Minimizing Risks and Liability for Ultrasound Probe Usage
Over the years, ultrasound technology has become an indispensable tool in modern medicine, playing a pivotal role in both diagnostics and interventional procedures, including vascular access. Its widespread use, however, has also served to highlight critical challenges that healthcare workers must directly address and mitigate – in particular, the risk of infection associated with contaminated ultrasound probes, covers, gels, and inadequate cleaning protocols. These specific issues not only jeopardize patient safety but can also serve to expose providers to significant legal, reputational, and financial liabilities.
In this blog post, we delve into the infection-related challenges tied to ultrasound components—including probe covers, gel, and transducers — and explore practical solutions to both minimize these risks and help safeguard patients and healthcare organizations.
Probe Disinfection Standards
The Spaulding Classification system, developed in 1939, provides a framework for categorizing medical devices based on their infection risk level: Non-Critical (for devices that come in contact with intact skin), Semi-Critical (for devices that contact mucous membranes or broken skin), and Critical (for devices that enter sterile tissue or the vascular system). Despite the ideal standards outlined by Spaulding, practical implementation of High-Level Disinfection (HLD) can remain challenging for many healthcare facilities due to limited resources, budget constraints, and the impact on workflow efficiency.
Adding complexity to this issue, various standards of care have evolved alongside technological advancements, many of which advocate for differing approaches to individual ultrasound probe disinfection scenarios. While the American Institute of Ultrasound in Medicine (AIUM) recommends low-level disinfection (LLD) combined with sterile transducer covers as adequate for certain procedures, newer guidelines - such as those from AAMI (2024) - advocate for stricter practices, including the use of sterile gel and covers for critical and semi-critical probes.
Probe Covers and Disinfection Challenges:
When it comes to infection prevention in particular, probe covers often play a crucial role by serving as barriers that minimize cross-contamination risks during ultrasound procedures. Probe covers are not infallible, however, with their ultimate efficacy often depending on a variety of factors, including material selection, proper application techniques, or adherence to manufacturer guidelines. In fact, guidance from organizations such as ECRI states explicitly that probe covers should be seen as a complement to – rather than a replacement for – effective cleaning and disinfection:
“The use of probe covers does not replace the need for HLD or sterilization of the probe after each use.”
For over 30 years, CIVCO has been a trusted leader in manufacturing high-quality ultrasound probe covers, dedicated to protecting both patients and clinicians. We offer an extensive range of sterile and non-sterile covers designed to meet diverse clinical needs. Using only the highest quality materials, our covers are trusted by healthcare professionals to provide effective protection against HAIs and ensure the highest standards of safety.
To learn more about how CIVCO’s viral probe covers can assist you in your ultrasound procedures, visit our website.
Ultrasound Gel: A Hidden Risk?
Ultrasound gel plays a critical role in ensuring the quality of diagnostic imaging by serving as a coupling medium between the transducer and the patient’s skin, with its primary function being to eliminate the air that would otherwise interfere with ultrasound waves, facilitating clearer and more accurate imaging. While alternative coupling agents exist, none match the effectiveness of traditional ultrasound gel. However, the benefits of ultrasound gel must also be weighed against the potential risks it introduces - particularly with regard to infection prevention.
Despite its widespread use, numerous global infection outbreaks have been linked to contaminated ultrasound gel, with pathogens such as Pseudomonas, Klebsiella, and Burkholderia identified as key culprits. Contamination can occur during manufacturing or through improper handling within healthcare facilities; multidose containers, shared use, and inadequate labeling and documentation of gel bottles exacerbate these risks, with gel bottles having frequently been identified as among the most contaminated items in ultrasound suites, further highlighting their potential as vectors for infection.
To mitigate these risks, healthcare providers should implement rigorous infection control measures. This includes using sterile gel for high-risk procedures, avoiding multidose containers, and ensuring proper storage and handling practices. Emerging technologies, such as gel-free barriers and hydrophilic scanning pads, offer innovative alternatives to traditional gel. These devices allow for ultrasound scanning with a sterile liquid, such as saline, reducing reliance on gel and minimizing contamination risks.
The stakes are high when it comes to liability. Contaminated gel has been implicated in bloodstream, skin, and respiratory infections, with recalls like the FDA’s Class I recall of Eco-Med ultrasound gels underscoring the gravity of the issue.
CIVCO’s Envision ultrasound probe covers and scanning pads enable completely gel-free ultrasound procedures. Designed with innovative viral barriers that are activated by a sterile liquid, Envision eliminates the need for gel while maintaining excellent imaging quality. Ideal for interventions and procedures like thyroid FNAs, CVCs, PICC lines, nerve blocks, and peripheral IVs, Envision enhances the experience for both clinicians and patients.
