Nelson Laboratories scientists, Michelle Lee, Audrey Turley, and Daniel Olsen, in collaboration with scientists from the Japanese National Institutes of Health, recently published important research for the development of in vitro skin irritation testing for medical devices. Their article, “Proof of concept testing of a positive reference material for in vivo and in vitro skin irritation testing”, was published in the Journal of Biomedical Materials Research.
The article reports the discovery, development, and testing of the first available material to be used as an extractable positive control for in vitro irritation testing. The material is the first shown to elicit a positive irritation response in both polar and non-polar extraction solvents. This discovery of an extractable positive control material was a key step in the progress of in vitro skin irritation testing for medical devices and helped prepare the way for the recently completed international validation of the irritation test method.
The article was awarded the Best Published Paper honor for 2017 from the Medical Device and Combination Products Specialty Section (MDCPSS) of the Society of Toxicology (SOT). MDCPSS is composed of many experts within the medical device industry including a dynamic mix of scientists from device manufacturing companies, contract research organizations, regulatory agencies, and consulting companies. The award will be presented in March at the 2018 SOT Annual Meeting in San Antonio, TX.