Endoscope-associated infections are a major concern for healthcare providers. Long-standing data suggests that the closed loop workflow of a reusable endoscope is susceptible to insufficient cleaning or inappropriate storage. This can result in pathogens entering a patient’s body via a contaminated device, causing exogenous infection. The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database holds multiple examples of adverse events related to the microbial contamination of endoscopes.

Endoscopes are especially vulnerable to contamination: their geometry is complex, and they are fragile and difficult to access for inspection. To mitigate the risk of endoscope-associated infection, FDA and other regulators have outlined strategies for reprocessing, a multistep cleaning process followed by disinfection or sterilisation. An FDA advisory committee meeting on reprocessing duodenoscopes covered factors including manual cleaning, device design, and microbiological culturing. 

Moving towards single-use endoscopes

The enduring challenge of microbial contamination has stimulated movement towards single-use endoscopes. On-market offerings include those from Olympus, BD, Boston Scientific and Ambu, giving hospitals a choice of single-use or reusable options.

Moving from a closed loop locally managed reprocessing model to an open, single-use workflow resolves the very important consideration of patient cross-contamination. However, it elevates the matter of environmental sustainability. This previously low-priority factor for endoscopy suites is now moving up the agenda for hospitals and the wider healthcare ecosystem. Another important factor is the cost profile of reusable versus single-use endoscopes.

Comparing reusable and single-use endoscopes is not as simple as it might first appear. Previous comparative studies, such as that conducted by the University of Southern Denmark, highlight single-use endoscopy workflows’ reduced requirements for PPE, cleaning equipment, and other resources involved in reprocessing reusable devices. Further comparisons between reusable and single-use endoscopes applaud the almost absolute removal of patient cross-contamination and infection risk but do emphasise the growing social responsibility to reduce waste. Disposing of a complex medical device after one use increases per-procedure costs and may not sit well with healthcare trusts.

So, what’s the answer? A single-use workflow is a sensible solution for small, simple medical devices which are hard to clean between uses. However, endoscopes are not small or simple.

Alternative solutions to the endoscope sterility challenge

In a previous whitepaper, we looked at single-use endoscope design and identified a possible market gap for devices with a small number of reuse cycles (Designing single-use endoscopes: Smaller, cleaner, cheap enough?).

A ‘semi-single-use’ disposable endoscope which can be disassembled for reprocessing might hold potential. So could a fully reusable endoscope which breaks down into simpler geometry to streamline cleaning, sterilisation and drying. These hybrid workstreams would also require a review of current reprocessing methodologies.

Endoscope service managers are already stretched handling day-to-day departmental needs such as organising equipment, managing costs, and overseeing patient risk management.  So, one solution to the challenge of reprocessing management is a holistic trust level model or an outsourced service model. With this approach, endoscopes are reprocessed and stored remotely, with hospitals receiving equipment on demand then returning it after use. Dedicated centres can reprocess complex devices in a thorough, cost-effective, and sustainable way. The need for on-demand flexibility in hospitals can be satisfied with long-term storage and transportation solutions, like that from Cantel Medical.

Reusable endoscopes have been in use since the 1850s when French physician Desormeaux developed an instrument to examine the urethra and bladder. But change is on the cards, with single-use, semi-single-use, and reprocessing-optimised devices holding great potential for sterile, sustainable, cost-effective endoscopy.

Find out more about our medical device development consulting services here.