To learn more about how Envision can enhance your ultrasound procedures, visit our website.
Legal and Financial Implications
Legal liability in the context of ultrasound disinfection and infection prevention is a complex and multifaceted issue - one that carries significant risks for healthcare providers, manufacturers, and institutions. Under product liability law, a manufacturer, distributor, or supplier may be held accountable for a defective product—even in the absence of negligence or specific intent to harm. In fact, plaintiffs need only demonstrate that the product was defective, the defect caused injury, and damages were sustained as a result. This principle extends responsibility across the entire supply chain, from the manufacturer to the distributor and ultimately to the healthcare facility and/or individual clinician. The reality is clear: anyone involved in the process, including hospitals and their staff, may be subject to lawsuits, particularly in cases where infection outbreaks are linked to contaminated products like ultrasound gel.
Historical cases illustrate the gravity of such risks, with a 2012 fungal meningitis outbreak caused by contaminated vials of methylprednisolone acetate highlighting how a single defective product can lead to widespread litigation. Similarly, product recalls - like the 2021 Class I recall of Eco-Med ultrasound gels underscore the potential for catastrophic consequences. This recall, which identified contamination by Burkholderia cepacia complex bacteria, resulted in over 119 reported infections and led to the company ceasing all operations. The lesson: that healthcare providers must mitigate liability by ensuring strict compliance with infection prevention protocols, maintaining detailed documentation, and using evidence-based practices to prevent harm.
Ultrasound probes and their associated disinfection protocols present another layer of legal risk. The choice of probe cover, the cleaning method employed, and adherence to infection control standards all factor into potential liability. Probe covers serve as essential barriers but should not be relied upon as the sole method of infection prevention, given their finite failure rates. Legal scrutiny often hinges on three critical questions:
-What preventive measures were taken to avoid injury?
-How swiftly was the injury recognized?
-Was the response appropriate?
In non-product liability cases, the burden of proof may shift to the hospital to demonstrate that reasonable care was exercised. A failure to develop, implement and/or adhere to rigorous infection prevention policies can result in findings of negligence.
To mitigate such legal exposure, healthcare providers must prioritize proactive measures, including regular updates to policies and procedures, robust staff training, and thorough documentation of compliance with evidence-based standards.
Risk Mitigation Strategies
Reducing risk and liability in relation to disinfection requires healthcare organizations to adopt comprehensive strategies that prioritize adherence to the standard of care. More often than not, this begins with a.) identifying an applicable standard and then b.) subsequently ensuring that all organizational policies and procedures are fully aligned with it.
It’s critical to remember than any deviation from established evidence-based policies and procedures create opportunities for negligence…and potential malpractice claims. As a result, organizations should focus on minimizing variability in both products and practices while developing clear, enforceable policies that can be effectively implemented and monitored amongst staff.
One key strategy for minimizing risk is to standardize disinfection protocols and products across the organization - reducing variation ensures consistency in care and decreases the likelihood of error or misuse. Additionally, policies and procedures should be viewed as “living documents” that are updated regularly to reflect advancements in technology and evidence-based practices. Failing to comply with internally developed policies can be more damaging than having no policies at all, potentially opening the organization up to claims of negligence and a failure to meet its own standards.
One practical step in mitigating liability is to implement aseptic non-touch technique practices, including – but not limited to - re-evaluating the use of ultrasound gel. Gel products can introduce unnecessary risk and serve as a source of infection and liability, particularly if reusable gel containers are used. Transitioning to single-use sterile gel packets or eliminating gel entirely where alternatives exist can reduce this risk.
Similarly, ensuring the proper use of sterile probe covers tailored to the specific procedure—such as vascular access procedures—can help to maintain the integrity of infection prevention protocols (remember, however, that sterile probe covers alone do not negate the need for thorough transducer cleaning and disinfection).
Looking Ahead: Staying Ahead of Liability Risks
As healthcare organizations continue to grapple with the complexities of evolving standards – and the industry as a whole sees increased scrutiny on infection prevention and patient safety – it’s important that medical professionals take proactive steps to address risks associated with ultrasound procedures. By embracing evidence-based practices, investing in advanced technologies, and fostering a culture of compliance, providers can not only safeguard their patients but also shield themselves from the significant legal and financial repercussions of preventable infections. 1
References:
1. “What’s Beneath the Sheath” – Minimizing Risk and Liability for Ultrasound Probe Usage (Webinar – Russ Nassof, JD)
COPYRIGHT © 2025. ALL RIGHTS RESERVED. CIVCO IS A REGISTERED TRADEMARK OF CIVCO MEDICAL SOLUTIONS. ALL OTHER TRADEMARKS ARE THE PROPERTY OF THEIR RESPECTIVE OWNERS. ALL PRODUCTS MAY NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW. PRINTED IN USA. 2025M-3421 REV. 1
In this blog post, we delve into the infection-related challenges tied to ultrasound components—including probe covers, gel, and transducers — and explore practical solutions to both minimize these risks and help safeguard patients and healthcare organizations.
