Roundtable: Endoscopes

Endoscopes continue to be a hot button issue in the health care industry, especially when it comes to the proper cleaning of these devices. They are also known to be very fragile and to break easily. TechNation sought out those in the industry familiar with endoscopes and asked about the latest technologies and what HTM professionals need to know about these devices.

The expert panel for this roundtable article on endoscopes includes Mobile Instrument Service & Repair Inc. National Education Coordinator Amanda H. Coss, Olympus America Inc. Director of Marketing for Core GI and Service, Philip Doyle, KARL STORZ Director of Field Operations, Crit Fisher, STERIS Instrument Management Services Flexible Scope Product Manager, Jonathan Hart, Capital Medical Resources owner, Lee Ann Purtell and J2S  Medical Director of Sales and Marketing, Sarah Stem.

Q: What are the latest advances in endoscopes?

Coss: The focus of late seems to be less on enhancing image quality and more so on efficiency and cleanliness. In response to current incidents involving cross-contamination with conventional endoscopy, there has been development and testing of single use video endoscopes as well as a disposable sheath prototype for both a gastroscope and colonoscope. This endoscope allows complete isolation of the scope itself encapsulated with a disposable sheath system. The disposable sheath system includes a sheath cover and cuff which incorporates all working channels for suction, irrigation, and tool passage. This allows the contaminated part of the procedure, the disposable sheath, to be discarded after patient use reducing the risk of endoscopic bioburden cross-contamination and infections. As for the single use endoscope, upon completion of procedure the entire scope is discarded.

Doyle: Flexible endoscopes for gastroenterology and pulmonology continue to evolve along multiple vectors in order to meet the simultaneous needs of doctors for better access to hard-to-reach parts of the anatomy, better image quality and advanced modes of visualization, more ergonomic handling, and durability that holds up under heavy daily use. Specialized endoscopes with larger channels, smaller diameters, enhanced imaging capabilities, and other unique differences are becoming available to help doctors choose exactly the right tool for each patient’s care. Highly advanced technologies like ScopeGuide compatibility (to create a 3D image of the shape and position of the scope inside the patient), Dual Focus (for on-demand close examination of the tissue) and Responsive Insertion Technology (for faster access to the cecum and more precise handling during therapeutic maneuvers) have added new clinical and economic value to endoscopes, even as the complexity of the endoscopes’ internal design and manufacturing has increased accordingly. In addition, endoscope manufacturers continue to pay close attention to the cleaning and reprocessing of each endoscope model, ensuring that users have access to validated methods of disinfection for peace of mind.

Fisher: There have been significant advances in the light output of rigid endoscopes over the past 5-10 years. Other milestones in the technology, however, have occurred in the functional aspects of rigid scopes, which have added new capabilities at times. A good example is a rigid rod-lens scope with technology designed to enable surgeons to select a desired direction of view using an adjusting knob. Another example is development of scopes that are used with near-infrared and ultraviolet light sources in combination with optical imaging agents to enhance imaging and aid in treatment of certain disease states, or to assess perfusion. Significant advancements also have been made in flexible scope technologies. Leveraging distal-chip technology, for instance, the industry is migrating more fully to the use of digital imaging versus traditional coherent glass fiber endoscopes, such as videoendoscope systems for ENT and GI applications, among others.

Hart: Endoscopes are now being made smaller and with more technology packed into each device. Enhanced resolution (high definition), increased maneuverability, and decreased size of insertion tube diameter are just a few of the features being marketed by OEMs. An additional paradigm shift is moving away from traditional eye piece (fiber) scopes to video equivalents that have a much clearer picture and higher resolution, such as video ureteroscopes. This allows the surgeon greater clarity and ease of performing a procedure.

Purtell: Throughout the last couple of decades there have been minimal changes to the overall design and functionality of endoscopes. Most of the design changes over the years have been to reduce the size of the scopes, while more recent developments offer scopes with rotation and “steering,” design changes that aid in easier cleaning, and more options for sterilization compatibility. The most significant advancements have come in the form of image technology. High definition has turned to “Ultra High Definition” and advanced imaging modalities within the camera system enhance the view of anatomy including fine detail, contrast, and improved clarity of tissue structures. These advancements are accomplished with changes to the scope optics and/or the camera settings. The Stryker AIM system for example, offers 5 imaging modalities including IRIS ENV, Clarity, Desaturation and DRE. Their light sources and SafeLight Cable enables the surgeon to perform minimally invasive surgery using standard endoscopic visualization or near-infrared fluorescence imaging so that enhanced visual assessment of vessels and the bile duct can be accomplished. Many of these newer technologies have not yet reached full market saturation.

