Extractables and Leachables West

Presentation

Title: Approaches and Challenges with Chemical Characterization and Toxicological Risk Assessment for Absorbable Medical Devices
Presenters: Dr. Kimberly Ehman, Director, Regulatory Toxicology
Molly Haan, Senior Technical Customer Support
Date/Time: Thursday, November 14, 2024, 11:40am PST

Presentation Abstract:

Title: Approaches and Challenges with Chemical Characterization and Toxicological Risk Assessment for Absorbable Medical Devices

Absorbable medical devices pose unique concerns for both chemical characterization and toxicological risk assessment (TRA). This presentation will provide a high-level overview of chemical characterization studies for absorbable medical devices, including exhaustive extractions, dissolution studies, and simulated-use approaches. The associated challenges will be addressed with specific case studies and proposed approaches for evaluation in the TRA. Additionally, chemical characterization and TRA may not always provide the full story for assessment of an absorbable device. Situations where additional data would be helpful (e.g., in vivo biocompatibility data) will also be discussed.