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Extractable/Leachable Chemistry Testing Strategies for Medical Devices

Published In: Medical Device Outsourcing

It has become more prevalent and acceptable to use the results of chemistry testing to assess the overall biocompatibility of medical devices. For many devices with prolonged or permanent patient contact, chemistry followed by toxicological assessment can provide a cost and time-saving alternative to in vivo tests such as chronic, sub-chronic, genetic, and carcinogenicity testing. Manufacturers preparing to submit their device for approval by the U.S. Food and Drug Administration (FDA) rely on ISO 10993 standards and FDA guidance on the application of those standards in the planning of their chemistry testing. When it comes to the details of chemistry testing, however, the ISO standards are often vague. Furthermore, the recommendations regarding the appropriate level of testing rigor can vary within FDA. The following offers a brief overview of the framework provided by ISO 10993 guidance documents for extractable/leachable (E/L) testing, as well as three testing strategies that satisfy both ISO 10993 and FDA requirements.

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Thor Rollins

Thor Rollins

Biocompatibility Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...


Matthew R Jorgensen, Ph.D.

Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. To characterize materials, Dr. Jorgensen has extensively used a wide variety of techniques including GC/MS, LC/MS, FTIR, UV/VIS, SEM, NMR, and several types of advanced spectroscopic techniques. His Ph.D. in Physical Chemistry from the University of Utah was based on the fabrication and analysis of titanium dioxide and silicon dioxide photonic crystals templated from the three-dimensional structure found in the exoskeleton of exotic weevils. During his time at the University of Utah, he received the Henry Eyring Research Fellowship, the DOW Chemical First Year Scholarship, and additional grants to travel and present his research at national and international conferences. His research has resulted in over 30 peer-reviewed publications.