Among the tests performed before bringing medical devices to market, the devices must be tested for their potential to cause an allergic reaction when they come in contact with skin. There are now several in vitro options for testing skin sensitization, but none of them have been validated for medical devices, which typically involve less concentrated exposures to potential sensitizers. However, a recent article in Applied In Vitro Toxicology describes research demonstrating that a 3D human skin tissue model can reliably detect even very low levels of known skin sensitizers in medical devices. The research is encouraging because the approach – which uses EpiDerm™ reconstructed human skin, along with the SenCeeTox® assay – could eventually replace animal models for certain medical device testing procedures, especially the widely used Guinea Pig Maximization Test.
According to the study’s authors, their primary aim was to “address is whether or not the SenCeeTox assay, which has been proven accurate and effective at identifying many types of compounds and materials, can accurately detect low levels of sensitizing chemicals of varying potencies in dilute medical device extracts that may contain monomers, oligomers, plasticizers, antioxidants, colorants, manufacturing process aids, mold release agents, sterilant residues, and the like.” The authors conclude that “the SenCeeTox assay combined with 3D EpiDerm tissues may be a useful in vitro model for accurately predicting the dermal sensitization potential of medical device extracts.”
The publishers of Applied In Vitro Toxicology, Mary Ann Liebert, Inc., are making the article freely available on the journal website until August 29, 2015.
Full citation: Coleman Kelly P., McNamara Lori R., Grailer Thomas P., Willoughby Jamin A. Sr., Keller Donald J., Patel Prakash, Thomas Simon, and Dilworth Clive. (2015). “Evaluation of an In Vitro Human Dermal Sensitization Test for Use with Medical Device Extracts.” Applied In Vitro Toxicology. June 2015, 1(2): 118-130. doi:10.1089/aivt.2015.0007.