Milan, 25 November 2014 – Seminar on Medical Devices for topical use
VitroScreen has partecipated to an unique event entitled ‘Evaluation of safety and efficacy of medical devices for topical use‘ which brought together 3 different Italian scientific societies: AFI (Associazione Farmaceutici Industria), CellTOX (Associazione Italiana Tossicologia in vitro) and SITOX (Società Italiana di Tossicologia).
A project sponsored by the Italian Istituto Superiore di Sanità (ISS) on the development of in vitro test methods for the evaluation of film forming properties of surface medical devices has been presented by Francesco Ranzini (VitroScreen) and Antonella Casiraghi (University of Milan). The experimental protocol proposed appears as very promising and it will be further developed.
To date, the approaches presented by the International Standards ISO 10993 for the evaluation of the biocompatibility of medical devices do not consider sustainability and integrated/mechanistic models nowdays recognized as the most scientific and predictive approach to evaluate hazard and safety of chemicals. Globally the presentations have emphasized the need to:
- move away from animal testing as requested crosswise by all legislations,
- adapt protocols of validated alternatives to medical device products,
- introduce more ethical and predictive biological approaches (i.e. based on 3D tissues) to quantify cytotoxicity and irritation potential of medical devices, their extracts and new materials.