A panel of health experts will meet in May to discuss the risk of antibiotic-resistant infections, or “superbugs”, associated with the use of endoscopes, following an outbreak of deadly carbapenem-resistant enterobacteriaceae (CRE) infectsions among patients treated at one California hospital earlier this year.
The FDA announced it was calling a meeting of its Gastroenterology and Urology Devices Panel for May 14 and 15, which is being asked to make recommendations on regulator actions needed to ensure the proper design and cleaning of certain endoscopes, including duodenoscopes.
The panel is being convened following several hospital infection outbreaks in recent years, which have been traced back to the devices and caused injuries and deaths.
The problem was highlighted several weeks ago by an outbreak at the UCLA Ronald Reagan Medical Center, which sickened seven, killed two and led to the hospital warning nearly 200 others that they might have been infected with a bacteria that resists antibiotic treatment.
On March 4, Cedars-Sinai, also in Los Angeles, sent out letters to 71 former patients after four were diagnosed CRE infections after they underwent an endoscopic retrograde cholangiopancreatography (ERCP) procedures involving the use of duodenoscopes. It is the same infection and the same procedure involving the same devices as the UCLA outbreak, causing at least one additional death.
In both cases, the hospitals blame the duodenoscopes, which they say are not properly sterilized when you follow the manufacturer’s cleaning and reprocessing directions. Both hospitals were using Olympus duodenoscopes.
Cedars-Sinai said in a press release that staff there meticulously cleaned the duodenoscope following the manufacturers’ instructions to no avail. The hospital infections, which were all linked to the same device, and occurred between August 2014 and January 2015.
The hospital indicates that it is now going above and beyond the manufacturer’s cleaning recommendations.
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 ERCP duodenoscope procedures occur each year in the U.S.
According to a recent FDA safety communication, duodenoscopes may have designs that make them difficult to clean properly even when doctors and health care professionals follow the recommended steps for cleaning it. 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 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.
According to the Federal Register notice: “The committee will make recommendations on: (1) The effectiveness of cleaning, high level disinfection, and sterilization methods; (2) the amount and type of premarket validation data and information needed to support labeling claims and technical instructions; (3) the appropriate use of other risk mitigations, such as surveillance cultures; (4) best practices and guidelines for reprocessing duodenoscopes and endoscopes at user facilities to minimize the transmission of infections; and (5) recommended approaches for ensuring patient safety during ERCP procedures, including a discussion of appropriate patient selection.”
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.