Automated Endoscope Reprocessing

Automated Endoscope Reprocessing (AER) uses a machine-based system that standardizes the cleaning, disinfection, and sterilization of endoscopes between patient uses. It automates high-level disinfection, rinsing, and drying steps to ensure consistent disinfection. AER has become the industry standard for reducing infection risks, enhancing patient safety, and meeting regulatory requirements.

How is AER different from Manual Reprocessing?

AER improves upon manual reprocessing through:

• More consistent results regardless of technician variability
• Greater efficiency with simultaneous processing of multiple scopes
• Reduced staff exposure to harmful chemicals
• Automatic documentation essential for patient safety and compliance
• Built-in validation with real-time alerts for process failures
• Controlled water quality management throughout the cycle
• Integration with ScopeTrac Advanced for comprehensive tracking
  
  

What are the Key Components of an AER System?

An effective AER system includes:

• Automated Endoscope Reprocessor unit with washing chamber and controls
• Specialized adapters for different endoscope models
• Calibrated chemical delivery system
• Water filtration and treatment
• Process monitoring technology and sensors
• Documentation software for compliance tracking
• Leak testing capability
• Thorough drying systems to prevent bacterial regrowth

These components work together within a well-designed workflow to maximize infection prevention, operational efficiency, and regulatory compliance.

5 Benefits of Automated Endoscope Reprocessing

1. Patient Safety

An examination of data regarding endoscope-transmitted infections found that 23.9 percent of bacterial cultures from endoscope channels on 72 gastrointestinal endoscopes resulted in the growth of more than 100,000 bacterial colonies after disinfection/sterilization and before use on the next patient.

When it comes to transmitting infection, the major factors are inadequate cleaning, staff choosing the wrong disinfecting agent, and/or staff failing to follow manufacturer guidelines for cleaning and disinfection. Facility staff should be continually trained on proper cleaning processes, but utilizing an AER can effectively avoid the latter two problems. Automating the cleaning process ensures compliance with manufacturer instructions and has been shown to more effectively remove residual organic matter.

The AER also ensures that flexible endoscopes are properly rinsed at the end of the disinfection cycle, which is crucial since patient exposure to disinfectants can cause issues such as chemical colitis, keratopathy, and damage to the cornea. (Residue levels of glutaraldehyde, a toxic chemical disinfectant, have been found to be 25 times higher on manually cleaned endoscopes than on those processed in an AER.)

2. Staff Safety

Many of the chemicals used in high-level disinfection can have profound, negative effects on health. For example, exposure to liquid glutaraldehyde can result in nasal irritation and bleeding, difficulty breathing, throat/lung irritation, hives, and contact dermatitis. Manual disinfection processes have the potential to expose workers to such disinfectant agents, while modern AERS, such as Advanced Sterilization Products’s Evotech ECR, protect staff by minimizing exposure to disinfectant agents.

3. Process Standardization

In larger, busier facilities—especially those with multiple reprocessing areas—it can be tough to make sure all staff use the same processes for reprocessing flexible endoscopes. Plus, there may be pressure to reprocess pieces as rapidly as possible to cope with case volume. This can lead staff to use procedural shortcuts and neglect attention to detail in order to move pieces faster. By purchasing and deploying modern AERs across your facility’s reprocessing areas, you can make sure that all technicians adhere to the established processes and reduce the opportunities for human errors that compromise patient care.

4. Facility Productivity

A 2014 study on endoscope use in Russia, China, and India found significant increases in productivity when facilities switched to automated endoscope reprocessing—especially when the average manual soak time was longer than the average endoscopy procedure time. For example, in Russia, the average endoscopy procedure time was 24.4 minutes, while the average manual endoscope turnaround time was 47.5 minutes. Switching from manual reprocessing to an AER reduced turnaround time and increased efficiency to the extent that the Russian facility was able to add an average of 3.9 procedures per day. This improved efficiency was consistent in facilities where the manual process times were already fairly rapid.

5. Finances

AERs lead to a variety of financial benefits. First, an increase in productivity means more cases can be scheduled and processed each day, which means facilities will have higher profitability. Additionally, 18 percent of endoscope damage happens while they’re being handled for reprocessing—and AER reduces handling of endoscopes by 34 percent. Thus, a switch to an AER would decrease endoscope damage and the need for repairs, saving facilities money which in today’s healthcare market is critical.

