UPDATE – Preventing superbugs: FDA clears redesigned Olympus endoscope

Updated to include information from Olympus. The FDA today said it cleared a redesigned version of Olympus‘ (TYO:7733) TJF-Q180V duodenoscope, with modifications intended to reduce the risk of bacterial infections. The company said it won new 510(k) clearance for the TJF-Q180V model, for modifications to both the design and labeling of the device. The redesigned endoscope from Olympus comes on the heels of a new report from the U.S. Senate’s health committee, which slapped blame on medical device companies and hospitals for deadly outbreaks of so-called “superbug” infections linked to the scopes. Duodenoscopes are used for endoscopic retrograde cholangiopancreatography procedures, in which the tube-like camera instruments are inserted into the throats of patients for a variety of different treatments, such as draining fluids from pancreative and biliary ducts blocked by tumors or gallstones. More than 500,000 such procedures are performed in the U.S. annually – but in February and March 2014, hospitals in Connecticut, Virginia, California and Washington state reported superbug outbreaks related to the devices and procedures. “We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices. The Olympus TJF-Q180V’s new design, as well as the new annual inspection program, is intended to reduce the risk of fluid leakage into the elevator channel, whic...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Business/Financial News Endoscopic / Arthroscopic Food & Drug Administration (FDA) Imaging Olympus Source Type: news