Ask the Experts: Endoscope Reprocessing

Ask the Experts: Endoscope Reprocessing 

By Jennifer Schraag

today’s surgicenter magazine asks the experts the key concerns encircling endoscope reprocessing. Each share their expertise, advice, and perspective on the topic.

OUR EXPERT PANEL:

• Nyla “Skee” Japp, RN, PhD, ACSP, CSPDM, with Phoenix-based Infection Control Specialties and nurse manager of the CSPD department at Banner Desert Medical Center in Mesa, Ariz.
• Stephen M. Kovach, BS, director of education with Healthmark Industries.
• Bradley Catalone, PhD, senior manager of infection control at Olympus America Inc.

Q: What are among the more concerning cleaning, disinfecting, and sterilization challenges in endoscope reprocessing?

JAPP: “In the past as well as today, endoscopes are concerning because of their complex structure. Cleaning is the most vital in the process because if the scope is not thoroughly cleaned it will not be disinfected or sterilized. I think too many times because of the hurried environment of getting more patients done, short cuts may be taken to save that precious commodity of time. The problem then of scrupulously hand cleaning with a brush and using copious rinsing of water to ensure biofilm is completely removed may not occur. Both rigid endoscopes and flexible endoscopes require special cleaning. Flexible scopes are very difficult to clean because of their numerous small channels and length. I also have concerns regarding the inspection of the flexible scopes ensuring that close attention is paid to the seams and body joints. Visual inspection for tears and holes can save a facility in repair costs.”

KOVACH: “I believe there are at least five areas of concern:

1. Cleaning in general is difficult on these items (scopes and instruments). Mostly the lumen items are very difficult to visually check. Also, not having complete information (on cleaning processes), and if complete information is given, following those instructions. AAMI TIR 12 is helping to make sure that proper information is given to medical facilities.

2. Checking for damage of the insulation of the shaft/sheath tube on instruments — checking is not being done on each instrument.

3. Function testing needs to be done on each instrument each time.

4. Sterilization instructions need to be followed.

5. Not enough time and instruments. Pressure is constantly put on the staff to turn around items quickly. To do it right takes time.”

CATALONE: “When it comes to cleaning and disinfection, everyone in the hospital, ambulatory surgery center (ASC) or private GI practice has an important role in ensuring that endoscopes are reprocessed and maintained. With this said, the majority of improper endoscope reprocessing occurs during the manual cleaning stage. Common reprocessing deficiencies are seen in the steps below.

Pre-Cleaning 

• Failure to reprocess unique channels (example: elevator wire or auxiliary water channel) 
• Not using the proper adapter to reprocess the air/water channels 
• Transporting the endoscope without using a closed container or with sharp accessories 
• Delayed reprocessing, especially for procedures performed at night or on weekends

Leak Testing 

• Use of damaged water resistant cap 
• Overlooking pressurization of scope prior to immersion 
• Incomplete angulation of the distal tip in all directions during leak test 
• Not following the manufacturer’s guidelines for reprocessing a damaged scope 

Manual Cleaning 

• Neglecting to dilute the detergent according to manufacturers specifications 
• Reuse of disposable brushes and other accessories 
• Failure to use manufacturer’s recommended cleaning adapters 
• Use of damaged or improperly reprocessed cleaning adapters 
• Using a sink or basin of insufficient dimensions 
• High level disinfectant 
• Inadequately testing the minimum effective concentration of high-level disinfectant according to manufacturer’s instructions (i.e., every cycle) 
• Failure to maintain a log of high-level disinfectant use and endoscope reprocessing 

Storage 

• Oversight in removing all valves and caps when storing the endoscope 
• Neglecting to ensure that scopes are hung with all locks in the free position 
• Crowded and unsecured scope storage areas 

“There’s a misconception that scopes will break and leak, regardless of how much care is taken with them. However, a majority of the repairs that we see are preventable. Scopes need to be leak tested after every procedure, and the condition of the water resistant cap must be checked with every use. Immediate bedside cleaning reduces the possibility of damage such as clogged nozzles and channels. Another important factor is proper endoscope handling. In general, be conscious of any surface with which a scope comes in contact, as it can be a potential source of insertion tube punctures and damage. Perform functionality and visual inspections of endoscopes prior to every procedure. An inspection of the functional aspects of the scope prior to each procedure will help to ensure that the scope is ready to be safely used. Additionally, proactive inspection of the condition of the instrument may significantly reduce the frequency and extent of repairs. Proper care, handling, and reprocessing in conjunction with the original equipment manufacturer’s provided instructions — such as leak testing after every procedure — will maximize the uptime of endoscopes.”

