For the treatment of gallstones, gallbladder disease, and pancreatic conditions, doctors often use a duodenoscope to see the uppermost reaches of a patient's small intestine, or duodenum. Doctors use duodenoscopes routinely for endoscopic retrograde cholangiopancreatography (ERCP) procedures. They are flexible, hollow, lighted tubes. The advantage of these procedures is that they are less invasive and traumatizing than traditional surgery.Each year, Americans undergo more than 500,000 ERCP procedures using duodenoscopes, according to the U.S. Food and Drug Administration’s website. Though, the biggest manufacturer of duodenoscopes — Japan-based Olympus — told the Los Angeles Times that the number was closer to 700,000. Now, duodenoscopes are being looked at more closely by the U.S. Food and Drug Administration as pieces have fallen off and remained in patients’ bodies.
Prior to this finding, the FDA had expressed concern about duodenoscopes because they present difficulties in keeping them sanitary. They may spread E. coli bacteria between patients. To combat the spread, hospitals switched to disposable tips to cover the camera and reduce bacteria. Now, new issues are appearing. Those produced by Olympus Medical Systems have fallen off in patients’ mouths and stomachs, according to reports filed with the FDA. Some have sharp edges, which has led to internal bleeding in patients, according to The New York Times.
There have been about 160 complaints reported to the FDA about the caps falling off. That “was above the expected numbers for that type of complaint,” according to an analysis from Olympus.
The FDA sent a warning letter to the company after an inspection at the Olympus plant in Tokyo late last year. The agency has said the company’s responses were “not adequate,” according to The Times. “The FDA does not agree that the risk to the patient is of a low enough risk to not warrant further action at this time,” the agency said.
Olympus spokeswoman,Jennifer Bannan, said the company has taken measures to address the problems, and that these actions will be further evaluated and expanded. “Olympus takes this warning letter very seriously,” she said in a statement emailed to The Times. “The company is working diligently to address the issues raised in the letter in a timely manner.”
Duodenoscopes also have a higher risk of transmitting superbug infections than traditional endoscopes due because of their design. The duodenoscopes have many small parts that make cleaning difficult. The sanitation of these parts is called reprocessing, according to the FDA. Gut bacteria can collect in these small parts. .
In a press release from the AGA, "The problem of this infection transmission lies in the complex design of the elevator channel in duodenoscopes, which can allow bacteria to remain after cleansing, even if reprocessing follows currently accepted procedures developed and approved by the manufacturers and FDA."
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