On Thursday, the U.S. Food and Drug Administration released a safety warning concerning a special type of endoscope called the duodenoscope that led to several cases of drug-resistant bacteria infections due to improper cleaning.
The device is recently linked to a series of infections with an antibiotic-resistant Enterobacteriaceae (CRE) that resulted in two deaths because of complications at the Ronald Reagan UCLA Medical Center in L.A., and 179 more patients who now may carry the superbug.
Two years ago, eleven more deaths linked to CRE infections were reported by the Virginia Mason Medical Center in Seattle. The center said that the probable cause is be the use of duodenoscopes.
Usually, drug-resistant bacteria get transmitted whenever safety protocols for cleaning the devices aren’t strictly followed, but L.A. health inspectors reported that all the disinfection procedures were followed in the hospital.
Other experts believe that the current safety protocols for the maintenance of some brands of duodenoscopes may not be enough since some flaws in their design may encourage the bacterial spread.
The experts explained that the duodenoscope, a medical device used to treat pancreatic and biliary blockages due to gallstones or tumors, has to curve to reach some remote corners of the patient’s body, but in those corners harmful bacteria may accumulate.
So, the duodenoscope was either not disinfected properly or the cleaning procedures provided by the manufacturer were flawed, experts claim.
Over the last two years, FDA received nearly 80 medical reports about superbug infections caused by duodenoscope procedures which affected 135 patients. At UCLA two patients recently died, while nearly 180 more were exposed to CRE. At the Virginia Mason Medical Center, eleven patients died, while 35 acquired an infection.
Medical device experts think that the main culprit for the bacterial infections may be the end of the duodenoscopes which may harbor hard-to-reach bacteria even after the proper cleaning procedures.
“You can very easily do everything right and still have some contamination. We’re finding this is a problem, but it’s probably one that we don’t have a very good solution to right now,”
explained Dr. Deverick Anderson from the Duke University.
Olympus, the manufacturer of duodenoscopes, recommends that health providers follow a stricter cleaning protocol when dealing with these devices. Especially the Olympus TJF-Q180V duodenoscope requires additional manual cleaning for an effective disinfection, according to the company.
Last week, the FDA announced that it didn’t plan to recall the duodenoscope involved in the CRE infections because the risk of acquiring the superbug is still incredibly low. As a comparison, every year nearly 500,000 Americans undergo an endoscopic procedure, while only a few hundreds got infected in the past couple of years.
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