‘Site of contact genotoxicity’ assessment for implants - Potential use of single cell gel electrophoresis in biocompatibility testing of medical devices

• Pre-validation study on comet assay for detecting site of contact genotoxicity. Acrylic implants containing EMS (AF + EMS) was used as test item. AF showed DNA damage at using whereas negative Ames and chromosome aberration test. Implants may cause ‘site genotoxicity’ without systemic Comet has potential use in medical device biocompatibility assessment. Toxicological risk assessment devices requires genotoxicity per ISO 10993, Part 3, which is designed to address gene mutations, clastogenicity and/or aneugenicity endpoints. ‘Site a genotoxic especially implants, that currently not addressed standards. We therefore performed initial validation the alkaline single cell gel electrophoresis (comet assay) devices, items made acrylic impregnated with ethyl methanesulphonate (EMS). detected increased migration implantation, but liver. The same also failed show any potentials, when tested standard battery Salmonella /microsome assays. suggested some can genotoxicity’, producing In conclusion, will add new dimension safety this be added genetic toxicology tests evaluating implants.