Key Takeaways from the AAMI TIR99 2024 Guidelines
Released in April 2024, the Association for the Advancement of Medical Instrumentation (AAMI)’s new “TIR99: 2024 – Processing of Dilators, Transesophageal and Ultrasound Probes in Health Care Facilities” is designed to provide specific guidance to facilities seeking to enhance their processing protocols for medical instruments.
Generally speaking, Technical Information Reports (TIR) differ from “standards” by providing detailed guidance and recommendations, rather than merely reinforcing mandatory requirements. TIRs are often used to address emerging issues or to provide more comprehensive information on specific topics, helping facilities implement best practices in a less “rigid” way.
To that effect, core topics covered in AAMI’s new TIR99 guideline include the proper use of probe covers and ultrasound gel, how to effectively transport and store devices, probe cleaning and decontamination, and high-level disinfection.
In this piece, we breakdown the AAMI “TIR:99:2024” guidelines into designated segments, highlighting within each key takeaways that you’ll want to know and be aware of. (For additional information or details relating to the guidelines, be sure to consult AAMI’s TIR99 2024 report.) Let’s dive in.
Key Highlights Relating to Probe Covers for Critical and Semi-Critical Devices:
Sterile Use:
“If probe covers and sheaths are used with probes classified as critical devices, ensure they are sterile. For semi-critical ultrasound probes, sterile sheaths should be used.” (page 10)
TIR99 suggests that all probe covers and sheaths used with critical devices be sterile. AAMI further recommends that users attempt to utilize sterile sheaths with ultrasound probes used in semi-critical procedures.
Probe Covers vs. Condoms:
“A 2020 study by Basseal et al. assessed 5,000 clinically used sheaths to determine whether they had leaks following transvaginal procedures and found that while breakage rates for commercial covers were much lower than previously reported, 0% to 5% of sheaths had leaks, depending on the type of sheath product, while condoms had breakage rates from 0.4% to 13% (Basseal, 2020).” (page 10-11)
The guidelines also draw attention to comparisons between probe covers and condoms, referencing a 2020 study by Basseal that assessed 5000 clinically used sheaths to determine whether they had leaks following transvaginal procedures. The study concluded that breakage rates for commercial covers were much lower than previously reported, with 0-5% of sheaths having leaks, depending on the specific type of product; conversely, 0.4%-13% of condoms were reported to have breakage rates.
FDA-Cleared Probe Covers:
“Covers and sheaths that are FDA-cleared for use on ultrasound probes for the probes in question should be used.” (page 10)
“[Single-use probe covers] are not intended to be a substitute for cleaning and high-level disinfection or sterilization, as leaks or contamination is possible even if the probe cover does not visibly look compromised.” (page 10)
The guidelines recommend that probe covers and sheaths that are FDA-cleared for use for the specific ultrasound probes in question should be used during procedures. TIR99 emphasizes that single-use probe covers and sheaths are not intended to be a substitute for cleaning, high-level disinfection or sterilization, which should always be performed post-procedure as specified by the probe manufacturer’s instructions for use. As evidence, TIR99 points to a study, published in 2014, that found high levels of bacterial contamination on transvaginal probes that had been covered with sheaths and disinfected with wipes, ultimately concluding that many such probes remain contaminated despite the use of medically adapted probe covers and conventional low-level disinfection.
Facility Procedures:
“The use of probe covers should be addressed in the health care facility policies and procedures.” (page 10)
TIR99 recommends that the use of probe covers should always be directly addressed in the healthcare facility’s policies and procedures.
Key Highlights Relating to Use of Ultrasound Gel and Accessories for Semi-Critical Devices:
The Relationship Between Ultrasound Gel and Healthcare-Associated Infections:
“USTG or an alternative coupling method such as saline or lubricant is essential for image quality by providing a medium for ultrasound signal transmission between the probe and tissue being scanned. The role of UTSG in health-care associated infections is well-documented, with contamination occurring at the point of manufacture (Abdelfattah, 2018; Nannini, 2015; Shaban, 2017; Yamunadevi, 2018) and during use (Cheng, 2016; Chittick, 2013; Hutchinson, 2004; Jacobson, 2006; Oleszkowicz, 2012; Olshtain-Pops, 2011; Organ, 2010; Westerway, 2016)…The use of ultrasound gel should be addressed in health care facility policies and procedures.” (page 11)
TIR99 points out that the use of ultrasound transmission gel (USTG) – or an alternative coupling method such as saline or lubricant – is essential for image quality, providing a medium for ultrasound signal transmission between the probe and the tissue that is being scanned. Unfortunately, the role of ultrasound gel specifically in healthcareassociated infections is well-documented, with the guidelines pointing to multiple studies over the last 20 years that highlight various contamination events that occurred at both the point of manufacture (Abdelfattah, 2018; Nannini 2015; Shaban, 2017; Yamunadevi, 2018) and during procedures (Cheng, 2016; Chitick, 2013; Hutchinson, 2004; Jacobson, 2006; Oleszkowicz, 2012; Olshtain-Pops, 2011; Organ, 2010; Westerway, 2016). The guidelines emphasize that as a result, the standard use of ultrasound gel should be directly addressed and decided upon by each individual health care facility.
