(418cl) Biocompatibility Evaluation of Skin Wearable Biosensor Systems

Recent advances in vitro diagnostics on human skin or organ surfaces rely on the use of sensors. The innovative body-powered nano-enabled wearable health monitoring systems has gained considerable interest recently owing to the advantages of low cost on energy harvesting and convenience on long-term wear. However, engineered materials may display unique properties that have impact on human health. Lack of biocompatibility in a skin-attachable sensor, can result in complications including: cell cytotoxicity, skin irritation, skin sensitization, skin chronic inflammation, and even the recalls on commercial products due to the reported dermatitis. Biocompatibility is the ability of a biomaterial to perform its desired function, without eliciting any undesirable local or systemic effects in the recipients. An evaluation of biocompatibility is one part of the overall safety assessment of wearable biosensors since it will protect human safety. Assessment of the materials biocompatibilities on skin is currently performed with the use of animals. Alternative non-animal related in vitro methods are demanded by Animal welfare and EU legislation. Here, we performed standardized in vitro screening of skin-wearable sensor materials. Nano-materials and other sensor components were assessed in vitro with two skin-related cell lines to characterize and evaluate their biocompatibility. The Food and Drug Administration (FDA) G95-1 and International Standard ISO 10993 serve as a frameworks for selecting tests to evaluate the biocompatibility of medical devices.

We performed a screening of engineered materials and nanomaterials used for skin-wearable biosensors using two cell lines and 3-dimensional tissues. Three characterized in vitro assays were used to measure the cytotoxicity, irritation and sensitization of the skin-attachable sensor materials. These in vitro assays could meet the FDA requirement, as well as minimize the usage of live animals.