Overview of duodenoscope
Duodenoscope is hollow, flexible, lighted tubes that allow doctors to view the patient’s small intestine or upper part of the duodenum. They are used by doctors in endoscopic retrograde cholangiopancreatography (ERCP) procedures. These tools can help doctors diagnose and treat serious, often fatal conditions, such as cancer or gallstones in the pancreas and bile ducts. The advantage of these procedures is that they are less aggressive than conventional surgery.
Each year, more than 500,000 Americans undergo duodenoscopes for ERCP procedures, according to the Food and Drug Administration website. However, Olympus, Japan’s largest manufacturer of duodenoscopes, told the Los Angeles Times that the number was approaching 700,000.
Some conditions diagnosed or treated by duodenoscopes are:
- Gallstones (a small mass that forms in the gallbladder and can get trapped in the bile duct).
- Injury or surgical complications to the bile or pancreatic vessels.
- Tumours or cancers of the bile ducts.
- Acute pancreatitis (inflammation of the pancreas).
- Chronic pancreatitis.
- Pancreatic pseudocysts (fluid-filled shock to the abdomen).
- Pancreatic tumours or cancers.
These devices play an important role in detecting and treating disease and are generally safe.
How duodenoscopes work
Doctors insert flexible, snake-shaped duodenoscopes into the mouth and pass through the throat, stomach, and upper intestine, also known as the duodenum. These endoscopes are different from the usual endoscopes used in procedures such as colonoscopies and are particularly useful for ERCP procedures.
Since duodenoscopes allow direct access to bile or pancreatic vessels, they are much more complex than other endoscopes. In addition to the small, illuminated camera on the tip, the duodenoscopes have a lever with a joint called an elevator mechanism. This additional feature makes it possible to increase or decrease the range of the physician’s equipment for performing biopsies and other sensitive procedures in the bile and pancreatic vessels.
Superbug infections and design flaws
In late 2013, the CDC warned the FDA about a possible link between endoscopes and multi-drug resistant bacteria (MDR), bacteria that are resistant to many antibiotics.
The first American event was held in Los Angeles County at the University of California at Los Angeles Medical Center. The family of bacteria found in the gastrointestinal tract is called carbapenem-resistant enterobacteriosis (CRE), which causes spread.
Doctors consider CRE infections to be “superbugs” because they are resistant to antibiotics and associated with a high death rate. According to the West Virginia Department of Health and Human Resources, the death rate for patients with CRE infection is approximately 50 per cent.
Tragedy Prevention: Superbugs and Medical Device Security Files The report, titled Ineffective Patient Monitoring, lists several flaws that allow it to spread.
How to scope design leads to infection
The risk of superbug infections is higher with duodenoscopes than other types of endoscopes because of their design. The scopes contain many small parts that make them more difficult to clean, a procedure called reprocessing, according to the FDA. Gut bacteria can collect in these small, movable parts. Because doctors reuse the scopes, bacteria left on the scope after cleaning may transfer from patient to patient. These bacteria can lead to serious superbug infections like CRE.
One of the parts where bacteria are most likely to collect is the elevator mechanism, according to The American Gastroenterological Association. In 2015, the AGA convened a meeting with regulators, manufacturers and doctors called “Getting to Zero” to discuss the problem of infection.
FDA regulatory measures
The FDA investigated the outbreak in 2013 but directed the makers of Scope to conduct further studies through 2015. These post-marketing surveillance studies are needed to collect data on how healthcare workers cleaned duodenoscopes “in settings around the world.
In December 2018, the FDA provided a safety dialogue with an update on these post-marketing studies. It also found “higher-than-expected contamination rates” for equipment even after cleaning. The results showed that 3% of the hits were positive for “less anxious organisms”. Another 3 per cent tested positive for “very anxious organisms.”
FDA statement said the results showed that the manufacturer’s instructions “were not sufficient” to prevent all infections. But it emphasizes that the patient is less likely to get an infection from the ERCP method.
The Health, Education, Work, and Pensions Committee criticized the FDA’s inaction. Avoidable tragedies: Patients report ineffective control of superbugs and the safety of medical devices, and the agency “wastes valuable time” trying to clean data from manufacturers. The committee said the agency had spent a lot of time ruling out mistakes made by hospital staff in maintaining cleanup procedures for contamination.