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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