Chemical characterization followed by toxicological risk assessment is one means of evaluating the biocompatibility of medical devices, particularly for genotoxicity, systemic toxicity and carcinogenicity endpoints. A screening-level exhaustive/exaggerated extractables analysis is often performed to estimate worst-case patient exposure. If the extractable amounts identified are above the toxicological threshold (the analytical evaluation threshold or AET), targeted leaching experiments, also called ‘simulated-use extractions’ per ISO FDIS 10993-18:2019 standard, are often used to evaluate additive exposure under more clinically relevant conditions. This is because it is believed that the results may have been above the toxicological threshold in the study, but may not produce the same result in clinically relevant conditions. There is currently a lack of a consensus for what extraction methodologies are most representative of physiological conditions, and this has resulted in wide variability in test methods for evaluating leachables from medical devices. The goal of the current research is to assess the impact of extraction solvent characteristics on the leachables profile of various device materials. Specifically, effect of pH of the extraction media (acidic, neutral and basic solutions) on the leachables profile of two polymer samples (silicone tubing and polyurethane tubing) was evaluated using LC/MS, GC/MS and ICP-MS for analysis of non-volatile, volatile/semi-volatile and metallic extractables. In addition, to evaluate the effect of matrix complexity of the extraction media on analytical instrument compatibility, recoveries of midpolar standards were determined by UV-Vis spectrophotometry using simulated blood test soil and 20% ethanol blood simulant. Results obtained from this study demonstrate that extraction solvent characteristics such as pH and composition can critically affect the types and concentrations of leachables from medical device materials.<br/>

Effect of solvent characteristics in evaluating targeted leachables in simulated-use extractions

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.