Please join us for our monthly meeting on November 18th, 12 pm EST. Our speaker, Michael Rush, is a Distinguished Chemist at Edwards Lifesciences, specializing in advanced mass spectrometry and non-target analysis. As co-chair of the BP4NTA E&L technical subcommittee, Michael drives best practices and workflow harmonization to improve reproducibility and innovation in chemical characterization
Abstract: Non-targeted analysis (NTA) continues to evolve as a critical tool for comprehensive chemical characterization, particularly in complex matrices such as medical device extractables and leachables (E&L). Recent work, including our publication in Analytical Chemistry (DOI: 10.1021/acs.analchem.5c04247), demonstrates how advanced mass spectrometric workflows can improve reliability and reproducibility in E&L studies. This research highlights issues with quantitation strategies for medical device biocompatibility.
A second focus of this presentation will be communicating confidence in identifications—a cornerstone for regulatory acceptance and scientific transparency. We will explore the ISO10993-18 and FDA draft guidance in respect to how Edwards reports confidence levels in identifications.
Finally, we will provide an update on the BP4NTA E&L Technical Subcommittee, which aims to harmonize best practices for NTA in E&L testing. The subcommittee’s initiatives include integrating regulatory guidance, promoting collaboration across industry and academia, and developing educational resources to support newcomers and experienced practitioners alike. These efforts seek to advance reproducibility, foster innovation, and strengthen community standards for non-targeted workflows.