Monocyte activation tests (MAT) are widely available but rarely used in place of animal-based pyrogen tests for safety assessment of medical devices. To address this issue, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods and the PETA International Science Consortium Ltd. convened a workshop at the National Institutes of Health on September 18-19, 2018. Participants included representatives from MAT testing laboratories, medical device manufacturers, the U.S. Food and Drug Administration’s Center for Devices and Radiologic Health (CDRH), the U.S. Pharmacopeia, the International Organization for Standardization, and experts in the development of MAT protocols. Discussions covered industry experiences with the MAT, remaining challenges, and how CDRH’s Medical Device Development Tools (MDDT) Program, which qualifies tools for use in evaluating medical devices to streamline device development and regulatory evaluation, could be a pathway to qualify the use of MAT in place of the rabbit pyrogen test and the limulus amebocyte lysate test for medical device testing. Workshop outcomes and follow-up activities are discussed.
Plus-sizing in the tire industry is the growing practice of replacing a vehicle's original equipment wheel size with a larger diameter wheel and replacing the tire with a lower aspect ratio tire of the same diameter. This practice is normally associated with aftermarket sales, and there is a growing trend for vehicle dealerships to fit these larger wheels/tires to new cars. This paper discusses the general practice and its effect on some of the performance characteristics of vehicles. A vehicle taken from the NHTSA New Car Assessment Program's rollover "Star" rating program is used to illustrate the impact of plus sizing on static stability. Some of the dynamic tire effects that could influence vehicle stability are discussed and preliminary testing data on the dynamic impact of plus sizing are presented.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.