Probe Disinfection Standards
The Spaulding Classification system, developed in 1939, provides a framework for categorizing medical devices based on their infection risk level: Non-Critical (for devices that come in contact with intact skin), Semi-Critical (for devices that contact mucous membranes or broken skin), and Critical (for devices that enter sterile tissue or the vascular system). Despite the ideal standards outlined by Spaulding, practical implementation of High-Level Disinfection (HLD) can remain challenging for many healthcare facilities due to limited resources, budget constraints, and the impact on workflow efficiency.Adding complexity to this issue, various standards of care have evolved alongside technological advancements, many of which advocate for differing approaches to individual ultrasound probe disinfection scenarios. While the American Institute of Ultrasound in Medicine (AIUM) recommends low-level disinfection (LLD) combined with sterile transducer covers as adequate for certain procedures, newer guidelines - such as those from AAMI (2024) - advocate for stricter practices, including the use of sterile gel and covers for critical and semi-critical probes.
Probe Covers and Disinfection Challenges:
When it comes to infection prevention in particular, probe covers often play a crucial role by serving as barriers that minimize cross-contamination risks during ultrasound procedures. Probe covers are not infallible, however, with their ultimate efficacy often depending on a variety of factors, including material selection, proper application techniques, or adherence to manufacturer guidelines. In fact, guidance from organizations such as ECRI states explicitly that probe covers should be seen as a complement to – rather than a replacement for – effective cleaning and disinfection:
“The use of probe covers does not replace the need for HLD or sterilization of the probe after each use.” For over 30 years, CIVCO has been a trusted leader in manufacturing high-quality ultrasound probe covers, dedicated to protecting both patients and clinicians. We offer an extensive range of sterile and non-sterile covers designed to meet diverse clinical needs. Using only the highest quality materials, our covers are trusted by healthcare professionals to provide effective protection against HAIs and ensure the highest standards of safety.
To learn more about how CIVCO’s viral probe covers can assist you in your ultrasound procedures, visit our website.
Ultrasound Gel: A Hidden Risk?
Ultrasound gel plays a critical role in ensuring the quality of diagnostic imaging by serving as a coupling medium between the transducer and the patient’s skin, with its primary function being to eliminate the air that would otherwise interfere with ultrasound waves, facilitating clearer and more accurate imaging. While alternative coupling agents exist, none match the effectiveness of traditional ultrasound gel. However, the benefits of ultrasound gel must also be weighed against the potential risks it introduces - particularly with regard to infection prevention.
Despite its widespread use, numerous global infection outbreaks have been linked to contaminated ultrasound gel, with pathogens such as Pseudomonas, Klebsiella, and Burkholderia identified as key culprits. Contamination can occur during manufacturing or through improper handling within healthcare facilities; multidose containers, shared use, and inadequate labeling and documentation of gel bottles exacerbate these risks, with gel bottles having frequently been identified as among the most contaminated items in ultrasound suites, further highlighting their potential as vectors for infection.
To mitigate these risks, healthcare providers should implement rigorous infection control measures. This includes using sterile gel for high-risk procedures, avoiding multidose containers, and ensuring proper storage and handling practices. Emerging technologies, such as gel-free barriers and hydrophilic scanning pads, offer innovative alternatives to traditional gel. These devices allow for ultrasound scanning with a sterile liquid, such as saline, reducing reliance on gel and minimizing contamination risks.
The stakes are high when it comes to liability. Contaminated gel has been implicated in bloodstream, skin, and respiratory infections, with recalls like the FDA’s Class I recall of Eco-Med ultrasound gels underscoring the gravity of the issue.CIVCO’s Envision ultrasound probe covers and scanning pads enable completely gel-free ultrasound procedures. Designed with innovative viral barriers that are activated by a sterile liquid, Envision eliminates the need for gel while maintaining excellent imaging quality. Ideal for interventions and procedures like thyroid FNAs, CVCs, PICC lines, nerve blocks, and peripheral IVs, Envision enhances the experience for both clinicians and patients.
To learn more about how Envision can enhance your ultrasound procedures, visit our website.
