Step into the Future: Trendsetting role of BSL BIOSERVICE in animal-free medical device testing

By Helge Gehrke, BSL BIOSERVICE GmbH, (a Eurofins partner laboratory), Germany

Acute irritation is a local, reversible inflammatory response of normal living skin to direct injury caused by the application of an irritant substance. The potential to induce skin irritation is an important consideration and is, beside cytotoxicity and sensitisation, one of three biocompatibility testing recommended for all medical devices (MD).

Up to now, current guidelines (ISO 10993-10) refer to the in vivo Draize Test that has been widely used to screen MD for skin irritancy. In order to replace in vivo testing, the ISO Technical Committee 194 published a revised version 10993-1:2009, in which the use of alternative animal free methods is specifically encouraged. Based on validation studies under the auspices of ECVAM, reconstructed human epidermis (RhE) models showed evidence of being reliable and relevant replacement tests for in vivo skin irritation. RhE models consist of normal human epidermal keratinocytes and therefore represent in vitro the target organ of the species of interest and closely mimic the biochemical and physiological properties of the upper parts of the human skin. The determined endpoint (cytotoxicity) is reliable and well known and can be combined with inflammatory markers, for further confirmation of obtained results.

So far, being an established standard for chemical testing, the method can be adapted for medical devices. Therefore, these models can be a suitable alternative for the in vivo rabbit skin irritation test to evaluate MD biocompatibility and can be a step into a free animal testing future. The reduction of animals in biocompatibility tests by encouragement of the development and validation of effective in vitro alternative methods is one of the outmost concerns at BSL BIOSERVICE (a Eurofins partner laboratory).

Being convinced that in vitro alternative methods represent the future, BSL BIOSERVICE takes a leading role and already offers different RhE models (EPISKIN™/EpiDerm™) for testing the irritating potential of medical devices.

Contact: hgehrke@bioservice.com