Advances in predicting patient exposure to medical device leachables

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 is 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. Herein, we provide an overview of these approaches, including considerations in developing and parameterizing exposure models, strategies that can be used to address the challenges associated with limited data, and potential future directions and improvements.