Q: Do you see a lot of bioburden build-up on these instruments, and if so, where?

JAPP: “Because most scopes are unable to be put in the ultrasonic cleaner, bioburden absolutely can become an issue with the scope. There are six basic steps in cleaning scopes: pre-cleaning, leak testing, cleaning, disinfection/sterilization, drying, and storing. All removal parts must be removed, soaked in enzymatic solution to begin the digestion of the protein, and then scrubbed with a brush to remove all the debris. All accessible channels must be brushed to remove particulate matter. Inspect what you have cleaned to ensure the scope is clean. All steps must be done in the correct order, and any short cuts will lead to scopes not being properly cleaned thus, build-up of bioburden.”

KOVACH: “At the tips of the instruments and inside all of the channels — these are the most difficult areas to clean with endoscopic instruments.”

Q: What challenges does the internal lumen, specifically, present in the proper cleaning, disinfection, and sterilization of the instrument?

JAPP: “Having the right-sized cleaning brush is vital to cleaning the lumen. If the channels are not clean, it will not be disinfected or sterilized.”

KOVACH: “The lumen and length of the instrument is very difficult to clean. Because it is so narrow (the diameters of the instruments are getting smaller and smaller), the staff who are cleaning these instruments must follow the manufacturers instructions to the letter. Technicians need proper equipment such as spray guns, brushes, and sonic cleaning equipment. Many departments do not have the proper cleaning equipment. Studies have shown that using sonic cleaning on lumen (not flexible scopes) items is very critical to having a clean instrument. In fact, Dr. Michelle Alfa in an article titled “Manual versus automated methods for cleaning reusable accessory devices used for minimally invasive surgical procedures,” published in the Journal of Hospital Infection (January 2004) stated the importance of using sonic cleaners with a retro-flushing type action found in certain sonic cleaners. This action helped in cleaning lumen-type items.”

CATALONE: “No ability to visually inspect and verify cleanliness. Also, some lumens are not designed to be brushed and cannot withstand the rigors of mechanical abrasion. For channels that do not get brushed, precleaning and manual cleaning in a timely manner is critical to prevent patient debris from drying and hardening in the channel. If this happens a modified procedure specific for delayed reprocessing should be performed.”

Q: What other challenges does the average endoscopic instrument present in the reprocessing realm?

JAPP: “The other challenges with endoscopes are cleaning the accessory parts. The items that can be disassembled for cleaning must be disassembled for cleaning, disinfection, and sterilization. The accessory items that have internal moving parts pose a great challenge in preparation for sterilization.”

KOVACH: “It is the time factor for cleaning and inspection that is challenging to the staff reprocessing these items regardless if it is a scope or an instrument. To do it right takes time. Some items have to be taken apart and flushed. Staff has to take the time to let the various cleaning solutions work. Enzymes need time to break down the target soil. Cleaning solution products are all different; no two are alike in my view. Always follow the manufactures instructions. “Staff tend to use the lower time limit for soaking. My view from experience is a time of at least five minutes is needed for soaking. Next is the verification of these items that they are clean, which can not be done visually. Having a quality process in place to monitor the process is so important. This has to be done to help ensure items are safe to be used. Each medical facility has to work with infection control, risk management, and their staff to put in a program that works for their medical facility.”

Q: How can central service (CS)/ sterile processing (SPD) personnel best be trained in the proper protocols in cleaning, disinfecting, and sterilizing scopes? What types of in-services and handson training should be given and how often?

JAPP: “CS/SPD staff must be trained to follow the manufacturer guidelines for cleaning, disinfection, and sterilization. In-services should be given initially by the manufacturer then reviewed with staff annually, with new staff in orientation and as determined by the manager.”

KOVACH: “Training is multi-pronged. It takes at least in-servicing from all of the following to have well-trained staff:

• The manufacturer of the equipment 
• The manufacturer of the cleaning solution used 
• The manufacturer of the scope cleaning system used 
• The manufacturer of the scope disinfection/ sterilization equipment used 
• The repair service should review reports on a monthly basis of the repairs of scopes and instruments to help in reducing
• At least yearly training on all scopes and equipment and have this documented 
• All new staff during their training period 
• All physicians should be trained in the proper use of the equipment and this should be documented at least yearly 

“Technology is dynamic and changing all the time. That is why all staff — including physicians — need to be updated. New products are being introduced that help staff verify their process and should be used as help in the training. Also, hands on training of the scopes and instruments and using various processes to test both equipment and staff for cleaning is important.”

