Elevating Sterile Processing Businesses Through Tailored Consulting Excellence
new drying recommendations section ( 6.5.2.2 ). Research has shown that waterborne microorganisms , such as Pseudomonas aeruginosa , can pose an infection risk to a portion of the endoscopy patient population , and the presence of microorganisms — in conjunction with retained moisture — can lead to the development of biofilm , especially if tap water is used to rinse the endoscope following the antimicrobial process .
Consistent with other AAMI standards , ST58:2024 recommends lumened medical devices have their lumens dried with flowing pressure-regulated instrument air or HEPA-filtered air for a specified period and pressure according to the instrument manufacturer ’ s written IFU . Research has shown that a minimum 10-minute dry time is effective for drying flexible endoscope channels , for example . The correct-sized adapter should be used . Using syringes or a handheld compressed air gun for drying is not recommended .
After processing devices in an automatic processor , they should be removed at the end of the cycle . If they remain in the automatic processor for an extended period , such as an hour , they should undergo reprocessing before storage or use . The standards also reminds that critical devices , such as ureteroscopes , should be used immediately after processing ( if not , they should undergo processing again before use ). ST58:2024 features a new section , 6.5.2.3 , Labeling of LCS / HLD items after processing , that provides recommendations to help identify patient-ready medical devices and prevent the use of unprocessed devices .
The packaging section has expanded to include criteria for selecting a sterile barrier system , which now includes EO sterilization ; a table was added to clarify the types of packaging recommended for each type of gaseous sterilization . Additionally , device storage recommendations have been expanded in
ST58:2024 to include additional methods for preventing microbial contamination . The section emphasizes the importance of storing completely dry devices . If drying cabinets are not used , dryness indicators can be used .
HVAC and cleaning updates A section for environmental cleaning ( 3.2.1 ) was added to ST58:2024 , mirroring the amendment in ANSI / AAMI ST79:2017 & 2020 Amendments A1 , A2 , A3 , A4 ( Consolidated Text ). A cleaning schedule and checklist is recommended to demonstrate compliance with the cleaning schedule . Additionally , a method to measure the thoroughness of cleaning should be incorporated , which includes cleaning verification tools such as ultraviolet visible markers and adenosine triphosphate ( ATP ) bioluminescence .
Heating , ventilation and air conditioning ( HVAC ) operating parameters also require careful consideration . A new section , 3.4.4 ., provides recommendations for creating a safe working environment , guiding users on safe ventilation patterns and other environmental controls to prevent the spread of potentially dangerous microorganisms and toxic chemicals . Policies and procedures should be in place to monitor and maintain the HVAC parameters , and records showing the monitoring results should be maintained and accessible . Additional ventilation recommendations specific to chemicals are provided in section 3.5.9 .
This article is only a high-level 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 .
Susan Klacik , BS , CRCST , FCS , CHL , CIS , AAMIf , serves as a clinical educator for the Healthcare Sterile Processing Association ( HSPA ).
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Elevating Sterile Processing Businesses Through Tailored Consulting Excellence
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