Endoscopes are important medical devices that come in a variety of models for many different procedures. TechNation invited experts to share their knowledge regarding these devices in this month’s Roundtable article.
Sharing their insights are:
FUJIFILM Healthcare Americas Corporation Executive Director of Endoscopy Product & Marketing Anthony Borrelli; Olympus Corporation of the Americas Executive Director of Marketing for Endoscopy Philip Doyle; Endo Technologies CEO Spencer Johnston; Medical Equipment Doctor’s Damon Kelley; Agiliti Director of Customer Training and Education Michael Matthews, MBA, CLSSGB; and Healthmark Industries Clinical Education Specialist John Whelan, BSN, RN.
Q: What are the latest advances in endoscopes in the past year?
BORRELLI: Important and recent advancements in the fields of endoscopy and endosurgery surround products that serve dual purposes and allow clinicians to perform a greater scope of procedures with the same technology. Two examples of Fujifilm empowering clinicians to achieve more with less include:
• Dual-channel Endoscope: Fujifilm’s EI-740D/S is the first dual-channel endoscope cleared by the U.S. Food and Drug Administration (FDA) for use in both upper and lower gastrointestinal applications. It is the only commerically available endoscopy approved for upper and lower applications, significantly expanding the capabilities of gastroenterologists and colorectal surgeons across a wide range of therapeutic procedures with fewer pieces of equipment.
• ELUXEO Surgical System with ELUXEO Vision is Fujifilm’s equipment tower – and the only system on the market – that allows surgeons to perform both flexible and rigid endoscopic procedures from the same tower. From an operations and workflow perspective, clinicians can perform a greater scope of procedures from one tower of equipment, spanning gastrointestinal, colorectal, and advanced endoscopy and surgical procedures from a single tower of equipment. The ELUXEO Vision technology enables real-time visualization of hemoglobin oxygen saturation (StO2) levels in tissue using laparoscopic and/or endoscopic imaging. Being able to detect StO2 levels helps surgeons identify potentially ischemic tissue, better positioning them to prevent tissue necrosis. ELUXEO Vision earned the Breakthrough Device Designation from the FDA.
Other important device and instrument advances are driving growth in new and exciting subspecialties within the field of endoscopy, specifically Third Space Endoscopy (TSE).
• TRACMOTION is an example of a small device that has a big impact on clinician workflow. It’s a retraction device equipped with 360° rotatable jaws, enabling easy grasping and re-grasping of large lesions during Endoscopic Submucosal Dissection (ESD). With TRACMOTION, an endoscopist uses simple single-hand movements to control the distal end of the product, independent of the endoscope’s movement, and can hold tissue without complicated locking mechanisms to assist with en bloc extraction, both directly and in retroflexion. Clinical studies demonstrate that the device simplifies the lesion extraction process and offers the potential to reduce ESD procedure time.
DOYLE: This year has brought exciting innovations to the U.S. market for GI endoscopy. Offering improved visualization of gastrointestinal bleeding and anatomical structure, Olympus’ new EVIS X1™ Endoscopy System received regulatory clearance and is being prepared for launch this year, along with two compatible endoscopes: the GIF-1100, a videoscope for use in the upper digestive tract, and the CF-HQ1100DL/I, a colonovideoscope for use in the lower digestive tract.
The EVIS X1™ Endoscopy System includes several new technologies that are aimed to help discover abnormalities. Red Dichromatic Imaging (RDI™) technology is designed to enhance the visibility of deep blood vessels and bleeding sources, and Texture and Color Enhancement Imaging (TXI™) technology optimizes the brightness, color tone and structure of the mucosal surface.i Brightness Adjustment Imaging with Maintenance of Contrast (BAI-MAC™) technology is a new image processing function to correct the brightness of dark portions of the image while maintaining the brightness of the brighter portions of the image in order to increase visibility of distant areas. BAI-MAC technology does not accentuate halation in the image.2
TXI, RDI and BAI-MAC technologies are not intended to replace histopathological sampling as a means of diagnosis.
For ERCP procedures which address issues in the biliary and pancreatic ducts, more than 6,000 TJF-Q190V duodenoscopes have been put into use in hospitals around the country. This scope offers a disposable distal endcap which aligns with FDA guidelines and offers improved visibility and access to the elevator at the distal end of the endoscope.3
Improper use of scope may result in patient injury, bleeding, and/or perforation. For complete indications, contraindications, warnings, and cautions, please reference full Instructions for Use (IFU) that accompanied your product.
