A number of consensus- and evidenced-based recommendations for processing flexible endoscopes have been available for some time. However, recommended practices based on the current and highest rated evidence to truly guide detailed actions has been needed to help all perioperative stakeholders follow the most effective processing practices to prevent infection transmission from contaminated flexible endoscopes.

Recognizing this need, on Feb. 1, AORN will release the 2016 update to “Guideline for Processing Flexible Endoscopes” to provide the perioperative community with the most detailed, evidence-based practice recommendations for processing flexible endoscopes in all procedural settings.

“Processing flexible endoscopes is very complex and there are many facets to the correct approach, which must include collaboration, education, and dedication to thorough cleaning and drying according to standardized, evidence-based practices,” stresses Sharon Van Wicklin, MSN, RN, CNOR, CRNFA(E), CPSN-R, PLNC, senior perioperative practice specialist at AORN and lead author of the guideline.

She says every health care professional who has any involvement with processing flexible endoscopes has a responsibility to stay educated and familiarize themselves with the latest evidence to protect patients. “We are all on the same team, whether it’s frontline nurses responsible for initial cleaning, sterile processing professionals at the helm of sterilization, perioperative leaders making purchasing decisions for new equipment, or manufacturers building these complex instruments and writing instructions for use (IFU).” 

For this guideline update, Van Wicklin completed an extensive literature review of 3,397 published pieces of evidence and identified 418 with the strongest evidence using the AORN Evidence Rating Model and Evidence Appraisal tools that were developed in 2013 and refined in 2015.

Several of the new evidence-based practice recommendations in the update will require immediate changes in the practice setting, for example, AORN now recommends against manual soaking of flexible endoscopes.

Here Van Wicklin shares six evidence-based practices from the guideline update to implement in your own facility:

1. Record the times that the endoscopy procedure is completed and the cleaning is initiated (see Recommendation IV)
Standardized documentation of times for the end of the procedure and for cleaning, such as with a whiteboard posted in the sterile processing area is a simple task that can make a big difference in effective processing. We know that biofilm begins to form in the lumens of flexible endoscopes within minutes. Having a process for recording the times that the procedure ended and cleaning was initiated enables processing personnel to ascertain how long the endoscope has been awaiting processing, to establish priority order, and to determine whether routine processing within the manufacturer's recommended time to cleaning is achievable, and if not, to implement the manufacturer's procedures for delayed processing.

2. Mechanically clean and mechanically process flexible endoscopes by exposure to a high-level disinfectant or a liquid chemical sterilant or mechanically clean and sterilize (see Recommendation VIII)
AORN now recommends that after manual cleaning and when compatible with the endoscope manufacturer’s IFU, mechanical processing should be conducted, rather than manual soaking for high-level disinfection. Mechanical processing includes mechanical cleaning, mechanical high-level disinfection or sterilization, and mechanical rinsing. The collective evidence shows that mechanical processing improves cleaning effectiveness, increases efficiency, minimizes personnel exposure to biohazardous materials, and can be more successfully monitored for quality and consistency. In addition to improved cleaning, mechanical processors may also provide improved rinsing of disinfectants and reduce the potential for patient injury associated with residual disinfectants remaining in the endoscope. Mechanical processors may reduce the risk of cross contamination from one load to another by allowing for single use cleaning and disinfecting solutions. Importantly, using mechanical processors reduces the potential for breeches in recommended processing protocols associated with human error and noncompliance. The consistency of mechanical processing may also minimize the potential for damage and the need for repairs. Some facilities may need to invest in mechanical processing equipment. Although this is an initial expense, studies from other countries, such as India, China, and Russia show that costs can be recouped for this purchase. 

3. Use cleaning verification tests (see Recommendation XIII)
Visual inspection alone, even with magnification, is not sufficient to determine cleanliness of complex devices such as flexible endoscopes. Cleaning verification tests are used to verify the ability of the cleaning process to remove, or reduce to an acceptable level, the organic soil and microbial contamination that occurs during use of a reusable device. Periodic verification of cleaning effectiveness may help reduce errors in manual cleaning and improve effectiveness. Cleaning verification tests such as adenosine triphosphate (ATP) and chemical reagent tests for detecting clinically relevant soils should occur when new endoscopes are purchased and at established intervals, such as after each use, daily. 

