The Facts About In Vitro Irritation

Operating room with monitor

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Audio

BiocompCHATibility

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


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

*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.

Dr. Joseph Carraway

Dr. Joseph Carraway

Dr. Joseph Carraway, DVM, MS, Scientific Director, Laboratory Services at NAMSA possesses 15 years of experience in medical device testing and evaluation with over 29 years in clinical medicine and surgery; biomedical science, surgical models and testing procedures; program and facilities evaluation; and regulatory affairs. He also has extensive experience in personnel and fiscal management and the development and implementation of a wide variety of training for animal technicians, veterinarians and investigators.

Sheri Krajewski

Sheri Krajewski

Sheri joined NAMSA in 2003 and currently serves as Senior Global Product Marketing Manager of Biological Safety. Sheri 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, she created the much sought-after NAMSA Training Series (NTS) for the iological 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

Don Pohl

Don Pohl is currently the Manager of Biological Safety & Validation at NAMSA. He holds a Bachelor’s degree from Ohio State University. Don has over 20 years of experience in the pre-clinical 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.