Ultrasound Gel Causing Infections: More Than Just Pregnant Women at Risk
You trust that hospital equipment is properly sterilized before it’s used on you . . . right? And that your safety is a hospital or clinic's number one concern? But what if it’s not? What happens when something goes wrong? And what if the danger comes from seemingly harmless items that don’t get a second thought, such as ultrasound gel?
This is exactly what happened earlier this year, when the United States Food and Drug Administration (FDA) warned doctors, hospitals and clinics about contaminated ultrasound gel that has caused infections in at least 16 patients.
Are YOU in Danger?
All of the known patients who were infected underwent trans-esophageal ultrasound exams during heart valve replacement surgery. While none of the patients were pregnant, the FDA asserts that infected ultrasound gel could pose some serious health risks in expectant mothers as well.
The contaminated gel, named Other-Sonic Generic Ultrasound Transmission Gel, is produced by Pharmaceutical Innovations Inc., based out of Newark, New Jersey. All of the lots manufactured between June and December of 2011 (numbered 060111, 090111, and 120111) were seized in a raid by U.S. Marshals, who were called in by the FDA after the discovery was made.
Sounds like something out of the next big Hollywood blockbuster, doesn’t it? Unfortunately for us, sometimes truth is way more dangerous than fiction.
Bacteria on the Loose
Other-Sonic gel, which does not have a label stating whether or not it is sterile, is considered “non-sterile” by the FDA. Initial investigations revealed that large amounts of Pseudomonas aeruginosa and Klebsiella oxytoca, both of which are dangerous bacteria. Even though unbroken skin normally serves as a protective barrier against infections, all bets are off if one of these strains happen to reach you. Skin eruptions, lung infections, pneumonia, and genital tract infections are just a few of the possible ailments caused by the bacteria.
Ironically, Klebsiella oxytoca is normally found in the digestive tract, where it’s basically harmless. Once it leaves the digestive tract and enters other areas of the body, however, it can quickly become a serious health problem. There is a potential risk for any patient undergoing an ultrasound, but those who receive more invasive ultrasounds where the transducer is inserted into the body, are the most susceptible to bacterial infections.
Protect Yourself . . . and Ask Your Doctor to Do the Same
The FDA is urging all healthcare professionals and hospitals to throw away the remaining inventory of the previously mentioned lots, and identify any patients that may have been exposed to the contaminated gel. Once identified, hospitals should carefully inspect each individual’s condition following the ultrasound to determine if any infection has taken place, and act accordingly. The FDA is also asking patients who recently had an ultrasound exam to closely monitor for any bacterial infections or illness.
Baum, Stephanie. "Ultrasound Gel Linked to Bacterial Infections Sparks Raid by U.S. Marshals." MedCityNews.com. 18 Apr. 2012. Web. 4 May 2012.
"Other-Sonic Ultrasound Gel May Be Linked to Risk of Infection, Colonization." AboutLawsuits.com. 19 Apr. 2012. Web. 4 May 2012.
Allen, Jane E. "FDA Warning: Infection Risks From Contaminated Ultrasound Gel." ABCNews.com. ABC News, 19 Apr. 2012. Web. 4 May 2012.