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BiocompCHATibility Podcast
The Facts About In vitro Irritation

The Facts About In vitro Irritation

BiocompCHATibility vor 5 Jahren

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43:14

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this episode, our hosts are joined by Dr. Joe Carraway,
co-author of the new research paper, “The suitability of
reconstructed human epidermis models for medical device
irritation assessment: A comparison of In Vitro and In Vivo
testing results,” which discusses in vitro irritation assays
and their viability for medical device testing. The three Rs in
this type of experimentation, which stand for Replacement,
Reduction and Refinement, are a concept always considered for new
test development. In vitro irritation is one of the latest to
reach the normative text of the ISO standards and manufactures
and laboratories will need to be prepared to evaluate and utilize
this test method. This episode provides in-depth details
regarding the timing of the standard, the viability and accuracy
of the test method and opportunities and challenges for
laboratories and manufacturers related to the standard.

“The standards were written in such a way that it was still
an option, and with the release of this new part 23… it
essentially mandates what you really need to be doing, if you
need to test for irritation {…} if you’ve determined that the
next step says you do an in vitro model before going into an in
vivo model.” Dr. Carraway

“The concern with predictive assays is you don’t want to have
false negatives. You can live with false positives because you
are typically going to do further testing to confirm
those.” Dr. Carraway

“If you have a positive response, one of the approaches is to
look at in vivo testing. Here, it’s a point to point comparison
of irritation.” Don Pohl

Discussion points include:

When will an in vitro method be expected for irritation?

What was the methodology of this comparison study?

How does the in vitro method compare against the primary skin
and intracutaneous study?

What are some challenges of the in vitro study?

What should manufacturers be doing now to prepare for the new
ISO 10993-23