Did Olympus Instruct Europe to Clean Duodenscopes with the MAJ-1888 Brush Two Years Before the United States?

We recently acquired a document that makes us believe that Olympus told Europe to clean contaminated duodenoscopes with the smaller MAJ-1888 brush two years before it told U.S. healthcare professionals. If it did so, it put millions of individuals undergoing ERCP procedures in the United States at risk of CRE superbug infections.

The document, which is in the form of a Dear Customer letter and appears to have been created and distributed by Olympus Europe located in Hamburg, Germany, is dated January 2013.  It recognizes that there has been a reported case of contamination and advises Olympus’ customers to use the MAJ-1888 brush in cases of heavy soiling or delayed reprocessing.  The brush “enables deeper access to the forceps elevator.”  This is one of the areas that requires particular attention while reprocessing, according to the bullet points in the first paragraph of the document.

In the United States, Olympus issued new reprocessing instructions for the TJF-Q180V model on March 26, 2015. The instructions call for additional brushing of the forceps elevator recess area with the MAJ-1888 brush.  It said “Olympus anticipates shipping the MAJ-1888 brushes to facilities no later than May 8, 2015.”  It makes no mention of the fact that it told European customers to use the brush over two years.

Over the past two years, there have been a significant number of incidents at hospitals involving contaminated duodenoscopes spreading CRE superbug infections including Ronald Reagan UCLA Medical Center, Virginia Mason Medical Center in Seattle and UPMC Presbyterian in Pittsburgh. We have already filed one lawsuit here in Philadelphia against Olympus on behalf of a patient that was diagnosed with a severe infection following a duodenoscope procedure.

The document from Olympus Europe is below: