The Importance of Accurate Chemical Characterization of Medical Devices Extractables

Chemical characterization of medical devices, involving the identification, quantification, and subsequent toxicological risk assessment of E&L compounds, is becoming increasingly accepted by regulatory agencies as a means to assess the biocompatibility of medical devices.  The proper implementation of this approach requires an accurate assessment of the E&L compounds that may be released from the device.  This presentation will discuss the challenges associated with accurately identifying compounds extracted from medical device materials and will illustrate the importance of accurate chemical characterization from a toxicological perspective.  The presentation will underscore the need for chemists and toxicologists to work collaboratively to assess the potential risk posed by patient exposure to E&L compounds released from medical device materials. 

Presented by Ron Brown, Toxicologist at Risk Science Consortium

Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment.  He recently retired from the US FDA and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology.  At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices.  While at the FDA, he served in a number of leadership roles in standards development organizations.  At the international level, he served for many years as convener of ISO TC194 WG11 which is responsible for the development and revision of the ISO 10993-17 standard, Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances.  At the national level, he represented the United States as an expert on ISO TC194 WG11 and served as co-chair of the AAMI Biological Evaluation Committee.  Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute.  He is a founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk.

Presented by Dries Cardoen, PhD, Sr. E&L Expert – Team leader at Nelson Labs

Dries Cardoen received his Ph.D. from the Faculty of Biology at the University of Leuven (Belgium) in 2011. After his academic career as a post-doctoral researcher, he started at Nelson Labs (formerly Toxikon Europe) in 2013 as study director in the Extractables & Leachables Department. He specialized in E&L projects of inhalation drug products and medical devices. Being a senior expert in these fields, he is currently leading the team of experts that is specialized in E&L of medical devices.

Sponsored by Nelson Labs

Nelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.

Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.