DOI: 10.1111/jdv.17238 JEADV POSITION STATEMENT Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices A. Herman,1,* W. Uter,2 T. Rustemeyer,3 M. Matura,4 K. Aalto-Korte,5 J. Duus Johansen,6 M. Goncß alo,7 I.R. White,8 A. Balato,9 nez Arnau,10 A.M. Gime K. Brockow,11 C.G. Mortz,12 13,† 14 V. Mahler, A. Goossens, on behalf of the ESCD, EECDRG, EADV Contact Dermatitis Task Force, EAACI 1 Department of Dermatology, Cliniques universitaires Saint-Luc, Universite catholique de Louvain (UCLouvain), Brussels, Belgium 2 Department of Medical Informatics, Biometry and Epidemiology, Univ. Erlangen/Nu €rnberg, Erlangen, Germany 3 Department of Dermatology and Allergology, Amsterdam University Medical Centres, Amsterdam, The Netherlands 4 Dermatology Unit, Skaraborgs Hospital Sko €vde, Sko €vde, Sweden 5 Occupational Health Unit, Finnish Institute of Occupational Heath, Helsinki, Finland 6 Department of Dermatology and Allergy, National Allergy Research Centre, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark 7 Department of Dermatology, Coimbra University Hospital and Faculty of Medicine, University of Coimbra, Coimbra, Portugal 8 Cutaneous Allergy Team, St. John’s Institute of Dermatology, Guy’s Hospital, London, UK 9 Department of Advanced Biomedical Sciences, University of Naples Federico II, Napoli, Italy 10 Department of Dermatology, Hospital del Mar. Universitat Auto noma de Barcelona, Barcelona, Spain 11 Department of Dermatology and Allergy Biederstein, School of Medicine, Technical University of Munich, Munich, Germany 12 Department of Dermatology and Allergy Center, Odense Research Center for Anaphylaxis (ORCA), Odense University Hospital, Odense, Denmark 13 Med. Faculty, Univ. Erlangen/Nuremberg, Erlangen, Germany 14 Contact Allergy Unit, Department of Dermatology, University Hospital KU Leuven, Leuven, Belgium † Present address: Paul-Ehrlich-Institut, Langen, Germany *Correspondence: A. Herman. E-mail: anne.herman@uclouvain.be Abstract Background In recent years, skin reactions secondary to the use of medical devices (MD), such as allergic con- tact 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 compo- sition 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. Received: 24 November 2020; Accepted: 8 March 2021 Conflict of interest The views expressed in this position paper are the personal views of the author as experts in the field of allergy and may not be understood or quoted as being made on behalf of, or reflecting the position of the respective national competent authority, the European Medicines Agency, or one of its committees or working parties. JEADV 2021, 35, 1444–1448 © 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 This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. The need for EU legislation to require disclosure and labelling 1445 Funding source None. Introduction • A new device identification system that will allow easier A medical device (MD) is defined as any instrument, equipment, traceability of medical devices. material or product intended to be used in humans for medical • An ‘implant’ card for patients containing information about purposes, the main action of which is not of pharmacological or implanted medical devices. immunological nature. • A robust financial mechanism to ensure patients are com- A great number of MDs exist, ranging from simple contact pensated in case they receive defective products. lenses and adhesive plasters to sophisticated pacemakers. As However, despite the claim for better protection of public defined in Annex VIII (Classification rules, Regulation EU 2017/ health and patient safety, the two new regulations do not offer a 745), they are classified into 4 categories (I, IIa, IIb and III) decisive benefit for the prevention and management of adverse according to their risk level, which is based on several criteria, events, such as irritant and allergic contact dermatitis caused by including indications, invasiveness, duration of use (<1 h, ingredients present in medical devices; they do not mention ≤30 days, >30 days) and implantability, but also the risk for the their qualitative composition nor explicitly require ingredient patient. labelling on the packaging of MDs. On 5 April, 2017, two new regulations for medical devices Although there is no doubt that MDs contribute to improve (MD) were adopted in the European Union, in order to provide the quality of clinical care, adverse reactions following their use better protection of public health and patient safety; these con- in patients are to be expected, including skin reactions, which cerned medical devices (Regulation EU 2017/745)1 and in vitro should be considered in the implementation process of the Med- diagnostic medical devices (Regulation EU 2017/746).2 ical Device Regulation. These two regulations entered into force on 25 May, 2017, Indeed, case series of allergic contact dermatitis (ACD) caused progressively replacing the existing directives, and were sup- by MDs have recently been published, particularly from medical posed to become fully applicable in May 2020 for medical devices in diabetic patients, such as glucose sensors and insulin