TechNation contacted experts in the health care community seeking input regarding endoscopes for this roundtable article. Representatives from third-party service organizations and original equipment manufacturers replied with an interest to share knowledge and insights.
Those participating in the roundtable article are Olympus Corporation of the Americas Global Senior Manager of Infection Prevention Melinda Benedict, FUJIFILM Medical Systems USA Inc. General Manager-Endoscopy Taisuke Fujita, MultiMedical Systems (MMS) Director of Surgical Services and BioMedical Solutions Chyrill Sandrini and Biomedical Support Systems Owner/CEO Hawa Zamani.
Q: What are the latest advances in endoscopes in the past year?
Benedict: Olympus continuously makes advances in its endoscopy equipment. The most recent advancement is the new TJF-Q190V duodenoscope, which received FDA 510(k) clearance on January 17, 2020. The advanced features of this duodenoscope include a sterile, disposable distal endcap designed for ease of reprocessing, as well as an expanded field of view and improved handling for improved clinical performance.
Fujita: 2019 was a big year for Fujifilm as the company advanced the market with the launch of eight new endoscopes, fulfilling a demand for new, high-quality, endoscopic imaging technology. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis and endoscopic treatment of the esophagus, stomach and duodenum. It features a removable, single-use distal end cap – a design that provides direct access to mechanically brush clean the elevator mechanism and surrounding recessed distal tip surfaces. Fujifilm’s suite of 700 Series endoscopes were designed for use with the ELUXEO video processor. Together, this technology duo combines unparalleled visualization capability with exceptional maneuverability and control to streamline access and enable optimal detection in both routine and complex procedures. ELUXEO’s 4-LED Multi-Light Technology creates Blue Light Imaging (BLI) and Linked Color Imaging (LCI) visualization modes which are designe
d to aid clinicians in the detection and their characterization analysis during exams.
Additional interventional launches include the EI-580BT Short Double Balloon Endoscope, a new tool designed to facilitate access in altered anatomy, as well as the EG-580UT and EG-580UR Endoscopic Ultrasonic Scopes equipped with a high resolution Super CCD image sensor which helps ensure sensitive and high quality images and are utilized in conjunction with the SU-1 Ultrasound Processor.
Sandrini: With Olympus owning over 70% of the market share and over $350 billion in revenue annually in the GI field I will answer to their advancements. I find it exciting after the introduction of therapeutic ultrasound scopes just two years ago how physicians are becoming more versed and skilled with higher success rates with these procedures. Also imaging across the GI platform continues to improve with 3D technology. The HD advancements are helping make early detection possible. Early detection, treatment and overall patient health is remarkable compared to just 10 years ago!
Zamani: Olympus received FDA clearance for the removable Endocap on their duodenoscopes due to the reprocessing concerns. Their model 190 series are coming out with these disposables that help lower contamination risk. Traditional endoscopy systems utilize Xenon white light design. However, newer systems utilize smart technologies that generate sharper pictures and videos with high-definition imaging.
Q: Can you briefly discuss any FDA updates and what they mean for endoscopes?
Benedict: The FDA issued a Safety Communication concerning duodenoscopes in August 2019. The agency recommended that duodenoscope manufacturers develop devices that include disposable components or that are fully disposable, and Olympus is continuing its work in furtherance of this recommendation. As duodenoscopes are used to access tortuous anatomy, their design is necessarily complex and design advancements need to be carefully tested to ensure the devices continue to meet vital clinical needs.
Fujita: In August, 2019, the U.S. FDA issued a Safety Communication recommending health care organizations transition to duodenoscopes with disposable parts and innovative designs to aid in the reprocessing process. Consistent with the FDA’s recommendation, Fujifilm has developed, and has already begun transitioning health care facilities to the ED-580XT duodenoscope that features a removable, single-use distal end cap – a design that provides direct access to mechanically brush clean the elevator mechanism and surrounding recessed distal tip surfaces. With the distal cap detached, the scope tip surfaces are more readily exposed and can be more easily reached and cleaned by brush compared to the fixed-end cap designs.
