Endoscopes continue to be a popular topic in the health care industry. We asked an expert panel to weigh in on all things endoscope, including the latest technologies and what to look for when purchasing devices.
The panel of experts for the roundtable article includes Richard Brickner, Laboratory Manager, Endoscopy MD; Philip Doyle, Director of Marketing, Gastroenterology, Olympus America Inc.; Brianne Flesher, Flexible Scope Repair and Sales Division, Product Manager, Mobile Instrument Service and Repair Inc.; and Marcelo Salvadé, Director, SH Medical.
q. Flexible endoscopes are on the ECRI Institute’s “Top 10 Health Technology Hazards for 2016.” How can HTM professionals play an active role in preventing infections?
Brickner: All endoscopy suite personnel should be trained in the latest infection/control recommendations. It is imperative to follow manufacturers’ and AER’s device specific reprocessing guides along with guidance documents and/or course training from professional organizations. Conduct periodic assessments of disinfection procedures and practices. Ensure the competency of all staff involved in endoscopic disinfection. Maintain a log of all high level sterilization, by model and serial number of endoscope.
Doyle: Curbing the spread of CRE and other life-threatening superbugs will require the cooperation, input and actions of many health care stakeholders working toward the same goal – similar to the collaboration required to achieve a successful outcome for any medical procedure. HTM professionals can play an active role in preventing infections by consulting device-specific reprocessing manuals for important information on reprocessing and servicing. Patient safety must always be the priority, which begins with careful attention to the detailed instructions.
Flesher: The reason endoscopes made the risk list has mostly to do with errors in proper reprocessing of scopes which result in patient infections. HTM professionals can play an active role in preventing infections by (1) knowing the reprocessing cycle (2) ensuring that reprocessing equipment is properly maintained and (3) checking for signs of damage on scopes that could allow introduction of contaminants. Well-maintained scopes that are properly handled and cleaned and reprocessed through a properly functioning AER greatly reduce the likelihood of infections.
q. How important is it to maintain automated endoscope reprocessors (AERs)? What steps can be taken to ensure the best results?
Brickner: AERs need to be regularly cleaned and maintained. Instruction and training should be given on operation and maintenance by the manufacturer or supplier. Filter systems must be regularly cleaned. Biocide concentration levels should be monitored by visual display and permanent record to determine the appropriate time to change the biocide. Though all machines should have a cycle for auto-disinfection, a maintenance schedule for the machine and water treatment system should be instituted to ensure tanks, pipes and filters are kept free of biofilms and deposits. Bacterial monitoring of machine and endoscopes is essential.
Doyle: Automated Endoscope Reprocessors (AERs) serve a critical role in endoscopic medical procedures in the way of infection prevention. Their proper use and maintenance ensures that these machines are functioning properly and effectively doing the job for which they were designed. The steps needed to ensure these units are in good working order are two-fold. First, they must be properly maintained. Endoscope reprocessor manufacturers have routine maintenance schedules that are designed to replace wearable parts as needed to ensure that these critically important machines stay in proper working condition. Secondly, all users must be well-versed on the proper use of the AER. Regular in-servicing by the manufacturer helps ensure that the units are being used correctly and efficiently by the end user.
Flesher: AERs are taken for granted in many facilities. The assumption is that you place the scope, push a button, and it is magically clean. But AERs must be maintained to manufacturer specifications. Also, external factors can impact performance. Hard water deposits and enzymatic build up can lower the water pressure circulating inside the AER reducing the effectiveness of cleaning internal channels.
q. What are the fastest-growing endoscopy product categories? What endoscopy-related products are most in demand?
Brickner: As awareness of the effectiveness of endoscopes in the diagnosis and treatment of colorectal cancer and advances in Intra-Operative Endoscopy (I.O.E.) are increasing, the types and amounts of less invasive better recovery time procedures increases. This is creating a demand for advanced visualization. High-definition and Narrowband Imagining (NBI) are the most in demand.
Doyle: Technology that contributes to early diagnosis continues to excel, as it helps address all three goals of health care reform: increased quality of care, decreased costs and enhanced patient satisfaction. Earlier detection and diagnosis through minimally invasive procedures means less intensive treatments for patients, resulting in reduced costs and overall patient satisfaction when the disease can be treated early and improve patient outcomes. Therapeutic procedures that reduce the level of invasiveness (e.g., from surgical intervention to endoscopic treatment) continue to increase as more physicians get trained on new techniques and endoscopes and therapeutic devices are refined to function more effectively and offer more specialized designs for the intended use. Quality also is a major area of attention in endoscopy, which is leading to greater focus on topics from minimizing rebleeding to improving adenoma detection rates. Efforts to increase screening rates will also lead to higher procedure volumes in GI facilities.
Flesher: Innovative case-related tools seem to grab the headlines, but we’ve seen strong demand for reprocessing tools such as cleaning brushes, channel flushing units, and automated digital leak testing devices. We receive an abundance of inquiries about these types of products on a daily basis, which tells us that there are still concerns with proper cleaning techniques.
Salvadé: In our field, the fastest growing endoscopy product category is Arthroscopy and Laparoscopy with very high demand for high-definition rigid endoscopes, HD video cameras and monitors to upgrade older version with images of lower quality.
q. How will that demand impact the endoscopy market in the future?
Brickner: As the advances in imaging increase, the number of procedure types a doctor can perform will increase.
Doyle: Market needs will drive demand for routine endoscopes that optimize screening outcomes (e.g., with advanced maneuverability and imaging capabilities) and specialized endoscopes designed with therapeutic procedures in mind, as reflected in their instrument and water jet channel sizes and locations, for example.
