Two cases of allergic contact dermatitis to different elements in identical ultrasound gels

Antón, Maria Dolores Martínez; Jáuregui, I; Galán, Cristina; Vicente, J.; Segurola, Aritza; Seras, Yolanda; Lirio, E. García; Irazábal, Begoña; Gamboa, P. M.

doi:10.1111/cod.13901

Cited by 4 publications

(3 citation statements)

References 5 publications

(4 reference statements)

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“…Sample selection criteria were derived from a multifaceted approach, integrating case reports of allergic reactions and occupational contact dermatitis, as well as the definitional parameters outlined in the Medical Device Regulation (MDR). Hence, the sample pool encompassed a broad spectrum of medical device categories, ranging from wound dressings to glucose sensors, and spanning diverse items like ultrasound (US) gels and dental glues 12,22–26 . Nonetheless, our primary focus was directed towards class I and IIa topically applied medical devices, characterised by compositions closely resembling cosmetic formulations in terms of preservatives and fragrances.…”

Section: Methodsmentioning

confidence: 99%

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Analysis of preservatives and fragrances in topical medical devices: The need for more stringent regulation

Stras,

Grassmann,

Van Campenhout

et al. 2024

Contact Dermatitis

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IntroductionMedical devices (MDs) have a long history of use, and come with regulatory frameworks to ensure user safety. Although topically applied MDs in the form of gels and creams might be used on damaged skin, their composition is often similar to that of cosmetic products applicable to intact skin, especially in terms of preservatives and fragrances. However, unlike cosmetics, these products are not subject to compound‐specific restrictions when used in MDs.ObjectiveThis study aimed to identify and quantify preservatives and fragrances in topically applied MDs and assess their safety towards the Cosmetic Regulation (EC) 1223/2009.MethodSixty‐nine MDs available on the EU market were subjected to previously validated liquid chromatography tandem mass spectrometry (LC–MS/MS) and gas chromatography–mass spectrometry (GC–MS) methods to identify and quantify occurring preservatives and fragrances.ResultsFindings revealed that 32% of the examined MDs did not provide comprehensive ingredient lists, leaving users uninformed about potential risks associated with product use. Furthermore, 30% of these MDs would not meet safety standards for cosmetic products and, most significantly, 13% of the analysed samples contained ingredients that are prohibited in leave‐on cosmetics.ConclusionResults highlight the pressing demand for more stringent requirements regarding the labelling and composition of MDs to enhance patient safety. Improved regulation and transparency can mitigate potential risks associated with the use of topically applied MDs.

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Section: Methodsmentioning

confidence: 99%

“…Hence, the sample pool encompassed a broad spectrum of medical device categories, ranging from wound dressings to glucose sensors, and spanning diverse items like ultrasound (US) gels and dental glues. 12,[22][23][24][25][26] Nonetheless, our primary…”

Section: Samplesmentioning

confidence: 99%

Analysis of preservatives and fragrances in topical medical devices: The need for more stringent regulation

Stras,

Grassmann,

Van Campenhout

et al. 2024

Contact Dermatitis

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“…Unluckily, certain chemicals were found to be used for the formulation of ultrasound gel that caused allergic reactions to the skin, such as isothiazolinones, methylisothiazolinone, phenoxyethanol (as preservatives), and Carbopol 940 (as a thickening agent), which are used in several cosmetics and industrial products. There are numerous publications describing patients who suffered from allergic dermatitis due to using these compounds in the formulation of the gel [ 22 , 23 , 24 , 25 ]. Furthermore, different types of polysaccharides were used in ultrasound gel formulations, which had some drawbacks such as clarity, transparency, homogeneity, and imaging quality [ 18 , 26 , 27 , 28 , 29 ].…”

Section: Introductionmentioning

confidence: 99%

Preparation and Evaluation of Polymer-Based Ultrasound Gel and Its Application in Ultrasonography

Afzal

Zahid

Rehan

et al. 2022

Gels

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Ultrasound imaging is a widely used technique in every health care center and hospital. Ultrasound gel is used as a coupling medium in all ultrasound procedures to replace air between the transducer and the patient’s skin, as ultrasound waves have trouble in traveling through air. This research was performed to formulate an inexpensive alternative to commercially available ultrasound gel as it is expensive and imported from other countries. Different formulations with different concentrations of carbopol 980 (CAR 980) and methylparaben were prepared with natural ingredients such as aloe vera gel and certain available chemicals that have no harmful effects on the skin. To justify the efficiency of the formulations; necessary physicochemical characteristics such as visual clarity, homogeneity, transparency, skin irritation, antibacterial activity, pH, stability, spreadability, conductivity, acoustic impedance, viscosity, and cost were evaluated. Moreover, a comparison study was also conducted with commercially available ultrasound gel that was utilized as a control. All samples showed excellent transparency and no microbial growth. S1 was the only formulation that met all of the requirements for commercial ultrasound gel and produced images that were similar to those produced by commercial ultrasound gel. So, this formulation could be used as an alternative to expensive commercial ultrasound gel for taking images in hospitals and medical centers.

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Contact Dermatitis in the Inpatient Hospital Setting–an Updated Review of the Literature

et al. 2022

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Two cases of allergic contact dermatitis to different elements in identical ultrasound gels

Cited by 4 publications

References 5 publications

Analysis of preservatives and fragrances in topical medical devices: The need for more stringent regulation

Analysis of preservatives and fragrances in topical medical devices: The need for more stringent regulation

Preparation and Evaluation of Polymer-Based Ultrasound Gel and Its Application in Ultrasonography

Contact Dermatitis in the Inpatient Hospital Setting–an Updated Review of the Literature

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