In a pandemic world, endoscope care should be at or near center stage

Marcia Frieze, CEO, Case Medical, keeps her fingers on the pulse of the market, particularly among SPD departments, anticipating a reserved shift.

“Two factors limit the broad adoption of partially or fully disposable endoscopes: Psychology and economics,” Frieze explained. “Endoscope manufacturers and others are in early stages of developing disposable components, and clinicians are even earlier in the awareness and acceptance of these new options. Understandably, new product adoption can be slow in the perioperative sphere due to risk aversion. Moreover, in this case, clinicians weren’t seeking these changes; rather, they are being forced upon them by circumstances and fallout from disease outbreaks tied to flexible endoscopes.”

But Frieze observes an inherent economics issue lingers, particularly exacerbated by the pandemic.

“The economic challenge is twofold: Disposables and single-use devices are an added cost, and hospitals have been dealing with narrow margins for years, even before the disruption of the COVID-19 pandemic,” she continued. “For many decision makers, any program that adds cost (or uncertainty) will be put on the backburner considering the immediacy of managing through this public health emergency.”

MIS procedure types may experience a product shift, acknowledges Carolyn Klimas,  Executive Director, Specialty Products Marketing, Olympus America Inc.

“Performance of the reusable endoscope will be superior,” he predicted.

Economics and sustainability remain litmus tests for any device migration, according to Gregg Agoston, Vice President, Business Development, SPD Transformation Services, SpecialtyCare.

“Cost [and] environmental waste are significant issues that will limit the conversion to disposable flexible endoscopes,” he said. “I believe that there will be a shift to hybrid endoscope technology. We already have disposable valves, etc. I do not believe that disposable or ‘semi-reusable’ flexible endoscopes are the answer as these will create significant amounts of waste every year, and most likely will be cost-prohibitive. We have to ask ourselves why we would consider disposable products versus reusable. If the answer is that we are concerned about the ability of our technicians to effectively clean and sterilize [or] HLD the endoscopes, we have uncovered the root cause of the problem.”

Agoston stresses that “flexible endoscopes are not the only complex instruments that are reprocessed in a hospital. There are robotic instruments and countless other complex instruments with multiple parts lumens and electronics.  If we cannot reprocess flexible endoscopes then we should be questioning if we can we reprocess any of these other complex instruments. Should we move to disposable for all of these instruments as well?”

Agoston refers to history – more than seven decades ago specifically – as a key discussion point.

“The current symptoms of flexible endoscopes that are not properly cleaned and prepared for surgery stem from a common root founded in the original SPD organizational model that was created in the 1940s and unfortunately has not changed to meet today’s demanding surgical instrument needs,” he indicated. “In the 1940s a movement began led by W.B. Underwood, John J. Perkins and the American College of Surgeons (ref. IAHCSMM Central Service Technical Manual) to remove instrument processing from the perioperative area to a centralized location, ‘Central Sterile Department.’ This change helped to standardize instrument processing, and it removed the responsibility of instrument processing from the nurses, allowing them more time with their patients.”

Back then, surgical instruments largely would be considered “non-complex” by today’s standards, Agoston continued. They consisted primarily of stainless steel devices used for cutting, grasping, dissecting, etc., along with basins and glassware.

“The staff for the newly created Central Sterile Processing Department often were promoted from dietary services since the functions of cleaning were seen as similar,” Agoston recalled. “Pay was a step up from dietary pay. Lost in this transition was the knowledge that the nursing staff had of how the instruments were used and their relative importance to the successful surgical procedure. SPD staff were expected have the capability to clean, inspect, assemble and sterilize all items that came through the department. This model worked primarily because of the simplicity of the instruments and relatively few instrument sets the department was responsible for.”

Advanced surgical procedures began  to emerge and grow, Agoston posits, and pressurized the 1940s SPD model.

