Endoscopic equipment is notoriously difficult to clean. Ports, channels, and nooks and crannies all offer wonderful hiding places for bacteria, viruses, and other pathogens, and lend themselves to the buildup of biofilm. Manufacturer’s guidelines are designed to offset these hazards, but introducing the human element into the cleaning and disinfection process means there is always room for error.
In January 2008, a facility leak-tested an endoscope and identified a leak in the bending rubber of a colonoscope after a procedure. Due to time constraints, the colonoscope was not processed and was packaged for delivery to the manufacturer for repair. That’s when things went from bad to worse.
“It was hung in the endoscope cabinet with clean and well-functioning endoscopes that were in active circulation,” says Patricia DeSouza, RN, BSN, CGRN, a consultant for establishing GI endoscopy units. “Needless to say, no sign was even placed on this dirty scope, and an unsuspecting nurse came along later and used this colonoscope for a procedure.”
It is frighteningly easy for something like this to happen in any facility. “I think this underscores the importance of following careful and consistent protocol to assure that these endoscopes are immediately taken out of circulation,” DeSouza offers. “I think that facilities, from my experience, are often confused as well about how to render such scopes high-level disinfected for return to the manufacturer when there is a leak, which may make this process difficult (the last thing you want to do is cause fluid invasion through the leak when trying to disinfect it). The original equipment manufacturer (OEM) should be contacted to give guidelines based upon where the leak exists, how large it is, etc.”
The reason for the mix-up, she explains, was traced back to the time element. “The endoscopy staff member hung the scope up, with the intention of processing and packaging it for delivery, but apparently didn’t get back to do it before the other nurse assumed that it was patient-ready — since it was, after all, hanging in the scope closet. I would imagine that an incident report would have to be filed and steps taken to evaluate and intervene, as appropriate, on that patient’s behalf. It’s scary,” she relates.
If it did harbor infectious material, that scope would have the potential to infect every new patient until it was properly cleaned, disinfected and repaired.
That’s not the only instance of recent infectious transmission. Sue Hetticher, MT (ASCP), CIC, an infection control practitioner (ICP) and epidemiologist in Long Beach, Calif., recounts the story of an outbreak related to a poorly inspected transesophageal echocardiography endoscope (TEE), which is used to perform a heart scan with endoscopy. “There was an outbreak of E. coli in sputum from open heart surgery patients who all had a TEE used during their surgery,” Hetticher recalls. “The TEE was not inspected properly each time before use and during the cleaning procedure. The probe on the TEE was old, cracked and frayed. The cardiac patients all developed E. coli in their sputums approximately 48 hours post-surgery. The same E. coli strain was isolated from the TEE on the second attempt of culturing.”
The outbreak occurred in May 2006 at a 370-bed acute care hospital in Los Angeles County where Hetticher was an ICP. The cardiac operating room (OR) tech was responsible for checking and cleaning the TEE, she continues, and there was one TEE dedicated to the two cardiac surgery ORs. “Cardiac surgery patients regularly had the TEE inserted at the beginning of the procedure, and the scope remained inserted for the entire duration. The TEE probe was cleaned between each patient with disinfectant and recorded; however, incorrect recording and poor disinfection technique was observed. Visual inspection revealed cracks in the ring of the TEE. The TEE probe was removed from patient care and returned to the manufacturer.”
The hospital’s policy and procedure manual outlined the appropriate cleaning principles, including this instruction: “The transducer must be cleaned and inspected before and after use and after each transesophageal echocardiography examination ... it should be inspected for perforations or tears in the outer casing.”
Hetticher outlines more about the scope’s composition: “The probe is covered by a hard, black, smooth plastic with depth markings. The transducer showed visible fraying and deterioration in the area surrounding the outer aspect of the transducer probe neck, and fraying with a white string protruding from the inner aspect. Notification was made to the Los Angeles County Department of Health officer, DPH Health Facilities, California Department of Public Health, and CDC-DHQP. There were multiple site visits by the acute communicable disease control (ACDC) unit.”
Ultimately, she says, there were nine of 19 patients with culture-positive E. coli infections (seven sputum, one blood, one blood and sputum), and all of the infections occurred within four days after surgery in a two-week period.
Overall, 23 environmental cultures were collected, including the TEE probe, which was cultured on June 2 and again on June 8, 2006. The TEE tested positive for Klebsiella pneumoniae on June 2 and was recultured on June 9 with the TEE probe attached to the machine and the power on. The probe, Hetticher says, tested positive on June 9 for E. coli. The TEE gel, gel cap, and outside cap were included in testing, but all of those samples were negative for E. coli except the TEE probe.
“After the first site visit, ACDC issued interim recommendations including antibiotic coverage for gram-negative organisms for cardiac surgery patients. Previously, the patients were given vancomycin prophylactically due to a MRSA problem, so a cephalosporin was added to prophylactic treatment,” she adds. “All the patients survived.”
Afterward, the TEE was removed from service, and a retraining session was documented with the OR techs. The staff continued to follow the manufacturer’s guidelines for proper cleaning and storage of the TEE, and, after the outbreak, used disposable sheaths to cover the transducer probe during each TEE procedure. Self-contained cleaning stations were installed for cleaning of the TEEs.
Of note, Hetticher says, “Three case isolates and the TEE had an indistinguishable PFGE pattern. The TEE probe was implicated as the cause of this outbreak due to multiple reasons, including the matching PFGE (pulse-field gel electrophoresis) isolates and the cracked surface of the TEE.”
