By Don Sadler
Independent perioperative consultant Deborah L. Spratt, MPA, BSN, RN, CNOR, CHL
Fiberoptic flexible endoscopes (FFEs) are some of the most critical pieces of equipment used in operating rooms. This makes proper endoscope cleaning and processing one of the most important perioperative tasks to be performed.
“At the end of every scope, there’s a patient who deserves proper care,” says Garland Grisby, endoscope service manager, Kaiser Permanente, and co-chair of AAMI Working Group 84.
Independent perioperative consultant Deborah L. Spratt, MPA, BSN, RN, CNOR, CHL, concurs.
“Every patient deserves a properly cleaned and terminally disinfected or sterilized scope,” she says. “Anything less and patients are at risk of a bloodborne infection or some other pathogen.”
Increased Risk
Failure to properly clean and process FFEs can lead to a wide range of different problems – ranging from increased risk of infections and exposure to hazardous and toxic chemicals to surgical delays that cost hospitals time and money.
Latisha Newell, BA, CST, CBSPDT, sterile processing manager with AnMed, points to the global wave of infections over the past decade that have been linked to improper cleaning of high-risk scopes such as duodenoscopes, EUS endoscopes and EBUS endoscopes.
Latisha Newell, BA, CST, CBSPDT, sterile processing manager with AnMed
“These could have been avoided if proper training, effective monitoring and quality assurance measures were in place,” she says.
There are far more outbreaks associated with flexible endoscopes than any other medical or surgical device, says Amber Wood, MSN, RN, CNOR, CIC, FAPIC, senior perioperative practice specialist with the Association of periOperative Registered Nurses (AORN).
“These have led to numerous patient infections and, unfortunately, even deaths,” says Wood. “Of more than 130 published outbreaks, mostly related to bronchoscopes and GI endoscopes, there were more than 25 outbreaks of multi-drug resistant organisms caused by duodenoscopes.”
According to Sharon A. McNamara, RN, BSN, MS, CNOR, a consultant with OR Dx+Rx Solutions for Surgical Safety, there are two main types of infections associated with patients having endoscopic procedures: endogenous infections and exogenous infections.
In the former, an improperly inspected endoscope with damage may result in a tear in the mucosal lining, exposing the circulatory system to microorganisms that can cause septicemia. Exogenous infections result when microorganisms are transmitted from an improperly processed scope, a scope that may have integrity issues or mechanical problems, or one that has been improperly cleaned or maintained.
“In either of these scenarios, if the issues with the scope are not discovered in the next processing cycle, the next patient will be exposed to the microorganisms remaining in the scope,” says McNamara. “This breakdown in systems may expose each patient the scope is used on to infection.”
Biggest Challenges
Perioperative staff face a number of different challenges when it comes to endoscope cleaning and processing. One of the biggest is the fact that these are complex medical devices with long, narrow channels that can be difficult to inspect and clean.
“The biggest challenges in endoscope processing are rooted in the sheer complexity of the process and the vast amount of resources needed to be successful,” says Wood. “There’s a narrow margin for safety. Even the most rigorous processing methods can be undermined by the design of the device or contamination of the endoscope after processing.”
While the complexity of endoscope design is certainly a challenge to proper cleaning and processing, Grisby lists other factors including insufficient processing equipment (e.g., brushes) and cleaning verification testing (e.g., soil marker, protein test, borescope) and inadequate or out-of-date equipment.
There is a variety of different types and models of FFEs and each one must be processed in strict accordance with the manufacturer’s instructions for use (IFU).
“IFUs can be long, containing hundreds of steps, and easily misunderstood,” says Pam Boulet, BSN, RN, CGRN, CFER, manager, clinical education specialist, at Steris.
Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS, clinical educator for the Healthcare Sterile Processing Association (HSPA)
“Even the same types of endoscopes may require different processing steps,” says Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS, clinical educator for the Healthcare Sterile Processing Association (HSPA).
