sterile processing
sterile processing
By Susan Klacik , BS , CRCST , FCS , CHL , CIS , AAMIf
New Guidance for Processing and Handling of Probes , Dilators and Accessories
A new technical information report ( TIR ) from the Association for the Advancement of Medical Instrumentation ( AAMI ) offers guidance for the processing of ultrasound probes and dilators in healthcare facilities . The document , AAMI TIR99:2024 Processing of dilators , transesophageal and ultrasound probes in healthcare facilities , provides recommendation about the selection and use of cleaning , disinfection and sterilization systems that have been cleared by the U . S . Food and Drug Administration ( FDA ) to process the devices and their accessories . This article provides an abbreviated summary of the document ’ s content .
Cleaning and point-of-use treatment emphasized
Cleaning is among the most important steps in the device processing cycle , and the design and use of ultrasound devices present unique challenges to the cleaning process . Some transducers are designed and used in a manner that the handle and connector do not have direct patient contact ( as opposed to the patient-contacting shaft and distal tip ). Because of this , different methods are recommended for processing the patient-contacting and nonpatient-contacting components . Diligent adherence to the instructions for use ( IFU ) is also essential to prevent device damage and infection .
Ultrasound transmission gel ( USTG ) and coupling agents , such as saline or lubricant , are critical for image quality . They are used with ultrasound-guided procedures and may be present on the device . During cleaning of contaminated dilators and ultrasound probes , personal protective equipment ( PPE ) should be worn . Further , policies and procedures should be developed and implemented to address all steps in the cleaning process , including point-of-use treatment , transporting from the point of use to the processing area , cleaning , rinsing and drying , and inspection .
A key difference with the processing of certain ultrasound probes is that the cleaning and disinfection process is performed at the point of use . This practice should be supported by a multidisciplinary risk assessment . TIR99 provides guidance on developing a policy to perform point-of-use treatment . This includes an algorithm for suggested workflow for transrectal , transvaginal and surface ultrasound device processing at the point of use . Recommendations are also provided for point-of-use treatment of the devices and their accessories to prevent soil from drying . The purpose is to reduce the level of bioburden and help prevent biofilm formation .
After point-of-use treatment is performed on probes and dilators , any devices not processed at the point of use are transported to the decontamination
area . They should be transported in a collection system that meets Occupational Safety and Health Administration ( OSHA ) requirements ( 29 CFR 1910.1030 ) for transporting hazardous items . This includes labeling the devices with a biohazard label , placing them in a red bag , or other methods for distinguishing contaminated contents . When transporting contaminated probes used for a semicritical application , they should not have contact with the cable or plug , which does not undergo high-level disinfection . Separating the transducer from the cable and connector can be done by using a containment system with an impermeable divider or by placing the transducer inside a bag that then goes inside the rigid container . Before transport , probes should be prepared in a way that prevents organic soils from drying . It is possible to prevent drying by covering them with a water-moistened towel , applying a pretreatment product to only the area that can undergo immersion , or using a humidity chamber pack .
Once the probes and dilators are received in the decontamination room , the cleaning process begins . For transesophageal echocardiogram ( TEE ) transducers , a leak test should be performed before cleaning begins because immersing the probes in water with compromised integrity can damage the device . The leak test is to be performed according to the IFU , and the results of pass or fail should be documented . To prevent patient harm , TEE probes that have failed the leak test should be removed from service . Further , to prevent damage , TEE transducers should not be coiled too tightly .
TIR99 also includes recommendations for manual and mechanical cleaning . At the end of the cleaning process , the probes , dilators and accessory components should be visibly clean and inspected to verify that all visible soil was removed . The guidance document describes a different process for some components that do not come in direct contact with the patient . These components are addressed in the IFU and describe a manual cleaning process , followed by low-level disinfection ( LLD ) or intermediate-level disinfection ( ILD ). After a probe or dilator has been cleaned thoroughly , it then undergoes disinfection or sterilization . TIR99 provides guidance about the different types of disinfection and sterilization and how to ensure the processes are performed safely and effectively . Automated HLD systems are preferred over manual HLD processes because they are more reliable , reduce human errors and reduce the risk of personnel exposure to chemicals .
Drying , transport , storage and more After HLD , the probe or dilator must be thoroughly dried to prevent waterborne pathogens ,
Cleaning is among the most important steps in the device processing cycle , and the design and use of ultrasound devices present unique challenges to the cleaning process .
Some transducers are designed and used in a manner that the handle and connector do not have direct patient contact ( as opposed to the patientcontacting shaft and distal tip ).
Because of this , different methods are recommended for processing the patientcontacting and nonpatientcontacting components .”
24 • www . healthcarehygienemagazine . com • june 2024