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Meeting MS&T22: Materials Science & Technology
Symposium Society for Biomaterials: Biomaterial Applications in Today’s Industry: Development, Translation & Commercialization
Presentation Title Predicting Patient Exposure to Medical Device Leachables
Author(s) David M. Saylor
On-Site Speaker (Planned) David M. Saylor
Abstract Scope Medical device materials contain chemicals that may pose toxicological concern(s) if released in sufficient quantities. Toxicological risk assessment approaches are increasingly being used in lieu of animal testing to address these concerns. Currently, these approaches rely primarily on in vitro extraction testing to estimate the potential for patients to be exposed to chemicals that may possibly leach out of device materials, but the clinical relevance of the test results are often ambiguous. Recent developments suggest physics-based models can be used to provide more clinically relevant exposure estimates. However, the lack of data available to parameterize and validate these models presents a barrier to routine use. This presentation will provide an overview of these approaches, including potential benefits and limitations of current models, and key technical challenges to expanding the applicability and improving the clinical relevance of the model predictions.


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