The Continuing Education course titled Advances in Safety Assessment of Medical Devices was applicable to both basic and advanced toxicologists. Metal alloys and polymeric materials which may be associated with safety concerns for the patient were discussed.
The focus of this course was to provide an outline of the various in vitro, in vivo, and in silico methodologies for the safety assessment of medical devices and to discuss how risk assessment approaches can be used in the biological evaluation process for medical devices. Presentations provided an overview of the biocompatibility test methods recommended by ISO 10993, US Pharmacopeia, and ASTM.
The first speaker and session chair, Dr. Niranjan S. Goud from Boston Scientific Corporation, started the session with an intensive overview of the various approaches that are currently used to evaluate the biological safety of medical devices.
The second speaker Dr. Jon E. Dahl from Nordic Institute of Dental Materials, Oslo, Norway, provided some approaches to evaluate the biological safety of plastic dental materials. He carefully outlined the use of resin-based materials in dentistry, the chemistry and curing process, and exposure assessment. He concluded that few adverse effects have been reported and those were usually related to allergic reaction.
Dr. Whitney V. Christian from Cardno ChemRisk explained the potential health risks associated with the use of metallic hip implants. He discussed a few case studies wherein he used the four steps of risk assessment to evaluate the risk of adverse health effects from hip implants.
The co-chair of the session Ron Brown from US FDA, provided guidance on the derivation of exposure limits for leachable chemicals released from medical devices when only limited toxicity data are available.
The course was well attended and elicited several questions that resulted in a good discussion, particularly from those involved in evaluating the safety of medical devices.
This blog discusses highlights from the SOT Annual Meeting CE Course “Advances in Safety Assessment of Medical Devices.”