Chemistry with the MFDS

BiocompCHATibility

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

In this episode, our hosts are joined by Dr. Charles Ducker who recently returned from Korea on a trip to give training to the MFDS (Ministry of Food and Drug Safety) about ISO 10993-18. Discussions include the use of the standards, the adoption of the standard by the Korean authorities, and continued challenges ahead of device manufacturers and testing labs.

“I think they (MFDS) were maybe surprised at the complexity. Laying out the information you have on your materials and the knowledge that you already have that may not lead to doing testing.”– Dr. Charles Ducker

“They were interested in how to apply ISO 1093-1 and how you apply ISO 10993-18 to the standard. And they want to know how to assess whether a laboratory has conducted the test appropriately.” – Dr. Charles Ducker

“One of the things I thought was very interesting…around Part 18, was what is different now vs the outdated version, and what changes came about. We had a lot of discussion about what is required and one of the big ones was AET and how we calculate it.” – Dr. Charles Ducker

“Also, about how we qualify methods, what components go into that and what data you have to have behind the scenes to support the fact that your methods are appropriate for the intended use.” – Dr. Charles Ducker

Topics include:

Korea’s current position with the use of ISO 10993-18
Qualification of a laboratory for chemical characterization testing
Solvents and temperatures, and the justifications for each

*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.

Charles Ducker

Dr. Charles Ducker is the Senior Director North American Analytical Services for NAMSA’s chemical characterization group where he oversees the design and execution of extractables and leachables testing programs for the medical device industry, LC/MS, LC/MS/MS, GC/MS, ICP/MS and ICP-OES technology. Specializing in LC/MS analysis, Dr. Ducker has 20 years of experience in the CRO and biotech industries and has earned a Ph.D. in Biochemistry/Molecular Biology from The Pennsylvania State University, as well as a B.S. in Biology from Millersville University.

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 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.

Chemistry with the MFDS

Published:

Content Type:

BiocompCHATibility

Charles Ducker

Sheri Krajewski

Don Pohl

Let’s Talk About Your Project