Needle Guides:
“Single-use disposable sterile needle guides should be used when available and appropriate for the procedure. As needle guides are critical devices, they should undergo point of use treatment, followed by cleaning and sterilization according to the manufacturer’s written IFU.” (page 11)
“Published literature has linked patient infections with Pseudomonas aeruginosa (Gillespie, 2007) and hepatitis C (Ferhi, 2013) to needle guides that were inadequately cleaned and sterilized.” (page 11)
TIR99 states that needle guides – which are designated as “critical devices” – should, if not single-use disposable, undergo point of use treatment, followed by cleaning and sterilization, according to the manufacturer’s written IFU. The guidelines go on to point to various published literature that has directly linked patient infections such as Pseudomonas aeruginosa (Gillespie, 2007) and hepatitis C (Ferhi, 2013) to needle guides that were inadequately cleaned and sterilized. When available, single-use disposable sterile needle guides should be used and prioritized in given procedures.
Key Highlights Relating to Cleaning of Critical and Semi-Critical Devices:
The Importance of Probe Cleaning:
“Cleaning is the most important step in the processing of dilators and ultrasound probes. Cleaning is the physical removal of clinical soil and contaminants (e.g. organic and inorganic material) from an item to the extent necessary for further reprocessing or for the intended use.” (page 14)
Defined as the “physical removal of clinical soil and contaminants (e.g. organic and inorganic material) from an item to the extent necessary for further reprocessing or for the intended use,” TIR99 states that cleaning is the most important step in the processing of dilators and ultrasound probes.
Why Probe Cleaning Shouldn't Be Overlooked:
“Thorough cleaning is essential before high-level disinfection or sterilization because inorganic and organic material that remains on the surface of instruments interferes with the effectiveness of these processes.” (page 14)
TIR99 points to the CDC’s “Guideline for Disinfection and Sterilization in Healthcare Facilities,” which emphasizes that thorough cleaning is essential before high-level disinfection or sterilization takes place (this is because inorganic and organic material that remains on the surface of instruments have the potential to interfere with the effectiveness of said processes).
Key Highlights Relating to Transportation of Critical and Semi-Critical Devices:
Thorough transport:
“Contaminated items (not including those items low level disinfected at point of use)... should be contained during transport from the point of use to the decontamination area.” (page 15)
“Due to the delicate nature of probe/dilators, [devices] should be placed in a containment system in a way that prevents damage. A containment system that minimizes movement of the device during transport should be used.” (page 15)
TIR99 states that contaminated items (with the exception of items that received low level disinfection) should be contained during transport from the point of use all the way to the decontamination area. The guidelines also specifically state that probes/dilators should be placed in a containment system in such a way that prevents damage, ideally in a containment system that minimizes movement in order to prevent damage of the device during transport.
Meeting OSHA’s Requirements:
“OSHA requires that:
A. All containers, devices, or carts used for containing contaminated items are marked with a biohazard label, a red bag, or other means of identifying contaminated contents; and
B. puncture-resistant, leak-proof on the sides and bottom, closable, and labeled containers must be used for devices with edges or points capable of penetrating container or skin.” (page 15)
TIR99 recommends that transport containment systems and carts be marked appropriately while expressly meeting OSHA’s requirements for transporting hazardous items, which specifically states that all containers, devices, or carts used for containing contaminated items be marked with a biohazard label, red bag, or other means of identifying contaminated contents. OSHA also requires that containers being used for devices with edges or points capable of penetrating the container or skin be puncture-resistant, leak-proof on the sides and bottom, closable, and labeled.
