FDA warning letter to duodenoscope manufacturers related to spread of infections

The FDA disclosed that it issued a warning letter on 12 August to Olympus Mèdical, Pentax and Fujifilm after outbreaks of infectious diseases and for failure to report problems with their duodenoscopes. In the Olympus case for failure to report 16 cases of patients contracting Pseudomonas aeruginosa infections; Pentax failed to report cases of carbapenem resistant Enterobacteriacae (CRE) infections. FDA inspections of the companies' sites in the USA and Japan found significant deviations from regulatory protocols and potential design flaws. Fujifilm was told that its latest duodenoscope introduced in the US lacked a 510(k) approval. The FDA has sent out recommendations for cleaning duodenoscopes/endoscopes requesting sterilization after cleaning and the use of a chemical solution to destroy bacteria.