What’s the future of single-use endoscopes?
BY V. RAMAN MUTHUSAMY, MD, MAS
Single-use endoscopes have been proposed as a definitive solution to the risk of endoscope-transmitted infections. While these infections have been reported for several decades, they have traditionally been associated with identified breaches in the reprocessing protocol. In 2015, numerous cases of duodenoscope-transmitted infections were reported after endoscopic retrograde cholangiopancreatography (ERCP) procedures. Many, if not most, of these cases were not associated with identified deviations from standard high-level disinfection protocols and occurred at high-volume experienced facilities. A subsequent FDA postmarket surveillance study found contamination rates were linked with potentially pathogenic bacteria in approximately 5% of duodenoscopes. Thus, amid growing concerns about the ability to adequately clean these complex devices, these events prompted the development of single-use duodenoscopes. Given the multifactorial causes leading to contaminated duodenoscopes, the advantages of such single-use devices are their ability to ensure the elimination of the potential of infection transmission as these devices are never reused. In addition to this primary benefit, the ability to create single-use devices could lead to more easily available specialty scopes and allow variations in endoscope design that could improve ergonomics. Single-use devices may also expand the ability to provide endoscopic services by eliminating the need for device reprocessing equipment at low-volume sites. However, several concerns have been raised regarding their use, especially if it were to become widespread. These include issues of device quality and performance (potentially leading to more failed cases or adverse events), cost, their environmental impact and current uncertainty regarding their indications for use. Furthermore, new alternatives such as reusable devices with partially disposable components or future low-temperature sterilization options may minimize the need for such devices. We will briefly discuss these issues in more detail below.
Dr. V. Raman Muthusamy
Given that nearly all cases of GI device–transmitted infections where standard reprocessing protocols were followed have occurred in duodenoscopes, I will focus on single-use duodenoscopes in this article. It is important that we reassure our patients and colleagues that standard reprocessing appears to be extremely effective with all other types of devices, including elevator containing linear echoendoscopes. Studies investigating the causes of why duodenoscopes have primarily been associated with device-transmitted outbreaks have focused on the complexity of the elevator including its recesses, fixed end-cap and wire channels. However, culturing has shown that up to one-third of contamination may occur in the instrument channels or in the region of the biopsy cap, leading to some potential residual sites of infection even when newly developed reusable devices with disposable elevators/end-caps are utilized.1 Another challenge with reprocessing is the ability to prove residual contamination does not exist. While culturing the devices after reprocessing is most used, it should be noted many sites with outbreaks failed to culture the culprit bacteria from the devices as accessing the sites of contamination can be challenging. The use of other markers of residual contamination such as ATP and tests for residual blood/protein have yielded variable results. Specifically, ATP testing has not correlated well with culture results but may be helpful in assessing the quality of manual cleaning.2
These challenges have made the concept of single-use devices more appealing given the lack of a need reprocess devices or validate cleaning efficacy. Currently, there are two FDA-approved devices on the market, but the published literature to date has largely involved one of these devices. To date, in four published studies that have assessed the clinical performance of single-use duodenoscopes in over 400 patients, procedural success rates have ranged from 91% to 97% with adverse event rates and endoscopist satisfaction scores comparable to reusable devices. Most of these users were expert biliary endoscopists and more data are needed regarding the performance of the device in lower-volume and nonexpert users. While indications for use in these studies have varied, I feel that there are four potential scenarios to utilize these devices: in patients with known multidrug-resistant organisms undergoing ERCP; to facilitate logistics/operations when a reusable device is not available; in critically ill patients who would not tolerate a scope-acquired infection; and in procedures associated with a risk of bacteremia.
While preliminary data suggest single-use duodenoscopes are safe and effective in expert hands, concerns exist regarding their implementation more broadly into clinical practice. First, the devices cost between $1,500-3,000, making them impractical for many health systems. One study estimated the break-even cost of the device to be $800-1,300 based on variation in site volume and device contamination rates.3 However, it should be noted that current enhanced reprocessing protocols for reusable devices may add an additional $75,000-$400,000 per year based on center volume.4 In the United States, there is currently payment by federal and some commercial payors that cover part or all of the device cost, but whether this will continue long-term is unclear. In addition, there is significant concern regarding the environmental impact of a broader mover to single-use devices. Reprocessing programs do exist for these devices, but detailed analyses regarding the environmental effects of a strategy using single-use versus reusable devices and the waste generated from each are needed.
Finally, while primarily created to avoid device-related infection transmission, other benefits can be realized with single-use devices. The potential for ergonomic enhancements (variable handle sizes or shaft stiffness, R- and L-handed scopes) as well as the creation of specialty devices (extra-long or thin devices, devices with special optical or rotational capabilities) may become more feasible with a single-use platform. Finally, the pace of endoscopic innovation and refinement is likely to quicken with a single use platform, and new advancements can be incorporated in a timelier manner.
Conclusion
In summary, I believe single-use devices offer the potential to improve the safety of endoscopic procedures as well as improve procedural access, enhance ergonomics, and foster and expedite device innovation. However, reductions in cost, refining their indications, and developing recycling programs to minimize their environmental impact will be essential before more widespread adoption is achieved.
Dr. Muthusamy is a professor of clinical medicine at the University of California, Los Angeles, and the medical director of endoscopy at the UCLA Health System. He reported relationships with Medtronic, Boston Scientific, Motus GI, Endogastric Solutions, and Capsovision.
References
1. Bartles RL et al. Gastrointest Endosc. 2018 Aug;88(2):306-13.e2.
2. Day LW et al. Gastrointest Endosc. 2021 Jan;93(1):11-33.e6.
3. Bang JY et al. Gut. 2019 Nov;68(11):1915-7.
4. Bomman S et al. Endosc Int Open. 2021 Aug 23;9(9):E1404-12.