Don’t mix contaminated components:
“Do not mix contaminated components with clean components. A contaminated probe used in a semicritical application should be protected from contact with the cable/plug, which will not undergo high-level disinfection. For endocavitary ultrasound probes and TEE probes, this can be accomplished by using a containment system that has an impermeable separation/divider, OR the transducer can be placed inside a bag which is placed inside the rigid container to separate the transducer from the cable and connector.” (page 15)
“During transport, cleaned, disinfected, and/or sterile items should be visibly marked Clean or Patient Ready and transported on a clean surface....A cleaned and disinfected probe should be protected from contact with the cable/plug which has not undergone high-level disinfection. Options include covering the probe with a visibly clean storage cover or using a containment system with dividers allowing the cord to pass through. Ensure containment and transport are addressed in health care facilities and procedure.” (page 23)
AAMI also advises against mixing contaminated components with clean components, stating that contaminated probes used in semicritical applications should be protected from contact with the cable/plug, as they will not undergo highlevel disinfection. In cases where probes have been high-level disinfected or sterilized, AAMI also suggests that efforts be made to eliminate contact between the probe and the cable/plug that have not received such treatment. To achieve this, the guidelines recommend utilizing containment systems with dividers (including for endocavitary ultrasound probes and TEE probes); TIR99 also suggests placing contaminated endocavitary/TEE ultrasound probes inside a bag within a rigid container to prevent contact with the clean cable/plug, as well as covering cleaned, disinfected, or sterilized probes within storage covers, to prevent contact with non-treated cables/plugs.
Key Highlights Relating to Leak Testing of Semi-Critical Devices:
Follow the Manufacturer’s IFU:
“If electrical leak testing of the device is required, follow the manufacturer’s written IFU for the process and equipment recommended.” (page 16)
TIR99 emphasizes that if electrical leak testing of the device is required, care should be taken to follow the manufacturer’s written IFU for the entire process.
Checking After Each Use:
“The structural and electrical integrity of TEE transducers should be checked between each use. The result of “passed” or “failed” should be documented along with the action taken if failed.” (page 16)
The guidelines also recommend that both the structural and electrical integrity of TEE transducers should be checked between each use, and that the result of “passed” or “failed” should be documented, along with the subsequent action that is taken if the transducer fails.
Key Highlights Relating to High-Level Disinfection of Critical and Semi-Critical Devices:
Overall Efficacy:
“Factors such as presence of organic soil on the item, design of the device, disinfectant dilution, contact time and temperature, mode of action, and microbial load in reusable solutions – can all have a significant impact on efficacy.” (page 18)
TIR99 states that a multitude of factors – including presence of organic soil on the item, transducer design, disinfectant dilution, contact time and temperature, mode of action, and microbial load in reusable solutions – can all have a significant impact on the overall efficacy of HLD.
Sterilization and High-Level Disinfection:
“Semi-critical devices, including dilators and ultrasound probes, should undergo sterilization. However, if the device cannot withstand sterilization processes, it should undergo, at a minimum, high-level disinfection.” (page 19)
The guidelines also state that semi-critical devices – including dilators and ultrasound probes – should undergo sterilization; conversely, devices that cannot withstand sterilization processes should undergo high-level disinfection, at a minimum.
Manual vs. Automated:
“Manual high-level disinfection continues to be used widely in many health care facilities as it can be the only option or method for processing the device due to costs and lack of an automated system. Manual high-level disinfection is not the preferred method due to safety and hazard concerns to the users and inconsistencies in the process from person to person.” (page 20)
Also touched on in TIR99 is the issue of methodology, with the guidelines directly stating that automated high-level disinfection systems are the preferred method over manual high-level disinfection processes. While manual high-level disinfection continues to be widely used in many health care facilities, AAMI definitively states that it is not the preferred method due to both safety and hazard concerns to the users, as well as inconsistencies in processes from person to person.
Drying After High-Level Disinfection:
“It is recommended that every probe/dilator after high-level disinfection be dried with a clean, lint-free cloth or non-linting wipe, and any areas that are inaccessible or have lumens should be dried using pressure-regulated instrument air or HEPA-filtered air.” (page 21)
AAMI recommends that every probe/dilator after high-level disinfection be dried with a clean, lint-free cloth or non-linting wipe, and that any areas that are inaccessible or human lumens be dried using pressure-regulated instrument air or HEPA-filtered air.
Key Highlights Relating to Storage of Critical and Semi-Critical Devices:
Storage Following High-Level Disinfection:
“Store probes and dilators according to the manufacturer’s written IFU to protect them from damage or contamination.” (page 23)
“A semi-critical probe/dilator that has undergone a high-level disinfection process should be stored with additional protection (e.g. in a clean cabinet or clean storage cover).” (page 23)
“TEE probes should be stored in a cabinet or other enclosure that:
A. Is of sufficient height, width, or depth to allow the probe to hang vertically without coiling and without any components touch the bottom of the cabinet, or the cabinet should be designed and intended by the manufacturer for horizontal storage of TEE probes.
