TechNation invited endoscope experts to share their knowledge with readers in this Roundtable article.
Participants who agreed to share their knowledge are:
- Fibertech Medical Partner Frank Majerowicz
- Agiliti Director of Customer Training and Education Mike Matthews
- ECRI Principal Project Engineer Mairead Smith
- Healthmark Industries (a Getinge company) Clinical Education Specialist John Whelan, BSN, RN
How have single-use endoscopes impacted health care facilities and biomed departments?
Majerowicz: In my opinion single-use endoscopes can be a great option as back up to standard endoscopes and for use with difficult procedures that may increase the possibility of damage to a standard endoscope. There could be a growing opportunity in ENT and urology procedures. However, I do not see single-use endoscopes impacting GI endoscopy anytime soon.
Matthews: While reusable endoscopes are still the most frequently used, single-use endoscopes have gained traction particularly within urology clinic practices because of recent manufacturer recalls and standards that require sterilization, as well as growing infection concerns. Disposable, single-use endoscopes offer a sterile solution that fits well with high patient turnover, but they are typically not the most cost-effective option.
Smith: Single-use endoscopes have gained traction in the last five or so years. ECRI sees many health care facilities using a combination of single-use and reusable models – even within a given scope type. While this offers many advantages for clinical workflow, reprocessing procedures, and infection prevention, it can also add complexity in other areas. For example, facilities need to ensure that clinical and technical staff are adequately trained on proper use of every model, and that accessories and consumables are stocked for each platform.
Whelan: The availability of fully disposable and partially disposable (i.e., single-use endcap) flexible endoscopes have provided alternate options to address long standing concerns re: the limitations and risks of manual and automated processing for these high-risk reusable medical devices. Reducing or removing the need to process all or part of the scope then lessens or removes work for both processing departments as well as HTM staff. The related use of single-use accessories (buttons and valves) with reusable endoscopes as well offers risk mitigation. In the U.S., there is widespread variation in the adoption of single-use endoscopes. Some clinical departments (e.g., anesthesia or respiratory therapy) may shift to predominantly using single-use scopes. Some GI endoscopy departments may opt to reserve the use of disposable scopes for select procedures (e.g., ERCP) or higher-risk patient populations.
What steps should be taken when looking to purchase endoscopes?
Majerowicz: Many health care facilities now consider pre-owned endoscopes as a cost-saving alternative to buying new. While in general a pre-owned endoscope will cost approximately 50% less than buying new there are important points to consider such as: 1. Trust the company you are purchasing from. 2. Ensure the endoscope was inspected and repaired prior to purchase (note there are companies that “flip” endoscopes without proper evaluation) 3. Confirm the warranty and what is covered. 4. Cheaper is not always better – because of the high cost of endoscope repairs you need to make certain the scope you purchased is in good working order.
Matthews: Because of high capital costs, hospitals often purchase the minimum number of endoscopes necessary for their current procedure loads, which doesn’t account for procedure growth or a spike in cases. Lack of stock puts increased pressure on reprocessing staff to turn scopes faster, which creates more opportunities for damage and makes preventive maintenance very difficult. Combined, these factors can quickly lead to excess, avoidable service and replacement costs. The full spectrum of endoscope care should be considered in the initial purchasing process, including needed investments in education and process improvement measures.
Smith: When selecting endoscopes, facilities should first identify which types of endoscopes need to be replaced and define clinical and technical requirements for these products. To obtain best pricing, look for opportunities to standardize across clinical areas (e.g., selecting the same manufacturer for both pulmonary and gastrointestinal scopes, or for both single-use and reusable scopes) and use a benchmarking service to identify potential savings. Consider what level of service coverage will best serve your facility – for example, full coverage is recommended for scopes that are used frequently, whereas risk-sharing or fee-for-service plans may be more cost effective for scopes that are used infrequently or require few repairs. And finally, negotiate for value-adds to service agreements, such as care and handling educational programs, scope tracking systems, loaners and no-charge delivery.
Whelan: The first step would be to inventory any/all clinical customers – to categorize models and numbers of scopes needed. Administrative discussions re: whether to purchase or lease from endoscope manufacturers would happen coincidentally. Depending on the size of the “purchase,” a cost per procedure lease that includes repair allowances may make better financial sense for a health system. Diligent planning would include a search of the FDA M.A.U.D.E. database for reported issues related to certain brands or models. A proactive and inclusive project team would include multidisciplinary input from clinical users, processing professionals, infection prevention, HTM and administration.
How often should endoscopes be inspected or have a PM?
Majerowicz: Routine endoscope inspections will insure they are in good working order, safe to use, and will help prevent unforeseen major repairs. There are some items that can be inspected by the clinical staff on a weekly basis that often are overlooked (such as chipping adhesive seals, chipped lenses and damaged insertion tubes). In addition, endoscopes should receive a qualified inspection every six months to insure proper and safe performance. At FiberTech Medical, we perform a full PM inspection every time an endoscope comes in for repair – regardless of the customer’s claimed issue.
Matthews: Some endoscopes define a specific timeframe for required PMs, such as those used in ERCP procedures. However, in instances where a PM is not defined by the manufacturer’s IFUs, the health care facility should define its standard based on their unique circumstances. For example, a teaching facility will likely need their scopes PMed more frequently than a non-teaching facility. Once per six months is typically a good starting point, but if a repair analysis shows that most scopes are breaking in less than six months, more frequent PMs should be considered. Each facility should work with their repair vendor to evaluate their scope repair trends and determine the best fit.