Why Infections Happen
“The first mistake that can be made is not using a sponge impregnated with an enzymatic detergent to wipe down the scope immediately after a procedure,” says Jack Kinville, marketing manager for Ruhof Corporation. “Allowing bioburden to dry on the sheath of the scope will make it harder for the techs to remove and will lower turnaround time.”
Sometimes, the cleaning solution is not changed as often as recommended. “It can be a common practice to use the same diluted enzymatic solution for multiple scopes and discard it at the end of each day. This can create a dangerous situation,” Kinville adds. “Optimally, the solution should be switched out after each case for maximum safety and to lower the risk of cross contamination.”
One of the hardest things to clean on a scope is the internal channels, he points out. “Since it is impossible to see inside, you can never be too sure if it is free of all contaminants. The usual way of cleaning them is to scrub the channels with a brush. Typical wire bristle brushes can gouge or scar the inside walls, which creates a place for bioburden to lodge itself, making it difficult to get out. Foam-tip brushes should be used instead, so that they expand inside the channels to give complete contact with the walls without damaging them, while forcing out all contaminants.”
A thorough rinsing of the scope with water after cleaning is very important to ensure that there is no residue left on or inside the scope, Kinville adds. “One of the biggest misconceptions in scope cleaning is that you can clean and sterilize with one product. This is impossible, since the sterilant would kill the enzymes before they have a chance to do their job. There must always be a two-step process. First, remove all the bioburden with an enzymatic detergent, and second, use a high-level disinfectant to sterilize the scope.”
Cleaning really is one of the most difficult parts of dealing with medical equipment. It is the most critical reprocessing step, says Bradley Catalone, PhD, director of research for Olympus America. “It removes more than 99.9 percent of the bioburden from the endoscope,” he points out. “If an endoscope is not properly cleaned, terminal disinfection or sterilization may not be possible. Failure to properly clean endoscopes has considerable consequences for both the patient and the healthcare provider.”
As Nancy Chobin, RN, CSPDT, says, “If it’s not clean, it can’t be sterile.” Chobin is the executive director of the Certification Board for Sterile Processing and Distribution, Inc.
Patient welfare is the main reason for proper cleaning, Catalone observes. “First and foremost, inadequate endoscope cleaning jeopardizes patient safety. Although the risk of infection in endoscopy is extremely rare, with an estimated incidence of one in 10 million procedures, documented cases of pathogen transmission have been invariably linked to the use of damaged/defective equipment and/or breaches in reprocessing,” he says. “Deficiencies in reprocessing are most commonly associated with failure to comply with the manufacturer’s instructions for endoscope cleaning. This includes not only executing the specified process, but also reprocessing the endoscope in a timely manner following use. In cases in which reprocessing is delayed, the standard procedure may not be effective. Check with your endoscope manufacturer for instructions on delayed reprocessing.”
If reprocessing is delayed, that allows for the accumulation and hardening of bioburden. Bioburden can dry into a nearly impervious substance — harder to remove than baby food cemented to a high chair.
Second, Catalone says, it’s not cheap to trace and treat an outbreak if a scope is poorly cleaned. “Healthcare facilities must expend considerable resources to investigate cases of both patient infection and pseudo-infection related to inadequate endoscope cleaning,” she says. “In addition, the identification of improper endoscope cleaning as part of an infection control investigation may lead to patient notification and testing, the consequences of which may be legal liability and immeasurable damage to the healthcare provider’s reputation.”
In short, don’t release an inadequately cleaned scope. If it’s used on a patient who acquires an infection as a result, you could be sued for millions of dollars and lose your reputation and your job.
Finally, Catalone adds, “Improper reprocessing may result in endoscope damage and higher repair costs for the facility.” That, too, can extend into the thousands of dollars. A complete rebuild of a standard endoscope can exceed $10,000. Overall, he says, “Failure to properly clean endoscopes produces a myriad of avoidable consequences that drain resources from effective healthcare delivery and improving patient outcomes.”
Preventing Scope-Related Infections
The first defense is a good offense, and in healthcare, that means education. If employees are educated about how to clean, and understand why certain steps are essential, they are much less likely to skip or short-change those steps.
“In an environment that is very dynamic with new technologies, responsibilities, and turnover, ongoing education and training allows your staff to keep current,” Catalone points out. “Olympus understands that educating facilities on proper handling of instruments is a vital component to maximizing their investment. To this end, Olympus provides service contract customers with an extensive selection of educational programs via Olympus University (courses that offer continuing education units).”
Other manufacturers understand this as well. They happily visit facilities and offer on-site training and education to ensure that employees are handling, cleaning, and disinfecting equipment the right way.
Manufacturers offer training videos on reprocessing of all different types of scopes, with step-by-step demonstrations of the entire procedure. Olympus offers these training DVDs for free at www.olympusamerica.com/cds in both English and Spanish.
But no matter how good the training, it’s always essential to have the manufacturers’ recommendations on-hand in the reprocessing area. They should also have access to multi-society guidelines. This way, employees can access those instructions as-needed for step-by-step instructions, to ensure they are not missing any steps in the process.
“Functionality and visual inspections of the endoscope should be performed before every procedure,” Catalone cautions. “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 up-time of endoscopes.”
He points out that there is a misconception that scopes will break and leak, regardless of how much care is taken with them. However, he says, “A majority of the repairs that we see are preventable. There are many things that can be done to substantially reduce the chance that a scope will require repair. 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. 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.”
Catalone summarizes his recommendations as follows:
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 coworkers and friends from other facilities, and challenge the device manufacturer’s sales representatives, field engineers and clinical specialists with questions and issues.