4. Use a drying cabinet for storage (see Recommendation IX)
The collective evidence shows that optimal storage of flexible endoscopes facilitates drying, decreases the potential for contamination, and provides protection from environmental contaminates. A wide variety of storage cabinets are available. Drying cabinets include a drying system that circulates HEPA-filtered air through the cabinet while filtered air under pressure is forced through the endoscope channels. The internal and external surfaces of the endoscope are continuously dried, suppressing bacterial growth. Studies related to the efficacy of drying cabinets compared with other methods of storage showed that drying cabinets effectively limited bacterial proliferation during storage.

5. Use a team to determine maximum storage time (see Recommendation IX)
AORN no longer recommends a five-day storage maximum, instead recommending that a multidisciplinary team including infection preventionists, endoscopy RNs, endoscopy processing personnel, endoscopists, and other involved personnel establish a policy to determine the maximum storage time that processed flexible endoscopes are considered safe to use without reprocessing. The collective evidence regarding the maximum safe storage time for processed endoscopes is inconclusive. Studies have shown that when correctly processed, flexible endoscopes may be safe to use for 48 hours to 56 days after processing. There are benefits to reducing unnecessary processing that include the reduced processing costs, reduced wear and tear on the endoscope and processing equipment, and lower replacement and repair costs. Further, safe storage times can be affected by factors unique to the facility including the type of endoscopes processed and stored, processing effectiveness, storage conditions, compliance with manufacturers' IFU, frequency of use, and patient population.

6. Ensure cleaning and processing is conducted by individuals who have received education and completed competency verification activities related to endoscope processing (see Recommendation II)
AORN makes this recommendation because the evidence shows that ensuring flexible endoscopes and accessories are processed by individuals whose primary duties are to clean and process flexible endoscopes minimizes variability and improves processing effectiveness. This education and demonstrated competency with processing flexible endoscopes also helps reduce the risk for errors and cross contamination. Individuals whose primary duties are to clean and process flexible endoscopes bring a specialized level of knowledge and skill to the processing procedure. Supporting the recommendation for processing by dedicated and competent individuals, AORN further recommends that:

• processing of flexible endoscopes is performed in the same manner in all processing locations;
• sufficient time and numbers of personnel are provided to permit thorough cleaning and processing of flexible endoscopes;
• endoscopy procedures are scheduled to allow sufficient time for cleaning and processing flexible endoscopes;
• an inventory of flexible endoscopes and accessories sufficient to meet the anticipated demand be maintained; and
• policies and procedures are established requiring that flexible endoscopes used for procedures performed at the bedside or outside of normal operating hours are processed in the same manner as endoscopes used during normal operating hours.

educators play a key role in implementation 

Educators play a critical role in supporting the implementation and ongoing commitment to the highest standards for processing flexible endoscopes, according to Donna Ford, MSN, RN-BC, CNOR, CRCST, a member of AORN’s board of directors. “I cannot think of a health care topic in the past 10 years when the education of those individuals performing the task could be more important for patient safety,” she says.

Ford believes education must be comprehensive to help team members understand the evidence-based rationale for safely cleaning and processing flexible endoscopes. For example, she says there is ample evidence in this guideline pointing to the importance of preventing formation of biofilm by having a clear understanding of what biofilm is, how quickly biofilm can begin to form, what measures to implement to prevent its formation, and how difficult it is to remove a mature biofilm, especially in the narrow lumens of flexible endoscopes. She says competency verification is critical to ensure team members can successfully demonstrate the thorough cleaning techniques necessary to remove biofilm.

“It is equally important for educators to assist processing personnel in understanding the potential implications of incorrectly performing or failing to perform manufacturer recommended steps such as leak testing,” Ford says. She also notes that ongoing education and competency verification is important to assure understanding of the regulatory requirements for wearing personal protective equipment and performing hand hygiene—two factors that are important in safely processing flexible endoscopes.

additional Resources

Access the updated Guideline for Processing Flexible Endoscopes in AORN’s 2016 Guidelines for Perioperative Practice.

Read more about the updated guideline in the current issue of Periop Briefing.

Learn more about AORN’s current model for evidence appraisal and rating.

for managers

Looking for guideline implementation support? AORN has done the heavy lifting by shaping Guideline Essentials, a comprehensive collection of implementation tools, explanatory materials and templates to support perioperative managers and educators in implementing this new guideline. 

Find resources to support sterile processing practices with AORN’s Guidelines and Tools for the Sterile Processing Team.