04:12am Sunday 12 July 2020

Contaminated Ultrasound Gel Tied to Outbreak of Healthcare-Associated Infections

“Ultrasound is a critical healthcare tool used every day in both diagnostic and interventional procedures,” said Paul Chittick, MD, lead author of the study.  “Although contaminated gel has been the cause of several documented outbreaks of infection, its potential role as a vehicle for spreading infections to patients is frequently overlooked.”

In December 2011, researchers uncovered an unusual cluster of P. aeruginosa in the cardiovascular surgery intensive care unit during routine infection control surveillance. The bug is known to increase the risk of bloodstream and respiratory infections in immune-compromised individuals.  Sixteen patients became colonized or infected with the bacteria, with all cases occurring in the respiratory tract. The outbreak was found to have stemmed from bottles of ultrasound transmission gel used during cardiovascular surgery.  Following replacement of this gel with a sterile product, no further cases occurred.

Cultures of gel from a bottle in use in the operating room grew P. aeruginosa that was identical to the outbreak strain. It was originally thought that the gel had likely become contaminated during use. However, sealed bottles of gel grew the same P. aeruginosa strain, proving that the product was contaminated during the manufacturing process at the plant of Pharmaceutical Innovations.

As a result of this investigation, the FDA issued a warning about the gel, alerting the risk of infection posed by the product and instructing healthcare providers and systems not to use the infected products.

The Beaumont Health System investigators also recently published proposed guidelines in Infection Control and Hospital Epidemiology for the use of sterile versus nonsterile ultrasound gel. These guidelines include the need for sterile, single-dose ultrasound gel to be used for all invasive procedures and give appropriate storage and warming methods for the gel. Prior to this, no such guidelines existed in the United States.



Paul Chittick, Victoria Russo, Matthew Sims, Barbara Robinson-Dunn, Susan Oleszkowicz, Kara Sawarynski, Kimberly Powell, Jacob Makin, Elizabeth Darnell, Judith A. Boura, Bobby Boyanton, Jeffrey Band. “An Outbreak of Pseudomonas aeruginosa Respiratory Tract Infections Associated with Intrinsically Contaminated Ultrasound Transmission Gel.” Infection Control and Hospital Epidemiology 34:8 (August 2013).


Published through a partnership between the Society for Healthcare Epidemiology of America and The University of Chicago Press, Infection Control and Hospital Epidemiology provides original, peer-reviewed scientific articles for anyone involved with an infection control or epidemiology program in a hospital or healthcare facility. ICHE is ranked 15 out of 140 journals in its discipline in the latest Journal Citation Reports from Thomson Reuters.

SHEA is a professional society representing more than 2,000 physicians and other healthcare professionals around the world with expertise in healthcare epidemiology and infection prevention and control. SHEA’s mission is to prevent and control healthcare-associated infections and advance the field of healthcare epidemiology. The society leads this field by promoting science and research and providing high-quality education and training in epidemiologic methods and prevention strategies. SHEA upholds the value and critical contributions of healthcare epidemiology to improving patient care and healthcare worker safety in all healthcare settings. Visit SHEA online at www.shea-online.org, www.facebook.com/SHEApreventingHAIs and @SHEA_Epi.

Society for Healthcare Epidemiology of America
Contact: Tamara Moore / [email protected]/ 202-745-5114
Study contact: Paul Chittick/[email protected]

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