JOHNSTON: With the upcoming launch of the new Olympus system, AI has taken the forefront of advancements in the industry. This new development will assist doctors in locating polyps and will lead to better care for the patients. Along with AI, we are seeing a decrease in physical logs and an uptick in the amount of computer screens in the reprocessing space. These screens are giving step-by-step instructions throughout the entire process, which helps less trained techs perform at a higher level.
KELLEY: Continued advancement in video endoscopy CCD chips and white light cancer detection.
MATTHEWS: Many industries are evaluating AI to determine if there are new opportunities or efficiencies that can be gained through automation – and flexible endoscopy is no exception. Several companies in the sterile processing field are already developing AI that can assist reprocessing staff in identifying early warning signs of damage as part of a borescope inspection of the internal channels of the endoscope. This will enable technicians to identify when scopes are damaged or inadequately cleaned – without requiring extensive time or training.
WHELAN: Ongoing concerns related to ineffective processing and cross contamination with flexible endoscopes have led to increased development of completely disposable endoscopes as well as duodenoscopes with disposable endcaps. Clinical research, FDA MAUDE database reports, and national standards/guidelines have increased focus on especially the need to carefully inspect reusable flexible endoscopes (best practice is with lighted magnification); and the need to actively dry endoscope channels – even after AER processing. Because of that, there has been an increased use of portable channel drying units as well as dedicated channel drying cabinets.
Q: What steps should be taken prior to repair/service of an endoscope?
BORRELLI: Before getting endoscopy equipment serviced or repaired, users should first contact their scope manufacturer or service provider and inform them of the specific damage and/or reason for return. After that, and before sending the equipment for service or repair, the endoscope must be reprocessed per the manufacturer’s recommendations to prevent subsequent handling of a contaminated instrument.
Standard manufacturer’s reprocessing instructions should be applied to an endoscope which is fully intact and has no leaks. However, if a breach has been detected in the watertight integrity of the endoscope, depending upon the characterizations of the leak (size, location, etc.), special reprocessing recommendations may be provided by the endoscope manufacturer, which may include scope pressurization during fluid immersion.
In certain cases, a leak may be so large that standard attempts to pressurize an endoscope during reprocessing to eliminate fluid invasion may not be possible. It’s also important to check with each manufacturer of an automated endoscope reprocessor (AER), if one is utilized to confirm their specific instructions and product claims for the automated reprocessing of an endoscope with a leak.
DOYLE: First and foremost, prior to handling an endoscope, make sure to wear personal protective equipment (PPE): Put on gloves, a lab coat, and any other necessary protective gear to prevent direct contact with potentially infectious material.
Request documentation from the parties responsible for the point of use/precleaning, leakage testing, manual cleaning and High-Level Disinfection or sterilization processes to ensure that they have been performed. This documentation should include the date, time, personnel involved, cleaning and disinfection agents used, and any observed issues or abnormalities.
I encourage our customers to take full advantage of the training we as the original equipment manufacturer (OEM) offer. We have dedicated staff that offer onsite education and equipment uptime support focused on repair reduction and cleaning, disinfection, and sterilization to assist with infection prevention.
JOHNSTON: The precleaning and leak test stages are crucially important to increase the life span of the scopes. Having an expert reprocessing tech is oftentimes the difference in a facility that can maintain their scopes versus a facility that wears their scopes out quickly. Lastly, communication is one of the biggest and easiest fixes we can offer. By offering specifics on the repairs and what the staff is having trouble with can point our techs in the right direction so that we can tailor the repair to the need of the doctor or staff.
KELLEY: Much depends on the damage the scope has, however, whenever possible the scope should be fully sterilized. Except when you have a confirmed leak in the scope, doing so would only further damage it. In this case carefully wiping down the scope and cleaning the best you can is necessary while using a red bag when shipping to signify that it is not completely clean.
MATTHEWS: First, clinical engineers should make sure they are following Department of Transportation regulations related to shipping contaminated endoscopes. Second, they should also be proactive in working and communicating with reprocessing staff to understand the stages that an endoscope must go through prior to patient use. This will enable clinical engineers to understand where there are opportunities for cross-contamination risks when an endoscope is damaged.
