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FDA Safety Communication: Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection

On April 18th, the FDA published a safety communication regarding a risk of infection from Other-Sonic Generic Ultrasound Transmission gel.  The alert specifies that Other-Sonic Generic Ultrasound Gel manufactured between June and December of 2011 should NOT be used because of bacterial contamination.  According to the FDA release, the contamination was found in lot numbers:

060111

090111

120111

The gel from these lots is sold in 250 milliliter bottles and 5 Liter dispensing containers.  The specific contamination found was the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca.  This contamination was identified after the FDA received a report from a hospital in which 16 patients had developed colonization or infection with the common thread of TEE ultrasound imaging using Other-Sonic gel. 

For the full report from the FDA, you can use the following link: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm299409.htm

The alert also brings up some very important points that often get lost in our day-to-day routine. 

First, you should realize that the introduction of bacteria can potentially cause inflammatory dermatitis, even on intact skin.

Second, the risk and potential severity is much greater when the gel is being used for more invasive procedures such as biopsies, transesophageal, transvaginal, or transrectal imaging.

Third, it is important to realize that any gel that is not labeled as sterile should be assumed to be non-sterile.  Furthermore, only gel that is labeled as sterile and is in an unopened package can be considered sterile. 

So at this point, each of you should check to see what type of gel you are using and have used since June of 2011.  If you have used this particular brand of gel, you should read the entire FDA document (listed above) and follow their recommendations.

It seems almost contradictory, but often in the diagnostic environment one can lose perspective on the most fundamental aspects of hygiene.  As referenced earlier, many times one “lets their guard down” because of the presumption that unbroken/intact skin makes contamination less likely.  Proper consideration should always be made for disinfection, protective and professional clothing, disposal of waste, and the proper handling/cleaning of anything coming in contact with the patient.

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