In Controversy over Transducer Disinfection, Intersocietal PoSITION Statement Earns Broad Support

Over the past decade, there has been a dramatic increase in the adoption of point-of-care (POC) ultrasound to improve patient care across a wide variety of medical specialties, including cardiology, emergency medicine, obstetrics and gynecology, orthopedics, vascular access, and more. But the rapid dissemination of POC ultrasound among new medical specialties, combined with conflicting guidance from clinical organizations, has led to widespread confusion about the infection control practices appropriate for POC ultrasound equipment.

In this blog post, we examine the rise of POC ultrasound, the controversy and confusion surrounding transducer disinfection practices, and the details behind a 2021 Intersocietal Position Statement that provides some much-needed clarity on the topic.

Advanced ultrasound visualization has proven to be a valuable tool for locating veins and guiding needles, catheters, and other devices during percutaneous procedures. The insertion of a peripheral IV catheter is the most commonly performed invasive medical procedure among hospitalized patients. Ultrasound guidance enables successful peripheral IV placement while reducing the number of failed insertion attempts and preserving vessel health.

Nancy Moureau, RN, PhD, CRNI, CPUI, VA-BC

“The use of ultrasound technology for the placement of vascular access devices has improved the overall patient experience. All efforts should be made to protect patient safety while maintaining—or even increasing—access to this valuable technology,” says Nancy Moureau, RN, PhD, CRNI, CPUI, VA-BC, a vascular access expert and CEO of PICC Excellence (Hartwell, GA), a vascular access education firm.

Arun Nagdev, MD

According to Arun Nagdev, MD, director of emergency ultrasound at Alameda Health System (Oakland), POC ultrasound has been practice-changing for the care of trauma and critically ill patients in the emergency department. “Ultrasound is a rapid, reliable tool that improves patient care by increasing diagnostic accuracy and increases the safety of lifesaving procedures such as central line placement,” he says.

Concern over Transducer Disinfection 

As reliance on ultrasound guidance for percutaneous procedures has increased, so have concerns over the potential for transmission of pathogenic microorganisms via ultrasound transducers. To promote patient safety, a number of health professional organizations published guidelines that established infection control practices for percutaneous procedures and for the cleaning and disinfection of transducers between procedures.

While the published guidelines agreed that contaminations transmitted via ultrasound transducers or coupling gels might equally pose a risk of patient infection, their recommendations regarding the level of disinfection appropriate for transducers varied widely.

Oliver Kripfgans, PhD

Central to the debate over disinfection practices is a mistaken understanding of the Spaulding Classification System for reprocessing medical devices when applying its recommendations to devices used in percutaneous procedures, explains Oliver Kripfgans, PhD, a medical ultrasound physicist and research associate professor at the University of Michigan. Published in 1957, the Spaulding system includes recommendations about the levels of cleaning, disinfection, and sterilization required for healthcare equipment. The Spaulding system is the foundation of FDA policy on the cleaning and disinfection of medical devices.

By misclassifying percutaneous procedures as ‘semicritical’ according to the Spaulding system, some organizations concluded that transducers must be processed using high-level disinfection (HLD) techniques, which typically involve placing transducers in an apparatus that exposes them to specialized disinfecting chemicals such as glutaraldehyde or a mist of hydrogen peroxide. Because of practitioner concerns about the transmissibility of pathogens via ultrasound procedures, many hospitals and infection control staff acceded to such recommendations—especially during the height of the COVID-19 pandemic—hoping that HLD would provide an extra margin of safety.

Meanwhile, citing a lack of evidence for the necessity of performing HLD—which can be both costly and time-consuming—a number of other organizations issued guidelines maintaining that adequate protection can be provided by using a disposable transducer cover or barrier during the procedure, followed by cleaning and low-level disinfection (LLD). Performed both before and after percutaneous procedures, LLD involves wiping indicated surfaces and equipment thoroughly with standard disinfectants having a documented microbial kill rate of at least 99%.

