Extractables and/or leachables from medical devices must be identified and quantified to establish their potential effect on patient health and safety. Accurate quantitation is essential to quantitative toxicological safety risk assessment to properly establish patient exposure to these chemicals. It is an unfortunate circumstance that accurate quantitation in E&L screening is complicated by the complexities of non-target analysis (NTA). In this presentation, the questions of when and how to quantitate are considered and the science-based approach adopted by Nelson Labs is discussed.

Presenter: Dennis Jenke PhD, Principal Advisor Nelson Labs Europe