When you line up these benefits next to the cost of an AER, it should be easy to see that an AER will rapidly pay for itself—whether through decreased endoscope repair, increased productivity, decreased staff downtime, or improved patient safety. Switching from manual soak to automated reprocessing is, quite simply, a no-brainer.

Importance of Automated Endoscope Cleaning

Reduce Human Error

In some cases, human intervention can catch issues that machines miss, but this is not one of them. An automatic endoscope reprocessor removes the guesswork that comes when you choose manual soaks over automated high-level disinfection. During a manual process, the scope must be completely submerged for the appropriate amount of time, loosely coiled to prevent damage and the disinfectant must be manually injected into all the scope ports. An AER allows for proper placement and ensures adequate contact and exposure with the disinfectant provided the instructions for use are followed. Additionally, automatic endoscope reprocessor lowers the risk of damaging endoscopes. Endoscopes are fragile and can be easily harmed if technicians mishandle them during a manual soak. A damaged endoscope that is put back into the rotation can negatively impact patient safety, while also hurting your facility’s budget by requiring expensive repairs and replacements.

Increase Patient Safety

Providing the highest level of patient safety should always be the top priority in everything that you do. Replacing your manual soaking process with an automatic process is an easy way to support patient safety. Manual reprocessing cannot guarantee proper sterilization, and it carries an increased risk of cross-contamination, according to Infection Control Today. An endoscope that isn’t properly cleaned and disinfected can retain and transmit the infection from one patient to the next. Per AAMI ST 91, 2015 using an AER is not met to replace the point of use cleaning and the manual cleaning of the scope prior to high level disinfecting or sterilizing. Always follow the manufacturer’s instructions for use for the processing of flexible endoscopes. If there is a discrepancy between the instructions for use of the AER and the flexible endoscope, a decision should be made based on the information obtained from both manufacturers. Flexible endoscopes must always be handled with care throughout all the processing steps.

The Automated Endoscope Reprocessing Workflow

The automated endoscope reprocessing workflow consists of several critical stages that must be performed in sequence to ensure proper decontamination. Each step builds upon the previous one to achieve complete elimination of pathogens while preserving the integrity of these delicate instruments.

Pre-Cleaning

Pre-cleaning begins immediately after an endoscopic procedure and is essential for effective reprocessing. This initial step involves:

• Wiping the insertion tube with enzymatic detergent at bedside
• Flushing all channels with enzymatic solution
• Removing and cleaning valves and other detachable components
• Transport to the reprocessing area in a closed container

This preliminary cleaning prevents biofilm formation by removing visible debris and organic matter before it can dry and adhere to surfaces. AER systems typically require this manual pre-cleaning step, as their automated processes are designed to work on endoscopes where gross contamination has already been addressed.

Washing

Once pre-cleaning is complete, the sterile processing technician takes over with the washing phase:

• Leak testing to identify any breaches in the endoscope's waterproof integrity
• Thorough channel irrigation with specialized enzymatic detergents
• Ultrasonic cleaning of sensitive components (in some systems)
• Precise temperature and pressure control to optimize cleaning efficacy

The washing cycle removes remaining bioburden and prepares the endoscope for disinfection. Technicians monitor parameters like water temperature, detergent concentration, and flow rates to ensure optimal cleaning results across all surfaces and internal channels.

High-Level Disinfection (HLD) or Sterilization

Following the washing phase, endoscopes undergo either high-level disinfection or sterilization:

• HLD typically uses FDA-approved liquid chemical germicides like glutaraldehyde, ortho-phthalaldehyde, or hydrogen peroxide
• The AER maintains precise contact time, temperature, and concentration
• All channels and surfaces are exposed to the disinfectant
• Automated monitoring ensures disinfection parameters meet regulatory requirements

While most endoscopes undergo HLD, sterilization of flexible endoscopes offers additional safety benefits for certain procedures. Regardless of method, proper tracking of HLD cycles is critical, which is why facilities need robust endoscope HLD management systems to maintain compliance and patient safety.

Rinsing and Drying

The final stages of the AER workflow are equally important in preventing recontamination:

• Multiple rinses with filtered or sterile water remove all chemical residues
• Forced air drying of all channels eliminates moisture
• Alcohol flushes in some protocols enhance drying effectiveness
• Final inspection ensures complete dryness

Proper drying is crucial as moisture remaining in endoscope channels can promote bacterial growth during storage. The entire process from bedside pre-cleaning to proper storage must be meticulously followed to maintain the safety and functionality of these critical instruments.

Challenges and Considerations of AER

While automated endoscope reprocessing offers significant advantages over manual methods, healthcare facilities must address several challenges to ensure optimal outcomes and patient safety.