Stem: The most exciting and valuable advances in endoscopy equipment would have to be high definition image quality, illumination and suturing assistance. That coupled with laparoscopic and capsule technology provide expanded imaging in difficult to reach body cavities. The major benefit is patient centered because these advancements require less invasive incisions, more accurate diagnosis and potentially a faster recovery period.

Q: How will those changes impact endoscope maintenance?

Coss: With the disposable sheath technology, the cost of repair would decrease as the scope would not undergo high-level disinfection or sterilization. The methods used to process these scopes are harsh and compromise the internal and external integrity of the scope. However, the scope would require a more frequent preventative maintenance schedule due to the increased use of the scope. In regards to single use endoscopes, repair and maintenance spend goes to “zero.” We recently worked with a customer to review the cost per case of disposable scopes versus traditional ones. We used their actual repair spend with us and studied their reprocessing activity to arrive at a per case cost for reprocessing. What we found was that the disposable scope would cost $700 more per procedure compared to traditional scopes. And that was a total cost including repair and maintenance and reprocessing costs. The technology is promising but the financials simply do not support disposables now.

Doyle: Endoscopes represent a sizable capital investment for health care facilities, but with careful handling and appropriate maintenance, they can provide years of reliable service in caring for thousands of patients. Because many of the newer capabilities of endoscopes are dependent on proprietary technologies and parts that are only available to the OEM, buyers will be more likely to protect their investment by having the OEM perform maintenance so that those unique capabilities are not lost through the use of outdated or third-party parts. Another concern that more and more customers have is whether endoscopes that have been repaired by someone other than the OEM are still validated for their endoscope reprocessor, calling the reliability of disinfection into question.

Fisher: The FDA has made a huge push for OEMs to rework their IFUs to make reprocessing and sterilization processes more clear and concise, while also strengthening patient safeguards. It should be noted that many of the changes in current scope technology are internal, with LED components and digital chip control cables replacing the traditional glass image and light fibers. This technology shift has elevated the visual aspects of surgery, but the higher costs of digital technologies have also made increased care in the handling and maintenance of these often delicate devices a critical concern.

Hart: Providing quality service to endoscopes is a science. When endoscope manufacturers release new products, service providers must invest in a rigorous engineering process in order to understand the complexity of the new device. Keeping up with these new product releases requires a robust process, including engineering, parts procurement and manufacturing, prototype and design verification, reprocessing efficacy testing, durability testing of materials, design and process validation, and service production.

Purtell: While the OEM should be readily able to service specialized endoscopes and video systems with advanced imagining technology, ISOs may be slower to offer service on newer equipment technologies without altering the functionality of the product. It will be important for the users to ask if repairs to the scope or camera system will affect the use of the product as it is intended. Additionally, the smaller the scope, the easier it is to damage so increased frequency of repairs may become apparent.

Stem: Sterile processing is where these changes impact maintenance. Endoscopy equipment exploring body organs is exposed to bacteria which if not properly cleaned provides serious risk. Normal precautions such as gloves and protective glasses can help reduce risk, in addition to proper disposal of waste parts.

Q: How can a health care facility with a limited budget meet its endoscope needs?

Coss: When buying scopes, health care facilities need to coordinate a multi-disciplinary team including gastroenterologists, GI department nurses, sterile processing, infection control, materials management, coding and patient accounts. This collaboration allows the facility to see all costs of the proposed scope, quantity of scopes needed, and how many procedures can be performed to get a return on investment picture. One of the best ways to stretch your dollar is to prevent equipment damage through ongoing education and preventative maintenance to ensure your endoscopes are in top working condition. Often consolidating reprocessing can bring down costs per case as well.

Doyle: Olympus offers – and other OEMs may offer – flexible leasing and financing options for customers to make even the most advanced equipment budget friendly. In addition, certified pre-owned and other non-new products are also available from Olympus, with the security of fully qualified OEM repairs and warranties but at a lower price point than brand-new equipment. To determine what initial investments to make, work with the manufacturer’s professional services team to develop an intelligent plan for upgrading your facility’s inventory based upon equipment usage and the number of years in service. This analysis can help establish a roadmap for which equipment to upgrade and when, based upon your allocated budget or other important factors.

