A 2011 bacterial infection outbreak at Beaumont Health System near Detroit has been traced to contaminated ultrasound gel — a finding that suggests more attention needs to be paid to targeting contamination of such products.
The study findings, published in the journal Infection Control and Hospital Epidemiology, are based on an investigation of an unusual cluster of infections involving the microbe P. aeruginosa in the cardiovascular surgery intensive care unit.
"Ultrasound is a critical healthcare tool used every day in both diagnostic and interventional procedures," said Paul Chittick, M.D., 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."
The microbe, which increases the risk of bloodstream and respiratory infections, was found in 16 patients in the Beaumont System. Checks of hospital facilities showed the outbreak stemmed from bottles of ultrasound transmission gel used during cardiovascular surgery. Following replacement of this gel with a sterile product, no further cases occurred.
Although researchers originally believed the gel had become contaminated during surgical use, sealed bottles of gel were also found to contain the same P. aeruginosa strain, indicating that the product was contaminated during the manufacturing process at the plant of Pharmaceutical Innovations.
As a result of this investigation, the Food and Drug Administration issued a warning about the gel.
The Beaumont Health System investigators also published the first proposed national guidelines in Infection Control and Hospital Epidemiology for the use of single-dose sterile vs. non-sterile ultrasound gel.
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