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

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

BiocompCHATibility vor 6 Jahren

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Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

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 test and how various products and
scenarios may call 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 anticoagulation
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