Over the past five years, practicing endoscopists have become acutely aware of the risk to patients from duodenoscope contamination related to the fact that these instruments can continue to harbor bacteria despite adherence to reprocessing protocols recommended by endoscope manufacturers. This conundrum is ultimately distilled for patients as an unquantifiable risk of intestinal colonization and/or infection due to exogenous bacterial transmission. For physicians and health care institutions, the issue remains murky and fraught with misstep as they struggle to implement protective practices based on constantly evolving recommendations from manufacturers and regulatory agencies.
Recently, the FDA recommended that health care facilities transition from fully reusable duodenoscopes to scope models featuring disposable parts, such as duodenoscopes with detachable single-use distal end caps. The disposable cap model theoretically facilitates enhanced manual cleaning around this problematic area, as retention of bioburden around the elevator has proven to be one of a number of potential reprocessing pitfalls. Two duodenoscope manufacturers have received FDA approval for duodenoscope models featuring the detachable distal end cap — the PENTAX Medical ED34-i10T duodenoscope (DEC™) and the FUJIFILM Corporation duodenoscope model ED-580XT (approved in November and March of 2019, respectively). Such advances in device design may lessen the contamination risk imposed by the elevator per se, but fail to attenuate the potential risk of reprocessing failures — for any reason — within other areas of the duodenoscope.1 Ultimately post-marketing studies will play a crucial role in determining the magnitude of risk reduction imparted by this device modification.
A single-use, fully disposable duodenoscope materialized in 2018 (Exalt Model DTM, Boston Scientific Corp, Natick MA). In a bench-top model, the disposable instrument was compared against three different models of standard reusable duodenoscopes and demonstrated comparable task completion and usability in expert hands.2 A first-in-human study followed, demonstrating that expert endoscopists could complete an Endoscopic retrograde cholangiopancreatography (ERCP) in 68 out of 70 patients using the disposable duodenoscope, accounting for all four ASGE grades of ERCP complexity.3 Two cross-overs to a conventional duodenoscope were required for successful cannulation.
Ultimately post-marketing studies will play a crucial role in determining the magnitude of risk reduction imparted by this device modification.
Theoretically, using only single-use duodenoscopes would entirely eliminate the risk of patient cross-contamination. In reality, implementation of this technology raises important questions and concerns related to cost, clinical productivity, inventory management (especially at higher volume centers) and environmental impacts. Performance characteristics and financial viability are two of the key determinants that will influence adoption of such a potentially disruptive technology. Determining financial viability will require that health care organizations develop relevant cost-analyses (with or without assistance from industry) that consider expenses related to purchase/lease of reusable duodenoscopes, staff time and materials required for reprocessing, maintenance and repair costs, expenses related to culturing/monitoring programs, in addition to potential monetary and non-monetary costs associated with a duodenoscope-related outbreak or event (reputational damage, litigation, etc.). Implementing single-use scopes obviates many of the aforementioned costs. Bang et al reported that the break-even cost for disposable duodenoscopes varies based on the ERCP procedure volume and also infection rates related to reusable duodenoscopes. According to their particular analysis, the break-even cost for low- and high-volume ERCP facilities were more than $1,300 and more than $800, respectively.4 At a competitive price point, implementation of single-use technology would likely be universal if one overlooks other potential pitfalls (technical and environmental).
Replacement of an entire reusable inventory (or part of it) for a cadre of fully disposable duodenoscopes also merits consideration of the following: presence or absence of on-site dedicated endoscope reprocessing staff and the facility’s physical infrastructure (presence of adequate space for storing bulky, single-use endoscope inventory). Also, facilities that treat patients at higher risk for bacterial colonization or infection following exposure to a contaminated scope might be more inclined to become early adopters of novel duodenoscope technologies.5 Ultimately, this is a rapidly changing space; competition for the Exalt-D disposable duodenoscope will enter the marketplace, and we will likely see additional iterative and disruptive technologies designed to decrease endoscope infection risk. Although the recent FDA recommendation pertains to changes in endoscope design, anticipated advancements in the field may also address aspects related to duodenoscope reprocessing, including opportunities to reduce the chance for human error, mistake-proofing of the HLD process and the introduction of quality controls that provide verification of reprocessing effectiveness.
Many centers have overcome substantial logistical and financial tribulations to meet evolving federal standards pertaining to duodenoscope management. Despite that, most programs would likely adopt a risk-reduction strategy for which there was robust, high-quality evidence demonstrating real-world effectiveness, usability (in the hands of all proceduralists) and fiscal soundness. Currently, absent such data, early adopters of these novel duodenoscope designs must be imbued with the hope that subsequent studies will confirm these to be true.
- The FDA recently issued a recommendation that health care facilities transition to duodenoscope models featuring disposable parts, in an effort to mitigate risk of duodenoscope transmission of bacteria.
- Two recent duodenoscope technologies are ready for prime time use: (1) detachable distal end caps which may improve access to the elevator during cleaning and disinfecting of traditional multi-use duodenoscopes, and (2) fully disposable duodenoscopes.
- Regulatory clearance for the duodenoscopes with detachable distal end caps were largely based on similarity to predicate devices (traditional duodenoscopes); to date, there is limited post-market information about the degree to which this innovation impacts the safety margin of multi-use duodenoscope reprocessing.
- Fully disposable duodenoscopes could eliminate duodenoscope-related transmission of bacteria. Key questions remain regarding the financial and logistical viability of full or partial adoption for low- and high-volume ERCP centers.
Drs. Higa, Ross and Tokar have no conflicts to disclose.
1. Thaker A.M., Kim S., Sedarat A., Watson R.R., Muthusamy V.R. Inspection of endoscope instrument channels after reprocessing using a prototype borescope. Gastrointestinal Endoscopy. 2018;88(4):612-619.
2. Ross A.S., Bruno M.J., Kozarek R.A., et al. A novel single-use duodenoscope performs similarly to 3 models of reusable duodenoscopes for endoscopic retrograde cholangiopancreatography: a randomized bench-model comparison.Gastrointestinal Endoscopy. 2019. Article in press.
3. Muthusamy V.R., Bruno M.J., Kozarek R.A., et al. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2019; Article in press.
4. Bang J.Y., Sutton B., Hawes R., Varadarajulu S. Concept of disposable duodenoscope: at what cost? Gut. 201968:1915-1917.
5. Kim S., Russell D., Mohamadnejad M., et al. Risk factors associated with the transmission of carbapenem-resistant Enterobacteriaceae via contaminated duodenoscopes. Gastrointestinal Endoscopy. 2016;83(6):1121-1129.