Not having the right processing equipment, such as brushes or proper sink arrangement, is another challenge.
“Further, if the facility does not have the adequate number of endoscopes to meet the scheduling demands, the processing technician may be pressured to rush through endoscope processing,” says Klacik. “This is a dangerous practice that’s never acceptable.”
Perhaps the biggest challenge in processing endoscopes is inadequate staff training and oversight.
“A lack of staff education in endoscope processing is definitely a big challenge,” says Boulet.
“Health care organizations struggle to find and maintain educated, competent endoscopy technicians who are dedicated to processing FFEs,” says McNamara. “Sustaining the education and competency of staff is an ongoing challenge, especially with the frequent introduction of new, innovative technologies.”
“The lack of in-services and continuing education provided for complex endoscopes poses a risk to patient safety,” adds Newell.
Common Mistakes
These and other challenges can lead to some common endoscope processing mistakes. For example, McNamara has observed technicians doing leak testing after performing automatic endoscope reprocessing (AER).
“If the scope has a leak, there is the potential for severe damage from the solutions used to reprocess it, along with the cost of equipment repair or replacement,” she says. “Skipping or forgetting the leak testing can expose patients to retained debris imbedded with microorganisms and possibly lead to infection.”
Boulet lists a number of other common mistakes associated with leak testing, including:
- Not inflating the scope prior to immersion
- Not allowing adequate time to observe for leaks
- Not having the endoscope submerged entirely
- Not moving the control knobs and depressing the switches
- Adding detergent prior to leak testing
Not following the manufacturer’s IFUs throughout the entire process is another common endoscope processing mistake.
“I recommend that the charts from the scope manufacturer and the automated scope reprocessing company be readily available to staff for constant reinforcement,” says Spratt.
Failing to thoroughly dry endoscopes may result in residual moisture remaining on or in the scope, creating an environment for microorganisms to survive and multiply.
“Bacteria can grow and proliferate rapidly, especially when there is a moist environment,” says Klacik.
“After eight hours of storage, for example, a contaminated endoscope may have tens of thousands to millions of bacteria present, which is an obvious infection risk for the next patient,” says Klacik.
Technology Solutions
The good news is that FFE cleaning and processing has received extensive interdisciplinary attention in recent years. This has led to an increased focus on how technology can be leveraged to automate, streamline and standardize endoscope processing. Examples include automatic endoscope reprocessors (AERs), visual inspection with borescopes and endoscope drying cabinets.
“Utilizing technology to automate processes as much as possible may be more efficient and consistent than manual processes and can reduce staff exposure to high-level disinfectants,” says Wood.
Boulet concurs.
“Automated processes such as AERs provide consistency and increase compliance with standards and guidelines,” she says. “In the future, I’m hoping to see AI technology incorporated in endoscope processing to assist with compliance and conformance to IFUs. AI is a great fit for endoscopy, especially with relation to manual cleaning and borescopes.”
Since endoscopes may appear clean but have debris or damage that can’t be seen without magnification, lighted magnification should be used for inspection. “Also, there may be damage or debris in internal channels that can’t be detected unless the channels are inspected with a borescope,” says Wood.
According to McNamara, the advent of AERs has had a great influence on providing a high-quality cleaning and decontamination cycle for FFE.
“However, there are important considerations for the operator to make sure the various scopes are connected properly, concentrations of cleaners and high-level disinfectants are appropriate, and all cycle parameters are observed for correctness and documented,” she says.
“Evidence has shown that AERs are more effective at processing endoscopes than manual processing,” says Klacik. “AERs are more efficient and provide a consistent result. They also reduce staff exposure to chemicals and diminish physical discomfort from repetitive motions.”
Newell stresses the importance of standard operating procedures that include the use of borescopes and cleaning efficacy tests prior to the AER process.
“Well-written policies should address scopes that are considered high risk and require protein testing every time,” she says.
