Duodenoscopes and Infection Control: The Role of SPD in Enhancing Duodenoscope Safety

 

By Martin Li, MA, CRCST, CER, CIS, CHL

 

 

Introduction

A duodenoscope is a hollow, flexible, lighted tube that allows doctors to see the top of a patient’s small intestine, known as the duodenum. These specialized scopes are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. During ERCP, doctors insert the duodenoscope through the mouth, passing it through the throat, stomach, and into the duodenum. This procedure provides direct access to the bile or pancreatic ducts, allowing treatment for conditions like gallstones, inflammation, tumors, or cancers [1]. Duodenoscopes are invaluable tools in modern healthcare, particularly in procedures such as endoscopic retrograde cholangiopancreatography (ERCP), where they play a critical role in diagnosing and treating conditions related to the pancreas, bile ducts, and gallbladder. These flexible, lighted tubes allow physicians to access the duodenum and perform intricate procedures that would otherwise require invasive surgery. Despite their importance, duodenoscopes have been at the center of several infection outbreaks over the past decade, primarily due to design flaws that complicate the reprocessing procedure. As Sterile Processing Department (SPD) educators, it is crucial to understand these challenges and the necessary infection control measures to mitigate risks associated with these devices.

The Critical Role of Duodenoscopes in ERCP Procedures

 

ERCP procedures are among the most common therapeutic endoscopic procedures performed in the United States, with an estimated 500,000 to 700,000 procedures conducted annually. These procedures are less invasive alternatives to traditional surgery for diagnosing and treating conditions such as acute and chronic pancreatitis, gallstones, pancreatic pseudocysts, and tumors in the bile ducts and pancreas. The precision and effectiveness of ERCP are largely due to the advanced design of duodenoscopes, which allow direct visualization and access to the bile and pancreatic ducts [2].

Design Challenges and Infection Risks

 

The sophisticated design of duodenoscopes, while beneficial for medical procedures, presents significant challenges for reprocessing. Unlike standard endoscopes, duodenoscopes are equipped with a complex elevator mechanism that helps manipulate accessories used during procedures. This mechanism, along with the scope’s numerous small parts and intricate channels, creates multiple areas where organic material and bacteria can accumulate. Despite rigorous cleaning and sterilization efforts, these design elements have led to several cases of residual contamination, which in turn has caused outbreaks of antibiotic-resistant infections, commonly referred to as “superbugs” [3].

One of the most significant risks associated with duodenoscopes is the potential for contamination with carbapenem-resistant Enterobacteriaceae (CRE), a group of bacteria that are resistant to most antibiotics and can cause severe, often life-threatening infections. The elevator mechanism has been identified as a critical point of failure in the cleaning process. Even when following the manufacturer’s instructions for use (IFU) and adhering to standard reprocessing protocols, residual bacteria can remain trapped in the elevator channel, leading to cross-contamination between patients [4].

The Impact of Design Flaws on Patient Safety

The impact of these design-related infection risks became glaringly evident in the 2010s, when several hospitals across the United States reported outbreaks of multidrug-resistant organisms (MDROs) linked to duodenoscope use. Investigations by the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and a U.S. Senate Committee revealed that the complexity of duodenoscope reprocessing contributed significantly to these outbreaks. Between 2012 and 2015, over 190 cases of superbug infections were reported in the United States and Europe, all traced back to contaminated duodenoscopes. The infections were severe, with some resulting in patient fatalities [5].

The design flaws in duodenoscopes not only endanger patient safety but also place a heavy burden on healthcare facilities, which must balance the need for these critical devices with the imperative to prevent infection. The risks associated with duodenoscopes have led to numerous lawsuits, particularly against Olympus, the leading manufacturer, which controls approximately 85% of the U.S. market. These legal challenges underscore the need for ongoing scrutiny of device design and reprocessing practices [6].

Infection Control Strategies in SPD

Given the inherent risks associated with duodenoscopes, effective infection control in SPD is crucial. The following strategies are essential for mitigating the risks of contamination and ensuring patient safety:

1. Strict Adherence to Reprocessing Protocols: SPD professionals must meticulously follow the reprocessing protocols outlined in the IFU. This includes manual cleaning, high-level disinfection, and sterilization of all duodenoscope components, paying particular attention to the elevator mechanism and other areas prone to contamination. Where possible, automated endoscope reprocessors (AERs) should be used to enhance the consistency and effectiveness of cleaning and disinfection processes.
2. Enhanced Surveillance and Monitoring: Routine surveillance for signs of contamination and infection outbreaks is critical. This includes regular microbiological testing of reprocessed duodenoscopes to detect any residual bacteria. Any signs of contamination should trigger immediate reprocessing and investigation to prevent patient exposure.
3. Implementation of Single-Use Duodenoscopes: In response to the infection risks associated with traditional duodenoscopes, some manufacturers have developed single-use duodenoscopes. These disposable devices eliminate the need for reprocessing and significantly reduce the risk of cross-contamination. Healthcare facilities should consider incorporating single-use scopes into their practice, particularly for high-risk procedures or patients.
4. Education and Training: Continuous education and training of SPD staff are vital for maintaining high standards of infection control. Staff should be well-versed in the latest reprocessing techniques, understand the risks associated with duodenoscopes, and be able to recognize potential signs of contamination. Regular training sessions should also include updates on new technologies and best practices in scope reprocessing.
5. Collaboration and Communication: Infection control is a multidisciplinary effort that requires close collaboration between SPD, infection prevention teams, and healthcare providers. Open communication channels should be established to ensure that any concerns or issues related to duodenoscope reprocessing are promptly addressed. This collaborative approach is essential for maintaining a culture of safety and continuous improvement in infection control practices.

Moving Forward: The Role of SPD in Enhancing Duodenoscope Safety

The challenges associated with duodenoscopes underscore the critical role that SPD plays in protecting patient safety. As SPD educators, it is our responsibility to ensure that our teams are equipped with the knowledge, skills, and tools necessary to effectively reprocess these complex devices. This includes staying informed about the latest developments in scope design, reprocessing technology, and infection control guidelines.

Moreover, SPD must advocate for continuous improvement in device design and reprocessing protocols. This can be achieved by participating in industry forums, collaborating with manufacturers, and contributing to research efforts aimed at enhancing the safety and efficacy of duodenoscope reprocessing. By taking an active role in these initiatives, SPD can help drive innovation and ensure that patient safety remains at the forefront of healthcare practice.

Conclusion

Duodenoscopes are indispensable tools in the diagnosis and treatment of serious gastrointestinal conditions, yet their complex design poses significant infection control challenges. The outbreaks of superbug infections linked to these devices highlight the critical need for rigorous reprocessing protocols, enhanced surveillance, and ongoing education within SPD. By implementing best practices in infection control and advocating for continuous improvement, SPD professionals can mitigate the risks associated with duodenoscopes and ensure the safety of the patients they serve.

References

1.https://www.drugwatch.com/duodenoscope/

2.fda.gov - Infections Associated with Reprocessed Duodenoscopes

3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7671768/

4.cambridge.org - A prospective, multicenter, clinical study of duodenoscope contamination after reprocessing

5.https://journals.lww.com/ctg/fulltext/2020/08000/infection_control_in_endoscopic_retrograde.7.aspx

6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8697464/