Olympus Revises Duodenoscope Cleaning Procedure

Olympus sent letters to health care facilities with updated reprocessing instructions for their TJF-Q180V duodenoscope following months of media attention concerning the risk of CRE superbug infections from contaminated scopes.

The key changes are detailed in a safety communication on the FDA website for gastroenterologists, gastrointestinal surgeons, endoscopy nurses, infection control practitioners, risk managers and staff in endoscopy reprocessing units.

The FDA recommends that facilities begin using portions of the new procedure immediately. The new manual cleaning procedure involves the use of a smaller bristle cleaning brush that has not been shipped yet by Olympus. The company anticipates shipping it by early May.

In the meantime, the procedure calls for raising and lowering the elevator three times during immersion while pre cleaning, additional raising and lowering of the forceps elevator during high level disinfection, and increased flushing volume and manual flushing steps of each endoscope channel as well as the elevator recess area.

The letter from Olympus America with the Urgent Safety Notification and Updated Label Information provides their complete revised instructions. It is available at http://medical.olympusamerica.com/sites/default/files/pdf/150326_TJF-Q180V_Customer_letter.pdf

The instruction manual for the medical device previously indicated that no reprocessing of the sealed elevator wire channel was necessary.  Olympus changed the device back in 2010 but did not seek 510(k) clearance for the change.  In 2014, the FDA requested the manufacturer submit an application demonstrating the substantial equivalence of the device to prior versions.  The application is still pending.

Our attorneys have filed the first lawsuit in Philadelphia for an infection following a procedure using a duodenoscope.  The procedure took place at a Seattle hospital who has denied evidence of any CRE infections.  A Philadelphia hospital has announced a CRE superbug outbreak of at least 8 cases, including two deaths, in patients who had duodenoscope procedures in 2013 and 2014.  However, Thomas Jefferson University hospital denies that there is any link to medical scopes.  Hospitals in Seattle, Los Angeles and Pittsburgh have all had outbreaks and concluded that the CRE infections were spread by contaminated duodenoscopes.

If you are a patient who has had an ERCP procedure involving a duodenoscope, our free ebook and additional information is available at http://www.mceldrewyoung.com/superbug-infections/