Smith: Endoscopes should undergo inspection and preventive maintenance as recommended by the product manufacturer or as otherwise determined by a facility’s alternative equipment maintenance interval. IPM intervals can be determined by the number uses/reprocessing cycles (e.g., every 100 cycles) or by a maximum time interval (e.g., 6 or 12 months). In general, intervals may vary based on scope type, scope age, repair history and frequency of use.
Whelan: PMs should occur minimally according to the frequency outlined in the Instructions For Use (IFU) from the endoscope manufacturer. Inspections should actually be integrated into the routine working flow of handling, clinical use and processing. Everyone who touches the scope should (minimally annually) have training and competency testing on how to inspect a scope, and what is expected if concerns are identified. More focused inspection should always occur (per IFU and national standards/guidelines) every processing cycle – as a unique step after manual cleaning. Best practices call out the need for enhanced visual inspection at this point – i.e., lighted magnification, and/or the use of a borescope. Cleaning verification testing for residual soil would also be part of this step. So, inspection is everyone’s responsibility, not just HTM staff.
What are some of the newest endoscope features?
Majerowicz: Olympus is about to launch its newest generation of endoscopes which will transition from xenon light to LEDs and advanced imaging capabilities. Other recent features include scope guide technology which provides for the position of the colonoscope during procedure and dual focus technology for closer examination of tissue.
Matthews: Technological features related to advanced light wave applications continue to grow to include amber light. Additionally, features that were once available as a sole function in many scopes can now run concurrently, allowing enhanced imaging and light feature groupings.
Smith: With ongoing concerns about infection prevention and the challenges of closely adhering to recommended reprocessing procedures, single-use endoscopes are one of the biggest innovations of recent years. Single-use models are now available for most major types of scopes – bronchoscopes, duodenoscopes, ureteroscopes, etc. Manufacturers are recognizing the benefits and finding ways to tie in the best features of reusable models with the strengths of single-use models, such as by offering both single-use and reusable from the same manufacturer, or by incorporating single-use components, like endcaps for duodenoscopes. Other manufacturers are focusing on advancements in scope navigation and control – like with robotic bronchoscopy.
Whelan: As referenced above, for several years now we have duodenoscopes with single-use endcaps and fully disposable endoscopes. Additionally, each generation of endoscopes offers higher definition cameras and image enhancements, as well as higher definition video monitors. More recent years have brought integration of AI software technology to the procedure room – to aid in diagnostic interpretation.
How can the life of an endoscope be extended?
Majerowicz: Endoscopes can last 10 years or more with proper maintenance. The biggest threat to endoscope performance is fluid invasion so preventing this type of damage should be a top priority. Otherwise, the OEMs and FiberTech Medical can perform full refurbishments keeping an endoscope in use if the features of the endoscope series is meeting the needs of the user.
Matthews: Our internal repair data has demonstrated that over 80% of endoscope damage is preventable through better care and handling practices. Education for users and reprocessing staff is critical to extending the useful life of endoscopes. Process audits are another tool to determine where damage is happening and how it can be prevented. Finally, preventive maintenance is essential to avoid catastrophic damage and ensure patients always receive the best standard of care.
Smith: Reusable endoscopes are fragile and must be treated with care to minimize the risk of damage. Staff who are responsible for pre-cleaning, manual cleaning, reprocessing and drying procedures should carefully adhere to the manufacturer’s reprocessing instructions for use. Leak testing and inspecting with borescopes can help identify certain types of device damage before it worsens. In addition, scopes should be protected from damage during transport, and clinical staff should be trained on proper use of the device, including how to use various tools through the working channel without causing damage.
Whelan: Again, this is the responsibility of everyone who touches the scope. Through proper handling during clinical use, and every staff member following best practices in all steps of processing, endoscopes can be more effectively maintained. This takes ongoing education, training, competencies and embedding inspections in the routine workflow. Elevating the level of focused inspection (inside and out) – to include borescopic examination of accessible channels allows for proactive versus reactive approaches to maintenance and care.
What else do you think TechNation readers need to know about endoscopes?
Majerowicz: Endoscopes are fragile instruments and expensive to maintain but, with proper care and handling and a qualified service provider, repair expenses can be kept in check. About 80% of endoscope repairs are because of accidental damage and not considered normal wear and tear, so clinical staff education and monitoring damage trends are important.
Matthews: Facilities often purchase new equipment without considering the full spectrum of requirements (and cost) to care for the device properly. Critical aspects, specifically reprocessing, can be overlooked and can lead to high incidences of preventable damage because of a lack of training and process gaps. If a facility’s current processes are already leading to damage, purchasing new endoscopes will not fix those underlying issues. Instead, costs will likely rise even higher as newer technology tends to be more expensive to repair.
Smith: Before purchasing, ask manufacturers for reprocessing instructions for use (RIFU). Confirm that your facility has the equipment necessary to perform reprocessing, including compatible automated endoscope reprocessors or liquid chemical sterilizers. Also, readers should expect ongoing changes to the endoscope landscape as the market for single-use models continues to evolve.
Whelan: Unfortunately, all too often clinical departments only have “just enough” scopes in inventory – with no cushion when scopes are sent for repair. HTM – along with processing professionals and infection prevention – can help advocate for more appropriate inventories. Additionally, such multidisciplinary advocacy is needed to make the case for embedding routine quality control when it comes to inspection. Owning (versus leasing) scopes potentially adds risk in that scopes kept in clinical circulation longer are more likely damaged – even from normal use.