ISO 10993-4: The Second Most Misunderstood Section of 10993

In this episode, two esteemed colleagues from Abbott, Tim Schatz and Ken Grove, join our hosts discuss ISO 10993-4:2017 Biological Evaluation Of Medical Devices – Part 4: Selection Of Tests For Interactions With Blood. Our experts highlight the general requirements of this very important and sometimes misunderstood segment of biological evaluations, including how to classify products requiring this testing and how various products and scenarios may call for different testing evaluations.

“We are discussing specifically contact with circulating blood directly or contact with circulating blood indirectly at its most basic element.” – Don Pohl

“When assessing blood damage, we really use a battery approach to assess the overall interaction of the medical device with blood.” – Tim Schatz

“In the event with the thrombosis NAVI model, you do end seeing thrombosis, you are allowed to go into using anti-coagulation model.” – Kent Grove

“(for platelets and leukocytes) You are trying to make sure that your new device or iteration performs at least as well as your marketed device—it’s a pretty quick test and definitely more sensitive than it used to be.” – Tim Schatz

“Now we have the ability to assess the variability in blood that can come in from one donor vs. the next, and what’s interesting is that we have a true positive and true control—it helps us understand how the blood is behaving specifically from a thrombosis aspect.” – Kent Grove

Discussion points include:

• General overview of the standard and applicability to various medical devices
• Strategies for new devices and design iterations
• U.S. and EU approaches, and where they may differ
• Challenges with Non-Anticoagulation Venous Implant (NAVI) studies, including possible improvements for future evaluations
• The blood loop model and the future state of this evaluation

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

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Meet the Speakers

Kent Grove; Principal Biocompatibility Scientist, Abbott

Kent Grove is responsible for providing complex biocompatibility testing strategies and technical support for medical device regulatory submissions. He has a combined experience of 10+ years in the field of Toxicology and Biocompatibility. Prior to joining the Abbott team, his professional experience had been primarily working in contract research organizations (CROs) where he served as a Director of Biocompatibility Services for American Preclinical Services and as a Study Director for WuXi AppTec. Mr. Grove has worked extensively in area of hemocompatibility with multiple publications relating to improving the current test methods used to assess blood-contacting devices.

Tim Schatz; Senior Biocompatibility Scientist, Abbott

Tim Schatz has been a part of Abbott’s Science and Technology Team for three years. As a Senior Scientist, he is responsible for the generation of biological evaluation plans and reports to support all phases of development across Abbott’s medical device portfolio. He previously served as Technical Scientist at American Preclinical Services, where he developed next generation in vitro biocompatibility tests to meet the demands of increasingly technical biological safety assessments for medical devices.

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 preclinical 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.