Michael J Connor, Deborah C Marshall, Vitali Moiseenko, Kevin Moore, Laura Cervino, Todd Atwood, Parag Sanghvi, Arno J Mundt, Todd Pawlicki, Abram Recht, Jona A Hattangadi-Gluth
PURPOSE: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non-radiation oncology devices. METHODS AND MATERIALS: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact)...
January 1, 2017: International Journal of Radiation Oncology, Biology, Physics