Flesher: I’m not sure that the simple but critical tools needed for reprocessing will ever be a huge demand driver in the broader endoscopy market. Bigger picture, more focus on proper reprocessing and maintenance of scopes and AERs will help reduce infection risks and that ought to support continued healthy growth in endoscopy procedures.
Salvadé: In my opinion, this demand will drive manufacturers to develop smaller HD cameras with built-in capabilities for recording images and videos. They may be inclined to integrate cameras with scopes in “all-in-one” instruments, easy to transport.
q. What are the most important things to look for when deciding whether to go with an original equipment manufacturer or a third-party endoscope provider?
Brickner: The most important thing to consider is reputation, quality of repairs and technical knowledge of the company performing the repairs. This is followed by the cost structure. OEMs often deem scope repairs to be overhauls (even if it’s just a minor repair) increasing the cost dramatically.
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, based on a position state from Medivators. 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.
Flesher: The incentives to use third-party repair providers are lower prices and better service than manufacturers provide. Reputable third-party repair firms offer the same repair as an OEM at a lower price and they back it with performance guarantees. Too often, repair transaction pricing is the sole consideration for sourcing decisions. Look for suppliers who offer preventative maintenance inspections, care and handling in-services, and comprehensive repair reporting so you can track progress. The supplier should provide each facility with reporting that allows them to spot trends and weaknesses.
Salvadé: Warranty mostly, years on the market, experience. Indeed, 20 years ago, SH Medical Corp. developed a brand named Stahl Endoscopy. With manufacturers mainly in Germany and USA, Stahl Endoscopy’s vision was in fact to attend the needs and demand for today’s high-quality standards at more affordable prices than well-established international brands like Storz or Stryker.
q. Is it possible to keep up with the latest endoscopy technology and improvements without buying brand new?
Brickner: Yes and No. It’s possible to be current with high-definition imaging and NBI being on the market for a few years and available on the used equipment market. However, rapid technological advances and high costs associated with the newest equipment, causes an unavailability of the most advanced equipment in the used market.
Doyle: While new endoscopes offer the most advanced technology on the market, when budgets won’t allow the purchase of new endoscopes through leasing or financing options, CPO endoscopes can offer access to previous-generation technology for purchase at a fair price.
Flesher: There are a wide range of procedural products on the market that enhance the capability of scopes. But technically, the only way to have the latest scope technology is to buy new scopes. The real question is, “Do we really need the newest scopes to provide excellent patient care?” If what you have now gets the job done, then invest in keeping it running as opposed to replacing it. The newest equipment on the market will usually come with features that are not necessarily required or even desired by physicians.
Salvadé: Yes it is and this is the beauty of this business that only this country, out of all in the world, provides. With leasing companies and hospitals getting rid of 1-year-old equipment, there is a great demand for them overseas. This is exactly why experience, warranty and service are a “must” to help buyers with that important decision of buying new vs. used or refurbished.
q. How can purchasers ensure they will receive the necessary literature and training tools?
Brickner: Every facility should be familiar with their equipment. Each endoscope has its own manual and reprocessing guide by model number. AERs also have manuals and device specific connections by manufacturer and model. Receive course training from and periodically review guidance documents from accredited professional organizations.
Doyle: It is important to consider what benefits and service the manufacturer will offer throughout the entire life of your equipment – not just at the point of sale. The initial attraction of a low price or single novel feature can be tempting, but the on-site training, education and support necessary to learn and maintain the equipment can be costly afterthoughts if not included with the purchase. Olympus provides a variety of educational resources for customers who purchase new and CPO equipment: on-site expert training and support; peer-to-peer education programs; and online tools for quick reference, such as technical assistance via live chat, reprocessing and repair information, white papers and training videos.
Flesher: Expect your provider to furnish you with the necessary literature, training and tools. And be sure to tap all your resources. Often we find users who are too reliant on manufacturers for support and training. After the sale, it can be difficult to get a vendor’s attention. That’s why we provide advice and education to customers even if their equipment is under warranty or service agreement.
Salvadé: By asking at the time of purchase. Most companies include user manuals as a norm, but many do not. There are also videos or personnel capable of providing training to set up or even use the equipment. Again, this is part of selecting a specialized company that can provide them.
q. What else do you think is important for HTM professionals/biomeds to know about endoscopes?
Brickner: Endoscopes are delicate precision instruments – proper care, handling, and storage is imperative to insure the longevity of a scope. Fluid invasion is the major cause of damage. Connecting and observing each endoscope with a handheld style leak tester prior to submersion of the endoscope will help to prevent fluid from inundating the endoscope.
Doyle: Intermittent servicing, or ignoring seemingly harmless issues, may only cause additional downtime and higher repair costs as these issues worsen. Increased downtime resulting from frequent equipment repairs can lead to a loss of revenue due to cancelled procedures, and loss of patient referrals if cancellations become frequent. Through preventative maintenance, health care facilities can benefit from improved up-time, capitated repair cost and priority service, if on contract, reducing the service spend overall for aging equipment. Olympus also offers free advisory services from a large nationwide team of endoscopy support specialists who can advise customers on how best to handle and care for their valuable endoscope assets, helping to minimize repairs and maximize useful life.
Flesher: Endoscopes are very delicate and easily damaged. One missed step in reprocessing could cause expensive damage to the scope, but most importantly, could even harm a patient. In addition, it is important to know that 90 percent of the damage to flexible endoscopes is preventable. Use the proper tools when cleaning and ensure all proper steps from pre-procedure to bedside and post-procedure and reprocessing. HTM professionals may view these as a purely clinical function, but HTM professionals bring a renewed focus on procedures and proper care.
Salvadé: That there are many choices that they can select from when purchasing endoscopes that are not new at incredible prices. Unfortunately, and specially in USA, many of them are not even aware.