“Fast forward to today’s advanced surgical procedures that require complex instruments – endoscopes, cameras, power tools, robotic instruments, Orthopedic/Neuro/Spine, etc.,” he continued. “These procedures could only be dreamed about in 1940. The associated skills needed for cleaning, inspection and sterilization of these complex instruments is much higher compared to the skills needed for non-complex instruments. Instructions for Use (IFU) went from one page of cleaning instructions to 37-plus pages for a robotic instrument, and over 100 pages for a flexible endoscope. 

“With hundreds of hospital- and vendor-owned instruments/sets being processed daily, the importance of a highly productive and effective SPD is just as important to the success of the surgical procedure as are the surgeons, anesthesiologists and nurses,” Agoston insisted. [Editor’s Note: Agoston shares his vision of a solution in the sidebar, Advance SPD to include higher-paid specialist teams on page 40]

Others foresee a more pervasive embrace of hybrid devices. In fact, a smaller segment (14.3 percent) argues that hybrids will be used by the majority.

But Hendee stops short of recommending full conversion to disposable/single-use devices.

“This might lead you to think I would prefer a fully disposable endoscope, but I do not,” Hendee clarified. “Solving processing issues would be a great leap forward for these devices but could cause others. Adding multiple disposable endoscopes each day to a facility’s waste stream is a cost and environmental concern. On the other hand, if only certain components were disposed of, processing outcomes could be improved, and other impacts could be minimized. I believe this win will drive Hybrid endoscopes to eclipse fully reusable models.”

“The scope should be redesigned to have disposable section that comes into contact with patient (insertion section),” Azizi asserted. “The electronic and control can remain reusable and sterilizable. This will be the safest for patient, the most cost-effective and environmentally friendly approach.”

SUDs make waves

More than one-fifth (21.4 percent) predict fully disposable/single-use devices will be added to a provider’s inventory stream, but not dominate what surgeons use.

“The move will be evident, and a contributing driver [will] be reported endoscope-related infections,” McGinty predicted. “Identification and tracking of infections to endoscopes is inconsistent, however. Industry will continue to develop single-use models that will ‘make sense’ to infection prevention-minded consumers to replace their reusable inventory.”

Natalie Reece, Endoscopy Clinical Educator, Key Surgical, casts doubt on the cost argument.

“For example, a study from last year titled, ‘Reusable Flexible Ureterorenoscopes are more cost-effective than single-use scopes: results of a systemic review from PETRA uro-group’ by Talso, et Al., found that, depending on the number of uses per repair (which varied between 8-29 procedures per repair), the cost per procedure for a scope was anywhere between $120 and $1,200 per procedure,.” she explained. “They say, ‘A significant trend was observed between the decreasing cost of repair with the number of usages,’ meaning the more usages you got before you needed to send out for repair, the cheaper overall that reusable scope would be for your procedures. They compare this with a couple other disposable ureterorenoscopes that cost $700, $1,500 or even $2,000 dollars a pop.”

Reece refers to an Ofstead & Associates research study published three years ago that examined 20 different scopes at three different sites, finding that all endoscopes had visible irregularities.

“What this tells us is that we’re currently not sending out our scopes for repair enough,” Reece argued. “The cost of repair per procedure should be so much higher, meaning that reusable scopes are not necessarily cheaper than disposable.” She cites another Ofstead study that investigated all of the variables involved in reprocessing, including the water, chemicals, PPE, salaries, time and other resources.

“For these reasons, I think most facilities will find that not only are disposable scopes just as good as reusable [scopes] during a procedure, but the quick set-up and low cost (compared to the actual true cost of reprocessing) will make them a no brainer,” she added.

But Reece remains realistic about progress.

“This is healthcare, however, and making changes is often like moving mountains,” she said. “The change is slow and takes time. Oftentimes the silos between decision makers prevent the necessary dot connecting that is needed in order to make the systemic change toward disposable scopes. Overtime, those who pay out for treating HAIs will incorporate their cost into the mix, and we’ll see that disposable scopes are a no brainer. Lastly, I believe that as these become more prevalent, vendors will be encouraged – or maybe even required; a girl can dream! – to design scopes that have recyclable components and have a smaller footprint on our landfills, though the likelihood of this happening in 10 years is slim.”