B. Prevents damage
C. Prevents the formation of moisture
D. Allows circulation of air; and
E. Protects the probe from environmental contamination”
“TEE probes can be stored in a closed storage cabinet. Conventional storage cabinets that circulate HEPA-filtered or instrument air throughout the cabinet may be used.” (page 24)
“The accepted maximum safe storage time for HLD processed ultrasound probes/dilators before they can no longer be considered safe for patient use is not well defined. A multidisciplinary team that can include infection preventionists, processing personnel, risk management personnel, and other clinical personnel should conduct a risk assessment to determine the maximum storage time for an ultrasound probe or dilator before it should be processed.” (page 25)
TIR99 states that probes/dilators should be stored according to the manufacturer’s written IFU, and that any devices that have undergone high-level disinfection should be stored with additional protection (i.e. in a clean cabinet or clean storage cover). With regards to TEE probes specifically, TIR99 states that such devices can be stored in a closed storage cabinet - including conventional cabinets that circulate HEPA-filtered or instrument air – that is of sufficient height, width, and depth to allow the probe to hang vertically without coiling and without any components touching the bottom of the cabinet. AAMI also specifically emphasizes that such devices be stored in an enclosure that:
o Prevents damage
o Prevents the formation of moisture
o Allows circulation of air
o Protects the device from environmental contamination
The guidelines also state that there is no well-defined “maximum” safe storage time for HLD processed ultrasound probes/dilators before they can no longer be considered to be safe for patient use. TIR99 instead suggests that each facility assemble a multidisciplinary team - consisting of infection preventionists, processing personnel, risk management personnel, and other clinical members - to conduct a risk assessment to help determine the maximum storage time for an ultrasound probe or dilator before it should be processed.
Proper Identification:
“Develop protocols to verify that user can readily identify a probe that has been appropriately processed and is ready for patient use.” (page 24)
AAMI also recommends protocols be developed to ensure that end users always readily identify whether a particular probe has been cleaned and/or high-level disinfected and is ready for patient use.
Key Highlights Relating to Documentation and Traceability:
Documentation of All Steps:
“All steps in device processing should be documented. Documentation can be paper-based or completely automated (digital) and linked to a computer that has a tracking system....All medical devices that have undergone a high-level disinfection or sterilization process should be documented and linked to the patient record on which the device is used for traceability. Documentation and traceability processes should be outlined in the health care facility’s policies and procedures.” (page 25)
AAMI states that all steps in device processing should be documented, either on paper or digitally using a tracking system. The guidelines also state that medical devices that have been disinfected or sterilized should be recorded or connected to the patient’s record for traceability, and that all such documentation and traceability procedures should be detailed in the health care facility’s policies and procedures.
Documentation Requirements:
"The processing record should contain the:
A. medical device processing personnel's identification (ID) or user ID;
B. unique probe/dilator ID;
C. date;
D. time; and
E. relevant cycle parameters to indicate cycle pass
Automated LCS/HLD units and manual soaking containers should be traceable in the processing record. The medical device processing personnel should be responsible for appropriately labeling the probe or probe storage cover prior to placing it in storage. The health care facility approved probe label should contain the following information:
1. processing record ID;
2. date and time probe was processed; and
3. expiry date if required by the health care facility" (page 25)
AAMI emphasizes that the processing record should include the medical device processing personnel’s identification or user ID, the unique probe or dilator ID, the date, the time, and the relevant cycle parameters to indicate a successful cycle. The guidelines also state that automated LCS/HLD units and manual soaking containers should be traceable in the processing record, and that the medical device processing personnel are responsible for appropriately labeling the probe or its storage cover before storage. The health care facility-approved probe label should contain the processing record ID, the date and time the probe was processed, and the expiry date if required by the healthcare facility.
About CIVCO Medical Solutions
For 40+ years, CIVCO Medical Solutions has been committed to making image-guided procedures safer through the design and manufacturing of innovative ultrasound products. From gel-free probe covers, needle guides, and probe transport, to automated solutions for device disinfection and device storage, our products are trusted by physicians and clinicians across a range of clinical specialties, including radiology, regional anesthesia, vascular access, men’s and women’s health, cardiology, infection control, sterile processing, and surgery. Our mission is clear: we seek to enable clinicians to provide safer outcomes by developing patient-focused products while delivering outstanding service and superior quality.
