Pseudomonas aeruginosa respiratory tract infections associated with contaminated ultrasound gel used for transesophageal echocardiography - Michigan, December 2011-January 2012.

In late December 2011, the Department of Epidemiology at Beaumont Health System (BHS) in Royal Oak, Michigan, noted an increase in the number of positive respiratory cultures in one surgical intensive-care unit (ICU), prompting further investigation. The increase in positive cultures was attributed entirely to Pseudomonas aeruginosa. Investigation by BHS staff members found that all of these positive cultures were related to use of ultrasound transmission gel from a single manufacturer during transesophageal echocardiography. Seven patients were infected with P. aeruginosa based on National Healthcare Safety Network (NHSN) criteria, and nine were colonized. Cultures from one open and one unopened bottle of the gel grew P. aeruginosa closely related to the outbreak strain based on molecular typing via repetitive extragenic palindromic polymerase chain reaction (rep-PCR). The Oakland County Health Department, the Michigan Department of Community Health, and the Food and Drug Administration (FDA) were notified of the findings. On January 23, all implicated ultrasound gel in multiuse bottles was removed from BHS facilities and replaced with a single-use, sterile ultrasound gel for all potentially invasive procedures. On April 18, FDA issued a Safety Communication* advising health-care professionals and facilities not to use certain lot numbers of the ultrasound transmission gel and further advising that the only ultrasound gel that is sterile is unopened gel in containers labeled as sterile. To date, no further respiratory cultures have been positive for P. aeruginosa.