By Amy Antonacci, MSN, RN
U.S. hospital-based and outpatient programs perform 40 million flexible endoscopy procedures annually[1]. That means more than 40 million instances each of pre-cleaning, leak testing, manual cleaning, high-level disinfection (HLD) or sterilization, and drying and storage. You’d think with that much practice, endoscope reprocessing would be executed without a hitch, but numerous studies have found that HLD, the most common endoscope processing method, does not reliably eliminate microbes.[2]
Amid the volume, there are variables in the requirements for processing individual scopes and these contribute to challenges. To overcome these challenges, organizations that that use flexible and semi-rigid endoscopes must adhere to strict processing protocols and establish a comprehensive Flexible and Semi-rigid Endoscopy Reprocessing Program based on nationally recognized standards. A program founded on six steps will set your organization on the path to consistently safer endoscopes.
Step 1: Inventory your scopes
Maintaining a list of the flexible and semi-rigid endoscope inventory (including loaner scopes) allows for situational awareness of the scope types and classifications, setting the stage for the correct processing.
It is crucial that endoscopy programs have knowledge regarding their inventory, including loaner scopes, and have classified the scopes using a nationally recognized classification system. Classification is multi-level and usually characterizes the scope as flexible or semi-rigid, then identifies its purpose (e.g., flexible bronchoscope, colonoscope, cystoscope, endoscope with further specialized versions, gastroscope, rhinolaryngoscope, sigmoidoscope, semi-rigid ureteroscope, sialendoscope, etc.) The type and use of each scope allow further classification (critical, semi-critical and non-critical) which, in turn, drives the processing requirements to address associated infection risk.
Maintaining a current list allows organizations to track:
- the age of the scope inventory
- the preventative maintenance status of each device
- when scopes require repairs, especially those that require repairs frequently
Classifying scopes reinforces knowledge by all key stakeholders of the endoscope processing variables and prevents confusion between semi-critical endoscopes and critical endoscopes that require sterilization.
Step 2: Establish policies and procedures for each category
Policies and procedures establish the foundation for endoscope processing and support standardization in accordance with the manufacturer’s instructions for use (MIFU). Policies and procedures should address each category and include the main points detailed in nationally recognized guidelines. Policies should detail the physical environment of the processing areas including floors, walls, ceilings, unidirectional workflow, air flow, lighting, magnification and water quality. Equipment-specific processes that must match the MIFU include: point of use cleaning; transport; hand-off communication; leak testing; decontamination; manual cleaning; high level disinfection; sterilization; and safe storage. Establishing thorough policies and procedures in addition to well-designed physical environments allows for maximum functionality in the spaces and compliance with guidelines; this supports effective processing and reduces the likelihood of microbial residual in processed scopes.
Step 3: Ensure physical environments for endoscope processing meet nationally recognized guidelines.
A physical environment intentionally designed or adapted to meet the guidelines allows for the best opportunity to process endoscopes in accordance with the MIFU. However, even the most challenging physical spaces can be set up to effectively complete endoscope processing. It is not necessary to invest in high-cost renovations or equipment. Some adaptations do not involve any cost, instead they require a solid understanding of the physical environment guidelines and how the organization can make adaptations to establish compliance. However, organizations should evaluate their program’s physical environment challenges and establish a capital plan that allows for improvements over time if needed.
Step 4: Train staff and evaluate competency at regular intervals.
Knowledge is power; a well-trained staff ensures that processing is completed consistently as intended every time. The importance of training and competency evaluation cannot be overstated. At the heart of endoscope processing are personnel who must understand the extreme importance of their work and adhere to the correct management of each piece of equipment they use or are processing. If possible, organizations should establish a dedicated team of highly trained personnel who learn how each piece of processing equipment works as well as the individual MIFU for each flexible or semi-rigid endoscope.
When evaluating competency, replace a punitive approach with an atmosphere that encourages questions and promotes relentless adherence to cleaning processes. Strive to create a high performing team that commits to high reliability.
Step 5: Maintain endoscopes and endoscope processing equipment appropriately.
Maintaining and testing endoscopes and processing equipment ensures that the equipment can function as intended and allows for the identification of malfunctioning or damaged equipment that should not be used until remedied. Most endoscopy processing departments have numerous pieces of equipment used to process, dry and store endoscopes. Each of these has an MIFU that outline the preventative maintenance requirements as well as testing requirements to verify effective processing. Additionally, all endoscopes should be on routine preventative maintenance schedules. This allows for the regular evaluation of the full inventory which will improve proactive identification of damage to both external and internal components of the scope, including the inner channel. Microbes and biofilm can adhere to damaged areas. Biofilm contributes significantly to bacterial persistence[3] and growth. Endoscopy processing programs should maintain inventory that is free from damage and verify that all equipment is functioning as intended and ready for use.
Step 6: Establish a vigorous quality program using nationally recognized quality indicators.
A high-quality endoscopy processing program starts with knowledge of the best practices and the benchmark quality indicators. A program that embeds quality will have situational awareness regarding how the program is performing overall compared to national benchmarks. Standardized reports on compliance with preventative maintenance, testing outcomes if performed, and attributed infections, should be provided to the organization’s quality committee. This level of monitoring allows for ongoing focus on variables that can be controlled.
Endoscopy procedures are important diagnostic and treatment options. Documented and confirmed infections and outbreaks provide evidence that pathogens can persist and multiply, potentially causing infections and patient harm. The very best way to mitigate the risk of acquired infections is to establish intentional and thorough endoscopy processing programs that roll into the organization’s overall quality program.
Comprehensive endoscopy processing programs include the following components:
1. Establishing and maintaining a current list of all flexible and semi-rigid endoscopes that includes scope classifications.
2. Establishing policies and procedures based on nationally recognized guidelines for processing flexible and semi-rigid endoscopes and the processing equipment in accordance with the MIFU.
3. Creating physical environments for endoscope processing that meet nationally recognized guidelines.
4. Training staff to the organization’s policies and procedures and the equipment MIFU and evaluating staff competency at regular intervals.
5. Maintaining endoscopes and endoscope processing equipment per MIFU.
6. Establishing a vigorous quality program using nationally recognized quality indicators.
– Amy Antonacci, MSN, RN, is a standards interpretation specialist for acute care and critical access hospital accreditation with ACHC and serves as an ACHC surveyor.
[1] Elghannam MT, Hassanien MH, Ameen YA, Elattar GM, Ray AAE, Turky EAW, Talkawy MDE. Single-use endoscopes: A narrative review. Int J Gastrointest Interv 2022;11:1-4. https://doi.org/10.18528/ijgii210055
[2] Ofstead CL, Smart AG, Hurst LL, Lamb LA. Endoscope processing effectiveness: A reality check and call to action for infection preventionists and clinicians. Am J Infect Control. 2025 Jul;53(7):785-793. doi: 10.1016/j.ajic.2025.04.003. Epub 2025 Apr 9. PMID: 40216193.
[3] Moshkanbaryans L, Shah V, Tan LY, Jones MP, Vickery K, Alfa M, Burdach J. Comparison of two endoscope channel cleaning approaches to remove cyclic build-up biofilm. J Hosp Infect. 2024 Aug;150:91-95. doi: 10.1016/j.jhin.2024.05.014. Epub 2024 Jun 1. PMID: 38830542.
