As the media headlines and news reports about improperly cleaned and sterilized endoscopic devices continue to whipsaw the general public and the healthcare community about quality and safety, they’re motivating the clinical and sterile processing professional to crack down on performance and practices and to buckle up for heightened scrutiny and oversight.
Disposable/single-use-only endoscopic devices – or even components of endoscopes – seem to be generating considerable interest as a popular alternative, just not quite reaching a fever pitch as some question feasibility and financial return on investment.
But if there were some way to design, develop and manufacture endoscopes in such a way to make them easier to clean, high-level disinfect and sterilize, how could it be done? And would it target all minimally invasive procedures or selected ones with a record of challenges?
“The technology and market already exist for fully disposable endoscopes as well as parts of endoscopes that are disposable,” assured John Whelan, R.N., Clinical Education Coordinator, Healthmark Industries. “As a result, this has either negated reprocessing entirely or partially. A good example are the duodenoscopes with removable elevator channels. This has significantly allowed better physical access for cleaning and HLD. For endoscopes that remain reusable, technology needs to allow similar improved access to internal channels and areas that traditionally have been harder to reach for effective cleaning.”
Crit Fisher, Director, Onsite Service & Operations, KARL STORZ Endoscopy-America Inc., offers a more practical approach.
“I think it is very realistic, and the customers are demanding it,” Fisher indicated. “It is also the best possible scenario for a positive patient outcome. As to the second part, I am not sure what areas could be simplified. What needs to happen is that we have to create standards for all OEMs that need to be followed.”
Chasing an ideal
The issue represents a moving target, according to Stephen Spanos, Medical Director, Ambu Inc.
“The design of scopes lends to inadequate cleaning,” Spanos declared. “Whether it is a channel or an elevator, there are certain components that cannot be replaced or eliminated as the scopes’ function is dependent on those features. When looking at solutions for these critical components that often result in cleaning failure, it must be considered whether changes to these components, such as using a sheath, will compromise the performance of the scope. If reusable scopes are going to continue to be a significant part of patient care, it will be important to develop new products that can withstand sterilization without degradation of function or lifespan. Ultimately, we believe single-use endoscopy is the solution when the goal of the medical community, regulatory agencies and society is to provide every patient and practitioner with sterile scopes that perform at the highest level.”
Melissa Kubach, National Specialty Educator, Mobile Instrument Service & Repair, certainly recognizes the desired outcomes and probable solutions but expresses concern about feasibility, practicality and viability.
“Improved designs that may include a disposable component that reduces risk, such as the emerging duodenoscope with a disposable cover that allows cleaning access to the entire elevator mechanism, will greatly improve cleaning efficacy for that specific endoscope model,” Kubach indicated. “Overall, the burden of simplifying and improving the cleaning process is difficult leaving few options without radical reconstruction. Endoscopes are complex by nature and microbial pathogens are ever-evolving. Complete replacement with disposable versions will not be completely embraced until there is no loss of technology, such as super high-definition image and enhanced light applications. The cost for making a disposable version truly equal to the quality, feel and function for all reusable models is not easily achieved and would be hard to provide at a realistic cost.
“Some simple endoscope models that are most likely not therapeutic in nature, are more realistic to replace with partial or completely disposable versions,” Kubach continued. “This is already happening with flexible intubation and basic airway models. Diagnostic urology is also embracing some disposable use; not due to cleaning difficulty so much as to the delicate nature and susceptibility to be damaged. Rhino laryngoscopes could be a likely candidate for replacement. As for the rest simplification is difficult at best.”
The overarching challenge may be that endoscopic design and manufacturing functionality outpace the capability to reprocess these devices or they’re simply not being designed with end-user maintenance capabilities in mind, according to Brandon VanHee, CRCST. CER. GTS. Clinical Education Manager, Key Surgical.
“Over time, minimally invasive procedures, including endoscopy, continue to increase in complexity and continue to require more complex tools to meet the needs of clinicians,” VanHee observed. “Historically, these complex tools have been designed with little regard for reprocessing and subsequent use. The reprocessing of flexible endoscopes has been an afterthought of the design process for far too long, and if the commercialization and use of single-use scopes is not a practical solution in the near-term, significant changes must take place in the early stages of the endoscope design process. Consideration of the material compatibility, component design complexity, and their interaction with the reprocessing cycle must be incorporated into the early stages of the development cycle. Consultation with sterile processing professionals and front-line endoscope reprocessors to identify challenges and areas of improvement in the reprocessing instructions of flexible endoscopes could significantly improve the overall success of endoscope reprocessing practices.”
Christian Ezagui, CER, CST, CRCST, Technical Resource Manager, Paces MedEquip LLC, calls for more research and development in making endoscopes more durable to use and reprocess, including exposure to chemicals.
“From a durability standpoint, I believe additional research can and should be completed to ensure endoscopes are manufactured with a higher level of tolerances, to create more robust devices,” Ezagui said. “Endoscopes are extremely fragile. Additional stability within the bending section with a more vigorous design would be ideal to minimize care and handling damage between uses.”
Clinical end users welcome and expect improvements in design for cleaning from device manufacturers, according to Gregg Agoston, Vice President, Minimally Invasive Surgical Support, SpecialtyCare.
“Duodenoscopes with their challenging architecture are particularly problematic given the dead-end design around the elevator,” Agoston noted. “Engineers should never design with dead ends as these areas cannot be easily cleaned or inspected. In addition, having the area around and under the elevator being in this dead-end area compounds the problem. The other area for improvement is creating sterilization systems that could effectively sterilize all flexible endoscopes. This would require manufacturers to build the endoscopes out of materials that can withstand the sterilization process.”
Agoston expresses some skepticism about disposable alternatives that may compensate for human behaviors that could be corrected through additional education and training.
“Disposable flexible endoscopes make sense only when their design incorporates areas that cannot be effectively cleaned or where economically, it is less expensive to use a disposable device,” he said. “We should not move to disposables only because technicians are not correctly following IFUs for processing. Segmentation of the processing workforce into those that work on general instruments and those that work on complex instruments is needed to ensure quality goals. For complex instruments, higher levels of training and management are needed to ensure that all processing steps are completed for every device.”
OEMs strive to lead
Meanwhile, OEMs Olympus America and Pentax Medical, both of whom have endured media and public scrutiny as well as regulatory direction around the design, manufacturing and reprocessing of endoscopic devices, say they’re striving to roll out the next iteration of minimally invasive tools.
“As the leading endoscope manufacturer, Olympus has played a crucial role in improving not only the clinical performance of endoscopes but also the reprocessing experience from one generation to the next, going back to the original gastrocameras and continuing through fiberoptic and video scope designs,” said Melinda “Mindy” Benedict, CIC, CFER, Senior Manager, Infection Prevention, Gastroenterology & Pulmonary Reprocessing Strategy Office, Olympus America. “For example, in recent years, we have made our endoscopes fully immersible to ease reprocessing and reduce the risk of accidental damage from fluids entering the scope. We have also simplified the design structure of our scopes and enhanced compatibility with several CDS methods and technologies. Looking to the future, we will continue to simplify and reduce reprocessing steps, make our Instructions for Use more visually rich and easier to follow, and add more disposable components to some endoscopes, such as our next-generation duodenoscope.”
Pentax Medical has been concentrating on the human element, according to J. Hudson Garrett Jr., Ph.D., Global Chief Clinical Officer.
“Pentax Medical has worked diligently to conduct extensive human factors studies to improve our reprocessing instructions for use,” Garrett indicated. “Our focus has been on people, processes and products to improve overall reprocessing efforts, build high-reliability systems of safety related to endoscope reprocessing and handling, and finally to re-engineer critical aspects of the endoscope itself to remove risky components and make them disposable. Recent human factors studies have resulted in completely overhauled reprocessing instructions for use that have been vetted by clinical stakeholders to include registered nurses and reprocessing technicians. These new instructions focus on a more visual approach to educating the user about the important steps of reprocessing and have simplified overall reprocessing steps and improved their reliability in regards to users completely following all critical steps.”
Quicker alternatives?
Short of radical redesign, might there be other options to explore? Some think so.
“A lot of engineering minds far greater than mine have been working on this problem for years,” said James Schneiter, Founder, America’s MedSource Inc. “Hopefully they’ll come up with a better design, sooner rather than later.
“In the meantime, I’ve often wondered why it isn’t possible to simply use a disposable prophylactic sheath to cover/enclose the endoscope,” Schneiter mused to Healthcare Purchasing News. “I believe that a .5mm clear Mylar film would work quite well. The clear Mylar film, or a similar polyester film, would not distort the image from the camera and the .5mm thickness would not inhibit the motion of the moveable tip on the scope.”
Minerva Loran, President, Clinical Choice, offers an even simpler point of view.
“Perhaps we should be asking if detergent and cleaning technology should change to make endoscope cleaning easier? If we had better cleaning detergents, would endoscope design need to change?” Loran asked.
Fouad Bahout, Vice President, Sales & Marketing, Surgmed Group, isn’t holding his breath.
“Given the complex inner workings of an endoscope, it’s quite unrealistic in my opinion to expect that they would be designed in a way that makes them easier to clean,” he said. “A simpler design can be a lot easier to clean, particularly when it comes to inner channels that are hard to access and are often the source of cross-contamination.”