Sandrini: The examination of the bile duct or pancreas is a procedure called an ERCP and a duodenoscope is used. This is the “superbug” scope that Olympus answered a lawsuit with a recall after several deaths occurred. The FDA is now suggesting disposable caps to help reduce possible errors in the HLD reprocessing procedures around the elevator channel. These caps are trying to eliminate the chance of human error and increase patient safety. If implemented, all ERCP manufacturers would have to comply. It will take time to study the between patient contamination to see if the caps are effective. I would like to challenge every facility across the U.S. to examine their patient scheduling practice and allow more than sufficient time for proper bedside cleaning and ample time for detailed HLD reprocessing times. I have seen a lot of issues with lack of sufficient ERCP scope inventory and back-to-back patient scheduling. Training, training and regular update trainings to all handling or cleaning these scopes will
help reduce the margin of error. Follow the IFUs – have them posted, and available for all employees to reference. Bottom line – do you have enough ERCP scopes for the cases being scheduled? And is your facility allowing the staff enough time to correctly disinfect? These two points will increase patient safety – with or without disposable caps!
Zamani: There were many infection transmissions occurring from the moving parts of duodenoscopes. They were difficult to disinfect as a result of the moving parts. So, the FDA recommends for end users to transition from fixed end caps to disposable or removable end caps. The FDA understands this will take time for everybody to transition. This new recommendation minimizes the risk of infection, but it still does not guarantee it.
Q: What steps should be taken prior to repair/service of an endoscope?
Benedict: Users should contact their endoscope manufacturer and/or repair company when damage has been found on an endoscope. The manufacturer should be able to provide directions on how to reprocess a damaged endoscope prior to sending the endoscope in for service and/or repair. For example, it may sometimes be necessary to manually disinfect the endoscope prior to service. Although the majority of endoscopy clinics use automated endoscope reprocessors, technicians should be trained on manual disinfection and the supplies required to perform this task should be stocked should the need arise.
Fujita: As routine service and occasional repairs are to be expected in medical devices, Fujifilm recommends health care enterprises partner with a vendor that both provides a service package suitable for their needs, as well as resources to prolong the life of the technology. In the last year Fujifilm has made efforts to ensure adequate resources for reprocessing professionals.
To prolong the life of and preserve the cleanliness of equipment, Fujifilm encourages health care institutions to only use cleaning brushes validated by the manufacturer, and if using Automated Endoscope Reprocessors (AERs), they should only use validated re-processors with the appropriate connectors. In addition, health care organizations should allow reprocessing professionals to dedicate adequate time and resources to reprocessing per the manufacturer’s instructions for use.
If a health care organization needs to return an instrument for service, Fujifilm recommends the following steps:
- Before returning any instrument for service, all devices should be reprocessed consistent with manufacturers’ validated instructions.
- If a scope has a leak before being returned, special handling/reprocessing recommendations should be followed. This information is typically made available by scope OEMs separate from the standard instruction manual.
Sandrini: First suggestion – glove up! All endoscopes whether rigid, semi-rigid or flexible are dirty until proven differently! Communication with your SPD/CS, urology, RT and HLD staff is imperative! Know the history. Ask – Was this endoscopy sterilized or was it disinfected? If not, make sure it comes to you in a red bag. In my experience the biomed staff isn’t directly involved with hands-on reprocessing, but handle the scopes when sending out for repair. Your repair company will be very thankful for your detective work and passing along your discovery!
Zamani: I tell my clients to make sure the scopes I pick up are safely stored in a case. That keeps them safe upon return and it assures safety and care for the equipment all around. Clinical engineers can begin validation processes as per FDA and OEM recommendations. The two methods utilized are by ATP swab sampling or colormetric protein swab sampling. These two methods are recommended by both state and federal and are located on their respective websites.
Q: How can biomeds help lower the risk of patient infection when it comes to endoscopes?
Benedict: Biomeds need to ensure endoscopes and related equipment and accessories (reprocessors, leak testers, flushing pumps, etc.) are maintained per the original manufacturer’s recommendations. Sending endoscopes to the manufacturer for repairs whenever any abnormalities or damages are observed is important. Although it may not be recommended by endoscope manufacturers, if biomeds choose to use a third-party repair center for endoscopes or choose to perform repairs themselves, they need to ensure they are aware of related issues and risks that may be associated with this practice.
Fujita: The U.S. FDA has been diligently working with industry to address and prevent potential infection issues. Fujifilm urges health care facilities to follow the recommendations stated in FDA safety communications to lower risk of patient infection in medical procedures.
A few tips for biomeds are as follows:
- Ensure that manufacturer’s device specific instructions are readily available to staff for all endoscopes and related validated reprocessing equipment (AERs, channel flushing aids, etc.).
