Olympus Duodenoscope Cleaning Instructions Revised After Infection Outbreak

The medical device manufacturer Olympus says it has developed a new method for cleaning certain endoscopes, which have been linked to a number of infection outbreaks at hospitals in recent months and years that have been blamed on an inability to properly sanitize the medical devices, even when following the manufacturer’s instructions. 

On Thursday, the FDA announced in a safety communication that Olympus had successfully validated new reprocessing instructions for some of its duodenoscopes. The agency has reviewed the process and is urging health care facilities to employ it.

Reprocessing is the term for cleaning and reusing medical devices that have come into contact with organic matter that could be infectious. Failure to properly sterilize such instruments can spread infectious agents, superbugs, and blood borne diseases from one patient to the next.

Concern arose earlier this year over the reprocessing of duodenoscopes after an outbreak of deadly carbapenem-resistant enterobacteriaceae (CRE) infections at UCLA Ronald Reagan Medical Center. The hospital reported that two patients had died and several had been sickened by the antibiotic-resistant infections, and sent warning letters to 180 patients that could have been exposed.

Shortly after, other hospitals announced they had tracked infections back to duodenoscopes as well, particularly those manufactured by Olympus.

Duodenoscope Infection Concerns

Duodenoscopes are flexible, lit tubes that are inserted down the throat to the top of the small intestines for gastrointestinal procedures. They allow contrast dye to be injected and can be used with other medical instruments to retrieve biopsy samples. The FDA estimates that more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope procedures occur each year in the U.S.

Following the recent infection outbreaks, the FDA warned about problems cleaning duodenoscopes, indicating that even when doctors and health care professionals follow the recommended cleaning steps, patients may still face a risk of infections.

Many of the devices include a movable “elevator” at the tip, which may trap pathogens and blood even when recommended cleaning techniques are used.

The new reprocessing instructions focus on the Olympus TJF-Q180V duodenoscope, which has been linked to at least two outbreaks. The FDA approved the new validation instructions despite the device not being properly approved for use.

“Olympus has a pending 510(k) application for its TJF-Q180V duodenoscope and the company continues to market its device while its application is under review,” the FDA safety communication states. “The removal of its device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year.”

The new instructions involve raising and lowering the elevator for the duodenoscopes several times while immersing them during precleaning and significant increases in the amount of manual brushing, flushing procedures, flushing volume and other measures. The company is also sending out a new brush for cleaning the elevator recess area.

The FDA is recommending that hospitals put the new cleaning instructions into use immediately and to train the appropriate staff on the proper cleaning of the duodenoscopes as soon as possible.

The FDA also announced earlier this month that it will hold a meeting of its Gastroenterology and Urology Devices advisory panels on May 14 and 15. The panels will be asked to make recommendations on regulatory actions needed to ensure the proper design and cleaning of certain endoscopes throughout the industry.

The FDA advisory panel will make non-binding recommendations to the FDA on how to proceed. While the FDA is not required to follow the panel’s advice it usually does, or the recommendations have a strong influence on whatever decision the agency does make.

A number of hospital infection lawsuits have been filed against Olympus in recent weeks by either former patients who were infected after ERCPs or by the family members of patients who died due to ERCP duodenoscope infections. The lawsuits accuse Olympus of negligence in failing to provide adequate cleaning instructions to hospitals, or failing to properly design its duodenoscopes.