Single-use gastroscopes: evolution, revolution, or involution?

Evolution signifies gradual improvement or steady adaptation. Revolution, by contrast, marks a radical shift, transforming the norm. Involution is a reversion inward, often with regressive outcomes. The emergence of single-use gastroscopes leads us to question whether this is truly a revolutionary innovation or a potential step backward.

“This overemphasis on infection risk, especially in gastroscopes where the risk is even lower than for duodenoscopes, questions whether single-use devices are indeed necessary from a safety standpoint.”

The introduction of single-use scopes was in response to a modern priority in endoscopy: the need to reduce infection risk. Under the promise of “net-zero” infection risk, single-use endoscopes have entered the market, with the aim of addressing the limitations of reusable devices. Reusable endoscopes, mainly duodenoscopes, have been associated with biofilm formation and the possibility of reprocessing errors, presenting potential contamination risks [1]. Single-use devices eliminate this risk by design, as they are discarded after each use. In addition, they could offer logistical advantages by avoiding downtime, reducing the need for reprocessing staff, and offering greater procedural flexibility.

The study by Römmele et al. in this issue of Endoscopy provides critical insight into this topic by evaluating the performance of the Ambu aScope Gastro Large (Ambu, Bad Nauheim, Germany), which features a 4.2-mm working channel and an outer distal diameter of 11.5 mm, comparable to standard reusable therapeutic gastroscopes [2]. Despite being a pilot study, the work by the Augsburg team in Germany offers valuable data. This study, the first of its kind for this device, presents initial data on its performance in clinical practice, reporting an 84% technical success rate (16 of 19 cases). The procedures included bleeding control, esophageal stenting, cryoablation, pancreas necrosectomy, and foreign body removal. Three cases required a crossover to a reusable gastroscope due to issues with poor visibility, occlusion of the suction channel by coagulum, and, in one instance, to facilitate the placement of an over-the-scope clip. User feedback revealed only fair satisfaction for the use of the endoscope. Handling (lacking stiffness) and image quality with risk of fogging were raised as the main concerns. These technical limitations align with earlier studies that reported similar challenges with single-use gastroscopes, particularly with image resolution and device maneuverability [3] [4].

The authors clearly acknowledge the study’s limitations. The sample size of 19 is a significant constraint, yielding a 95%CI for technical success that ranges from 63% to 95% (not provided by the authors). This wide interval underscores the uncertainty around these findings. At the same time, the lower bound of the 95%CI presents an unacceptably low margin for considering this technology ready for our daily practice. Some may argue that technical success should equate to that of reusable endoscopes if single-use devices are to replace reusable endoscopes. In other words, single-use gastroscopes have not yet achieved the adaptability required to replace reusable devices in therapeutic procedures.

Given the low number of examinations, some may question whether the results are valid. They likely are! The user feedback from multiple endoscopists should provide a more generalizable impression. One-sided bias seems less likely, as the broad response ranges (spanning the entire Likert scale) suggest that any potential bias went both ways. While most endoscopists used the endoscope only once or twice and may not have appreciated its full potential (possible learning curve), technical issues are less subjective and remain a concern.

Sustainability emerges as a critical factor in evaluating single-use scopes, and we must ask ourselves whether the promise of infection control is worth the environmental cost. In a recent study by Pioche et al., the carbon footprint of single-use gastroscopes was estimated at 10.9 kg CO₂ eq. per use, compared with 4.7 kg CO₂ eq. for reusable gastroscopes – a 2.3-fold greater footprint. This discrepancy – equivalent to a 28-km drive or 6 days of household emissions – presents a substantial environmental impact. Although eliminating reprocessing reduces water consumption, the production and disposal of single-use scopes significantly increase carbon emissions [5].

Moreover, is the infection risk associated with endoscopy reprocessing a genuine public healthcare issue? A systematic review identified 24 multidrug-resistant bacteria outbreaks and reported 32 deaths due to duodenoscope-related infections worldwide between 2008 and December 2018 [6] [7]. To put this into perspective, the likelihood of dying from a lightning strike in the USA appears much higher than that from an endoscopic retrograde cholangiopancreatography-related infection. Between 2006 and 2021, 444 lightning-strike fatalities occurred in the USA [8], highlighting how rare these adverse outcomes actually are. This overemphasis on infection risk, especially in gastroscopes where the risk is even lower than for duodenoscopes, questions whether single-use devices are indeed necessary from a safety standpoint. So, while single-use scopes could offer a relative risk reduction in endoscopy-related infection incidence, the absolute risk reduction is extremely low.

One might wonder whether we are, in fact, facing an involution – a step backward when the full picture is considered. “New isn’t always better,” as the saying goes, and this encourages us to assess innovations not only for their immediate benefits but also for their broader consequences. Looking ahead, we will likely see a refinement of the technical aspects of single-use scopes to enhance their applicability, alongside efforts to develop sustainable manufacturing and disposal solutions. Larger and randomized studies will also likely emerge to further validate their role across diverse clinical settings. However, the potential benefit in reducing infection risk is unlikely to be demonstrated through randomized controlled trials, as the required sample size would be enormous, making such studies unfeasible. The inclusion of sustainability impact is essential in future studies, reflecting a current demand within the medical community [9] [10].

In summary, single-use gastroscopes present an intriguing development, with theoretical benefits for infection control and operational flexibility. However, their environmental footprint and the actual clinical relevance of infection prevention must be carefully weighed. Whether this represents evolution, revolution, or involution in endoscopy will depend on our ability to align technological advancements with sustainability and real clinical need.

Publication History

Article published online:
11 December 2024

• References

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