Olympus Issues New Reprocessing Instructions for Endoscope Linked to CRE Outbreaks

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The maker of duodenoscopes linked to 2 recent outbreaks of the superbug Carbapenem-Resistant Enterobacteriaceae, or CRE, has provided customers with new instructions for reprocessing the devices.

New Cleaning Instructions Validated for Olympus TJF-160F and TJF-160VF Duodenoscopes

March 15, 2016 – Olympus Corp. announced today that it has issued updated reprocessing instructions for its TJF-160F and TJF-160VF model duodenoscopes. The manufacturer sent a letter to healthcare facilities and other users of the devices this week outlining the new reprocessing instructions. An updated manual and a box of MAJ-1534 brushes required for the updated cleaning procedure accompanies the letter.

Olympus Validates Duodenoscope Cleaning Protocol

Olympus Corp. of the Americas sent the new guidelines to U.S. hospitals on March 26, recommending that its customers begin using them immediately. Key changes to the duodenoscope reprocessing protocol include:

Precleaning:

  • During immersion, raise and lower the elevator three times

Manual Cleaning:

  • Additional brushing of the forceps elevator recess area
  • The revised cleaning procedure requires brushing of the forceps elevator recess with two different-sized brushes. In addition to the brush that is currently used to clean the elevator recess area, the MAJ-1888 brush (or MAJ-1888 equivalent) will be provided for further cleaning of this area. Olympus anticipates shipping the MAJ-1888 brushes to facilities no later than May 8, 2015.
  • Additional flushing of forceps elevator recess area
  • Additional raising/lowering the forceps elevator

Superbug Linked to 2 Deaths; Hundreds Potentially Exposed

The Olympus TJF-Q180V duodenoscope has been linked to at least 11 CRE superbug infections — including 2 deaths — at 2 separate Los Angeles hospitals in February. Hospital officials said the bacteria survived on the scopes and was passed from patient to patient despite following Olympus’ instructions for disinfecting the devices.

The duodenoscope consists of a flexible fiber-optic tube that is passed down the patient’s throat, through the stomach and small intestine during endoscopic retrograde cholangiopancreatography (ERCP) procedures. The scopes have “elevator channels” that are used to bend the device in tight spaces and allow for attachments such as catheters or guide wires. Experts believe CRE bacteria builds up in these areas.

Endoscope Suspected in CRE Outbreak Not Approved by FDA

FDA said it is reviewing Olympus’ new guidelines as part of a broader evaluation of the duodenoscope. FDA approval is required for all substantive updates to medical devices sold in the U.S.

Congressman Ted Lieu, D-Calif., said the new guidelines were an important “first step,” but pointed out that the FDA has not yet confirmed their effectiveness for cleaning the duodenoscopes.

“Hopefully this will work, but we won’t know for some time,” Lieu told The Associated Press. “But I do commend them for taking action.”

Olympus Warned Europe About Duodenoscope Cleaning Problems 2 Years Before U.S. Outbreaks

Olympus may have known about problems with cleaning its duodenoscopes nearly 2 years before superbug outbreaks hit the U.S., according to an article published in the Los Angeles Times. The finding raises questions as to why U.S. health officials weren’t notified sooner.

“That is not how device makers should run their business. It’s clear Olympus knew something was not correct about its existing cleaning instructions,” Rep. Ted Lieu (D-Los Angeles) told the Times.

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