WHELAN: Standards/guidelines have directed for cleaning verification testing (after manual cleaning and before the AER) – for all “high risk endoscopes.” It would be prudent to make sure any endoscope going out for or returning from repair undergoes such testing. Additionally, borescopic examination of exterior surfaces and accessible channels allows identification of damage as well as residual bioburden.
Q: How can biomeds help lower the risk of patient infection when it comes to endoscopes?
BORRELLI: Biomedical engineering can help reduce potential patient infection risks associated with endoscopes by ensuring the proper maintenance of all equipment involved with endoscope reprocessing including but not limited to endoscopes, automated endoscope reprocessors (AERs) and their accessories/channel adapters, channel flushing aids, cleaning brushes, etc. In addition, biomeds can help to ensure that all related scope-specific reprocessing instructions and validated reprocessing equipment instructions are readily available for staff.
Staff should be trained not only on the intricacies of endoscope reprocessing and infection control practices, but also on identifying scope irregularities, signs of damage and problems with scope functionality as such abnormalities can impact reprocessing outcomes.
When available, quick reference guides or reprocessing wall charts should be posted to support staff adherence to manufacturers’ instructions.
DOYLE: Biomeds (biomedical engineers) should conduct regular maintenance and inspection of endoscope reprocessing equipment, such as automated endoscope reprocessors (AERs) and drying cabinets. This equipment is intended to properly and effectively eliminate residual contamination. Biomeds should also perform routine checks, calibration, and repairs of equipment to maintain optimal performance. They can also monitor AERs’ performance, water quality and documentation compliance to identify any deviations or issues.
JOHNSTON: Moving from reusable to disposable buttons and tubing will go a long way in minimizing the risk of bioburdens. Aside from that, using proper procedures when cleaning/brushing the scopes will ensure that bioburdens never gain a foothold in the first place. We see scopes come in with crud and crust built up for months on the distal end, and the staff never noticed at the facility. We work to get the scopes back to a safe level by replacing these parts and providing training to the staff on what to look for and how to prevent bioburdens.
KELLEY: Always follow OEM instructions for the cleaning and sterilizing of all endoscopes.
MATTHEWS: A proactive and deliberate preventive maintenance inspection process is important to finding endoscopes that are potential sources of infection risks to patients. In fact, there have been several studies related to flexible endoscope infections that have demonstrated that a common root cause of infections is endoscope damage. Endoscopes can also be damaged in ways that allow them to function during a procedure – but they can no longer be cleaned effectively. A consistent inspection process can help capture some of these “unseen” factors where infection risk can unknowingly be passed along to patients.
WHELAN: Delivering consistent, ongoing quality control for any/all automated processing equipment – i.e., inspections, PMs, repairs – and complete documentation of same. Additionally, following manufacturers’ IFUs for filter changes (e.g., pre-AER, AER, storage cabinets), help ensure that processes are safe and effective. One of the newer standards recommendations is focused on making sure leak testers (handheld or automated) are delivering the correct PSI. Note that one of the most common endoscope leak testers still in use does not provide such QC on its own – supplemental testing is required.
Q: How do you determine total cost of ownership and return on investment when shopping for endoscopes?
BORRELLI: Assuming healthcare delivery organizations have evaluated the clinical impact of new technology and have confirmed it will 1) provide better care, 2) improve efficiency, 3) support financial objectives, 4) lower maintenance costs, and 5) potentially attract new patients, then it’s time to evaluate the following factors to determine the TCO and ROI of the equipment.
Purchasing / Acquisition of Technology
Deciding whether to lease or purchase your endoscopy equipment can have an impact on your TCO.
When it comes to leasing equipment, one might face lower up-front costs, more frequent opportunities to upgrade technology, and lower maintenance costs, but they will also likely pay more overtime as they won’t gain equity or have any ROI down the road. When purchasing equipment, you tend to face lower long-term costs. Equipment ownership can increase the value of your practice, particularly when you eventually sell the equipment.
Service Programs
Healthcare organizations need to evaluate what kind of service program the technology provider offers; is it all-encompassing, capitated all-encompassing, or is it “cost-per-service”? Be sure to fully understand the possibilities and limitations of your service program to have greater confidence in your future service budget and support.
