sterile processing
sterile processing
By Susan Klacik , BS , CRCST , CIS , CHL , FCS , AAMIf
AAMI Updates Chemical Sterilization , HLD Standard
This article is only a highlevel summary of the updates and additions to ST58:2024 .
SP professionals are urged to review and have access to the entire standard , which can be accessed at www . aami . org .”
The Association for the Advancement of Medical Instrumentation ( AAMI ) released its updated ST58 Chemical sterilization and high-level disinfection in healthcare facilities . The standard guides the selection and use of liquid chemical sterilants ( LCSs ), high-level disinfectants ( HLDs ) and gaseous chemical sterilizers cleared for marketing by the U . S . Food and Drug Administration ( FDA ) for use in healthcare facilities . Some of the key changes are addressed in this article .
One notable change is that ANSI / AAMI ST41 Ethylene oxide sterilization in healthcare facilities : Safety and effectiveness has been added to ST58:2024 ; therefore , AAMI has withdrawn ST41 from its available standards . Another significant addition , found in the Foreword , references the 2017 multidisciplinary stakeholders meeting hosted by AAMI that recommended sterilization of endoscopes used as semi-critical devices . Recent research shows that some pathogens are resistant to HLD . Additionally , medical devices and instructions for use ( IFU ) are becoming more complex , and new low-temperature sterilization methods make it possible to sterilize devices in roughly the same time or less as those exposed to HLD processes .
Water quality , drying and safety
ST58:2024 reflects the terminology “ point-of-use treatment ,” which aligns with other AAMI documents . Removing debris , flushing lumens , discarding single-use items , disassembling instrumentation , maintaining moisture on the devices , and placing items in the appropriate Occupational Safety and Health Administration-labeled biohazardous container are also emphasized .
Device instructions for use ( IFU ) often have a time requirement for cleaning , and research supports the need to initiate the cleaning process as soon as possible following the procedure . To align with IFU and recommendations , ST58:2024 addresses the importance of communication between clinical areas and the decontamination room , and a new section , 5.3.5 , provides recommendations for the information to be communicated . Further , methods to minimize the time between use and decontamination have been added in another new section , 5.3.6.2 , and section 5.4.7 provides recommendations for cleaning verification testing and borescopic examination . Cleaning is one of the most vital steps for ensuring effective disinfection and sterilization ; therefore , new sections have been added to ST58 ’ s quality control section to assist with verifying device cleanliness and proper function of mechanical cleaning equipment . Section 8.2 , Monitoring of mechanical cleaning equipment , recommends verification testing be performed on all mechanical cleaning equipment . The section details when testing should be performed , the types of test methods available , record keeping and key outcomes . What ’ s more , section 8.3 , Verification and monitoring of the cleaning process , addresses inspection methods for medical devices . Recommended methods of visual inspection include the use of lighted magnification — and borescopes to inspect the inner channels / lumens — which is consistent with ANSI / AAMI ST91 Flexible and semi-rigid endoscope processing in healthcare facilities .
Hand hygiene is another essential aspect of medical device processing . The revised version of ST58 includes an expanded section about hand hygiene that addresses where sinks should be located . Specifically , it is recommended that handwash sinks remain separate from those used to process medical devices .
Previously , ST58 had two chemical sterilant classifications , LCS / HLD and gaseous chemical sterilants . ST58:2024 includes a third category : foam or gel . New sonicated hydrogen peroxide mists are included throughout the standard , and Annex K , Sonicated hydrogen peroxide mist , has been added for users seeking additional information about this new disinfecting technology . A brief discussion about the differences between manual and automated disinfection processes is included under the “ General considerations ” and “ Liquid chemical sterilants / high-level disinfectant selection and use ” sections . It states that manual HLD and LCS are subject to variability and inconsistency while explaining that automated processors are designed to deliver the LCS and HLD solutions to all medical device surfaces to achieve effective LCS or HLD . A new section has been added to ST58:2024 that addresses chemical spills .
All water references have been updated to the new standard ANSI / AAMI ST108:2023 Water for the processing of medical devices . This includes the type of water quality to use , such as critical water for the final rinse ( a new section , 3.4.3 , addresses water quality recommendations for specific uses ). Another noteworthy addition in ST58:2024 is that as part of the facility water management plan , there should be a periodic microbial assessment of the automated equipment reprocessor ( AER ) and processing equipment to identify water contaminants or contaminated equipment that may contribute to recontamination of the device after HLD . Periodic microbial assessment of the water used for final rinse should be considered to identify any contaminants that can contribute to recontamination of the device after LCS or HLD .
Drying is a critical step in the HLD / LCS process and can reduce the risk of device recontamination . Based on this information , ST58:2024 added a
18 • www . healthcarehygienemagazine . com • december 2024