Ahead of Kimberly Ehman presentation on 'Expanding the toxicologist’s toolbox: application of proposed new approaches in ISO 10993-17 (FDIS) to facilitate toxicological risk assessment of medical devices' we wanted to give a sneak peek into her session and get some exclusive insights.
Tell us more about your upcoming presentation at E&L Europe 2023?
I’ll be speaking about the recently published ISO 10993-17:2023 standard for medical device toxicological risk assessment (TRA), with a focus on some of the new concepts that can be applied to help streamline the evaluations. Specifically, my presentation will address the challenges with conducting TRAs for exhaustive extractables, and how two tools introduced in the updated standard (i.e., the toxicological screening limit [TSL] and adjusted exposure dose) can be applied in the TRA. For example, the TSL can be used to screen large numbers of chemicals, and the adjusted exposure dose can be applied to mitigate concerns when worst-case exposure assumptions are considered.
Why did you choose to tackle this topic?
I chose to address this topic as it is timely (i.e., the standard has been under revision for years and was just published in September of 2023), and the updated version of the standard introduces several new concepts that will be invaluable to toxicologists conducting medical device TRAs.
What are the main challenges in your day-to-day work relating to E&L?
Medical device TRAs can be incredibly challenging for a variety of reasons. Currently, the requirements around chemical characterization per ISO 10993-18:2020 frequently yield to very large datasets to evaluate in the TRA, and oftentimes the conclusions around potential risk are unfavorable. This then leads to additional chemistry testing (e.g., leachables or simulated-use extractables) and/or additional biocompatibility testing, which can delay submission timelines and increase testing costs. I believe some of the new tools in ISO 10993-17:2023 have the potential to streamline the risk assessment approach and ultimately save the manufacturer both time and money.
Get to know Kimberly Ehman
Dr. Ehman is the Director of Regulatory Toxicology at WuXi AppTec Medical Device Testing, with a focus on medical device and combination products. Dr. Ehman has over 20 years of toxicology and medical device experience, with expertise in toxicological risk assessments for medical devices, food and beverage products, and electronic nicotine delivery systems. Prior to joining WuXi AppTec Medical Device Testing, she worked as a toxicologist for RTI International, Toxicology Regulatory Services, and Altria Client Services. She holds a B.Sc. degree in Biology from Seton Hill University and a Ph.D. in Parasitology from McGill University.