"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.
Source: Society for Healthcare Epidemiology of America via EurekAlert!