To learn more about how CIVCO Medical Solutions can help you to achieve safer, more efficient image-guided procedures, please visit our website: https://www.civco.com
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Generally speaking, Technical Information Reports (TIR) differ from “standards” by providing detailed guidance and recommendations, rather than merely reinforcing mandatory requirements. TIRs are often used to address emerging issues or to provide more comprehensive information on specific topics, helping facilities implement best practices in a less “rigid” way.
To that effect, core topics covered in AAMI’s new TIR99 guideline include the proper use of probe covers and ultrasound gel, how to effectively transport and store devices, probe cleaning and decontamination, and high-level disinfection.
In this piece, we breakdown the AAMI “TIR:99:2024” guidelines into designated segments, highlighting within each key takeaways that you’ll want to know and be aware of. (For additional information or details relating to the guidelines, be sure to consult AAMI’s TIR99 2024 report.) Let’s dive in.
Key Highlights Relating to Probe Covers for Critical and Semi-Critical Devices:
Sterile Use: “If probe covers and sheaths are used with probes classified as critical devices, ensure they are sterile. For semi-critical ultrasound probes, sterile sheaths should be used.” (page 10)
TIR99 suggests that all probe covers and sheaths used with critical devices be sterile. AAMI further recommends that users attempt to utilize sterile sheaths with ultrasound probes used in semi-critical procedures.
Probe Covers vs. Condoms:
“A 2020 study by Basseal et al. assessed 5,000 clinically used sheaths to determine whether they had leaks following transvaginal procedures and found that while breakage rates for commercial covers were much lower than previously reported, 0% to 5% of sheaths had leaks, depending on the type of sheath product, while condoms had breakage rates from 0.4% to 13% (Basseal, 2020).” (page 10-11)
The guidelines also draw attention to comparisons between probe covers and condoms, referencing a 2020 study by Basseal that assessed 5000 clinically used sheaths to determine whether they had leaks following transvaginal procedures. The study concluded that breakage rates for commercial covers were much lower than previously reported, with 0-5% of sheaths having leaks, depending on the specific type of product; conversely, 0.4%-13% of condoms were reported to have breakage rates.
FDA-Cleared Probe Covers: “Covers and sheaths that are FDA-cleared for use on ultrasound probes for the probes in question should be used.” (page 10)
“[Single-use probe covers] are not intended to be a substitute for cleaning and high-level disinfection or sterilization, as leaks or contamination is possible even if the probe cover does not visibly look compromised.” (page 10)
The guidelines recommend that probe covers and sheaths that are FDA-cleared for use for the specific ultrasound probes in question should be used during procedures. TIR99 emphasizes that single-use probe covers and sheaths are not intended to be a substitute for cleaning, high-level disinfection or sterilization, which should always be performed post-procedure as specified by the probe manufacturer’s instructions for use. As evidence, TIR99 points to a study, published in 2014, that found high levels of bacterial contamination on transvaginal probes that had been covered with sheaths and disinfected with wipes, ultimately concluding that many such probes remain contaminated despite the use of medically adapted probe covers and conventional low-level disinfection.
Facility Procedures:
“The use of probe covers should be addressed in the health care facility policies and procedures.” (page 10)
TIR99 recommends that the use of probe covers should always be directly addressed in the healthcare facility’s policies and procedures.
Key Highlights Relating to Use of Ultrasound Gel and Accessories for Semi-Critical Devices:
The Relationship Between Ultrasound Gel and Healthcare-Associated Infections: “USTG or an alternative coupling method such as saline or lubricant is essential for image quality by providing a medium for ultrasound signal transmission between the probe and tissue being scanned. The role of UTSG in health-care associated infections is well-documented, with contamination occurring at the point of manufacture (Abdelfattah, 2018; Nannini, 2015; Shaban, 2017; Yamunadevi, 2018) and during use (Cheng, 2016; Chittick, 2013; Hutchinson, 2004; Jacobson, 2006; Oleszkowicz, 2012; Olshtain-Pops, 2011; Organ, 2010; Westerway, 2016)…The use of ultrasound gel should be addressed in health care facility policies and procedures.” (page 11)
TIR99 points out that the use of ultrasound transmission gel (USTG) – or an alternative coupling method such as saline or lubricant – is essential for image quality, providing a medium for ultrasound signal transmission between the probe and the tissue that is being scanned. Unfortunately, the role of ultrasound gel specifically in healthcareassociated infections is well-documented, with the guidelines pointing to multiple studies over the last 20 years that highlight various contamination events that occurred at both the point of manufacture (Abdelfattah, 2018; Nannini 2015; Shaban, 2017; Yamunadevi, 2018) and during procedures (Cheng, 2016; Chitick, 2013; Hutchinson, 2004; Jacobson, 2006; Oleszkowicz, 2012; Olshtain-Pops, 2011; Organ, 2010; Westerway, 2016). The guidelines emphasize that as a result, the standard use of ultrasound gel should be directly addressed and decided upon by each individual health care facility.
