It takes a village to compose a standard for The Association for the Advancement of Medical Instrumentation (AAMI). These experts in sterilization volunteer their time and energy, focusing on patients and best practices for all healthcare. Each committee is made up of manufacturers, scientists, and health care practitioners in surgical services, endoscopy units, and sterile processing. Their range of expertise in practice and experience extends from large university health systems to small ambulatory surgery centers. Collectively, they come together to share their knowledge and to speak for the practitioner, the user, and the manufacturer.

It has taken a long seven years for the committee of Working Group 84 (ST-WG84 – Endoscope reprocessing WG) to update Standard 91. In 2021, a new updated version of Standard 91 was released, and while it may be a bit more comprehensive, the detail provided in the new version will serve endoscopists for some time to come. AAMI states, “the document pays meticulous attention to all steps in the processing of flexible endoscopes and accessories is critical to ensure that they are rendered safe for subsequent patient use.”

The association posted an interview with Mary Ann Drosnock, director of Clinical Affairs at Healthmark Industries and a member of AAMI’s Endoscope Reprocessing Working Group (ST-WG 84). She says, “We really beefed it up,” since its inception. “We wanted to make sure that everybody's voices were heard and that all comments were discussed and resolved properly,” she added. “There was no question afterwards. This guidance is about patient safety and we have the data baked in to support it.”

The guidance reaches each of the following endoscopes in health care facilities:

• Flexible Gastrointestinal (GI) Endoscopes
• Flexible Bronchoscopes
• Flexible Ear, Nose, and Throat Endoscopes
• Surgical Flexible Endoscopes (e.g., flexible ureteroscopes)
• Semi-rigid Operative Endoscopes (e.g., choledochoscopes)

In short, “The updated standard provides new guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfection, and/or sterilizing.” Specifically, the classification for high-risk scopes, such as bronchoscopes and ureteroscopes. It provides an updated guidance for drying, as well as proper storage and handling. There are recommendations against manual disinfection, guidance for testing water in automated endoscope reprocessors (AERs). This will avoid the final-rinse water re-contaminating the scopes. Be sure to read the guidance for determining the length of storage, or “hang time,” that a scope can withstand before needing to be reprocessed, as well as the drying guidelines.

As we review the guidance documents and standards in AAMI, it is important to understand the guidance language from a must to a shall. A must guides the processor that describes “unavoidable” situations, including those mandated by government regulation. A shall requires the SP to strictly follow the guidelines. A should indicates that among several possibilities one is recommended as particularly suitable, that a certain course of action is preferred but not necessarily required. A may indicates that a course of action is permissible within the limits of the recommended practice. A can is a statement of possibility and capability.

The increase of care in the updated standard involves Cleaning Verification Testing that states the following:

For High-Risk Scopes, they shall be monitored with cleaning verification after each cleaning. 

For scopes that are not high-risk, the processor should verify using cleaning verification tests when new endoscopes are purchased and at established intervals (e.g., at a statistically significant frequency based on the number of procedures performed). *See Annex F, for statistical frequency determination. Consider other factors: endoscope type, technician competency…

Endoscopes should be inspected with each reprocessing cycle.

Lighted magnification should be used to inspect for debris and damage.

If a scope repeatedly fails cleaning verification, the technician considers inspection with a borescope before sending it for repair. Borescope Inspection can help the Endo/SP technician view the internal channels and can be used periodically at a frequency determined by the facility. Before using a borescope, the practitioner should make sure the endoscope is dry.

“Those endoscopes associated with infectious outbreaks that are difficult to process and have increased risk or those with complex design are described as, Duodenoscopes, linear ultrasound (EUS) endoscopes, bronchoscopes, endobronchial ultrasound (EBUS) endoscopes, ureteroscopes, cystoscopes and all those determined by the facility. Sterile Processing and Endoscopy departments may want to review the recent FDA publication Hospitals and Endoscopy Facilities: Important Recommendations for duodenoscopes.”

It states to “consider using duodenoscopes that havedisposable components, if available at your facility; this design may lower but not eliminate risks of infection. When you do use them, carefully follow the manufacturer’s instructions for the assembly of the caps and distal ends.” They also directed the practitioner (Endoscopy and Sterile Processing departments) to “ensure staff is meticulously following reprocessing instructions and to institute a quality control program that includes sampling and microbiological culturing, and other monitoring methods.” The detailed report can be found at https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication

As we all move forward to best practices for our processing teams and our patients, consider joining the ANSI/AAMI committee. Your expertise, as a technician/practitioner is invaluable to the collective village. To gain more knowledge and guidance, you can purchase ANSI/AAMI ST 91 2021 – Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilities athttps://www.aami.org/st91.

References:

Hospitals and Endoscopy Facilities: Important Recommendations. (2022, April 14). Retrieved from https://www.fda.gov/medical-devices/safety-commun...

Drosnock, M. A. (2022, April). The New Aami ST91: An Updated Standard for Flexible Endoscope Processing. HSPA Annual Conference & Expo. San Antonio; Grand Hyatt River Walk .

ANSI/AAMI ST 91 2021 – Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilities