During this episode, our hosts are joined by Andy Wyen, Toxicologist at NAMSA, to answer questions received during NAMSA’s live Webinar on the new ISO 10993-18:2020. As this new standard is a complete re-write from the 2005 version, it is stirring up industry and leaving many manufacturers confused and searching for the most efficient adoption methods.
- Triplicate testing and how to determine if there is low variability in a sample before extraction has occurred
- AET: How to calculate the number of devices used in clinical use for a chronic device that can be used during someone’s lifetime
- Whether NVR used to establish exhaustive conditions affect the AET calculation for analysis
- Whether the same replicates (single, duplicate, and triplicate) apply to NVR
With the release of 10993-18:2020 on January 15, 2020, it is crucial for professionals involved with the Biological Evaluation of medical devices to understand the standard’s use, interpretation and requirements, as well as how an effective link now exists to the overall Biocompatibility Evaluation as described in ISO 10993-1.
Connect with Andy: https://www.linkedin.com/in/andy-wyen-3448486/
Also be sure to check out our Biocompatibility Strategy Navigator.
|Andy Wyen, M.S., DABT; Toxicologist, NAMSA
Andy Wyen has been with NAMSA for more than 15 years, holding various positions such as R&D Technician, Chemist, Biocompatibility Study Director and Toxicologist. His expertise includes analytic chemistry, chemical characterization, biocompatibility and toxicology within the medical device industry. He obtained his Bachelor’s and Master’s Degrees in Pharmacology/Toxicology from the University of Toledo.
|Sheri Krajewski-Bibins; Product Marketing Manager – Biological Safety, NAMSA
Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.
|Don Pohl; Principal Product Development Strategist, NAMSA
Don has over 25 years of experience in the pre-clinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and Project Manager for Biological Safety and Biological Risk Assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1, as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices. Don holds a Bachelor’s degree from Ohio State University.