Fisher: It all begins with education. It is imperative that all hospital employees that come in contact with endoscopes be thoroughly informed and trained on using proper techniques when transporting and handling these devices. In addition, tracking the scope throughout the process and gathering pertinent information can help generate outlying data. This information can then help in identifying and addressing specific problem areas where scope damage is taking place. This represents an important tool that supports customers’ efforts to bend the cost curve by reducing breakage and extending the mean time to repair.

Hart: There are many service options available to customers. Understanding all available options is important. Customers should be weary that they might be sacrificing quality when choosing a less expensive alternative. Great quality repair that is budget friendly is what every health care facility desires. Get to know all service options from your vendor of choice.

Purtell: One challenge for many facilities is not having adequate inventory to keep up with growing caseloads. Thus, facilities may take short cuts such as using IUSS (Immediate Use Steam Sterilization) or rush the cleaning, reprocessing and inspection process to turn over scopes quickly. This “rush” creates a greater risk to patient safety from inadequately cleaned scopes to equipment malfunction. Fortunately, there are many great options to secure additional equipment without breaking the budget. There are many reputable and highly rated sources for obtaining both new and pre-owned medical equipment that fits any budget. Budgets go beyond the initial acquisition costs so remember to include maintenance costs into the equation. Equipment leasing and financing are also a great option for many facilities and may provide a tax advantage to the purchaser. Maintenance and service agreements can also provide fixed costs for repairs on a case-by-case, or annual, basis. One of the most important considerations to reducing expenditures is to ensure that staff are properly trained in the care, reprocessing and inspection of the endoscopes. We highly advocate for facilities to have one or two dedicated endoscope specialists who are highly trained and have the appropriate testing equipment to inspect scopes at a high level to help reduce extensive repairs and to ensure that the equipment is safe for patient use. Take advantage of the training offered by your scope provider or repair provider or consider utilizing an independent organization to provide in-depth, technician-level scope training.

Stem: Health care facilities with a limited budget are well served by an ISO partner that is capable of repairing their equipment to OEM specifications. This is especially helpful with equipment that falls outside of the standard service contract. The OEM will often elect not to repair and suggest a complete replacement where an ISO can complete a repair or exchange (with a pre-owned unit) for as much as 50 percent less than the OEM comparison.

Q: What are the most important things to look for when deciding to purchase an endoscope from an original equipment manufacturer or a third-party provider?

Coss: OEMs will always offer the latest technology, but it comes at a cost. Clinically speaking, is the newest necessary? Does it improve patient outcomes or reduce case time? If not, purchasing pre-owned endoscopes can be an affordable option for getting your hands on great technology. Once purchased, reputable third-party repair companies can offer the same repair quality the OEMs offer at a lower price. Look for value added services when purchasing your endoscopes. A true repair partner offers additional services such as preventative maintenance, educational in-services and a comprehensive repair report to track repair trends.

Doyle: How the endoscope is refurbished plays a vital role in how the endoscope is reprocessed. For example, Olympus does not sell patented, proprietary parts to others, so ISOs must do their best to recreate these parts and approximate OEM performance specifications. This reverse engineering by ISOs can lead to performance deficits. Should an endoscope purchased from an ISO not function as expected, the additional OEM repairs required to restore the endoscope to its original specifications could exceed any perceived initial savings the facility found attractive. While OEM CPO endoscopes are validated by the majority of AER manufacturers, AER manufacturers appear to be uncomfortable with guaranteeing the results of their reprocessors when used with endoscopes refurbished by ISOs. Before purchasing an ISO-refurbished endoscope, facilities should check with their AER manufacturer about whether the endoscope will be validated to minimize risk in the event of a lawsuit.

Hart: We all know that customers pay a premium for a brand new car versus a used vehicle, and the depreciation of that new vehicle hits as soon as you drive it off the lot. When purchasing a used endoscope, you must have confidence in the repair/refurbishment process of that vendor. Have you visited their repair facility? What is their engineering process? Where do they procure parts? Understand the warranty provided with the device.

Purtell: Some important questions to ask are: What features do you want in the scope? Are you “adding” additional inventory or “upgrading” to a newer model? Do you need just the endoscope or do you require any additional instrumentation or video towers? Is the scope you are requesting compatible with the existing light source and video processor? Is the scope compatible with the sterilization method you intend to use? Does the repair vendor offer full service capabilities on the equipment they sell? (Even on new technologies? When repair is needed is the scope “repaired” or “exchanged”? Keep in mind that scopes that are “exchanged” lose SN# tracing.) What is the warranty and what does it cover or exclude? (Standard warranties typically exclude user damage or misuse.) What is the average and maximum cost to repair? Has the scope been previously overhauled? Was this overhaul from a third-party or OEM? (Either option may be acceptable however you may want to know the answer to this question in advance of the purchase.) Is the scope patient-ready? Are there any notable cosmetic defects such as dents/buckles or discoloration?