devices, and in May 2022 for in vitro diagnostic medical devices.3 pumps. The first case caused by an insulin pump was described However, due to urgent priorities related to the coronavirus cri- in 19855 and by a glucose sensor in 2016,6 followed by a consid- sis, the Council and the Parliament adopted Regulation 2020/ erable number of similar cases. As a result of investigative chro- 5614 amending Regulation (EU) 2017/745 on medical devices matographic analyses and the performance of patch tests in regarding application dates of certain of its provisions on 23 patients to confirm sensitization, various known allergens were April, 2020. It postpones the date of application of the Medical identified in several types of MDs, that is ethyl cyanoacrylate,6,7 Devices Regulation until May 2021, whereas for the In Vitro isobornyl acrylate (IBOA),8–11 N,N-dimethylacrylamide12 and Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) colophonium.13 2017/746), the corresponding date of application remains the As briefly illustrated above, the problem regarding the pres- same (May 2022). ence of allergens in MDs is not limited to devices for diabetic These regulations contain important changes to the previous patients. Many other cases of ACD from various devices have system to enable the sector to produce safer and more innovative been reported in the literature in recent years. For example, devices and help address future challenges. medical dressings and adhesives containing acrylic com- Regarding patient benefits, the new regulations are intended pounds,14 or foam wound dressings containing alkyl glucosides, to introduce: well-known allergens in cosmetic products,15 for which no coop- • ‘Better protection of public health and patient safety’, that eration from the respective manufacturers could be obtained is stricter pre-marketing control, particularly for high-risk during the clinical investigation of patients. Surgical glues con- devices (e.g. coloured contact lenses or equipment for lipo- taining cyanoacrylate,16 described as causes of ACD in diabetic suction), strengthening of clinical evaluation and investiga- patients as well,7,17 MDs used in cardiology, such as silicone in tion and stricter requirements on the use of hazardous pacemakers,18 and even colophonium and herbal extracts in self- substances. adhesive electrocardiography electrodes19 are involved. Dental • A comprehensive EU database on medical devices, a large prostheses, endoprosthesis, etc. are also concerned. Medical part of it available for the public, such as a newly introduced gloves, labelled as medical devices and personal protective equip- summary of safety and performance for all Class III and ment, used by healthcare workers containing latex and rubber implantable devices. chemical accelerators are also responsible for ACD.20,21 JEADV 2021, 35, 1444–1448 © 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 1446 Herman et al. Publications have reported mislabelling in several products Standardization in nomenclature of pharmaceutical ingredients labelled ‘accelerator-free’ gloves.22 and certainly of cosmetic ingredients is well established.23 The The list of MDs causing ACD is extremely long, affects all current absence of such requirements for MDs might explain medical specialties, is extremely varied and ever-changing, mak- why there is an increasing tendency to market topical prepara- ing it impossible to establish an exhaustive and current date list tions, for example wound gels and skincare products as medical on this subject. devices, possibly in order to avoid the more restrictive regulatory framework of the community code related to medicinal products Discussion for human use and the cosmetic regulation. It is noteworthy to point out that labelling the list of ingredients Furthermore, with regard to information regarding materials is an integral component of European legislation concerning incorporated into the device that could result in sensitization or packaged foodstuffs (Regulation (EU) No. 1169/2011), medici- an allergic reaction by the patient or user, we strongly encourage nal products (Directive 2001/83/EC) and also cosmetics (Regula- implementation of an obligation of MD manufacturers to coop- tion (EC) No. 1223/2009), which informs consumers exposed to erate and disclose all information necessary for the management them, and protects them from re-exposure in case of known of patients who have suffered an adverse event. This particularly allergy. Paradoxically, no equivalent provision on labelling of concerns full disclosure of the components (to the treating components present in MDs has been laid down in the Medical physician) of the device that has induced the reaction in order to Device Regulation. From a medical point of view, it remains elu- carry out patch testing in case of ACD. sive why such devices are currently not subject to a similar legis- Instead of, or in addition to the respective specification in the lation as there is no plausible substantial difference regarding Question & Answer list for implementation as outline above, an consumer or patient safety. overarching