, invasiveness, duration of use (<1 hour, ≤ 30 days, > 30 days), and implantability, but also the risk related to the patient. Although there is no doubt that MDs have greatly contributed to improve the quality of clinical care, they are able to sensitize and provoke allergic contact dermatitis (ACD). Recently, several cases of ACD caused by MDs have been published, particularly from glucose sensors and insulin pumps. In the current issue, Hyry et al report on the incidence of ACD to glucose sensors in patients with diabetes in southern Finland. The first case of ACD caused by an insulin pump was described in 1985 and by a glucose sensor in 2016, respectively. Since then, the number of cases has increased considerably, making ACD from glucose sensors a “hot topic” in this regard. During the last decade, several authors have highlighted isobornyl acrylate (IBOA) and N,N-dimethylacrylamide (DMAA) as potent allergens in the glucose sensor FreeStyle Libre, one of the most widely used sensors in Europe, and also in other parts of the world. Due to lack of communication with, and cooperation from, the manufacturers regarding the qualitative composition of the sensor, the presence of both allergens in Freestyle Libre could only be identified by investigative chromatographic techniques. Besides the ones identified, even other allergens might be present as not all patients reacting to this sensor are allergic to the substances hitherto identified. Poor and nontransparent sharing of information by the manufacturers marketing MDs for diabetics was already pointed out by Heineman et al in 2015 concerning insulin pumps. Manufacturers continue to refuse collaboration and communication despite numerous requests from the medical society. In the literature over the last three years, the most recent example concerns information obtained by the ANSM (Agence Nationale de Sécurité du Medicament et des Produits de Santé) in France, in May 2019, who informed that Abbott had modified one component of the Freestyle Libre (Abbott Diabetes Care, Witney, Oxon, UK) glucose sensors. However, the provided information is of no help to the diabetic patient as precise information is lacking: are IBOA and/or DMAA still present? Which component has been modified? This is still not known even when requesting information from the manufacturer. Many authors have called attention to the need for full ingredient labeling of other MDs as well, for example, medical dressings and adhesives containing acrylic compounds, or foam wound dressings containing alkyl glucosides, well-known allergens in cosmetic products, for which no cooperation from the respective manufacturers could be obtained either. This information is crucial, also in the light of potential type I hypersensitivity reactions, including anaphylaxis, as in the case of an alginate dressing. In fact, all medical specialties are concerned, other examples including, but not limited to, surgical glues containing cyanoacrylate, also described as a cause of ACD in patients with diabetes, MDs used in cardiology, such as silicone in pacemakers, but also colophonium and herbal extracts in self-adhesive electrocardiography electrodes. The list of MDs causing ACD is much longer, extremely varied, and ever-changing, making it impossible to establish an exhaustive and up-to-date list on this subject. To ensure better protection of public health and patient safety, on April 5, 2017, two new regulations on MDs (Regulation EU 2017/745) and in vitro diagnostic MDs (Regulation EU 2017/746) were adopted. They entered into force on May 25, 2017, progressively replacing the existing directives, and will become fully applicable in May 2020 for MDs and May 2022 for in vitro diagnostic MDs. These regulations contain important changes to the current system to enable the sector to produce safer and more innovative devices and help address future challenges. The safety of the MDs and in vitro diagnostic MDs shall be provided by a new Medical Device Coordination Group, composed of member state experts and chaired by the Commission, that enables increased cooperation between member states in the field of vigilance and market surveillance and a mandatory coordination assessment of multinational clinical investigations. Regarding patient benefits, the new rules introduce: • “Better protection of public health and patient safety”, that is, stricter premarketing control, particularly for high-risk devices (eg, colored contact lenses or equipment for liposuction), strengthening of clinical evaluation and investigation, and stricter requirements on the use of hazardous substances. • A comprehensive European Union database on MDs, a large part of which will be available for the public, such as a newly introduced summary of safety and performance for all class III and implantable devices. DOI: 10.1111/cod.13354