Needle Guides:
“Single-use disposable sterile needle guides should be used when available and appropriate for the procedure. As needle guides are critical devices, they should undergo point of use treatment, followed by cleaning and sterilization according to the manufacturer’s written IFU.” (page 11)
“Published literature has linked patient infections with Pseudomonas aeruginosa (Gillespie, 2007) and hepatitis C (Ferhi, 2013) to needle guides that were inadequately cleaned and sterilized.” (page 11)
TIR99 states that needle guides – which are designated as “critical devices” – should, if not single-use disposable, undergo point of use treatment, followed by cleaning and sterilization, according to the manufacturer’s written IFU. The guidelines go on to point to various published literature that has directly linked patient infections such as Pseudomonas aeruginosa (Gillespie, 2007) and hepatitis C (Ferhi, 2013) to needle guides that were inadequately cleaned and sterilized. When available, single-use disposable sterile needle guides should be used and prioritized in given procedures.
Key Highlights Relating to Cleaning of Critical and Semi-Critical Devices:
The Importance of Probe Cleaning:
“Cleaning is the most important step in the processing of dilators and ultrasound probes. Cleaning is the physical removal of clinical soil and contaminants (e.g. organic and inorganic material) from an item to the extent necessary for further reprocessing or for the intended use.” (page 14)
Defined as the “physical removal of clinical soil and contaminants (e.g. organic and inorganic material) from an item to the extent necessary for further reprocessing or for the intended use,” TIR99 states that cleaning is the most important step in the processing of dilators and ultrasound probes.
Why Probe Cleaning Shouldn't Be Overlooked:
“Thorough cleaning is essential before high-level disinfection or sterilization because inorganic and organic material that remains on the surface of instruments interferes with the effectiveness of these processes.” (page 14)
TIR99 points to the CDC’s “Guideline for Disinfection and Sterilization in Healthcare Facilities,” which emphasizes that thorough cleaning is essential before high-level disinfection or sterilization takes place (this is because inorganic and organic material that remains on the surface of instruments have the potential to interfere with the effectiveness of said processes).
Key Highlights Relating to Transportation of Critical and Semi-Critical Devices:
Thorough transport:
“Contaminated items (not including those items low level disinfected at point of use)... should be contained during transport from the point of use to the decontamination area.” (page 15)
“Due to the delicate nature of probe/dilators, [devices] should be placed in a containment system in a way that prevents damage. A containment system that minimizes movement of the device during transport should be used.” (page 15)
TIR99 states that contaminated items (with the exception of items that received low level disinfection) should be contained during transport from the point of use all the way to the decontamination area. The guidelines also specifically state that probes/dilators should be placed in a containment system in such a way that prevents damage, ideally in a containment system that minimizes movement in order to prevent damage of the device during transport.
Meeting OSHA’s Requirements:
“OSHA requires that:
A. All containers, devices, or carts used for containing contaminated items are marked with a biohazard label, a red bag, or other means of identifying contaminated contents; and
B. puncture-resistant, leak-proof on the sides and bottom, closable, and labeled containers must be used for devices with edges or points capable of penetrating container or skin.” (page 15)
TIR99 recommends that transport containment systems and carts be marked appropriately while expressly meeting OSHA’s requirements for transporting hazardous items, which specifically states that all containers, devices, or carts used for containing contaminated items be marked with a biohazard label, red bag, or other means of identifying contaminated contents. OSHA also requires that containers being used for devices with edges or points capable of penetrating the container or skin be puncture-resistant, leak-proof on the sides and bottom, closable, and labeled.