Product and Training Quality
TCO and ROI will be highly impacted by the quality, durability and longevity of your equipment. To maximize the life of your equipment, it’s important to partner with and purchase from technology manufacturers who prioritize the importance of training and scope handling, and who offer this training on a routine and ongoing basis.
DOYLE: Olympus’ first priority is patient care and safety; however, we recognize that finances do play a role in building your endoscopy portfolio. Total cost of ownership (TCO) is an analysis that places a single value on the complete lifecycle of a capital purchase. Factors that are considered in this analysis include:
- Capital Cost
- Labor Cost
- Reprocessing Cost
- Supplies and Accessories
- Service Cost
MATTHEWS: Flexible endoscopes are increasingly complex and delicate, which can lead to increasingly expensive repairs. One of the best ways to decrease your total cost of ownership and increase ROI is by reducing unnecessary repairs over the life of the scope. In general, catching damage early tends to result in less expensive repairs versus waiting until the scope no longer functions. Repair vendors should provide tools to biomedical and reprocessing technicians to help them to identify early warning signs of damage and minimize unnecessary repair costs. These vendors should also provide reporting to monitor repair consumption and offer education to minimize common gaps in the care and handling of endoscopes that can contribute to additional costly damage to scopes.
WHELAN: This is multifactorial; and includes considerations for number and type of endoscopic procedures, inventory required and related costs, methods for processing (HLD versus sterilization) and their related costs, and estimated repair frequency and dollar amounts. Consideration should also be given to owning versus leasing scopes. The older a scope is, the more likely it is to have damage; and this is a patient risk.
Q: What else do you think TechNation readers need to know about purchasing and servicing endoscopes?
BORRELLI: I believe the most important thing TechNation readers should keep in mind is that quality of “purchasing” and “servicing” is highly driven by their vendor selection. When selecting their technology provider(s), they should seek a true partnership versus a transactional relationship. They should seek a responsive partner that drives continuous technological innovation, creates training opportunities, and provides clinical support on an ongoing basis.
When it comes to investing in technology, they should ensure that the product portfolio is a complete package, combining visualization/image clarity, ergonomics/control, access, in addition to quality service packages.
DOYLE: Healthcare facilities must consider a wide range of factors when purchasing and servicing endoscopes. How many scopes do we need to maintain the timely flow of patients through our department? What mix of different types and sizes of upper and lower scopes, plus specialty scopes, will we need to handle the variety of anatomical and clinical needs that we may see? Which scopes have a reputation for durability and also offer the technical performance and post-sales support our facility needs to be successful? How can OEM service help us keep our lab up and running through loaners, quick turnaround times, and original manufacturer parts and expert knowledge, and how can the OEM support our staff to reduce service costs through education about proper care and handling of these valuable assets?
JOHNSTON: Some facilities celebrate not having to send their scopes in for repair for a year or more. I would argue that periodic service to your scopes is paramount to lowering cross contamination risks. The glue bands oxidize over time, creating pockets where bodily fluids get in, but don’t necessarily come out during reprocessing. We keep track of your repairs and offer pattern recognition behind the scenes to offer training to the staff. The service contract for your equipment should be a partnership between your staff and mine, and we should communicate accordingly. Quotes are free to gauge the market pricing for a wide variety of scopes, so please don’t hesitate to reach out.
KELLEY: To reduce any loss of revenue during an inevitable equipment repair downtime, consider purchasing devices for backup procedures. Often you can obtain a slightly older model at tremendous cost savings that operates the same as your newer model and is compatible with your current system.
MATTHEWS: Three big challenges for reprocessing staff are high turnover rates, demand for regular training and education and internal pressures to expedite their cleaning procedures to meet surgical case demands. Given these challenges, it’s no surprise that our internal research has demonstrated that over 80% of damage is related to poor care and handling practices. Clinical engineers, reprocessing staff, clinical staff and repair vendors should collaborate on strategies to improve processes that are customized to fit the individual challenges at their facilities.
WHELAN: The best protection for our patients is a proactive versus reactive approach. This can best be realized through a multidisciplinary system approach – where clinical engineering is at the table regularly with processing professionals, infection preventionists, clinicians and administration. Every discipline has “a piece of the pie” and a unique and deserved perspective.
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2Data on file (DC00436067)
3Data on file (11/May/2022)
