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Duodenoscope FAQs

Frequently Asked Questions

What is a duodenoscope and what purpose does it serve?
Duodenoscopes are specialty endoscopes designed for use by healthcare professionals for endoscopy procedures including Endoscopic Retrograde Cholangiopancreatography (ERCP) and endoscopic surgery within the duodenum.

What is ERCP?
Endoscopic Retrograde Cholangiopancreatography (ERCP) is an endoscopic procedure most commonly performed to diagnose and treat conditions in the pancreas, bile duct and gallbladder. The patient health conditions that are treated by ERCP procedures include life-threatening jaundice (unprocessed bile in the bloodstream caused by gall stones). This technique, performed globally on an estimated 2 million patients per year provides a highly effective and minimally invasive alternative to an intensive, open surgery or percutaneous (through the skin) procedure.

Were customers informed about medical literature reports regarding cross-contamination associated with duodenoscopes? Do benefits of ERCP procedures outweigh the risk of cross-contamination?
In Chapter 1 of the current TJF-Q180V Reprocessing Manual and its previous versions it is pointed out that the medical literature reports incidents of cross-contamination resulting from improper cleaning, disinfection, or sterilization. Effective reprocessing of duodenoscopes used in ERCP procedures has been analyzed by an Advisory Committee of the US Food and Drug Administration (FDA) after several cross-contamination incidents in the USA. The FDA’s analysis indicates that the reported duodenoscope-associated infections in the US have occurred in patients who have had procedures with duodenoscopes from all three major manufacturers. In an FDA statement from February 23, 2015, Dr.William Maisel recognized, “The vast majority of ERCPs are conducted without incident and often to the patient’s great benefit. For most patients, the benefits of this potentially life-saving procedure far outweigh the risks of possible infection.", Olympus continues to explore all options to further reduce the risk of infection associated with our duodenoscopes.

What has Olympus done to react to the situation?
In order to provide additional safeguards during reprocessing and especially during the manual cleaning phase, Olympus has just issued a supplemented version of the Reprocessing Manual in May 2015 (please see attachment). The new version of the TJF-Q180V Reprocessing Manual contains additional, mandatory cleaning and flushing steps and requires use of a dedicated cleaning brush (MAJ-1888 or MyBrush). These brushes are smaller-bristle brushes for use in cleaning the forceps elevator recess.
Additionally Olympus has issued a new cleaning information sheet .

Can the TJF-Q180V duodenoscope continued to be used?
The TJF-Q180V duodenoscope is fully approved to be used as described in the Operating Manual and the Reprocessing Manual. Olympus strictly adheres to the regulatory requirements that are set by the competent authorities. To ensure safe disinfection of the duodenoscope, it is essential to rigorously follow the validated reprocessing instructions.

Have the new reprocessing instructions been validated? Are they ensured to be effective?
The updated process was carefully validated at an independent testing laboratory and utilizing industry-accepted, scientific norms. In their Safety Communication of March 26, 2015, the US competent authority Food and Drug Administration (FDA) wrote: “At the end of February 2015, Olympus submitted new high level disinfection validation data to FDA. The agency has reviewed this data and believes that, when followed, the new, validated reprocessing instructions for the Olympus TJF-Q180V duodenoscope are robust, and demonstrate consistent and reliable cleaning and high-level disinfection. At FDA’s request, Olympus has issued the new, validated instructions for reprocessing the TJF-Q180V duodenoscope.”

Why is Olympus promoting a “myBrush GmbH” single use cleaning brush in its Europe, Middle East and Africa region and is it comparable to MAJ-1888?
To ensure sufficient supply levels, OEKG is endorsing the use of a locally manufactured brush. The brush was tested by Olympus prior to launch and has an analogue performance to the MAJ-1888. It is fully cleared to be used as described in the Reprocessing Manual.

Is Olympus issuing new instructions for their other duodenoscope models?
The reprocessing manuals provided with Olympus’ other duodenoscopes describe the procedures to follow meticulously for effective cleaning and disinfection. Olympus is actively monitoring and investigating the matter to determine any next steps.

Why does Olympus have different current models of duodenoscopes?
As a multi-national company manufacturing and marketing products for the regulated healthcare industry, Olympus’ offerings must address customer preferences, medical society guidelines, competent authority requirements and the expectations of many other recognized authorities in every country in which the Company operates. As a result of these forces, there are sometimes market variations in our products and their instructions for use.

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