Medical device - Skin sensitization study (Current and future trends)

Medical device testing for its biological safety (biocompatibility) and clinical use is crucial, time consuming and exhaustive process. Researchers and industry specialists are always in search of efficient, economical, precise, and novel methodologies to prove the safety and performance of these medical devices using latest advancement in in vitro/in vivo experimental toxicological methods. Animal testing has been performed for several years and has yielded most meaningful scientific findings to human community. As per People for the Ethical Treatment of Animals (PETA), every year more than 100 million animals are been killed in US laboratories alone for biological lessons, medical training, curiosity-driven experimentation, and chemical, drug, food, and cosmetics testing. The numbers are even massive when considered at global scale. Several industries are getting benefited out of these testing such as cosmetics, pharmaceuticals, household goods, pesticides etc. Medical device industry is not an exception and claims a huge share in animal testing. Our current whitepaper puts light on latest advancements, alternate methods to animal testing and equivalent biochemical analytical methods for proving the biological and toxicological safety of medical devices in a better way. The major aim of current whitepaper is to highlight alternate testing methods of medical devices with reference to ISO 10993-10 (tests for skin sensitization). Further, in accordance with OECD guidelines and ISO 10993-2, this paper supports the reduction of animal usage and helps in addressing the requirements in an economical way. 

For more info: ISO 10993-10: Test for skin sensitization (Current and future trends)

Authors: Mr. Viswanath S, Dr. Jesudas B and Dr. Mounika G

Authors would like to convey their gratitude towards Mr. Mathiyazhagan M (Deputy General Manager, Medical device Materials Center of Excellence, HCL) and Dr. Mathiyazhagan R (Toxicology consultant, Material Center of Excellence, HCL) for their valuable guidance and insights for publication.