Publications by authors named "Tatiana Milasova"
Medical devices are integral to a wide array of medical interventions and are increasingly utilized in both clinical and home settings. Within the oral cavity, intraoral medical devices are employed for various applications, to improve quality of life and maintain oral health and hygiene. However, the dynamic and complex environment of the oral cavity, characterized by the influence of factors, such as saliva composition, fluctuating pH, and microbial flora presents a challenge to ensure the safety of end-users.
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- - This study presents a new method using the EpiOcular 3-D tissue model to test the irritation and phototoxicity of medical devices and drugs that come into contact with the eye, targeting diverse materials like medical devices and ophthalmic solutions.
- - The testing protocols are similar to those used for cosmetic products, aiming to improve predictions of irritation that typically rely on less accurate rabbit tests, by utilizing insights from previous skin irritation studies.
- - By enhancing testing protocols for medical devices, the research aims to promote safer and more standardized evaluations of eye-related products, while decreasing the need for animal testing and supporting regulatory frameworks for safety assessment.
Assessment of dermal irritation is an essential component of the safety evaluation of medical devices. Reconstructed human epidermis (RhE) models have replaced rabbit skin irritation testing for neat chemicals and their mixtures (OECD Test Guideline 439). However, this guideline cannot be directly applied to the area of medical devices (MD) since their non-toxicity assessment is largely based on the testing of MD extracts that may have very low irritation potential.
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