“There was great concern that we were actually harming patients by requiring high-level disinfection because it significantly limited the availability of our ultrasound transducers,” says Kripfgans, who spearheaded a taskforce convened by the American Institute of Ultrasound in Medicine (AIUM) to consider the evidence and practices associated with transducer disinfection for these types of procedures.

“We wanted to ensure that ultrasound remained both safe and available,” he adds.

Intersocietal Taskforce Supports Low-Level Disinfection 

The taskforce evaluated the peer-reviewed literature and concluded that there was effectively no pertinent evidence supporting a requirement to perform HLD between percutaneous procedures.

At the beginning of 2021, the taskforce published an Intersocietal Position Statement endorsing the use of LLD effective against bloodborne pathogens for the cleaning and disinfection of transducers used in percutaneous procedures. The statement has now gained the support of 22 health professional organizations representing more than 800,000 physicians, nurses, infection control specialists, and other health professionals. 

LLD involves wiping indicated surfaces and equipment thoroughly with standard disinfectants having a documented microbial kill rate of at least 99%.

“We hope that having the support of so many organizations will encourage the widespread adoption of appropriate disinfection practices in clinical and professional settings, which will bring significant benefits to patients,” says Kripfgans.

“The last thing we want to do is make it harder for clinicians to do the right thing,” says Nagdev. “Imposing requirements for performing HLD between percutaneous procedures would significantly limit our ability to use POC ultrasound in the emergency department.

“Our goal is to improve practice and ensure safety so that ultrasound technology is available for all patients,” he adds.

Position Statement Highlights

LLD is adequate for percutaneous procedures, especially when transducer covers are used. Evidence shows that rare cases of infection are typically linked to the use of nonsterile or contaminated coupling gels, failure to use a transducer cover, or improper cleaning—but not to the use of LLD techniques. 

Transducer covers for transcutaneous procedures are meant to protect the sterility of the procedure, not to make the transducer sterile. Just as a surgeon’s hands are not sterilized prior to glove application, a transducer need not be sterilized. A cover provides adequate separation of the transducer from the procedure, as gloves do for the surgeon’s hands.

Requiring HLD for percutaneous procedures is “not evidence based” and will increase “the possibility of safety events if percutaneous procedures are performed without ultrasound guidance.” The Spaulding system classifies percutaneous procedures such as peripheral IV insertion as noncritical, and therefore requiring only LLD between uses. For semicritical and critical procedures, it may be appropriate to use HLD that involves agents or disinfecting processes designed to sterilize the surface of the transducer. However, these substances and processes take considerable time, may damage the transducer, and represent significantly higher processing costs. 

Intersocietal Position Statement Signatories (May 2022)

American Academy of Emergency Medicine (AAEM) 1 
American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM)
American College of Emergency Physicians (ACEP)
American College of Osteopathic Obstetricians and Gynecologists (ACOOG)
American College of Radiology (ACR)
American Medical Society for Sports Medicine (AMSSM) 2 
American Institute of Ultrasound in Medicine (AIUM)
American Registry for Diagnostic Medical Sonography (ARDMS)
American Registry of Radiologic Technologists (ARRT)
American Society of Anesthesiologists (ASA) 3 
Association for Professionals in Infection Control and Epidemiology (APIC)
Association for Vascular Access (AVA)
Emergency Nurses Association (ENA)
Infusion Nurses Society (INS)
International Society of Ultrasound in Obstetrics and Gynecology (ISUOG)
Point-of-Care Ultrasound (POCUS) Certification Academy
Society for Healthcare Epidemiology of America (SHEA)
Society for Maternal-Fetal Medicine (SMFM)
Society of Academic Emergency Medicine (SAEM) 
Society of Breast Imaging (SBI)
Society of Hospital Medicine (SHM) 
Society of Radiologists in Ultrasound (SRU)

1. Independently, the Emergency Ultrasound Section of the American Academy of Emergency Medicine (EUS-AAEM) has also endorsed the position statement. 

2. The AMSSM board has voted to Affirm for Value the position statement. 

3. The ASA Council has approved support with the following notation: “Since the document has neither been presented to nor approved by either the ASA Board of Directors or House of Delegates, it is not an official or approved statement or policy of the society. Variances from the recommendations contained in the document may be acceptable based on the judgment of the responsible anesthesiologist.”