guideline or multifaceted legislation amending the For consumers and patients, but also prescribers, that is medi- existing Regulation EU 2017/745 in order to make ingredients in cal professionals, it is important and urgent to obtain more MDs transparent (e.g. by full qualitative labelling on the pack- transparency regarding the composition of MDs. Therefore, as age, similar to cosmetics) could endorse better protection of medical experts and members of scientific societies specialized in public health and patient safety. Beyond the complete and pre- allergy and adverse skin reactions (European Society of Contact cise information that could be provided, following a standard- Dermatitis, European Environmental and Contact Dermatitis ized terminology such as INCI and INN, complete labelling of Research Group, European Academy of Dermatology and Ven- MDs would contribute to reduce direct and indirect cost of ill- erology, and European Academy of Allergy and Clinical ness associated with the management of allergic complications. Immunology), we strongly recommend that the European Com- Moreover, based on full labelling requirements within the EU mission review the current regulations for MDs with regard to regulation implementation, physicians prescribing MDs would labelling of all ingredients. be able to identify the presence of allergens in a sensitized sub- Although requirements for labelling are addressed in several ject. In these cases, a safer and more suitable alternative can then sections of Regulation EU2017/745, Annex I, 10.4.5. (on label- be proposed. ling) does not mention allergenic or sensitizing components. Such a refinement of implementation of MD-legislation is Yet, Annex I 23.4 (Information in the instructions for use) urgently required in view of the many publications highlighting states: ‘[. . .] The information shall cover, where appropriate: allergic complications, including ACD, and challenges of man- -precautions related to materials incorporated into the device agement of adverse events following the use of MDs: [. . .] that could result in sensitization or an allergic reaction by the patient or user’. Frequent occurrence of severe chronic skin reactions To comply with this claim, a specification regarding labelling Following several isolated cases of ACD caused by MDs during of ingredients should be included in the Question & Answer (Q the last 5 years, the number of cases has increased considerably, & A) list for implementation. Preferably, this should include full making ACD from glucose sensors a ‘hot topic’. This increasing labelling, but at least the following minimum requirement epidemic could easily have been limited if manufacturers had ‘Labelling needs to include skin (and airway) sensitizers as iden- collaborated and replaced the actual culprit ingredients. But in tified in CLP (H317) used at any stage in the production of the practice, replacing known sensitizers with less allergy-prone medical device with body contact, with or without drugs subassemblies is probably considered a delicate task and a real included’. challenge for manufacturers. However, due to this lack of collab- Although there are probably several steps at different produc- oration, an increased prevalence of ACD among users of Free- tion sites in the manufacturing of MDs and because many rele- StyleTM LibreTM (Abbott Diabetes Care, Witney, Oxfordshire, vant allergens in the MDs are not yet CLP (H317) classified, we UK) has been observed by many dermatologists. In May 2018, believe that it is important to require full labelling for any the ANSM (Agence Nationale de Securite du Medicament et des device, as is the case for pharmaceutical products and cosmetics. Produits de Sante) reported that about 0.2% of FreeStyle Libre JEADV 2021, 35, 1444–1448 © 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 The need for EU legislation to require disclosure and labelling 1447 users reported a skin reaction.24 In 2019, a Belgian study Impact on the quality of life of the patients reported that ACD occurred in 5.5% of FreeStyle Libre users.25 Skin reactions due to MDs have been repeatedly reported to decrease patient quality of life.28 For example, itching due to Lack of cooperation provided by MD manufacturers in the the skin complications associated with MDs leads to impaired diagnostic process concentration, distraction, but also drowsiness owing to Several papers and communications between colleagues from impaired sleep29 and experience additional stress. The patient all over Europe have revealed the lack of communication is already suffering from a pathology beforehand, for which a with, and cooperation from, the manufacturers regarding the MD has been used; hence, it is often difficult for the patient qualitative composition of the MDs.26 Surprisingly, despite to see himself suffering from another problem related to his numerous requests from the medical profession, reported in medical device. When the problems are dermatological, they the literature over the last 3 years, manufacturers continue to are visible and may affect the patient even more due to refuse collaboration and