Contact sensitivity to electrocardiogram electrodes due to acrylic acid: A rare cause of medical device allergy

Hansel, Katharina; Tramontana, Marta; Bianchi, Leonardo; Cerulli, Emilia; Patruno, Cataldo; Napolitano, Maddalena; Stingeni, Luca

doi:10.1111/cod.13403

Cited by 11 publications

(11 citation statements)

References 10 publications

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“…In this study the prevalence of contact allergy to acrylic acid in 436 patients was 0.5% with two relevant positive reactions, both due to the presence of this monomer as an impurity in the hydrogel part of ECG electrodes. This observation suggests a role of medical devices as a source of (meth)acrylate allergy, particularly with regard to electrodes . Recently, acrylic acid sensitivity was also described in a case of allergic contact dermatitis due to isobornyl acrylate contained in glucose sensor …”

Section: Discussionmentioning

confidence: 86%

“…This observation suggests a role of medical devices as a source of (meth) acrylate allergy, particularly with regard to electrodes. [4][5][6][7] Recently, acrylic acid sensitivity was also described in a case of allergic contact dermatitis due to isobornyl acrylate contained in glucose sensor. 9 Recently, Bruze et al tested acrylic acid (1% and 0.1% pet.)…”

Section: Discussionmentioning

confidence: 99%

“…In the last 5 years, allergic contact dermatitis due to monomeric acrylic acid (CAS no. 79–10‐7) contained as an impurity in electrode hydrogel for electrocardiogram (ECG) and transcutaneous electrical nervous stimulation (TENS), was reported . The aims of this study were to estimate the prevalence of acrylic acid contact sensitivity in consecutive patients, the sources of its sensitivity, and if 2‐HEMA is a good marker for detecting acrylic acid allergy.…”

Section: Introductionmentioning

confidence: 99%

“…79-10-7) contained as an impurity in electrode hydrogel for electrocardiogram (ECG) and transcutaneous electrical nervous stimulation (TENS), was reported. [4][5][6][7] The aims of this study were to estimate the prevalence of acrylic acid contact sensitivity in consecutive patients, the sources of its sensitivity, and if 2-HEMA is a good marker for detecting acrylic acid allergy. on Soffix tape (Artsana, Grandate, Italy), and readings were performed on day (D)2, D4, and D7.…”

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confidence: 99%

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Acrylate and methacrylate allergy: When is patch testing with acrylic acid recommended?

et al. 2019

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Section: Discussionmentioning

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Acrylate and methacrylate allergy: When is patch testing with acrylic acid recommended?

et al. 2019

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“…9 Many medical devices, such as implants and glucose meters, contain chemicals that may leach and cause toxicity. [10][11][12] Depending on the type and the duration of the contact with the body, a device may be evaluated for its biocompatibility, including the potential to produce localized sensitization responses. 13 Pre-market submissions for medical devices address sensitization potential with data gathered primarily with the GPMT or Buehler tests as recommended by the International Organization for Standardization (ISO) standard 10993 Part 10.…”

Section: Introductionmentioning

confidence: 99%

PreSS/MD: Predictor of Skin Sensitization Caused by Chemicals Leaching from Medical Devices

Borba

Alves

Braga³

et al. 2022

Preprint

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Safety evaluation for medical devices includes the toxicity assessment of chemicals used in device manufacturing, cleansing and/or sterilization that may leach into a patient. According to international standards on biocompatibility assessments (ISO 10993), chemicals that could be released from medical devices should be evaluated for their potential to induce skin sensitization/allergenicity, and one of the commonly used approaches is the guinea pig maximization test (GPMT). However, there is growing trend in regulatory science to move away from costly animal assays to employing New Approach Methodologies including computational methods. Herein, we developed a new computational tool for rapid and accurate prediction of the GPMT outcome that we named PreSS/MD (Predictor of Skin Sensitization for Medical Devices). To enable model development, we (i) collected, curated, and integrated the largest publicly available dataset for GPMT; (ii) succeeded in developing externally predictive (balanced accuracy of 70-74% as evaluated by both 5-fold external cross-validation and testing of novel compounds) Quantitative Structure-Activity Relationships (QSAR) models for GPMT using machine learning algorithms, including Deep Learning; and (iii) developed a publicly accessible web portal integrating PreSS/MD models that enables the prediction of GPMT outcomes for any molecules using. We expect that PreSS/MD will be used by both researchers and regulatory agencies to support safety assessment for medical devices and help replace, reduce or refine the use of animals in toxicity testing. PreSS/MD is freely available at https://pressmd.mml.unc.edu/. Keywords: sensitization, GPMT, QSAR, deep learning,

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Common Allergens

Foti¹,

Bonamonte²,

Romita³

et al. 2021

Clinical Contact Dermatitis

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Contact sensitivity to electrocardiogram electrodes due to acrylic acid: A rare cause of medical device allergy

Cited by 11 publications

References 10 publications

Acrylate and methacrylate allergy: When is patch testing with acrylic acid recommended?

Acrylate and methacrylate allergy: When is patch testing with acrylic acid recommended?

PreSS/MD: Predictor of Skin Sensitization Caused by Chemicals Leaching from Medical Devices

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