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  2. Oct 7, 2020

Human-Based Skin Irritation Tests Can Replace Animals in Safety Evaluation of Medical Devices

Study in a Sentence: New research using reconstructed human epidermis for irritation testing of medical device extracts validated that these models are acceptable replacements for the rabbit intracutaneous irritation test.

Healthy for Humans: The assessment of skin irritation is an essential component of the safety evaluation of medical devices. Traditionally, animals have been used for these tests, however, several companies have developed human tissue models that can produce robust and valuable reproducible results. The International Organization for Standardization requires that these models undergo rigorous testing before they can be used in safety assessment, a major step towards regulatory acceptance of nonanimal methods for irritants in medical devices. 

Redefining Research: Numerous internationally organized studies showed that the reconstructed human epidermis models produced results that were essentially equivalent to those from the skin irritation test using rabbits. These results show that this tissue model can detect the presence of strong skin irritants at low levels, demonstrating that they are a suitable alternative to animals for this use. 


De Jong WH, Carraway JW, Liu C, Fan C, Liu J, Turley AP, et al. The suitability of reconstructed human epidermis models for medical device irritation assessment: A comparison of In Vitro and In Vivo testing results. Toxicology in Vitro. 2020; 69. 

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