Antibiotic-resistant infections have become a major problem in hospitals and healthcare facilities. One of the sources of such infections is the use of contaminated medical devices, including the duodenoscope. A duodenoscope is a specialized endoscope used for visualizing, diagnosing, and treating conditions of the pancreas and bile ducts.
The device is inserted through the mouth into the duodenum, the first section of the small intestine. However, duodenoscopes have been found to be difficult to clean and disinfect, which has led to the spread of antibiotic-resistant bacteria among patients.
The prevalence of antibiotic-resistant bacteria in healthcare settings has been increasing, leading to a rise in hospital-acquired infections and deaths. The Center for Disease Control and Prevention (CDC) reports that each year, more than 2 million people in the United States are infected with antibiotic-resistant bacteria, and at least 23,000 people die as a result.
ne of the major contributors to the spread of antibiotic-resistant bacteria is the overuse and misuse of antibiotics, which leads to the evolution of resistant strains of bacteria. However, contaminated medical devices also play a role in the transmission of these bacteria.
Duodenoscopes have been cited as one of the main sources of healthcare-associated infections caused by antibiotic-resistant bacteria. The design of the device, which allows for the insertion of instruments into a narrow channel, makes it difficult to clean and disinfect. In addition, the device is used to perform procedures in the pancreas and bile ducts, which are areas of the body that are normally sterile. This makes it especially important to ensure that the device is completely free of bacteria before it is used on another patient.
In 2015, duodenoscopes were found to be responsible for an outbreak of antibiotic-resistant infections at UCLA’s Ronald Reagan Medical Center. The infections, which were caused by carbapenem-resistant Enterobacteriaceae (CRE), resulted in the deaths of two patients and the infection of seven others. Upon investigation, it was found that the duodenoscopes used in the procedures were contaminated with the bacteria, and that the cleaning and disinfection protocols used by the hospital were insufficient to remove the bacteria from the devices.
Following the outbreak at UCLA, the FDA issued a safety alert warning healthcare providers about the risk of antibiotic-resistant infections associated with the use of duodenoscopes. The alert recommended that healthcare providers consider using alternative devices, or that they implement additional measures to reduce the risk of infection. The FDA also recommended that healthcare facilities use duodenoscopes with disposable components, such as disposable end caps, to reduce the risk of transmission of bacteria.
In response to the outbreak at UCLA, several hospitals and healthcare systems began using sterilization techniques that were more effective than those recommended by the duodenoscope manufacturers. One such technique, known as hydrogen peroxide gas plasma sterilization, was found to be effective in eliminating the bacteria from the devices. However, this technique was not approved by the FDA or the manufacturers of the duodenoscopes.
In 2018, the FDA approved the first duodenoscope with disposable components, the Pentax Medical Video Duodenoscope ED34-i10T2. This device features a single-use distal cap, which covers the end of the device and prevents the accumulation of bacteria. The distal cap is removed and disposed of after each use, and the rest of the device is cleaned and disinfected according to standard protocols. This device represents a significant step forward in preventing the transmission of antibiotic-resistant bacteria through duodenoscopes.
Despite the availability of devices with disposable components, the majority of duodenoscopes used in the United States are still the older models that require more labor-intensive and time-consuming cleaning and disinfection protocols. In addition, there is still the risk of transmission of bacteria from patients to healthcare workers, and from patients to other patients, even with the use of disposable components. This underscores the need for continued vigilance and attention to infection prevention in healthcare settings.
In addition to the use of devices with disposable components, other measures can be taken to reduce the risk of transmission of antibiotic-resistant bacteria through duodenoscopes. These include improving cleaning and disinfection protocols, implementing more frequent testing for bacterial contamination, and using antibiotics sparingly to reduce the likelihood of developing antibiotic-resistant strains of bacteria. In addition, healthcare providers can employ infection control measures such as hand hygiene and isolation precautions to minimize the spread of bacteria.
In conclusion, antibiotic-resistant bacteria pose a significant threat to the health and well-being of patients in healthcare facilities. The use of contaminated medical devices, such as duodenoscopes, is one of the sources of infections caused by these bacteria. The development of duodenoscopes with disposable components represents a significant step forward in preventing the transmission of antibiotic-resistant bacteria through these devices.
However, continued vigilance and attention to infection prevention measures are needed to further reduce the risk of transmission and ensure the safety of patients. Healthcare providers, manufacturers of medical devices, and regulatory agencies all have a role to play in minimizing the risk of infections caused by antibiotic-resistant bacteria.