Validation study for the evaluation of MCTT HCE™ test method for eye safety assessment of medical devices

According to ISO 10993-23 (Biological evaluation of medical devices – Part 23: Tests for irritation, Annex D2), no specific alternative test method has yet been established to identify substances that may cause eye irritation or serious eye damage in medical devices. Therefore, the in vivo animal test OECD TG 405 continues to be used. This study adapted the in vitro eye irritation test (EIT) using the MCTT HCE™ Reconstructed Human Corneal Epithelial (RHCE) model, which was originally developed for testing chemicals, to the testing of ophthalmic medical devices such as contact lenses and intraocular lenses. A validation study, carried out in accordance with OECD GD 34, aimed to confirm transferability (2 produced medical devices and 2 spiked extract vehicles), proficiency (4 produced medical devices and 3 spiked extract vehicles), and reproducibility (8 produced medical devices and 9 spiked extract vehicles). The results demonstrated a combined predictive capacity of 89.6% sensitivity, 87.3% specificity, and 88.4% accuracy based on 285 runs. Spe­cifically, the test showed 85.7% sensitivity, 100% specificity, and 92.9% accuracy for classifying produced medical devices (140 runs) and 93.8% sensitivity, 76.3% specificity, and 84.1% accuracy for classifying solutions spiked with chemicals before extraction (145 runs). These findings confirm the reliability of the “MCTT HCE™ EIT for medical devices” in assessing the irritation potential of medical device extracts, including the detection of low concentrations of potent irritants.