Legal and Financial Implications
Legal liability in the context of ultrasound disinfection and infection prevention is a complex and multifaceted issue - one that carries significant risks for healthcare providers, manufacturers, and institutions. Under product liability law, a manufacturer, distributor, or supplier may be held accountable for a defective product—even in the absence of negligence or specific intent to harm. In fact, plaintiffs need only demonstrate that the product was defective, the defect caused injury, and damages were sustained as a result. This principle extends responsibility across the entire supply chain, from the manufacturer to the distributor and ultimately to the healthcare facility and/or individual clinician. The reality is clear: anyone involved in the process, including hospitals and their staff, may be subject to lawsuits, particularly in cases where infection outbreaks are linked to contaminated products like ultrasound gel.
Historical cases illustrate the gravity of such risks, with a 2012 fungal meningitis outbreak caused by contaminated vials of methylprednisolone acetate highlighting how a single defective product can lead to widespread litigation. Similarly, product recalls - like the 2021 Class I recall of Eco-Med ultrasound gels underscore the potential for catastrophic consequences. This recall, which identified contamination by Burkholderia cepacia complex bacteria, resulted in over 119 reported infections and led to the company ceasing all operations. The lesson: that healthcare providers must mitigate liability by ensuring strict compliance with infection prevention protocols, maintaining detailed documentation, and using evidence-based practices to prevent harm.
Ultrasound probes and their associated disinfection protocols present another layer of legal risk. The choice of probe cover, the cleaning method employed, and adherence to infection control standards all factor into potential liability. Probe covers serve as essential barriers but should not be relied upon as the sole method of infection prevention, given their finite failure rates. Legal scrutiny often hinges on three critical questions:
-What preventive measures were taken to avoid injury?
-How swiftly was the injury recognized?
-Was the response appropriate?
In non-product liability cases, the burden of proof may shift to the hospital to demonstrate that reasonable care was exercised. A failure to develop, implement and/or adhere to rigorous infection prevention policies can result in findings of negligence.
To mitigate such legal exposure, healthcare providers must prioritize proactive measures, including regular updates to policies and procedures, robust staff training, and thorough documentation of compliance with evidence-based standards.
Risk Mitigation Strategies
Reducing risk and liability in relation to disinfection requires healthcare organizations to adopt comprehensive strategies that prioritize adherence to the standard of care. More often than not, this begins with a.) identifying an applicable standard and then b.) subsequently ensuring that all organizational policies and procedures are fully aligned with it.
It’s critical to remember than any deviation from established evidence-based policies and procedures create opportunities for negligence…and potential malpractice claims. As a result, organizations should focus on minimizing variability in both products and practices while developing clear, enforceable policies that can be effectively implemented and monitored amongst staff.
One key strategy for minimizing risk is to standardize disinfection protocols and products across the organization - reducing variation ensures consistency in care and decreases the likelihood of error or misuse. Additionally, policies and procedures should be viewed as “living documents” that are updated regularly to reflect advancements in technology and evidence-based practices. Failing to comply with internally developed policies can be more damaging than having no policies at all, potentially opening the organization up to claims of negligence and a failure to meet its own standards.
One practical step in mitigating liability is to implement aseptic non-touch technique practices, including – but not limited to - re-evaluating the use of ultrasound gel. Gel products can introduce unnecessary risk and serve as a source of infection and liability, particularly if reusable gel containers are used. Transitioning to single-use sterile gel packets or eliminating gel entirely where alternatives exist can reduce this risk.
Similarly, ensuring the proper use of sterile probe covers tailored to the specific procedure—such as vascular access procedures—can help to maintain the integrity of infection prevention protocols (remember, however, that sterile probe covers alone do not negate the need for thorough transducer cleaning and disinfection).
Looking Ahead: Staying Ahead of Liability Risks
As healthcare organizations continue to grapple with the complexities of evolving standards – and the industry as a whole sees increased scrutiny on infection prevention and patient safety – it’s important that medical professionals take proactive steps to address risks associated with ultrasound procedures. By embracing evidence-based practices, investing in advanced technologies, and fostering a culture of compliance, providers can not only safeguard their patients but also shield themselves from the significant legal and financial repercussions of preventable infections. 1
References:
1. “What’s Beneath the Sheath” – Minimizing Risk and Liability for Ultrasound Probe Usage (Webinar – Russ Nassof, JD)
COPYRIGHT © 2025. ALL RIGHTS RESERVED. CIVCO IS A REGISTERED TRADEMARK OF CIVCO MEDICAL SOLUTIONS. ALL OTHER TRADEMARKS ARE THE PROPERTY OF THEIR RESPECTIVE OWNERS. ALL PRODUCTS MAY NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW. PRINTED IN USA. 2025M-3421 REV. 1