Don’t mix contaminated components:
“Do not mix contaminated components with clean components. A contaminated probe used in a semicritical application should be protected from contact with the cable/plug, which will not undergo high-level disinfection. For endocavitary ultrasound probes and TEE probes, this can be accomplished by using a containment system that has an impermeable separation/divider, OR the transducer can be placed inside a bag which is placed inside the rigid container to separate the transducer from the cable and connector.” (page 15)
“During transport, cleaned, disinfected, and/or sterile items should be visibly marked Clean or Patient Ready and transported on a clean surface....A cleaned and disinfected probe should be protected from contact with the cable/plug which has not undergone high-level disinfection. Options include covering the probe with a visibly clean storage cover or using a containment system with dividers allowing the cord to pass through. Ensure containment and transport are addressed in health care facilities and procedure.” (page 23)
AAMI also advises against mixing contaminated components with clean components, stating that contaminated probes used in semicritical applications should be protected from contact with the cable/plug, as they will not undergo highlevel disinfection. In cases where probes have been high-level disinfected or sterilized, AAMI also suggests that efforts be made to eliminate contact between the probe and the cable/plug that have not received such treatment. To achieve this, the guidelines recommend utilizing containment systems with dividers (including for endocavitary ultrasound probes and TEE probes); TIR99 also suggests placing contaminated endocavitary/TEE ultrasound probes inside a bag within a rigid container to prevent contact with the clean cable/plug, as well as covering cleaned, disinfected, or sterilized probes within storage covers, to prevent contact with non-treated cables/plugs.
Key Highlights Relating to Leak Testing of Semi-Critical Devices:
Follow the Manufacturer’s IFU:
“If electrical leak testing of the device is required, follow the manufacturer’s written IFU for the process and equipment recommended.” (page 16)
TIR99 emphasizes that if electrical leak testing of the device is required, care should be taken to follow the manufacturer’s written IFU for the entire process.
Checking After Each Use:
“The structural and electrical integrity of TEE transducers should be checked between each use. The result of “passed” or “failed” should be documented along with the action taken if failed.” (page 16)
The guidelines also recommend that both the structural and electrical integrity of TEE transducers should be checked between each use, and that the result of “passed” or “failed” should be documented, along with the subsequent action that is taken if the transducer fails.
Key Highlights Relating to High-Level Disinfection of Critical and Semi-Critical Devices:
Overall Efficacy:
“Factors such as presence of organic soil on the item, design of the device, disinfectant dilution, contact time and temperature, mode of action, and microbial load in reusable solutions – can all have a significant impact on efficacy.” (page 18)
TIR99 states that a multitude of factors – including presence of organic soil on the item, transducer design, disinfectant dilution, contact time and temperature, mode of action, and microbial load in reusable solutions – can all have a significant impact on the overall efficacy of HLD.
Sterilization and High-Level Disinfection:
“Semi-critical devices, including dilators and ultrasound probes, should undergo sterilization. However, if the device cannot withstand sterilization processes, it should undergo, at a minimum, high-level disinfection.” (page 19)
The guidelines also state that semi-critical devices – including dilators and ultrasound probes – should undergo sterilization; conversely, devices that cannot withstand sterilization processes should undergo high-level disinfection, at a minimum.
Manual vs. Automated:
“Manual high-level disinfection continues to be used widely in many health care facilities as it can be the only option or method for processing the device due to costs and lack of an automated system. Manual high-level disinfection is not the preferred method due to safety and hazard concerns to the users and inconsistencies in the process from person to person.” (page 20)
Also touched on in TIR99 is the issue of methodology, with the guidelines directly stating that automated high-level disinfection systems are the preferred method over manual high-level disinfection processes. While manual high-level disinfection continues to be widely used in many health care facilities, AAMI definitively states that it is not the preferred method due to both safety and hazard concerns to the users, as well as inconsistencies in processes from person to person.
Drying After High-Level Disinfection:
“It is recommended that every probe/dilator after high-level disinfection be dried with a clean, lint-free cloth or non-linting wipe, and any areas that are inaccessible or have lumens should be dried using pressure-regulated instrument air or HEPA-filtered air.” (page 21)
AAMI recommends that every probe/dilator after high-level disinfection be dried with a clean, lint-free cloth or non-linting wipe, and that any areas that are inaccessible or human lumens be dried using pressure-regulated instrument air or HEPA-filtered air.
Key Highlights Relating to Storage of Critical and Semi-Critical Devices:
Storage Following High-Level Disinfection:
“Store probes and dilators according to the manufacturer’s written IFU to protect them from damage or contamination.” (page 23)
“A semi-critical probe/dilator that has undergone a high-level disinfection process should be stored with additional protection (e.g. in a clean cabinet or clean storage cover).” (page 23)
“TEE probes should be stored in a cabinet or other enclosure that:
A. Is of sufficient height, width, or depth to allow the probe to hang vertically without coiling and without any components touch the bottom of the cabinet, or the cabinet should be designed and intended by the manufacturer for horizontal storage of TEE probes.
