Jul 11, 2023 | Sterile Processing

AAMI ST91: A Review of the New Standards and Discussion on Enhanced Compliance

Just over a year ago, new AAMI ST91 guidelines were released to healthcare facilities. The new document revised ambiguous endoscope processing guidelines to increase competency and patient safety. Additionally, the guide was designed to serve as “comprehensive guidance to achieve best practice for each stage of processing flexible endoscopes.”

The revisions are based on new advancements in medical instrumentation as well as medical research that shows “outbreaks of multi-drug resistant organism infections related to flexible endoscopes.” The study revealed that the complex, sophisticated devices were failing to pass multiple reprocessing steps which significantly impacted patient safety. Furthermore, additional academic publications documented multiple breaches in processing that resulted in subsequent infections.

While new AAMI ST91 guidelines will help to mitigate these risks (and subsequently improve patient safety and facility compliance), healthcare facilities can take it one step further by having an electronic tracking solution in place. Below, we’ll discuss the new requirements and recommendations processing teams need to be aware of as well as how an electronic solution like CensiTrac helps you stay compliant.


What's Been Updated in AAMI ST91

The in-depth AAMI ST91 standards includes several requirements and recommendations for healthcare facilities to meet if they want to be AAMI compliant. These guidelines include:

  • Updates to training, certification, and competency: Improper training is a leading cause of endoscope processing errors. According to one source, “deficiencies or inadequate training and education have been shown to be a major contributing factor in endoscope reprocessing failures.” The new document recommends that personnel who will perform endoscope processing or sterilization tasks complete in-depth, formal training and competency verification prior to their first solo assignment. The document also recommends employees should be certified in endoscope disinfection and sterilization within two years of employment and keep the certification up-to-date throughout employment.
  • Clarification around cleaning steps and verification checks: A crucial error in many sterile processing departments (SPDs) is improper timing of the cleaning process. The new AAMI ST91 guidelines include a clause on delayed processing which ensures instruments are cleaned within 60 minutes following the procedure. Additionally, the updated version recommends performing a cleaning verification check after each use of high-risk endoscopes, which includes duodenoscopes, bronchoscopes, linear ultrasound endoscopes, and more.
  • Increased focus on instrument drying: Recent research has shown that certain bacteria can survive in wet environments, increasing the risk of infection among patients. To avoid this, it’s recommended endoscopes and all lumens and channels be dried for a minimum of ten minutes via mechanical air before storage. If moisture is still detected (both inside and/or outside of the instrument), more drying time is needed.
  • Improved storage requirements: When instruments are placed into storage, they should be placed in either drying cabinets or conventional cabinets. While new guidelines don’t specify which is better, scientific research is showing drying cabinets reduce the risk of retained moisture and microbial contamination.

It’s not yet mandatory for healthcare facilities to comply with all new guidelines outlined in AAMI ST91. However, Mary Ann Drosnock, Director of Clinical Affairs at Healthmark Industries, encourages facilities to start taking steps now to meet the new standards. “The words within the document mean something,” she said. “If it says ‘shall’ or ‘must’, these are requirements that need to be met as soon as possible. If it says ‘should’, it’s a recommendation.”


Mary Ann encourages organizations to complete an in-depth review of the document to determine what is required and what is recommended and then perform a gap analysis. “This will help you determine where the low-hanging fruit is and what you can do now to improve your facility.”


Adopt New AAMI Guidelines With Electronic Tracking

With numerous new guidelines to meet, healthcare facilities who rely on paper-processes or Excel spreadsheets to track cleaning and sterilization processes are likely to become overwhelmed. Electronic tracking software like CensiTrac and ScopeTrac Advanced capture and track the entire cleaning process and provides verification in seconds, enabling facilities to easily meet new compliance requirements.


Kelly Swails, Director of Clinical Services at Censis Technologies, described how Censis tracks instruments throughout the sterilization process: “Censis timestamps technician actions so everyone can see exactly when endoscopes were cleaned, dried, and stored.” (Timestamps, incidentally, are a new requirement included in AAMI ST91.) Prior to a procedure beginning, OR staff can quickly pull up reports and verify endoscopes have been properly cleaned, high-level disinfected, dried, and stored prior to starting a procedure. This significantly reduces patient risk and streamlines the verification process.


Kelly went on to describe how the tracking system can help facilities improve training and education to reduce patient safety risks. “Rather than digging through ‘dirty paper’ to find past information, you can get insights in just a few seconds,” she said. She gave the example of looking at an increase in improperly dried scopes and attributing it to a single employee. Training can then be given to this employee, eliminating the risk and helping the facility be compliant.


For organizations looking to use CensiTrac or ScopeTrac Advanced as their electronic documentation system, Kelly has some advice for getting started. “Use the system for cleaning, cleaning verification tests, high-level disinfection and drying,” Kelly said. “Document each of those processes.” She described that by documenting these processes, facilities can quickly understand where inefficiencies lie and how to mitigate them.


Don't Wait for Mandates – Get Ahead With Censis

While some AAMI ST91 guidelines are not yet mandatory, it’s highly recommended for healthcare facilities to start now. Censis helps you get started with in-depth documentation and tracking tools. Staff can easily drill down into data to verify instruments have gone through all necessary cleaning steps as well as review previous data to remedy inefficiencies or errors.


Want to learn more about how Censis helps you meet industry compliance requirements? Contact a representative today.