CATALONE: “Cleaning is the most critical reprocessing step, removing more than 99 percent of the bioburden from the endoscope. Failure to properly clean endoscopes has considerable consequences for both the patient and the healthcare provider. First and foremost, inadequate endoscope cleaning jeopardizes patient safety. Although pathogen transmission in endoscopy is rare, documented cases of pathogen transmission have been invariably linked to breaches in reprocessing, with the majority being associated with a failure to properly clean the endoscope according to manufacturer’s instructions. Second, healthcare facilities must expend considerable resources to investigate cases of both patient infection and pseudoinfection related to inadequate endoscope cleaning. In addition, the identification of improper endoscope cleaning as part of an infection control investigation may lead to patient notification and testing; a consequence of which may be multiple lawsuits and immeasurable damage to the healthcare provider’s reputation. And finally, improper reprocessing may result in endoscope damage and higher repair costs for the facility. Overall, failure to properly clean endoscopes produces a myriad of avoidable consequences that drain resources from effective healthcare delivery and improving patient outcomes. “Olympus provides service contract customers with an extensive selection of educational programs via Olympus University. Additionally, on-site endoscopy support specialists provide in-service trainings, tips and suggestions for avoiding scope damage. Olympus has also just announced the release of two training DVDs for the reprocessing of Olympus GI endoscopes and bronchoscopes.”

Q: What else would you like to add to this dialogue?

JAPP: “In order to elevate the profession of CS/SPD, managers and directors have to step up to the plate and insist that staff have proper training to do their jobs. One way is through certification, but still today too many managers and directors in CS/SPD are still not certified in the profession. If supervisors and managers are not certified, how can they expect their technicians to have certification? How can we continue to complain about the low moral, the low wages — the basement — and no respect if we do not ensure patients are getting clean and sterile instruments? Being certified does measure competence so why is not every state in this country making certification a requirement for CS/SPD? I cannot buy that we are just too busy. Tomorrow is too late and today is the time to begin the process.”

KOVACH: “I too believe that training has to be stressed more and testing of staff must take place more than once a year. Equipment is constantly changing and training needs to be ongoing. It is also my personal belief that some type of monitoring and or testing should be done. I have seen a lot over the years both as a user and manufacture. Many of the errors I see can be prevented with a good quality improvement program. The quality program relies upon both the staff observations and monitoring the complete process. Using product that helps you solve concerns like cleaning verification products that if used can help prevent concerns before they happen. Just waiting to have the government state you must test and monitor is not the answer.”

CATALONE: “A nurse or tech can do the following to help prevent incidents of infection:

• Read, understand, and follow the manufacturer’s instructions and the guidance provided by professional organizations like ASGE, SGNA, etc.
• Join and participate in organizations such as the SGNA or APIC 
• Stay current by subscribing to and reading infection control-related magazines, literature, and journals 
• Talk with co-workers and friends from other facilities, challenge the device manufacturer’s sales representatives, field engineers, and clinical specialists with questions and issues” 

Why is leak testing so important?

Terry Bader, chief executive officer at Verimetrex, comments, “Endoscopes feature mechanical, illumination and video technologies, all of which respond poorly to contact with the fluid that can enter through an undetected leak. Given the sharp and hot instruments used in concert with scopes and excessive wear and tear, damage that can allow a leak is common, occurring in around 1 percent of procedures. Scope manufacturers warn that an omitted or poorly performed leak test can lead to a fluid invasion that greatly escalates the damage to the scope and raises the risk of cross-patient infection by allowing pathogens to escape disinfection then pass out of the scope through an undetected leak. SGNA, APIC, SHEA, and other healthcare professional organizations all require leak testing in their reprocessing regimens.”

Bader continues, “Endoscope reprocessing combines high volume (50 scopes in a day is not uncommon) and a series of distinct protocols that feature multiple steps (e.g. leak testing, manual cleaning, high level disinfection, etc.) to create a true rapid assembly line process. Some protocols, such as high level disinfection, are automated to ensure best practices compliance. Leak testing, though complex, is performed manually, allowing the technician to stray from proper testing methods (typically when reprocessing activity is high). As a result, technicians fail to detect a third of leaks, on average, leading to fluid invasions that generate 50 percent to 60 percent of scope repair costs.”