Key Takeaways: 20 Critical Updates to Prevent Patient Infections & Outbreaks Related to Endoscope Use

Important Updates to the AORN Guideline for Processing Flexible Endoscopes

Processing flexible endoscopes remains a serious problem. These devices contribute to more outbreaks than any other medical or surgical device. AORN updated this guideline to help periop teams prevent patient infections and outbreaks related to endoscope use.

The updated guideline offers advice on processing flexible endoscopes, including point-of-use treatment, leak testing, manual cleaning, cleaning verification, inspection, high-level disinfection, drying, transport, and storage. Below is a round-up of what’s new and updated in the guideline.

Guideline for Processing Flexible Endoscopes

Key Takeaway

Flexible endoscopes are complex medical devices that require equally complex processes for effective cleaning and processing.

Update Explanation

NEW: Reusable flexible endoscopes that are manufacturer validated for sterilization should be sterilized when possible. Sterilization provides the greatest margin of safety and assurance that the item is safe for use. 2.1

NEW: Because of the challenges with cleaning, the US Food and Drug Administration has recommended that the industry move toward device designs that make processing easier, more effective, or unnecessary, which includes single-use flexible endoscopes or disposable components (e.g., distal endcap, elevator mechanism). 1.4

Key Takeaway

Systems and human factors play a significant role in contributing to errors in endoscope processing.

Update Explanation

NEW: Education and behavioral changes are needed to improve accountability, but these individual factors cannot be fully achieved unless system reliability is improved to enhance the performance of human factors. 22.1

NEW: Leaders should maintain safe working conditions, which includes addressing ergonomic concerns. 19.2, 19.2.1

NEW: Although selecting personal protective equipment with the highest levels of fluid protection available is critical for worker safety, it is uncomfortable for personnel. When used in combination with cooling devices, taking frequent, short breaks from heat exposure may help reduce discomfort. 4.2, 4.3, 19.2.2

Point-of-Use Transport

Key Takeaway

Dried bioburden makes cleaning more difficult and can lead to the development of biofilm, rendering high-level disinfection (HLD) or sterilization ineffective.

Update Explanation

NEW: The hand-over process from the transporter to decontamination personnel should include communication of the time that point-of-use treatment was completed and whether point-of-use treatment began immediately after use of the endoscope, and if not, the time that endoscope use was completed and whether the endoscope was kept moist until point-of-use treatment could be performed. 6.7

NEW: When it is not possible to initiate manual cleaning within the endoscope manufacturer’s recommended time frame (e.g., within 60 minutes), personnel should follow the manufacturer’s IFU for delayed processing (e.g., extended soaking). 8.2, 8.2.1

Cleaning

Key Takeaway

Endoscope exposure to procedural variables may impair cleaning and drying.

Update Explanation

NEW: The endoscope may require additional cleaning if the endoscope was exposed to simethicone, a radiographic medium, lubricants, tissue adhesives, poor bowel preparation (e.g., in emergency procedures), or a large amount of blood. 8.10.1

NEW: The hand-over process from the transporter to decontamination personnel should include whether the endoscope was exposed to these factors during the procedure. 6.7

NEW: Simethicone may be difficult to remove from flexible endoscopes and can impair drying. 8.10.1, 12.1

NEW: Simethicone should not be added to the water or irrigation bottle. If necessary, researchers have recommended delivering low concentrations directly into the working channel rather than adding it to the water bottle. 15.2.2

Cleaning Verification and Inspection

Key Takeaway

Cleaning is an essential step in the processing of flexible endoscopes.

Update Explanation

NEW: Use at least 10x magnification to inspect the distal end of duodenoscopes. 9.3.1

NEW: Borescopes allow for visual inspection of internal channels and may identify damage or debris that would otherwise be undetected. A clean borescope should be used to visually inspect accessible channels of flexible endoscopes before sterilization or HLD. 9.4

NEW: Borescope inspection should be performed by competent personnel as part of a comprehensive visual inspection and cleaning verification program. 9.4.1, 20.2.3, 21.3

NEW: For flexible endoscopes that are identified as high risk by the health care organization (e.g., duodenoscopes, ultrasound endoscopes, bronchoscopes, ureteroscopes, cystoscopes), manual cleaning efficacy should be verified with a cleaning verification test after each use. 9.5.1

Drying

Key Takeaway

Drying is an important terminal step in the processing of flexible endoscopes.

Update Explanation

NEW: Experts have identified drying of processed endoscopes as an area that needs focus because of the widespread problem with retained moisture that is underrecognized and often overlooked. Despite recommendations for drying before storage, compliance with drying protocols is low in North America. 12.1

NEW: All accessible channels of HLD-processed flexible endoscopes should be dried in accordance with the manufacturer’s IFU with pressure-regulated instrument air or HEPA-filtered air for a minimum of 10 minutes or until no visible moisture remains. 12.1, 12.5, 12.5.3

NEW: Drying should be performed even if an automated endoscope reprocessor with an air purge cycle or extended dry time feature is used. 12.1.1

Storage

Key Takeaway

The maximum storage time for HLD-processed flexible endoscopes is inconclusive.

Update Explanation

NEW: Moderate-quality evidence supports a maximum storage time of 7 days, although longer storage times may be safe (e.g., 21 days, 56 days), depending on the conditions (e.g., optimal processing, drying, and storage; liquid chemical sterilization). 13.7

NEW: The following are considerations for the storage time risk assessment:

• type of endoscopes
• frequency of use
• patient population
• compliance and effectiveness of protocols for cleaning, inspection, processing, water quality, and drying
• type of storage cabinet
• storage conditions (e.g., restricted access)
• practices for handling and transporting processed endoscopes
• the endoscope and storage cabinet manufacturers’ IFU. 13.7.1

Review the full AORN Guideline for Processing Flexible Endoscopes

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