The FDA announced in January 2016 that Olympus America was recalling its TJF-Q180V duodenoscope because of concerns about contamination leading to serious antibiotic-resistant bacterial infections. In an effort to reduce the risk of infection, Olympus updated the product with a new design and labeling modifications.
Duodenoscopes are small, tube-like medical devices used to diagnose and treat health problems in the liver, bile ducts and pancreas. They are designed to be cleaned and reused. However, over the past few years, despite following the manufacturer’s instructions on cleaning, many hospitals reported duodenoscope-related infection outbreaks. Some patients died from these serious infections.
Now, a new UCLA study has identified risk factors for bacteria transmission from tainted scopes. Researchers hope the study results will help to reduce the risk of future bacterial outbreaks.
Researchers Identify Factors that Increase Risk of Duodenoscope Infection
The study was published in the journal Gastrointestinal Endoscopy, and involved data from 104 patients at the Ronald Reagan UCLS Medical Center. Eight patients at their facility were sickened in 2015, and three died because of contaminated duodenoscopes.
Doctors at the center had traced the outbreak to two duodenoscopes, finding that one patient had undergone two separate procedures with a different scope each time, and all those that developed infections had undergone procedures with one of two reusable scopes.
In this study, the doctors sought to evaluate why only some of the patients exposed to these duodenoscopes became infected. All of these patients had gone through procedures with those two specific contaminated duodenoscopes, but only some acquired the serious carbapenem-resistant enterobacteriaceae (CRE) infection.
Analysis of the data showed that about 14.4 percent of the patients developed an active infection. Risk of infection increased with the following factors:
1. If a stent was placed in the bile duct using a tainted scope
2. If the patient had a history of bile duct cancer
3. If the patient was a hospital inpatient at the time of the procedure
Researchers stated that their findings were not surprising, as inserting a stent via the scope into the bile duct provided a space for bacteria to grow. They also noted that a bile duct tumor in a cancer patient could cause a blockage that fostered bacteria growth.
The scientists called for doctors to use enhanced-level disinfection techniques to reduce the risk of spreading infection, and to consider specific patients who could be at an increased risk of CRE infection.
Duodenoscopes Sicken 250 People Worldwide
The outbreak that occurred at Ronald Reagan UCLS Medical Center was only one of many. In 2016, the U.S. Health, Education, Labor, and Pensions Committee released a report noting that the scopes had been linked to antibiotic-resistant infections that sickened at least 250 patients worldwide. The hospitals and medical centers affected by these outbreaks included the New York-Presbyterian/Weill Cornell Medical Center, the UMass Memorial Medical Center, the Advocate Lutheran General Hospital in Illinois, the Virginia Mason Hospital and Medical Center in Seattle, and the Harford Hospital.
According to the report, Olympus was aware as early as 2013 that their duodenoscopes could harbor and spread bacteria even after cleaning according to the manufacturer’s instructions, but they didn’t alert the FDA or hospitals until February 2015.