Our hosts are joined this week by Dr. Ted Heise, convener of TC 194/WG 14. This group is responsible for the re-write and release 10993-18 Biological evaluation of medical devices —Chemical characterization of medical device materials within a risk management process. This much anticipated standard is expected to provide greater detail and guidance regarding the use of characterization within the biological evaluation of medical devices.
“There are no technical changes allowed when FDIS is translated to International standard.” – Ted Heise
“The distinction between chemical information and analytical testing is one of the important changes in the new document.” – Ted Heise
“You can use this standard to answer different types of questions and that a well-documented plan can justify an approach to answer one question.” – Don Pohl
“The document includes a tabulation of solvents with varying degrees of polarity. It also emphasizes that your solvents should not degrade your test article.” – Ted Heise
Discussion points include:
- High-level overview of the changes to the standard, including what the most significant changes mean for manufacturers
- The differentiation between material and chemical characterization
- Discussion of degradation of materials and the importance of selecting proper solvents for extraction
- Discussion of AET (Analytical Evaluation Threshold)
Also be sure to check out our Biocompatibility Strategy Navigator.
|Ted Heise, PhD, RAC; Vice President, Regulatory & Clinical Services, MED Institute
Theodore (Ted) Heise has over 25 years of experience in regulatory and clinical affairs, and currently serves as Vice President Regulatory & Clinical Services at MED Institute. In this capacity, Dr. Heise leads efforts to develop scientifically robust regulatory and clinical study strategies for the company’s clients: entrepreneurs, consultants and developers bringing new medical products through the complex steps of the development process.
Graduating Magna Cum Laude with a B.S. in chemistry from the University of Nebraska at Omaha, Dr. Heise went on to earn a Ph.D. in analytical chemistry from Iowa State University. He has been a member of the Regulatory Affairs Professionals Society since 1993, and the American Chemical Society since 1988.
For the past 12 years Dr. Heise has been a U.S. delegate to ISO TC 194, the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices. He currently serves as convener of TC 194/WG 14. As convener, Dr. Heise is leading the process of re-writing ISO 10993-18 to reflect current best practices in chemical characterization, including evaluation of extractables and leachables.
Connect with Ted here https://www.linkedin.com/in/ted-heise-3925a6154/
|Sheri Krajewski-Bibins; Product Marketing Manager – Biological Safety, NAMSA
Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She 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, Sheri created the much sought-after NAMSA Training Series for the biological 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; Principal Product Development Strategist, NAMSA
Don holds a Bachelor’s degree from Ohio State University. He has over 25 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.