Knowledge is Power – Why you should #KnowYourBiomarker

Republished with permission from the blog of AJ Patel. This is the second post in a series on advances in genomic testing and the future of cancer treatment — see the first post here.

When I was diagnosed 8 years ago with non-small cell lung cancer (NSCLC), I was told I had 6 months to live. It was the worst time of my life, and I wallowed in misery for nearly a week before I decided I needed to take action. I turned to the internet, which at first did nothing to alleviate my misery. But then I stumbled upon the patient advocacy organization LUNGevity and made a phone call that changed the trajectory of my entire diagnosis.

​That one call—and the connections and information that came out of it—are the reason I’m alive today.

Continue reading “Knowledge is Power – Why you should #KnowYourBiomarker”

Breaking Down Barriers – Improving Access to Comprehensive Biomarker Testing for Cancer Patients

This is the first in a series on advances in genomic testing and the future of cancer treatment.

The last two decades have brought remarkable advances in cancer treatment with the use of precision medicine. Twenty years ago, the major weapon doctors had against most advanced cancers was a harsh regimen of chemotherapy — a one-size-fits-all treatment that leaves patients debilitated while offering limited survival.

The shift to more targeted treatments began after researchers discovered that many cancers are driven by mutations in specific genes. This was most robustly exemplified in non-small cell lung cancer (NSCLC). Pharmaceutical companies have now developed more than two dozen drugs for patients with NSCLC that directly target specific genes and mutations, leading to better overall outcomes.

The impact of these advances “has been enormous,” says Dr. Wendy Levin, Chief Medical Officer at Biofidelity, a cancer diagnostic company. “If we can get a patient on a targeted agent that’s more effective and better tolerated, we know that they will have a major survival advantage.”

Continue reading “Breaking Down Barriers – Improving Access to Comprehensive Biomarker Testing for Cancer Patients”

Is it Time to Move Beyond CLABSI?

When it comes to infection control in vascular access, central line-associated bloodstream infections (CLABSIs) certainly get the most attention. Yet the medical community is increasingly recognizing how infections associated with other types of vascular access devices are putting patients at risk.

Take peripheral IV (PIV) catheters, the most commonly used type of vascular access device. Nearly 90 percent of hospitalized patients require a PIV at some point during their stay, and PIV usage far outnumbers that of central vascular access devices (CVAD). PIVs, therefore, account for an infection rate that approaches the CVAD infection rate in absolute terms.

Yet there is currently no mandatory reporting system for bloodstream infections associated with PIVs in the U.S., making it one of the most underreported types of infections in vascular access. Epidemiologist Robert Garcia, an infection preventionist with 40 years of hospital experience, shares these concerns — and he has a plan to address this significant patient safety issue.

Continue reading “Is it Time to Move Beyond CLABSI?”

2021 INS Standards Highlight Anti-Reflux Technology for Needleless Connectors

Guest post by Nancy Moureau, RN, PhD, CEO of PICC Excellence

In vascular access, needleless connectors (NC) are now recommended worldwide to maintain closed IV systems and promote safety by preventing needlestick injuries. Over the past 25 years, many different NCs have come onto the market, with wide variations in design and function among the various types. As a result, there is a lot of confusion among clinicians regarding the proper use and management of these small yet complex devices, which can have serious patient safety implications.

Fortunately, the Infusion Nurses Society provides some clarity on this issue by significantly expanding its guidance on NCs in the 2021 Infusion Therapy Standards of Practice. This includes clearer definitions of the various types of NC technology and emphasizes the importance of understanding how to use each type properly to minimize blood reflux.

Many clinicians are not aware of the impact blood reflux can have, or view it as a minor issue that can be easily addressed with proper flushing. However, evidence is mounting that reflux is largely avoidable and leads to many complications that seriously impact patient safety.

Continue reading “2021 INS Standards Highlight Anti-Reflux Technology for Needleless Connectors”

UGPIV Practices: Are they jeopardizing patient safety?

