The U.S. Food and Drug Administration said it has issued warning letters to manufacturers of medical scopes linked with recent superbug outbreaks, citing violations found during inspections of facilities in the United States and abroad.
The devices, called duodenoscopes, are flexible tubes inserted down the throat in a procedure called endoscopic retrograde cholangiopancreatography, or ERCP. More than 500,000 ERCPs using duodenoscopes are performed in the U.S. annually, usually to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors or gallstones.
The FDA issued the letters on Aug. 12 to all three makers of the duodenoscopes — Olympus Corp, Fujifilm Holdings Corp. and Pentax Medical, a unit of Hoya Corp.
Duodenoscopes have been associated with episodic infections for more than a decade, but the rising tide of antibiotic-resistant bacteria, or superbugs, are making these infections more dangerous and difficult to treat.