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Show THE UNIVERSITY OF UTAH Maude Analyzed Jonathan Powers (James Kris Koford) Department of Undergraduate Studies University of Utah The MAUDE database is operated by the FDA (Food and Drug Administration) - CDRH (Center for Devices and Radiological Health. It represents reports of adverse events involving medical devices used in public, private, and nonprofit hospitals. The database consists of all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The FDA provides this database to the public as well as a search engine. The FDA's search tool is limited to a much smaller scale and makes it difficult to gather this information in a meaningful way. We created a software system to sort and analyze this data. This will be useful in a number of applications; including scholarly research. This project is unique in that it draws help from multiple departments in order to reach ambitious goals set in both medical and marketing research. Currently the system is being used to conduct research and trend analysis on coronary stents; targeted more specifically at Boston Scientific's TAXUS stent product line. With this program it will be possible for faculty members at the University to conduct meaningful and important medical research to help them identify problems with medical devices. There is also potential to expand the system to a much broader audience. With the help of experienced and knowledgeable faculty members in the writing, medical, and business fields it will hopefully be possible to both provide research for free to those who need it as well as turn it into a profitable venture. James Kris Koford |