According to Klacik, using automatic dryers and drying cabinets to thoroughly dry endoscopes, including the narrow channels, can help prevent a moist environment where bacteria can grow.
“Borescopes are vital as well because they allow users to observe the channels for bioburden and debris, scratches or any other problem that could interfere with the integrity of the channel,” she says.
Technology can also verify that leak testers are functioning properly. Klacik recommends that automated leak testers be placed on a calibration schedule to verify that the leak tester is producing the correct pressure.
“It’s possible for leak testers to fail,” says Klacik.
Manual handheld leak testers and leak tester tubing should be inspected for damage, leakage and pressure output, Klacik adds. “Pressure verification should be performed for each type of leak tester in the facility every day that endoscopes are used,” she says. “Calibration ensures that an endoscope will be challenged with the proper pressure each time when being tested for leaks.”
Standards and Guidelines
In 2022, the Association for the Advancement of Medical Instrumentation (AAMI) released the updated ANSI/AAMI ST91:2021 to reflect current research and advancements in FFE processing. According to Klacik, one of the most important recommendations is ensuring that all staff performing FFE processing duties complete formal training and competency verification in all aspects of endoscope processing prior to working independently.
“Section 6.3.1 of the standard recognizes the importance of formal training and competency verification by stating that this must be done prior to the employee’s first assignment,” says Boulet. “It also recommends that employees who process endoscopes earn a certification in flexible endoscope processing within two years of employment and maintain this certification.”
Additionally, the updated standard recommends that perioperative leaders be knowledgeable about sterilization and high-level disinfection (HLD) practices.
“Leaders need to confirm that flexible endoscope processing is being performed to professional standards and in compliance with regulations,” says Klacik.
Leaders should also ensure that there is sufficient time and staffing to perform all processing steps in accordance with the manufacturer’s IFUs and the latest standards, guidelines and regulations.
“Shortcuts of any kind are never acceptable,” says Klacik.
Boulet also points to the standard’s recommendations for drying.
“It recommends a minimum of 10 minutes of drying with pressure-regulated forced instrument air or a minimum of HEPA-filtered air,” she says.
Importantly, ANSI/AAMI ST91:2021 recognizes that AERs are endoscope disinfectors, not endoscope dryers.
“It states that even though an AER has an air purge cycle, this doesn’t satisfy the drying recommendation,” says Boulet. “Anyone who has ever taken an endoscope out of an AER knows there is still moisture coming from it. Therefore, drying should be achieved outside of the AER.”
In addition to ANSI/AAMI ST91:2021, perioperative professionals can refer to the AORN Guideline for Processing Flexible Endoscopes. This document provides FFE processing guidance in the areas of point-of-use treatment, leak testing, manual cleaning, cleaning verification, inspection, sterilization, HLD, drying, transport and storage.
According to Wood, the most recently updated guideline includes a renewed focus on the importance of drying processed endoscopes after high-level disinfection.
Garland Grisby, endoscope service manager, Kaiser Permanente, and co-chair of AAMI Working Group 84
“Retained moisture is a widespread problem that is underrecognized and often overlooked,” says Wood. “There is low compliance with drying protocols despite longstanding recommendations to dry endoscopes before storage.”
While simethicone is commonly used by many gastroenterologists as a de-foaming agent to improve visibility during endoscopy, Wood says it can inhibit effective cleaning of reusable devices since it can be difficult to remove from water bottles, tubing and endoscope channels.
“Researchers have recommended that if simethicone is necessary, low concentrations should be delivered directly into the working channel rather than being added to the water bottle,” she says.
Ensure Patient Confidence
“Patients who enter our facility should have the confidence that we’re going to take the best care of them, and this includes a properly processed endoscope,” says Grisby. “So, it’s important to make sure you have a dedicated group of scope processors who are properly trained and, perhaps most important, want to process scopes and take pride in it.”