A new continuing education program details how a lack of standardized policies related to ultrasound-guided peripheral IV (UGPIV) catheter insertions can negatively impact patient safety. The webinar also suggests UGPIV performance improvement initiatives that “can help to create a culture of safety across the healthcare continuum,” according to presenter Nancy Moureau, RN, PhD, an internationally recognized expert and consultant in vascular access and CEO of PICC Excellence.

The on-demand webcast, Patient Safety and Ultrasound-Guided Peripheral IV Placement: The Need for Standardized Practices, offers 1 contact hour of continuing education for nurses. It is sponsored by Parker Laboratories.

“While the use of ultrasound guidance to improve success during PIV catheter placements is becoming more common, suboptimal aseptic technique and variations in supply usage poses a very serious risk to patients,” said Dr. Moureau. “To increase safety during UGPIV insertions, healthcare organizations should adopt a multidisciplinary approach to standardize policies and procedures based on current evidence and recommendations, while at the same identifying opportunities for pragmatic, incremental improvements.”

Continue reading “UGPIV Practices: Are they jeopardizing patient safety?”

The Future of Breast Cancer Treatment: Destroying Tumors with a Laser

Breast cancer patients have long been in need of reliable therapeutic options that reduce pain and the risk of disfigurement. At the forthcoming MedTech conference of the Advanced Medical Technology Association (AdvaMed, Washington, DC), laser therapy specialist Novian Health Inc (Chicago) will showcase a novel technology for the ablation of early-stage breast tumors. The company’s CE-marked system is seeking to displace existing surgical procedures as the treatment of choice for early-stage breast tumors.

Every year, more than 275,000 women in the United States and 2 million around the world receive the dreaded diagnosis of breast cancer. The news can be overwhelming, triggering sudden and intense emotions. One participant in a study of patient responses to a breast cancer diagnosis said she felt “paralyzed and frozen with fear.”

Continue reading “The Future of Breast Cancer Treatment: Destroying Tumors with a Laser”

D&D remembers Regis Philbin

While this post is a departure from our usual medicine-focused content, we at D&D wanted to acknowledge the recent passing of Regis Philbin. A few members of our staff were fortunate enough to meet Regis during his 88 years on earth — their reminiscences are below.

From Greg Dennis, retired co-founder of Dowling & Dennis:

Regis Philbin had a son who was confined to a wheelchair and relied upon a small piece of technology made by a large medical company. As it happened, Dowling & Dennis did some PR consulting work for that company.

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COVID-19 and the Importance of Virtual Learning: The Future of Medical Education

When the novel coronavirus began sweeping around the world earlier this year, it left doctors, hospitals and public health experts scrambling for answers. How should diagnoses of COVID-19 cases be made? What are the symptoms that need the most careful monitoring? What are the right treatment options for each stage of the disease? And what happens if patients have other conditions, such as being pregnant? The answers were—and continue to be—evolving so rapidly that it has been hard for overworked physicians, nurses and other healthcare providers to keep up.

But there is one place they can turn quickly for the latest information—a free online training module from a medical education company called CaseNetwork. First released on March 17, this program also illustrates the growing potential of virtual, case-based medical education even long after the pandemic has subsided.

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Protecting Kidney Patients in the COVID-19 World

For the 30 million Americans living with some form of kidney disease, the current COVID-19 pandemic brings a host of additional challenges not faced by the general population—like a greater risk of developing serious complications if they contract the virus. And for the 500,000 Americans with kidney failure who rely on dialysis treatments to stay alive, these challenges only multiply. Do they follow “stay-at-home” orders and skip their dialysis treatments, or do they risk exposure by going to a dialysis clinic where social distancing is difficult, if not impossible, to enforce? Either decision could have life-threatening consequences.

And what about the procedures to create and maintain the necessary access to their bloodstream that makes dialysis possible? In mid-March, the CMS deemed these procedures “non-essential,” leading to a host of cancelled appointments and operations. Even when CMS reversed its decision days later, the confusion that resulted from the chaos left many physicians, hospitals and patients unsure of which path to follow.

Continue reading “Protecting Kidney Patients in the COVID-19 World”