B. Prevents damage
C. Prevents the formation of moisture
D. Allows circulation of air; and
E. Protects the probe from environmental contamination”
“TEE probes can be stored in a closed storage cabinet. Conventional storage cabinets that circulate HEPA-filtered or instrument air throughout the cabinet may be used.” (page 24)
“The accepted maximum safe storage time for HLD processed ultrasound probes/dilators before they can no longer be considered safe for patient use is not well defined. A multidisciplinary team that can include infection preventionists, processing personnel, risk management personnel, and other clinical personnel should conduct a risk assessment to determine the maximum storage time for an ultrasound probe or dilator before it should be processed.” (page 25)
TIR99 states that probes/dilators should be stored according to the manufacturer’s written IFU, and that any devices that have undergone high-level disinfection should be stored with additional protection (i.e. in a clean cabinet or clean storage cover). With regards to TEE probes specifically, TIR99 states that such devices can be stored in a closed storage cabinet - including conventional cabinets that circulate HEPA-filtered or instrument air – that is of sufficient height, width, and depth to allow the probe to hang vertically without coiling and without any components touching the bottom of the cabinet. AAMI also specifically emphasizes that such devices be stored in an enclosure that:
o Prevents damage
o Prevents the formation of moisture
o Allows circulation of air
o Protects the device from environmental contamination
The guidelines also state that there is no well-defined “maximum” safe storage time for HLD processed ultrasound probes/dilators before they can no longer be considered to be safe for patient use. TIR99 instead suggests that each facility assemble a multidisciplinary team - consisting of infection preventionists, processing personnel, risk management personnel, and other clinical members - to conduct a risk assessment to help determine the maximum storage time for an ultrasound probe or dilator before it should be processed.
Proper Identification:
“Develop protocols to verify that user can readily identify a probe that has been appropriately processed and is ready for patient use.” (page 24)
AAMI also recommends protocols be developed to ensure that end users always readily identify whether a particular probe has been cleaned and/or high-level disinfected and is ready for patient use.
Key Highlights Relating to Documentation and Traceability:
Documentation of All Steps:
“All steps in device processing should be documented. Documentation can be paper-based or completely automated (digital) and linked to a computer that has a tracking system....All medical devices that have undergone a high-level disinfection or sterilization process should be documented and linked to the patient record on which the device is used for traceability. Documentation and traceability processes should be outlined in the health care facility’s policies and procedures.” (page 25)
AAMI states that all steps in device processing should be documented, either on paper or digitally using a tracking system. The guidelines also state that medical devices that have been disinfected or sterilized should be recorded or connected to the patient’s record for traceability, and that all such documentation and traceability procedures should be detailed in the health care facility’s policies and procedures.
Documentation Requirements:
"The processing record should contain the:
A. medical device processing personnel's identification (ID) or user ID;
B. unique probe/dilator ID;
C. date;
D. time; and
E. relevant cycle parameters to indicate cycle pass
Automated LCS/HLD units and manual soaking containers should be traceable in the processing record. The medical device processing personnel should be responsible for appropriately labeling the probe or probe storage cover prior to placing it in storage. The health care facility approved probe label should contain the following information:
1. processing record ID;
2. date and time probe was processed; and
3. expiry date if required by the health care facility" (page 25)
AAMI emphasizes that the processing record should include the medical device processing personnel’s identification or user ID, the unique probe or dilator ID, the date, the time, and the relevant cycle parameters to indicate a successful cycle. The guidelines also state that automated LCS/HLD units and manual soaking containers should be traceable in the processing record, and that the medical device processing personnel are responsible for appropriately labeling the probe or its storage cover before storage. The health care facility-approved probe label should contain the processing record ID, the date and time the probe was processed, and the expiry date if required by the healthcare facility.
About CIVCO Medical Solutions
For 40+ years, CIVCO Medical Solutions has been committed to making image-guided procedures safer through the design and manufacturing of innovative ultrasound products. From gel-free probe covers, needle guides, and probe transport, to automated solutions for device disinfection and device storage, our products are trusted by physicians and clinicians across a range of clinical specialties, including radiology, regional anesthesia, vascular access, men’s and women’s health, cardiology, infection control, sterile processing, and surgery. Our mission is clear: we seek to enable clinicians to provide safer outcomes by developing patient-focused products while delivering outstanding service and superior quality.
To learn more about how CIVCO Medical Solutions can help you to achieve safer, more efficient image-guided procedures, please visit our website: https://www.civco.com
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