- Provide proper training for reprocessing personnel utilizing but not limited to manufacturer provided training materials.
- Ensure only manufacturer validated brushes and AERs are utilized in the reprocessing process.
- Ensure single-use, disposable components are in fact disposed of, and are not reused.
- Confirm endoscopes are properly maintained and function as intended.
- Ensure that institutional policies and procedures have been established for equipment maintenance including periodic maintenance as recommended by each scope manufacturer.
- Work closely with staff to ensure applicable personnel routinely inspect endoscopes for damages including missing/chipped adhesives, broken/cracked lenses/distal tips as well as any signs or evidence of residual foreign matter on scope surfaces. If any damage or residues are observed, scopes should be returned for evaluation/service.
- Educate reprocessing personnel that irregularities (ex. resistance) detected during channel cleaning by brush can be indicative of kinked/damaged channels which may interfere with ability for channels to be adequately cleaned.
- Develop procedures for periodic evaluation of already reprocessed scopes in storage cabinets. Any observed traces of fluid/droplets beneath scope hanging in cabinet or signs of stains/residues on distal scope tip may be indicative of inadequately dried scopes.
Sandrini: Respond quickly to any requests for help from your SPD or HLD departments. Follow the OEM guidelines on PMs and test cycles of your reprocessing devices. Prepare yourself with troubleshooting information from the OEM manuals and suggest to those departments, or if you are responsible for managing the endoscope fleet, set up a preventative maintenance inspection to occur every six months. Suggest regular in-service training to occur every six months for your biomed team and those departments involved in the care, handling and reprocessing.
Zamani: Biomeds can help develop performance improvement programs for endoscopy scope and systems that can provide monitoring and surveillance. They can help lower risks by reporting noncompliant measurements. The safety committees at these facilities or the environment of care can take these hazards and figure out the resolutions for each hazard to seek closure. Proper documentation is the key that will make a successful program.
Q: What else do you think TechNation readers need to know about purchasing and servicing endoscopes?
Benedict: Endoscopes play an important role in the detection, prevention and treatment of many types of cancers and other conditions throughout the body. They are intricately designed and engineered devices with hundreds of unique parts working in tandem to provide clinicians with the access and image quality required to see and treat irregularities. As such, it is vitally important that customers treat the after-sale service decision with just as much care and deliberation as the decision to make the actual purchase.
To ensure endoscopes are functioning as they were designed, the OEM should be used for service and repair needs. This is important to ensure: that the parts used to repair the endoscope are never compromised, that the repair process is done according to current OEM protocol, and that the technicians performing the repair are OEM trained.
OEMs are uniquely qualified to perform the service and repair of the endoscopes they manufacture due to the rigor and quality standards they must adhere to as FDA regulated entities. Third-party repair organizations may provide more economical servicing options due to use of non-OEM parts, a repair process that is not OEM certified and technicians who have not been trained by the OEM, but it is important to note that these organizations are neither FDA regulated nor FDA registered.
Fujita: While state of the art technology and clinical utilization of endoscopes are crucial factors for physicians, other purchasing considerations should include after sales support, comprehensive product in-services, training aids and educational materials such as informative quick reference guides which describe manufacturer’s reprocessing recommendations in a simpler format (to be used in conjunction with the standard operation manuals). Fujifilm wants to drive home the message that appropriate endoscope care can benefit patients and hospitals. Patients can face a reduced risk of cross-contamination, and hospitals can face less scope downtime, less administrative work when scopes are properly cared for. All of these factors contribute to ensuring health care organizations are selecting the right vendor for their technology needs.
Sandrini: Certified preowned with warranty can save your facilities thousands of dollars. Always buy from a reputable re-seller such as MMS. Your vendor should be able to provide installation and training. Ask for final inspection reports so you have record of what repairs occurred to add to your CMMS. This will help you to be ready for any questions from surveyors. Remember “working good enough” on your flexible endoscopes isn’t OK! Every device should be working to OEM specifications! When it isn’t, send it out for the quick minor repair or it is in danger of becoming a major repair or a patient fail during procedure. These minor repairs are quick and are minimal in cost. This will help your facility increase uptimes and decrease major repair costs!
Zamani: My clients utilize my services because I go out of my way to help build long-lasting relationships and we provide excellent customer service and support. I really like to go above and beyond for our clientele.
