FDA issues warnings to duodenoscope makers linked to infection outbreaks

The US Food and Drug Administration has sent warning letters1 to three makers of duodenoscopes whose devices have been linked to outbreaks of multidrug resistant strains of carbapenem resistant enterobacteriaceae. The three firms are Olympus Medical Systems, Fujifilm, and the Pentax division of Hoya.

The letters fault two of the manufacturers for failing to alert the FDA promptly after they learnt that patients had developed infections after undergoing endoscopic procedures with their devices, in one case waiting three years to file the required report. Under federal rules …