Mobile Instrument Service & Repair’s  Clinical Education and Training Manager Melissa Kubach, homes in on performance quality perceptions.

“We have yet to see widespread adoption of disposable scopes largely because they do not match the performance of reusable scopes at a price point that allows for substitution,” Kubach noted. “As quality and user experience improve, disposables will capture market share, provided the cost compares favorably to reusable scopes. Comparable image, performance and maneuverability are important. Loss of technology, such as near focus, specialty light wave applications and endoscope position monitoring may play a role as well. Reimbursement is key, especially when you are requesting insurance companies to cover cost for which they were not historically responsible.

“Considerations of a known safe reusable alternative method may be appealing for higher-risk duodenoscopes but other common models may not make the cut,” she concluded.  

Yet others anticipate the tide turning more dramatically.

“Where possible, single-use endoscopes will continue to offer significant productivity and cost-management benefits for hospitals – much the way that other areas in the hospital have long since moved from reusable equipment to fully disposable to enable greater efficiencies and patient safety,” Escobar indicated. “This shift will alleviate the potential for device cross-contamination and ensure that each patient has a sterile device used on their procedure. This is highly advantageous to healthcare leaders, such as infection preventionists and healthcare risk managers. Not only will it free SPD to focus energies and investments in reprocessing devices that cannot be disposable, it will also enable hospitals to reduce the extensive investment in purchasing and maintaining reusable endoscopes. These devices require an incredible amount of resources to ensure they are ready in a timely manner and adequately prepared for safe use on the next patient.” 

By Integrated Endoscopy’s measure, the gate has been opened.

Cripe cites as examples single-use shaver blades in arthroscopy, single-use pressure transducers in cardiac medicine and even syringes, depending on how far back one traces. “The costs associated with repair, processing, sterilization and OR down-time are some of the key drivers to the rigid endoscopy conversion as well as the performance degradation over time, which is the direct result of processing and sterilization,” he added.

“In the near term, we see synergies and complementariness between reusable and single-use devices,” Lord noted. “But in the medium and longer term, we believe the market will consistently migrate fully to single-use devices. When you can combine high-definition visualization without the headaches, expense or risk of reusable endoscopic platforms, once you experience the benefits, there’s really no reason to go back. Is anyone today begging to go back to 35mm film cameras when we have our high-quality iPhone cameras in our pocket?”

Lord extols additional benefits single-use models can bring. “Complicated vendor contracts put the risk of obsolescence on the customer,” he indicated. “Pristine Surgical’s high-definition digital platform is scalable and extendable, eliminating the risk of obsolescence – and the software and hardware can be seamlessly upgraded without further capital expenditure.” 

“First, as disposable products continue to be developed, the cost will become more competitive,” she surmised. “This will impact the price barrier that many facilities have and make the product more appealing. Another issue with disposables is picture quality. I think disposable products will continue to evolve and have better picture quality, or have a range of picture quality options with different price points. Another issue to be considered with any disposable item is the environmental impact. Many companies offer recycling programs for various products. If this is feasible with disposable scopes, it would be an enticing option to reduce the environmental impact and decrease prices.”

Sonstelie acknowledges that hybrid models, equipped with disposable components for critical areas of the endoscope, such as distal tips and elevator mechanisms, may offer an alternative to continue operating in the current state. But she classifies it as more of a transitional role.

“There are too many infections and risks to patient safety with some current reusable models,” she insisted. “Additionally, we know that some scopes cannot be cleaned effectively, even when following the IFU. If we convert these critical components to disposables, there are still parts of the scope that remain difficult to clean and inspect. For example, the channels can be damaged and harbor bioburden, creating a patient safety risk. I think having disposable components for the most critical areas of the endoscope is only a partial or temporary solution.”