Ashland, MA – A special open-access issue of Toxicology In Vitro, Reconstructed human epidermis (RhE) model for evaluation of medical devices irritant capacity, includes five papers that feature MatTek’s industry-leading EpiDerm tissue. The papers focus on pre-validation and validation of the EpiDerm method for medical devices testing, evaluation of the variables in the in vitro testing of medical devices, preparations of the controls and benchmarks used in the validation, and a comparison of human patch testing against EpiDerm and two types of in vivo rabbit testing currently endorsed by ISO 10993.
MatTek scientists, together with colleagues from Medtronic, RIVM, Ceetox, and Nelson Labs, have pioneered the development and standardization of an assay which evaluates the skin irritation potential of medical devices extracts. This work was built upon EpiDerm protocols for skin irritation and corrosion testing that had been validated and regulatory accepted worldwide (OECD TG 431, 439). The research resulted in a working draft standard by the International Organization for Standardization (ISO). ISO/WD 10993-23 Biological evaluation of medical devices, currently under development, will determine a validated method that establishes a standard for testing skin irritants using the reconstructed human epidermis model. Once established, the standard will be an instrumental step forward in the continued reduction of animal testing.
This development is the outcome of a collective effort of multi-laboratory round-robin testing, which was presented at the Society of Toxicology 2017 Annual Meeting. The study was an international endeavor that included both private and public organizations from the EU, Asia and the USA. The scientific team, which included three MatTek scientists, won the award for Best Overall Abstract, awarded by the Medical Device and Combination Product Specialty Section of the Society of Toxicology.
MatTek Corporation is a global leader in the production of the highest quality in vitro human tissue models for safety and efficacy testing for the chemical, cosmetic, household product, and pharmaceutical industries. For over 25 years, MatTek has established a reputation for the consistent manufacture of quality in vitro human tissue models, and the continuous development of innovative tissue engineering technologies and assays.
Access the Toxicology In Vitro special issue.