Flexible Endoscope Processing Gets Even More Serious

Experts share best practices to prevent worst-case scenarios.

Endoscopes are critical tools that assist in the performance of minimally invasive procedures by helping the provider examine internal body cavities and organs. They are often essential aids in the diagnosis of disease and in the execution of surgical procedures without making large incisions.

These tools, which are some of the most commonly used tools in outpatient surgery, tend to be complex in terms of both operation and sterilization, however. Expensive, fragile and notoriously difficult to clean, endoscopes present numerous challenges for sterile processing departments. If technicians do not follow the devices’ strict, voluminous (and sometimes convoluted or vague) manufacturer instructions for use (IFUs), as well as the potential for human error, inadequate cleaning and disinfection of an endoscope can increase patient infection and cross-contamination risks, with potentially life-threatening consequences.

Below the surface

According to a Johns Hopkins University study, infections stemming from improper sterilization of endoscopes are higher than expected at ASCs. Each year in the U.S., more than 15 million colonoscopies, for example, and seven million upper-GI endoscopies are performed. The study from six different states showed infection rates tied to endoscopes occurred in one out of every 1,100 procedures.

Fortunately, risk levels can be reduced through step-by-step guidelines, ongoing training and strict adherence to infection control practices.

Design challenges and infection risks

“Reprocessing flexible endoscopes is particularly challenging due to a combination of design complexity, infection control risks and strict procedural requirements,” says Elizabeth Thompson, associate director of sterile processing/endoscopy at the Hospital of the University of Pennsylvania in Philadelphia.

For example, the long and narrow channels, bends and multiple internal lumens of flexible endoscopes are difficult to clean thoroughly. The devices also contain sensitive optics, electronics and materials that can be easily damaged by improper handling or harsh disinfectants.

“Human error is a leading factor in failed reprocessing.”
— Elizabeth Thompson

“Because they are reusable and come into contact with mucous membranes or sterile areas, any lapse in cleaning or disinfection can result in cross-contamination and healthcare-associated infections,” says Ms. Thompson.

In addition, dangerous pathogens like CRE (carbapenem-resistant Enterobacteriaceae) have been linked to improperly reprocessed devices. This bacteria, normally found in the human gut, can be very difficult to treat when it spreads to other parts of the body, sometimes leading to high mortality rates.

Strict guidelines and training

At Penn, which operates multiple hospitals, almost 90,000 outpatient surgeries were performed in fiscal year 2023, many of which used endoscopes. The establishment of and adherence to processing guidelines and training specifically for endoscopes has become an important part of Penn’s process to ensure its patients stay safe.

The health system’s strict process is designed to reduce human error, avoid potential infection risks and preserve the delicate parts of every endoscope being used in high rotation.

“Reprocessing requires a precise, multistep process within a limited amount of time as stated within the IFUs,” says Ms. Thompson, who says each step of the cycle must be performed with vigilance. “Each step must be done in sequence, thoroughly and documented. It’s time-consuming and labor-intensive, but it works.”

Missteps in endoscope processing can be avoided by paying close attention to these very common trouble areas:

• Inadequate cleaning, disinfection and drying that can lead to microbial transmission.
• Lack of training and non-compliance leading to overall reprocessing failures.
• Failure to adhere to manufacturer guidelines for reprocessing of these devices.
• Delayed reprocessing that can lead to buildup of biofilms that are challenging to remove.

Ms. Thompson says the strict regulatory and manufacturer guidelines for each device should dictate the way these devices are reprocessed. “Everyone must comply with CDC, FDA, AAMI and manufacturer-specific protocols, which can vary and evolve periodically,” she says. “Failure to strictly adhere to these guidelines can lead to noncompliance, legal risk and jeopardized patient safety.”

At Penn, staff training has proven effective in the effort to avoid human error. “Human error is a leading factor in failed processing, including missed steps, improper drying or contamination during storage,” says Ms. Thompson. She recommends that staff be specially trained and certified, as well as conditioned to maintain vigilant focus while performing repetitive tasks. Another important consideration is the impact of resource and workflow constraints. For example, at facilities where there are both high procedural volumes and limitations in reprocessing equipment capacity and staffing. Workers can feel pressured to rush through the processing of scopes. To stay on schedule, endoscopists might be forced to reuse scopes prematurely, increasing infection risk to patients.

Ms. Thompson adds that critical equipment such as automated endoscope reprocessors requires ongoing maintenance, calibration and validation. If this upkeep isn’t maintained, even the best reprocessing systems will fail.

Tips for success

Ms. Thompson helped establish a few very important steps to ensure proper reprocessing across Penn’s hospitals. All staff charged with reprocessing endoscopes are trained in the same exact protocols, whether inpatient or outpatient.

The first step involves manual cleaning. While other devices can often be placed directly into automated washers and sterilizers with minimal manual intervention, that’s not true of endoscopes. “Flexible endoscopes require extensive manual cleaning before disinfection or sterilization,” says Ms. Thompson. “No automated process alone is sufficient.”

Endoscopes also can’t be sterilized with high heat, a common way in which many other tools are reprocessed. “Flexible endoscopes are heat-sensitive, so they cannot undergo steam sterilization, which is the most effective and commonly used method,” says Ms. Thompson.

Endoscopes are also at a high risk for biofilm formation. “The moist internal channels and frequent patient use increase the risk of biofilm formation that is resistant to disinfectants,” she says. “Rigid or simple instruments typically do not retain moisture or support biofilm as easily as flexible endoscopes do.”