communication. Due to lack of stigmatization. According to some authors, patients perceived cooperation, some medical centres have carried out physico- their skin as disfigured.29 The lack of clear information (also chemical analyses, such as gas chromatography–mass spec- on alternatives) noted above greatly increases the distress of trometry (GC-MS) themselves in order to identify the patients affected by dermatological complications, particularly sensitizing culprits in medical devices.7,8,10–12 However, such ACD. complicated chromatographic analyses are not available in all centres. The correct diagnosis (ACD vs. irritant contact der- Severe cases of type I hypersensitivity matitis) may be delayed or, even worse, missed if patients are While the majority of skin complications secondary to the use of not tested with all relevant allergens. As a result, most medical devices are either irritant contact dermatitis or ACD, patients remain poorly advised with delays in diagnosis and there exist rare cases of Type I hypersensitivity as well, such as in management. In the case of glucose sensors, 35% of the the case of anaphylaxis following the contact with an alginate patients reduced the wear time of their medical devices or dressing.30 Information about the presence of a known allergen stopped using them because of dermatological complica- is already important in delayed-type hypersensitivity, but is even tions,27 with significant deterioration of their quality of life. more crucial in the case of potentially life-threatening anaphy- Due to lack of labelling and lack of information provided by laxis. the manufacturers in case of adverse events, physicians are limited in their information about safe alternatives. Conclusion Analytical techniques such as the one described above do not The two new regulations concerning medical devices (Regula- provide a guarantee to identify every possible allergen. This tion EU 2017/745) and in vitro diagnostic medical devices means that in addition to those having been identified, other (Regulation EU 2017/746) intend to provide better protection sensitizers might also be present, which renders identification of of public health and patient safety. However, they do not all possible culprits impossible. Adequate management thus provide a benefit for the prevention and management of remains at stake. adverse events, such as contact dermatitis. Due to the increasing number of cases of allergic contact dermatitis from Cost of illness to the patients and the society medical devices leading to deleterious effects on quality of life Skin problems that occur after using MDs also increase the treat- of the patients and increasing cost of illness, this gap should ment costs. Not only the purchase of new treatments (adhesives, be closed by appropriate specifications in the Q & A docu- emollients, protection creams or even topical corticosteroids), ments produced for implementation of the new Medical prescribed for prevention or treatment, but also additional fol- Device Regulation or respectively in an overarching guideline low-up consultations by physicians or dermatologists who per- or an amendment to the Medical Device Regulation. As a form patch testing. For example, a Danish study revealed that minimum requirement, the following should be specified and the cost for paediatric patients with skin complications due to implemented: ‘Labelling needs to include skin (and airway) glucose sensor is 154.3 USD higher than patients without skin sensitizers as identified in CLP (H317) used at any stage in problems.28 It should be noted that this price does not take into the production process of the medical device with body con- account the real costs related to appointments for diabetes tact, with or without drugs included’. It would be preferable check-ups, visits to the dermatologist, the loss of income for the to have full labelling as is the case for cosmetics and pharma- patient due to work stoppages and medical consequences of a ceutical products, because some ingredients are not yet recog- poorer control of diabetes. The price for the patient is thus well nized as contact sensitizers. Moreover, full cooperation of underestimated. Moreover, the analytical analyses described manufacturers with the medical community is essential in above are very time-consuming and create a considerable cost case – sometimes even severe – adverse (skin) reactions for the society as well. occur. JEADV 2021, 35, 1444–1448 © 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 1448 Herman et al. Acknowledgements 13 Passanisi S, Lombardo F, Barbalace A et al. Allergic contact dermatitis and diabetes medical devices: 2 clinical cases. Contact Dermatitis 2018; 79: We would like to thank Marie Baeck (Department of Dermatol- 115–117. ogy, Cliniques universitaires Saint-Luc in Brussels, Belgium), 14 Mestach L, Huygens S, Goossens A, Gilissen L. Allergic contact dermatitis Mark Wilkinson (Department of Dermatology, Leeds Teaching caused by acrylic-based medical dressings and adhesives. 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Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology