The tide of in vitro medical device testing is changing with the discovery of an extractable positive control at Salt Lake City, UT based microbiology lab, Nelson Laboratories. A major element in the development and validation of in vitro alternatives to in vivo animal testing, this discovery may mean regulatory acceptance of in vitro testing is much closer than previously expected.
SALT LAKE CITY, UT – March 19, 2015 – Working in concert with the Public Welfare Institute of Scientific Research Foundation, the National Institute of Health Sciences, Kawasumi Laboratories, Inc., and Terumo Corporation, Nelson Laboratories’ (www.nelsonlabs.com) recent discovery of an extractable positive control may help in vitro advocates overcome what has been a major road block in garnering regulatory support for in vitro skin irritation testing for medical devices.
The testing of medical devices for potential skin irritation has typically involved the use of in vivo testing in laboratory animals. In an effort to reduce the need for laboratory animals, alternative methods for testing for potential skin irritation in vitro have been developed. While these in vitro methods have been shown to provide results consistent with animal testing data, they have involved the use of direct chemical solutions as positive controls. To provide a method more applicable to medical device testing – in which devices are extracted in polar and non-polar solvents – scientists have been looking for an extractable material that will induce a positive irritation response in both polar and non-polar extraction vehicles, and it appears they may have found it.
Nelson Laboratories Senior Biocompatibility Lab Analyst, Daniel Olsen, highlights the significance of this discovery, “The success of the in vitro method, as it relates to FDA regulatory adoption, is partially dependent on our ability to provide a medical device specific, in vitro validation. We anticipate the discovery of this extractable positive control will give us the data FDA requires. This is a major step forward for in vitro skin irritation testing of medical devices.”
Visit www.nelsonmedtechinsights.com to learn more about Nelson Labs’ in vitro medical device testing research and advancements.
Nelson Laboratories and associates will present their in vitro skin irritation testing research at the upcoming Society of Toxicology Meeting, on Wednesday March 25, 2015 in San Diego, California. For more information visit www.nelsonlabs.com.