TS03 Inc Trust Units TSTIF

FDA Probing Extent of Duodenoscope Contamination Problem

[echo2]

In its July Maude reports, the FDA has reported a preliminary study in a letter to Olympus of 73 institutions (only 67 submitted samples) where all three brands of duodenscopes in wide use were sampled between June 2015 and March 2016 following high level disinfection reprocessing (two from each institution) and found 39% of ERCP centers had one or more contaminated scopes in use and 21 - 28% of scopes in use were contaminated and culture positive for bowel or intestinal bacteria. No patient infections were associated with these contaminated scopes, as the study appears to have been aimed at determining only the extent of the contamination problem. One presumes Fuji and Pentax, the other manufacturers of commonly used duodenoscopes also received the same letter. " The letter's conclusions regarding this study states: "process control dose not offer a guarantee to prevent contaminated duodenoscopes from being used. "" i.e., the existing processes or protocols using high level disinfection using reprocessors do not work to prevent patient exposure to contaminated scopes.

I am not sure if the press has run with this yet or if this has been reported here previously.

The sooner TSO3 can get it's data completed and submitted to the FDA to support extending claims further to include these duodenscopes, (especially the Olympus Q180V), the better for all concerned with providing safe quality of care.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5741002

The FDA maude site of problems with Olympus and other scopes only grows by the month.

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