The use of extractables and leachables (E&L) chemistry testing has become integral and often essential in the evaluation of medical device biocompatibility. E&L testing focuses on identifying and quantifying potentially harmful chemicals that can leach from medical devices into the human body. This testing ensures that any chemicals present do not pose a significant risk to patients. The industry has placed significant emphasis on the methodologies of E&L testing; however, it’s crucial to remember that the ultimate purpose of this testing is to inform toxicological risk assessments (TRAs). Proper toxicological analysis sets stringent requirements and constraints on E&L testing to ensure safety and compliance. The ISO standard governing TRAs, ISO 10993-17, is currently undergoing a significant update, addressing changes that have been long overdue. These updates aim to refine and enhance the standards by which toxicological risks are assessed in medical devices.
The presentation will delve into the current draft updates of ISO 10993-17 and explore how these changes will affect future TRAs, the chemistry used in toxicological evaluations, and the broader implications for biocompatibility. Key points of discussion will include a review of the fundamental principles underlying TRAs for medical devices. The updates to ISO 10993-17 will particularly focus on rational exposure estimates, providing a more accurate and realistic assessment of chemical exposure levels. Additionally, the presentation will clarify the differences and applications of the Threshold of Toxicological Concern (TTC) compared to the Analytical Evaluation Threshold (AET), highlighting how these thresholds are used to determine safety margins in the evaluation process. Overall, the updates aim to enhance the safety and effectiveness of medical device biocompatibility assessments.