Dr. Muthusamy is a Professor of Clinical Medicine at the David Geffen School of Medicine at UCLA and the Medical Director of Endoscopy for UCLA Health.
Over the past half decade, there has been tremendous innovation in the design of duodenoscopes, including single use devices, to reduce the risk of transmission of infections from these devices. At present, it is unclear what the preferred long-term solution will be, but single use devices have the potential to play an important role in improving the safety of ERCP.
Since 2015, there has been a surge of innovation regarding the reprocessing of duodenoscopes. In 2019, the FDA recommended that “hospitals and endoscopy facilities transition to innovative duodenoscope designs to help improve cleaning and reduce contamination between patients, including designs with disposable caps or distal ends.”1 However, it is unclear if using reusable devices with disposable tips or elevators will suffice or if maximizing patient safety will require transitioning to single-use duodenoscopes. While the majority of contamination of devices appears to occur at the elevator and distal cap, there is data suggesting contamination may occur in the instrument channel.2 It is unclear if moving to a model utilizing reusable devices with distally detachable components will be sufficient if improvements in cleaning and reprocessing of the instrument channel are not also achieved. While the current evidence is limited, one preliminary study does appear to show a reduction in average ATP levels post-reprocessing using devices with a disposable endcap.3
The advantages of products that seal or protect the distal tip of the duodenoscope or devices that have disposable distal components such as caps and elevators are that they will likely preserve the current model of device reprocessing and reusage and will likely be less expensive than a single-use approach. However, as noted above, such an approach may not completely eradicate the risk of instrument channel associated defects or biofilm development. Furthermore, continued reprocessing of these devices with HLD will likely incur additional costs due to increased observation/monitoring of the manual cleaning steps and verification of the adequacy of these steps as well as the overall HLD process. Unfortunately, no current gold standard exists that accurately documents the adequacy of reprocessing after high level disinfection. This is a major challenge in comparing competing technologies and approaches, as well as ensuring that devices are fully decontaminated. A future low temperature sterilization technique that is proven to be feasible, safe and effective could solve many of these challenges, but currently this option does not exist. Thus, the advantage of single-use devices is that these challenges are eliminated and the potential for device transmitted infections to patients is eradicated since it is only used in one patient.
In addition to the benefits regarding infection prevention, single-use devices offer other potential benefits. These include the ability to develop specialty or customizable devices, including those that may have stiffer or more flexible insertion tubes, right or left-handed versions, customizable handle/knob sizes and the possibility for rapid adaptations to be developed. Future devices may also incorporate additional features such as customization designed to facilitate usage based on patient position (supine vs. prone) or devices with multiple cameras (forward and oblique) to aid in scope advancement in angulated or altered upper GI anatomy. However, multiple disadvantages exist and these include cost, medical waste and concerns on whether performance will be comparable to existing reusable devices. Preliminary studies have suggested acceptable and comparable performance4,5,6,7, but further data are needed, especially among less expert users. Costs are currently high but are likely to decline with increased market competition as well as with growing clinical adoption due to economy of scale. Finally, ongoing recycling efforts for these devices are being developed and but will need time to become fully established in the years to come.
In my opinion, there are four major potential indications for single-use devices. The first and most obvious clinical scenario involves using them in patients with known or suspected multi-drug resistant organisms to avoid device contamination that could subsequently infect other patients. A second possible indication would be to use them in patients who are critically ill who would not be able to withstand a scope acquired infection,such as immunosuppressed patients (organ transplant recipients, those undergoing chemotherapy to treat a malignancy, or who are in the ICU with sepsis). A third category would be those who are undergoing procedures that carry an increased risk for post-procedure bacteremia or device-related infection transmission. These include the use of cholangioscopy, the performance of biliary brushing or ablation techniques or biliary stent placement, which has been shown in two studies at sites of outbreaks to be associated with an increased risk of device-associated infection transmission.8,9 Finally, single-use devices would facilitate logistics by providing an available device during the weekend/nights when a device or reprocessing capabilities may not be readily available. This could include intra-operative procedures where a sterile scope may be preferred, at low-volume satellite facilities that may not have on-site reprocessing capabilities or as a backup to the reusable fleet on unusually busy days.
While I believe it is too soon to predict exactly which device types will be used predominantly, it is quite likely that at least the transition to devices with disposable distal components is permanent and that single-use devices will likely play an increasing role in our care for patients with pancreaticobiliary diseases.
Disclosures
Dr. Muthusamy has received consulting fees from Boston Scientific, Interpace Diagnostics, Medivators and Medtronic. He has been a speaker for Torax Medical (now Ethicon, part of the Johnson & Johnson Medical Devices Companies). He has ownership interest in Capsovision.