Ultimately, the reprocessing of endoscopes needs to be highly regulated precisely because it’s so labor-intensive.

“Flexible endoscopes require strict adherence to detailed protocols, comprehensive training and documentation for each reprocessing cycle,” says Ms. Thompson. “Endoscopes are often used multiple times a day in high-volume settings, leaving limited time for proper reprocessing between uses.”

One of the most effective ways to ensure that endoscopes are properly reprocessed on a consistent basis is through effective training of staff. Studies suggest overwhelmingly that training staff in reprocessing results in overall better adherence.

Here’s how training works at the University of Pennsylvania:

• Vendor and manufacturer training. Onsite sessions are scheduled with endoscope and reprocessor manufacturers biannually. Staff are also trained in device-specific protocols that can vary among different endoscope models.

• Biannual hands-on demonstrations. In-person, step-by-step walkthroughs of each stage are demonstrated for staff, including pre-cleaning, leak testing, manual cleaning, disinfection, drying and storage. Staff learn precisely how to reprocess using actual scopes and realistic scenarios.

• Biannual competency-based training. Staff are required to know the competency checklists and to demonstrate proficiency before working independently. This process includes periodic skills assessments and recertifications, usually every six months for skills and every 12 months for certification.

• Video modules and online learning. Penn uses manufacturer videos and hospital-created modules to bolster training. This allows for flexible scheduling and visual reinforcement of the more complex steps.

• Standard Operating Procedures (SOPs) and manuals. Penn created a manual to provide easy-to-follow SOPs. The manual is posted in each reprocessing area.

• Simulations and mock drills. Penn created contamination or equipment-failure scenarios to test staff response. These help identify staff members’ knowledge gaps while improving their critical thinking skills under pressure.

• Peer-to-peer training/preceptorship. New or less-experienced staff are paired with preceptors for on-the-job mentorship. This reinforces consistency and helps them retain knowledge.

• Quizzes and knowledge checks. Penn uses short periodic quizzes to reinforce training and assess staff members’ understanding of the protocol. These case-based or scenario questions are relevant to the most common challenges that staff face with endoscope turnover.

• Biannual refresher courses. The hospital offers mandatory biannual education that incorporates any guideline updates, along with a review of common errors and hands-on revalidation.

“Our hospital follows strict, evidence-based guidelines for reprocessing flexible endoscopes to ensure patient safety and prevent infections,” says Ms. Thompson. “These guidelines are already issued by multiple regulatory and professional bodies.”

The devices’ IFUs, which facilities are legally and clinically obligated to follow for all scopes, include directions about which detergents and chemicals to use, how long to soak the devices, drying and storage requirements, as well as maintenance schedules. The CDC offers the Guideline for Disinfection and Sterilization in Healthcare Facilities. The FDA provides manufacturer-specific instructions and updates on device safety alerts.

The Joint Commission holds facilities accountable through routine audits and competency checks. This ensures that staff maintain proper logs and documentation of the work being done.

Worst-case scenarios

The impact of not adhering to guidelines is multi-fold, at worst leading to serious infection complications and even death for a patient, along with serious legal repercussions.

The most serious infection risks tend to involve pseudomonas aeruginosa, CRE and mycobacterium tuberculosis.

“These infections can lead to serious complications, hospital stays or even death,” says Ms. Thompson. “Residual organic material such as blood, tissue and secretions creates a perfect environment for biofilms, which protect bacteria from disinfectants and are very hard to remove once established.”

Poor reprocessing has caused documented infection outbreaks in facilities and can result in lawsuits, loss of accreditation and fines, as well as incalculable reputational damage.

There’s also the potential for damage to the equipment itself. “Incomplete cleaning allows residue buildup, leading to scope malfunction, shortened lifespan and costly repairs or replacements,” says Ms Thompson.

One regional hospital’s SPD success story

HARD WORK The combination of design complexity, infection control risks and strict procedural requirements makes endoscope reprocessing a challenging-but-vital part of GI operations.

At Rochester (N.Y.) General Hospital, Melissa Natoli, LPN, CRCST, CER, CIS, director of sterile processing for Rochester Regional Health, helps ensure that surgical procedures at its facilities go smoothly.

It’s working. According to Health Data Management, the health system significantly lowered infection rates by implementing strategies focused on leveraging its electronic health records and streamlining clinical workflows.

The records can now identify and track areas where infection is detected so it can be prevented. Overall, Boston Consulting Group reported a 20 percent reduction in all hospital-acquired infections.

While not every case involved reprocessing, one of the biggest issues for Ms. Natoli’s team is leveraging the time it takes to properly reprocess endoscopes when they are needed.

“The need for a quick turnaround makes the technicians processing these scopes feel under pressure,” she says. “In a busy GI suite or OR, multiple cases may need these scopes quickly and it can cause undue stress while processing.” She works to avoid having staff miss steps simply because they must turn around instruments so quickly.

One way she’s addressed the issue is by establishing guidelines on how to properly reprocess these devices so that everyone who ultimately handles them post-use knows exactly how to fulfill the goals, and to train staff about the importance of the process. This means no shortcuts, no matter how quickly the endoscopes are needed.

Ensuring endoscopes are sterile and in proper working order goes beyond merely reprocessing them. “The process of transporting these high-priced items to and from the procedural suites can lead to damage of these scopes,” says Ms. Natoli.

“Communicating the risks to staff is key to having them trained on reprocessing these scopes so they understand the impact they have on the patients,” says Ms. Natoli. “I always explain to staff that even though we don’t always see a patient or know their names or date of birth, we play a key role in the procedures being performed.” OSM