Oh No, Another Failed Cyto!

BiocompCHATibility

A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.

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In this episode, our guests are joined by Melissa Cadaret, NAMSA’s Director of Global Compliance and Process Improvement, to discuss the ever-confusing ‘cytotoxicity failure.’ Manufacturers can sometimes experience confusing results due to unexpected cytotoxicity results. What must manufacturers understand in order to properly navigate the cyto failure, whether expected or unexpected? Listen in as our experts discuss these challenges and best practices derived from NAMSA’s thousands of cytotoxicity tests and results.

“I would say generally, we see some type of cytotoxicity failure weekly.” – Melissa Cadaret

“Cytotoxicity is not really an endpoint. It’s a screen.” – Sheri Krajewski-Bibins

“It is what it is, and it is what it’s not.” – Don Pohl

“It’s the only biological effect listed as an overall screen for biocompatibility.” – Don Pohl

“Things like copper and antimicrobials really wreak havoc and contribute to a lot of cytotoxicity failures. Some of your residues from your cleaning and in processing aspect are also a huge culprit.” – Melissa Cadaret

“It might have been expected. You can get pretty good at predicting cytotoxicity.” – Don Pohl

Discussion points include:

• What does it mean when one receives a failed cyto result?
• What useful information can you gather from a cytotoxicity test?
• What materials and devices can typically have problems associated with cytotoxicity tests?
• What should you do if you know your material is going to fail cyto?

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

Also be sure to check out our Biocompatibility Strategy Navigator.