Stem: The most important factors to consider when deciding to purchase endoscopy equipment is FDA clearance, warranty, and the cost of a service contract. J2S Medical provides repairs for equipment in addition to re-certified capital options, both of which extend the hospita’s budget and well below the OEM option.

Q: What do HTM professionals need to know about purchasing and servicing endoscopes?

Coss: All too often HTM professionals find themselves in a “buy what I tell you” mode. Of course, HTM professionals defer to clinicians on these decisions, but top performing HTM teams help lead the assessment and acquisition process. Obtaining references on the ISO or OEM from other facilities to confirm the quality of repairs and reputation of the company is key. When purchasing endoscopes, make sure the company has a regional sales representation presence and is knowledgeable about the equipment. Ensure the vendor offers customer service support for real time diagnostic troubleshooting.

Doyle: Buying certified pre-owned from a FDA-approved OEM is significantly different from purchasing a pre-owned endoscope from an ISO. When purchasing a CPO endoscope from an OEM, the refurbishments completed will bring the tool back to its original “like-new” specifications, using original manufacturer parts and components. ISOs are not regulated by the FDA, and are only responsible for returning the refurbished item to “within a reasonable approximation of the manufacturer’s specifications.” It is important to note that many OEMs do not sell the proprietary parts that enable endoscopes to function the way they were designed and FDA-approved to function – which is why many AER manufacturers will not guarantee the results of their reprocessors when used with endoscopes refurbished by ISOs. It’s always recommended that endoscopes in need of repair be returned to the OEM for servicing. Many OEMs offer service contracts to keep repair costs down and loaner equipment to reduce downtime. When it comes to making a purchase decision, education will prove invaluable. Research the manufacturer’s track record, the durability of the equipment and the manufacturer’s post-sale support. The investment should go beyond just the purchase of the equipment – the manufacturer should be a partner in ensuring staff is properly trained and the equipment is well-maintained.

Fisher: Partnering with the appropriate vendor can pay off in the long run. Customers should also analyze and assess the total cost of ownership of their scopes and avoid focusing on transactional business. In addition, these professionals need to fully understand their facility and case volume. Studies have indicated that a lack of adequate par levels of equipment can lead to higher repairs because the products have to be turned over more frequently.

Hart: As much as possible! These professionals need to understand their service provider’s repair methodology. What is their engineering process and repair process? What other value is the vendor providing to the end users? Inventory control analysis, department evaluations, preventative maintenance inspections, in-servicing and data analytics should all be provided by the vendor to the end user. The professionals should expect their vendor of choice to be a true partner in managing this portion of their business.

Purtell: While visual inspections remain the most important inspection step, staff are often challenged with lack of tools and expertise to fully validate the complete scope system, resulting in uncertainty and the increased risk of faulty or unsafe equipment making their way into the surgical rotation. Often overlooked are the inspection of the distal, internal optics, and lighting pathway, that can affect the performance and safety of the equipment. Regular validation, and the ability to troubleshoot the opto-mechanical systems will result in fewer end-user complaints, reduce repairs, and will maintain your equipment investment in top form for safe and effective use. Biomed, clinical engineers and sterile processing personnel can benefit from a scope inspection “station” that includes the ability to inspect and measure image quality, measure light output and document damage. Compliance requirements from regulatory bodies such as Centers for Medicare & Medicaid and The Joint Commission, and even manufacturer IFUs, suggest routine inspection and documentation of equipment inventory. Maintaining a written equipment inventory that includes incident history and documentation of preventive maintenance are two key components of a good equipment maintenance plan and can help you meet regulatory demands.

Stem: HTM professionals need to know they are working with a partner that provides a quality product, an OEM matched warranty and the highest level of liability insurance. Service paperwork should be discussed as well. Repairs and purchased equipment should arrive with OEM specifications listed and image quality in a photo printed; all signed off with technician initials with the current date. Most health care facilities are comfortable with the ISO option and enjoy the deep discounts, friendly customer experience and quick turn-around versus the OEM.

This article was originally published on TechNation.