Proper Training and Maintenance

Despite automation, effective AER implementation depends heavily on well-trained staff and proper system maintenance:

• Personnel must understand both manual pre-cleaning requirements and correct AER machine operation
• Regular validation testing confirms equipment functions within specifications
• Preventive maintenance schedules prevent unexpected downtime
• Documentation of training and competency assessment ensures regulatory compliance

Facilities must invest in comprehensive training programs that cover both theoretical knowledge and hands-on practice. Additionally, establishing clear maintenance protocols and service agreements helps maximize AER system longevity and performance reliability.

Potential Risks & Strategies

Even with automated systems, several risks require proactive management:

• Improper pre-cleaning before AER processing
• Inadequate connection of endoscope channels to the AER system
• Use of incorrect or incompatible detergents and disinfectants
• Failure to identify damaged endoscopes prior to processing

Understanding these common scope reprocessing failures and how to avoid them is essential for any reprocessing program. Effective risk mitigation strategies include standardized protocols, regular competency assessments, and implementing electronic tracking systems that provide alerts when steps are missed or parameters fall outside acceptable ranges.

Future Trends in AER Technology

The field of automated endoscope reprocessing continues to evolve with several emerging trends:

• Integration of artificial intelligence for process optimization and early fault detection
• Enhanced connectivity between AER systems and hospital information systems
• Development of single-use disposable components to reduce cross-contamination risks
• Advanced documentation capabilities with real-time compliance monitoring
• Reduced chemical and water consumption through more efficient designs

These innovations aim to further improve patient safety while simultaneously enhancing operational efficiency and environmental sustainability. As regulatory requirements become increasingly stringent, next-generation AER technologies will likely incorporate more comprehensive tracking and verification features.

How ScopeTrac Advanced Can Help

ScopeTrac Advanced represents the cutting edge of endoscope management technology, addressing many challenges associated with traditional reprocessing methods:

• Comprehensive tracking from procedure room to storage cabinet
• Real-time documentation of all reprocessing steps
• Automatic alerts for missed steps or approaching reprocessing expirations
• Simplified regulatory compliance with automated reporting
• Staff accountability through personalized logins and timestamps

By implementing ScopeTrac Advanced, healthcare facilities can significantly reduce reprocessing errors while streamlining workflow. The system's intuitive interface minimizes training requirements while maximizing compliance, helping departments meet regulatory standards without sacrificing efficiency. The robust reporting capabilities also provide administrators with valuable insights for process improvement and quality assurance, making ScopeTrac Advanced an essential component of modern endoscope reprocessing programs.

FAQ

What is an automated endoscope reprocessor?

Automated Endoscope Reprocessors (AERs) are machines used in Sterile Processing and Endo/GI Departments to reprocess endoscopes, such as duodenoscopes, and endoscope accessories. AERs are designed to kill microorganisms in or on reusable endoscopes by exposing their outside surfaces and interior channels to high level disinfectant or liquid chemical sterilant solutions.¹

What disinfectant is most common for use with automated endoscope reprocessing systems?

While glutaraldehyde has historically been the most commonly used high-level disinfectant for automated endoscope reprocessors (AERs).

Glutaraldehyde (2-3.5%) remains popular due to its:

• Broad spectrum antimicrobial activity
• Well-established efficacy data
• Relatively low cost
• Compatibility with most endoscope materials

Many healthcare facilities use electronic tracking systems like ScopeTrac Advanced to monitor disinfectant parameters including concentration, temperature, and contact time to ensure optimal disinfection.

How long does it take to reprocess an endoscope?

Reprocessing times vary when reprocessing endoscopes depending on the type of scope. Typical steps included in endoscope reprocessing include:

• Point of Use/Bedside Cleaning
• Leak Testing
• Manual Cleaning which may include:
  • External Cleaning
  • Internal Brushing
  • Mechanical Endoscope Flushing Aid (ie Scope Buddy - that's Steris so ?)
• Cleaning verifications (Channel Check, ATP Testing, Boroscope)
• Mechanical Cleaning in AER
• Drying (Mechanical Air)
• Storage

Note: If scope reprocessing does not start within 60 minutes upon completion of procedure, then extended reprocessing is required which involves additional soak time.

Citation:  

Health, Center for Devices and Radiological. 2021. “Information about Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation.” FDA, May. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/information-about-automated-endoscope-reprocessors-aers-and-fdas-evaluation.