Clinical Context

Pseudomonas aeruginosa is typically found in water and soil, but when contacting the skin surface, it may cause inflammatory dermatitis, even on intact skin. If it is introduced to body sites where it is generally not found, such as the upper airway, the lower gastrointestinal tract, or the female genital tract, it may colonize or cause an infection.

Klebsiella are often present in the digestive tract without causing infection, but if introduced into the lungs or other tissues, serious infections could include pneumonia, wound infection, or sepsis.

Study Synopsis and Perspective

The US Food and Drug Administration (FDA) has notified healthcare professionals and facilities to stop using Other-Sonic Generic Ultrasound Transmission Gel manufactured June 2011 through December 2011 because of concerns about bacterial contamination with P aeruginosa and Klebsiella oxytoca.

According to an alert sent by MedWatch, the FDA's safety information and adverse event reporting program, contamination was found in lot numbers 060111, 090111, and 120111, which are lots that include 250-mL bottles and 5-L dispensing containers.

"This ultrasound gel presented serious health risks to patients, particularly vulnerable ones," said Dara A. Corrigan, the FDA's associate commissioner for regulatory affairs. "Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health."

The gel is manufactured by Pharmaceutical Innovations Inc and is a nonsterile gel used in ultrasound procedures designed to assist transmission of the ultrasound signal from the transducer to the body.

According to the FDA, patients who have been exposed to these lots of Other-Sonic Generic Ultrasound Transmission Gel should be identified and assessed for signs of negative outcomes due to these procedures and evaluated further if necessary.

The safety communication notes that the FDA received a report from a hospital that 16 patients had developed colonization or infection with P aeruginosa. Each of these patients was examined with transesophageal ultrasound probes using Other-Sonic Generic Ultrasound Transmission Gel that was later found to be contaminated.

US Marshals, acting at the request of the FDA, then seized and tested unopened bottles of Other-Sonic Generic Ultrasound Transmission Gel at the reporting hospital and at the manufacturer's facility.

"The FDA's testing revealed that the finished product contained significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca," the agency states. "This result suggests that the source of this contamination occurred during the manufacturing process."

P aeruginosa is found most often in water and soil and can cause inflammatory dermatitis, even on intact skin. Klebsiella bacteria are often found in the digestive tract, where they do not often cause infection; however, potentially serious infections can develop when other tissues, such as the lungs or the bloodstream, are exposed.

Contact Pharmaceutical Innovations Inc at 973-242-2900 with questions and to report adverse events associated with use of the contaminated gel. The company notes that opened and unopened containers of the contaminated gel should be handled as biohazardous materials and disposed of by following the proper procedures.

Recommendations for Healthcare Professionals Regarding All Ultrasound Transmission Gels

The only ultrasound gel that is sterile is unopened, ultrasound gel containers or packets labeled as sterile. Ultrasound gel products that are labeled as nonsterile or that have no information in the label regarding sterility are NOT sterile.

All clinicians should review applicable policies and clinical practice standards to ensure that technicians, clinicians, and staff always use sterile ultrasound gel for those procedures requiring use of sterile ultrasound gel.

All clinicians should review the instructions for use, as well as hospital/facility policies, to assess whether sterile ultrasound gel is required for a particular procedure, or if nonsterile ultrasound gel is recommended for procedures using ultrasound transducers.

As recommended in clinical practice standards, all clinicians should use sterile ultrasound gel for all sterile body site procedures, as well as for any invasive procedures using ultrasound-guided biopsy.

Clinicians should use sterile ultrasound gel for procedures with mucosal contact in which biopsy is not planned, but in which any potential added bioburden should be avoided or in which mucosal trauma is likely. Examples of such procedures would include transesophageal echocardiography procedures, transvaginal ultrasound procedures without biopsy, and transrectal ultrasound procedures without biopsy.

Clinicians should realize that once a container of sterile or nonsterile ultrasound gel is opened, it is no longer sterile, and it may become contaminated during ongoing use. Opened containers of ultrasound gel should be used promptly for low-risk procedures on intact skin and for low-risk patients. The original container of ultrasound gel should be used and then discarded and should never be refilled or "topped off" during use.

Clinicians should review clinical policies regarding the handling of ultrasound gel products and should consider these recommendations when choosing the ultrasound gel product, size, and type.

More information regarding the warning is available on the FDA Web site.