The Latest on Flexible Endoscope Care

Gastroenterology Instrument Reprocessing and Care Infection Prevention

By: Dan Cook | Editor-in-Chief

Published: 9/15/2022

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New guidance focuses on proper storage and the adequate drying of internal channels.


In March, the Association for the Advancement of Medical Instrumentation (AAMI) updated ANSI/AAMI ST91:2021, its standard for the cleaning and storing of flexible endoscopes. The new guidance document — which addresses new technologies used for the care of endoscopes, concerns about the cleanliness of the instruments and how proper care impacts patient safety — is based on insights and consensus of industry leaders, clinicians, sterilization professionals and FDA representatives. The authors of the document, which expands upon new recommendations for endoscope reprocessing released by the FDA in April based on concerns over the proper reprocessing of urologic endoscopes, wanted to make sure everyone’s voice was heard and that all comments were discussed and resolved. Ultimately, the guidance is about improving patient safety with data-driven initiatives. 

Garland-Rhea Grisby, CFER, CSPDT, an endoscope service manager at Kaiser Permanente in Northern California and co-chair of AAMI’s Endoscope Reprocessing Working Group, which revised the guidance document, says the updated standards, requirements and recommendations are based on peer-reviewed research and account for scientific discovery, patient safety data and manufacturers’ instructions for use.

The new guidance included a renewed focus on these key categories of endoscope care: 

• Scope drying and storage. Thorough drying has been shown to reduce the risk of microbial contamination following high-level disinfection from the recontamination of the endoscope by waterborne microorganisms during rinsing, says Susan Klacik, BS, CRCST, CIS, ACE, CHL, FCS, a clinical educator at Healthcare Sterile Processing Association (HSPA) in Chicago. “The presence of these microorganisms in conjunction with retained moisture can lead to the development of biofilm and increase patient infection risks,” she adds. 

Recent research has led to many revisions to ST91’s drying recommendations after completion of the cleaning and disinfection process, according to Ms. Klacik, who notes endoscope channels should be dried for a minimum of 10 minutes with pressure-regulated forced instrument air or, at minimum, HEPA-filtered air. 

Endoscope reprocessors used to rely on automated endoscope processors (AERs) and standard storage cabinets to dry scopes, notes Mr. Grisby. “However, several studies found moisture inside of some scopes after processing in an AER and three to four days of being stored in standard storage cabinets,” he says. “The realization was that we could no longer leave drying to gravity.”

Some storage cabinets have integrated adapters and tubing that aide in drying scopes during storage, points out Mr. Grisby. (See “Thinking of Buying Endoscope Storage Cabinets” to check out the latest options.) “There are also scope drying dies that can dry scopes in the processing rooms before storage,” he says. “It’s best for facilities and reprocessing departments to consider one of these options.”

CLOSER LOOK Inspection with a borescope allows for visualization of the internal working channels to check for damage and cleanliness.

The updated ST91 recommends that storage cabinets should be placed in a secured location, not in procedure rooms or within three feet of a sink. Visually inspect scopes and storage cabinets for cleanliness when placing the instruments in cabinets and removing them for patient use, says Ms. Klacik, who says cabinets should be cleaned according to the manufacturer’s IFU weekly or when visibly soiled. 

Importantly, notes Ms. Klacik, an endoscope that appears clean can harbor debris that cannot be seen without magnification. “Cleaning verification used after endoscope cleaning and before disinfection may detect residual organic soil and microbial contamination present on a surface, even if the devices appear clean,” she says.

• No manual disinfection. The new guidance recommends against the manual high-level disinfection of scopes, in part because of the “variability and consistency in personnel responsible for the process,” according to the new standard. “There are simply too many inconsistencies with the manual process,” says Mr. Grisby. “The manual process is only as good as the processor that is doing the job. If an employee is fatigued or not feeling their best, the manual process might not be performed the correct way and steps might be missed. While most facilities have made the move to the automated process, globally we are not there yet. Access to the right market and limited financial resources can get in the way.”

• Storage time. Determining the length of storage, or “hang time,” that a scope can withstand before needing to be reprocessed is a challenge for many facilities. “This is precisely the reason why the move was made to performing a risk assessment when determining the length of hang time for scopes,” says Mr. Grisby. “There are several factors to consider.”

For example, he points out some storage locations are in high-traffic areas and others have restricted access to the cabinet. “This is why we’ve emphasized that a multidisciplinary team of stakeholders, including infection prevention, at individual facilities should determine what, if any, risks there are in extending or shortening hang time,” says Mr. Grisby.

The updated document is intended to give facility leaders and managers a source to reference when asking frontline staff to add steps to their reprocessing routines in the interest of increased patient safety. “When they want to introduce change in their facility that can improve safety, they might get pushback from leadership because there are few guidelines out there that say what they should do or how to do it,” says Mr. Grisby. “That’s why they need this document to back up and outline what needs to be done.”

Balancing the scheduling of cases while allowing enough time in between procedures for proper endoscope reprocessing can be a challenge of high-volume facilities. Mr. Grisby also points to an overall lack of staff education as a potential problem area. “The challenge is employee knowledge,” he says. “Facilities should have a training plan in place for any new hires that will handle endoscopes in the procedure room or in the reprocessing room.”

He’s found it helpful to discuss proper endoscope care during daily huddles or department meetings to ensure physicians, infection preventionists and frontline staff are on the same page. Mr. Grisby reaches out before staff or committee meetings to make sure endoscope care is included on the agenda so he’s not mentioning the topic in the middle of a workday and interfering with patient care of the flow of busy staff members and physicians.

The new standard comes with extensive appendices citing peer-reviewed research and data to support the requirements and recommendations. “We’re not just throwing out statements just because we want facilities to do these things,” says Mr. Grisby. “We want facility leaders and frontline staff to have the research and patient safety data at hand to advocate for change in their departments.” OSM

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