TO INVESTIGATE THE CHALLENGES ASSOCIATED WITH ADHESIVE SKIN REACTIONS IN WEARABLE ECG SENSORS
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Adhesive skin responses are a major barrier to sustained and safe application of wearable ECG monitors. The study aimed to evaluate the extent of dermatological problems due to adhesive electrodes, determine their influence on the subjects comfort during long-term measurement, and develop approaches for the suppression of side-effects. In this way, the study used primary qualitative methods and thematic data analysis with 8 participants, including medical technicians and biomedical engineers, with 7 open-ended questions. The efficacy of the product was validated, as the long-term use of standard adhesive electrodes was often associated with skin redness, itching, and even more severe dermatological symptoms. These concerns greatly affected participant adherence to sensor wear and sometimes affected the accuracy of ECG reading by premature removal or dislodging of the sensor. The results also confirmed that subjects with sensitive skin were preponderantly affected, indicating that electrode materials and adhesives need to be adapted for individual users. Comparative testing also showed that hydrogel and hypoallergenic adhesives resulted in lower levels of irritation, and challenges remain in balancing strong adhesion with no discomfort during prolonged wear.This research found that minimising adhesive-related skin reactions is crucially important for enhancing the clinical utility and acceptance of the wearable ECG patch. Recommendations have involved the production of biocompatible, gaspermeable adhesive materials, the inclusion of no adhesive attachment means to attach sensors to the body, and an increased focus on personalisation in sensor design. Regulatory considerations also emerged as ignoring adhesive safety has led to non-compliance with standards, including FDA, ISO 10993, IEC 60601, HIPAA and GDPR frameworks. Overall, the study has highlighted the need to balance medical function and user comfort in the design of systems to improve compliance, data quality, and patient safety in long-term ECG monitoring.
