Dayna Kerecman Myers 1, Alan M. Goldberg 1, Albrecht Poth 2, Michael F. Wolf 3, Joseph Carraway 4, James McKim 5, Kelly P. Coleman 3, Richard Hutchinson 6, Ronald Brown 7, Harald F. Krug 8, Anthony Bahinski 9 and Thomas Hartung 1,10 1
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; 2 Dr. Knoell Consult GmbH, Mannheim, Germany; 3 Medtronic plc, Minneapolis, MN, USA; 4 NAMSA, Northwood, OH, USA; 5 IONTOX LLC, Kalamazoo, MI, USA; 6 J&J Medical Devices, Preclinical Center of Excellence, Sommerville, NJ, USA; 7 FDA, Center for Devices and Radiological Health, Beltsville, MD, USA; 8 EMPA, Swiss Federal Institute for Materials Science & Technology, St. Gallen, Switzerland; 9 Wyss Institute for Biologically Inspired Engineering at Harvard University, Boston, MA, USA; 10University of Konstanz, Konstanz, Germany.
Amid growing efforts to advance the replacement, reduction, and refinement of the use of animals in research, there is a growing recognition that in vitro testing of medical devices can be more effective, both in terms of cost and time, and also more reliable than in vivo testing. Although the technological landscape has evolved rapidly in support of these concepts, regulatory acceptance of alternative testing methods has not kept pace. Despite the acceptance by regulators of some in vitro tests (cytotoxicity, gene toxicity, and some hemocompatibility assays), many toxicity tests still rely on animals (irritation, sensitization, acute toxicity, reproductive/developmental toxicity), even where other industrial sectors have already abandoned them. Bringing about change will require a paradigm shift in current approaches to testing – and a concerted effort to generate better data on risks to human health from exposure to leachable chemicals from medical devices, and to boost confidence in the use of alternative methods to test devices. To help advance these ideas, stir debate about best practices, and coalesce around a roadmap forward, the JHU-Center for Alternatives to Animal Testing (CAAT) hosted a symposium believed to be the first gathering dedicated to the topic of in vitro testing of medical devices. Industry representatives, academics, and regulators in attendance presented evidence to support the unique strengths and challenges associated with the approaches currently in use as well as new methods under development, and drew next steps to push the field forward from their presentations and discussion.
Keywords: in vitro testing, refinement, skin sensitization, threshold of toxicological concern (TTC), nanotoxicology
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