Endoscopes are important medical devices utilized by healthcare facilities to screen, diagnose, or treat patients. When facilities utilize reusable endoscopes, there’s a risk of infection if proper manufacturer reprocessing steps aren’t followed. To minimize the risk, the Association for the Advancement of Medical Instrumentation (AAMI) has collaborated with the American National Standards Institute (ANSI) to establish the ST91:2021 standards for sterilizing endoscopes. Ensuring strict compliance with these standards is vital to ensure the safety of patients undergoing endoscopy procedures at your facility.
Healthcare facilities in the United States conduct over 20 million endoscopy procedures annually, which involve contact with a patient’s tissue and mucous, posing risks of person-to-person and environmental infections. Inadequate sterilization and storage practices can result in potential disease and outbreaks within your facility. It falls upon an organization’s leadership to establish policies, provide training, ensure the availability of suitable equipment, and implement relevant standards to address these concerns.
The ST91 standards are comprehensive and detailed, aimed at keeping patients safe and reducing complications. Endoscope reprocessing has traditionally relied on manual cleaning and high-level disinfection. The revised ST91: 2021 standards provide added importance to drying and storing flexible endoscopes. If organic residues and infectious material persists in the endoscope channels due to reprocessing failures, they can multiply if moisture is present. Proper drying is crucial for ensuring patient-ready scopes. Meticulous storage conditions and equipment are essential for keeping the endoscopes contamination-free after reprocessing.
The ST91 Reprocessing Recommendations
The ST91 standards developed by the AAMI and ANSI provide comprehensive guidance to achieve best practices for cleaning, disinfecting and/or sterilizing, drying, packaging (where required), and storage of endoscopes. The standards are data-based and aimed at improving patient safety. They cover:
- Definition of high-risk scopes. Some types of scopes are more difficult to clean due to specialized levers and smaller, more specialized components. This further decreases the margin of error in the cleaning and reprocessing steps with an already tight margin of error windows.
- Expanded leak testing methods. Your facility should have both automated and manual leak testers. These testers should be periodically verified and calibrated.
- Current recommendations for drying endoscopes. Endoscope channels must be dried with pressure-regulated forced filtered air for at least 10 minutes. Instrument air or high-efficiency particulate air (HEPA)-filtered air is vital for preventing contamination and formation of biofilms. This period should be extended if moisture is visible. This reduces microbial recontamination of endoscopes and biofilm formation within them by water-borne organisms.
- In the past, staff used long soaking periods to ensure decontamination. This increased their risks of adverse effects. ST91 provides precise guidance about the time required for disinfection and warns about the hazards of manual disinfection.
- Technical guidance about sinks. They should be deep enough to allow complete submersion of endoscopes during cleaning and leak testing. Their height should be adjustable for staff comfort and ergonomics.
- Communicating technical information about testing the water quality used for the final rinse is important. Safe water is crucial to prevent contamination at this stage.
- Appropriate packing and sealing specifications of reprocessed endoscopes are necessary. This keeps your facility ready for emergency procedures.
- Even with appropriate packing, endoscopes don’t remain sterile forever. ST91 specifies how reprocessed endoscopes can be stored before needing reprocessing.
The ST91 standards define specific drying and disinfection times, eliminating the need for lengthy disinfection basin processes and improving your hospital’s endoscope usage.
The U.S. FDA (Food and Drug Administration) is concerned about the risks of infections associated with reprocessed endoscopes. The FDA recommends that all healthcare facilities follow one of these steps:
- Precleaning, leak testing, cleaning, disinfecting, rinsing and drying
- Precleaning, leak testing, cleaning, and sterilization
It is important for your facility to follow all recommended infection control practices. Your facility must report any adverse events related to the use of endoscopes (including infections) to the manufacturer and the FDA under the medical device reporting regulations. Stringent compliance with the ST91 standards will improve patient safety and reduce the need for such reporting.
ST91 Standards — Implementation
ST91 compliance requires significant changes in facility-wide practices. Staff training and equipment acquisition are likely to need considerable capital outlay. All personnel engaged in endoscope reprocessing should undergo formal training followed by competency verification. You may also need to procure appropriate equipment.
A three-basin setup of adjustable height will facilitate your staff to perform disinfection effectively and without physical stress.
Endoscope drying cabinets come with many valuable features. These include pressure-regulated forced instrument-grade air or HEPA-filtered air that helps the endoscope’s internal lumen to dry. The positive pressurization inside the cabinet stops free-floating debris in the environment from entering the cabinet. A well-specified endoscope drying cabinet will provide safety and efficiency beyond standard scope storage cabinets and help your facility meet and maintain ST91 compliance.
Drying cabinets reduce the risks of retained moisture and microbial contamination. You can minimize the costs associated with ST91 compliance by acquiring one scope drying cabinet and then storing the reprocessed endoscopes in a standard scope storage cabinet. The requirements may change over time and require drying in storage. Drying and storage cabinets should be kept away from basins to avoid water-borne contamination due to splashing.
Capsa Healthcare’s TruAir™ Scope Drying Cabinets are ST91 compliant and have four configurations to accommodate 4 to 18 endoscopes. Capsa Healthcare’s cabinets are an excellent investment; you can upgrade them to meet changing requirements. Your facility can implement future changes swiftly and avoid completely replacing existing solutions.
Capsa Healthcare is a trusted healthcare support organization committed to serving the industry and delivering expertise. Products are engineered for dependability and durability. When you need technical support or service, Capsa Healthcare has a comprehensive service program designed to help you maintain uninterrupted care delivery.
ST91:2021 Fundamentals
Physicians at your facility use endoscopes for medical procedures, and it’s crucial to reprocess these devices after each use to prevent infections. Endoscopes are costly and delicate instruments, and proper cleaning and disinfection require expertise and suitable equipment.
The ST91 standards offer detailed guidance to your staff on safely processing reusable endoscopes and accessories, ensuring patient safety, and teaching effective reprocessing methods. Choosing equipment carefully to maintain ST91 compliance in your hospital is essential. The magnitude of the pharmacy industry means that organizations and pharmacists must adopt cutting-edge technologies to keep up with demand and maintain efficiencies. Automation is one of the major enablement levers.
ST91 compliance not only improves your facility’s endoscope management and patient safety but also helps reduce hospital-acquired infections, which are vital for preventing healthcare-associated illnesses and controlling costs. Capsa Healthcare can assist you in selecting, obtaining, and operating the necessary equipment to adhere to these critical standards, providing expandable and upgradeable solutions to keep your hospital adaptable and prepared for the future.