MatTek, in collaboration with Medtronic, RIVM (the National Institute of Public Health and the Environment) and several other research partners, has been awarded by the Medical Device and Combination Product Specialty Section of the Society of Toxicology for the Best Overall Abstract at SOT 2017.
An international group of public and private institutions from the EU, USA and Asia contributed to this validation study which demonstrated that reconstructed human epidermis models could be an acceptable alternative to the ISO 10993-required rabbit skin irritation test for assessing medical device biocompatibility.
MatTek would like to extend its thanks to all of the sponsors and participants of this study who contributed to the overall sucess of this international validation.
Abstract 2153b: Round Robin Study to Evaluate the Reconstructed Human Epidermis (RhE) Model as In Vitro Skin Irritation Test for Detection of Irritant Activity in Medical Device Extract
W.H. De Jong10, S. Hoffmann11, M. Lee9, H. Kandarova5, S. Letasiova5, L. J. De La Fonteyne10, C. Pellevoisin3, C. Tornier3, C. Bremond3, Y. Haishima8, A. M. Zdawczyk7, A. Turley9, J. A. Willoughby2, M. A. Bachelor4, B. Rollins1, and K. P. Coleman6. 1Arthrex, Inc, Naples, FL; 2Cyprotex US LCC, Kalamazoo, MI; 3EpiSkin Academy, Lyon, France; 4MatTek Corporation, Ashland, MA; 5MatTek IVLSL, Bratislava, Slovakia; 6Medtronic, PLC, Minneapolis, MN; 7NAMSA, Northwood, OH; 8National Institute of Health Sciences, Tokyo, Japan; 9Nelson Laboratories, Inc., Salt Lake City, UT; 10RIVM, Bilthoven, Netherlands; and 11SEH Consulting and Services, Paderborn, Germany.
Assessment of dermal irritation is an essential component of the safety evaluation of medical devices. A protocol employing RhE EpiDerm (MatTek), according to OECD 439 used for neat chemicals, was optimized in 2013 using liquid irritants spiked into polymer extracts (Casas et al., TIV, 2013) and in 2014 with another RhE, SkinEthic RHE (EPISKIN SA). In 2016, an international round robin validation study was conducted to confirm these results. Two RhE models were evaluated: EpiDerm tissues in 18 laboratories and SkinEthic RHE tissues in 8 laboratories. Four irritant polymers and three non-irritant controls were obtained or developed and certified prior to use. Blinded polymer samples were extracted with sesame oil and saline per ISO 10993-12 (i.e., 3 cm2 mL solvent extracts incubated at 37 ± 1 °C for 72 ± 2 hours with agitation). The apical surfaces of tissues were dosed with 100 μL extract aliquots. Positive and negative solvent controls were included. Tissues were kept in humidified incubators at 37 °C with 5% CO2. Incubation times were 18 hours (EpiDerm) and 24 hours (SkinEthic RHE). After incubation and rinsing with PBS, cell viability was determined by the colorimetric MTT reduction method. Cell viability reduction greater than 50% was indicative of skin irritation. Both the EpiDerm and SkinEthic RHE tissues were able to correctly identify virtually all of the irritant polymer samples either in the saline, sesame oil or both solvent extracts. Our results indicate that RhE tissue models can detect the presence of strong skin irritants at low levels in dilute medical device polymer extracts. Therefore, these models may be suitable replacements for the rabbit skin irritation test to evaluate medical device biocompatibility.
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