Common Contracts
1 similar Distribution Agreement contracts
Distribution AgreementDistribution Agreement • January 13th, 2012
This thesis aimed to identify and analyze surgical fire reports submitted to FDA’s Manufacturer and User Device Experience (MAUDE) database to support the Preventing Surgical Fires (PSF) initiative (www.fda.gov/preventingsurgicalfires). Surgical fires occur on or in patients undergoing medical procedures and are preventable medical errors. They may occur when an ignition source, oxidizer, and fuel come together and can result in serious injury or death. FDA regulates elements of the fire triangle as either medical devices or drugs and therefore receives surgical fire reports submitted to MAUDE. The internal database was searched over two years (2008-2009), for keywords and devices implicated in surgical fires. The records were read individually to identify surgical fire reports. The data was analyzed to determine the number of reports, their severity, and how many referenced oxygen use, or use of alcohol-based skin preparation agents. The total number of surgical fire reports submitted
