FDA update June 8, 2012

Update on Bacteria Found in Other- Sonic Generic Ultrasound Transmission Gel that poses risk of infection

Background:

Pseudomonas aeruginosa  is found most often in water and soil. Patients exposed to the bacteria on the surface of their skin could develop inflammatory dermatitis, even on intact skin. Pseudomonas aeruginosa is not usually found in places such as the upper airway, the lower GI tract or the female genital tract—if it is introduced to those places, it could colonize or cause an infection. Klebsiella bacteria is often found in the digestive tract where they do not often cause infection; however, when the lungs or other tissues are exposed to Klebsiella bacteria, either minor problems or more serious infections such as pneumonia, wound infection or bloodstream infections could occur.

Scope:

  • The FDA received a report from a hospital that 16 patients had developed colonization or infection with the bacteria Pseudomonas aeruginosa. 
  • Each of these patients were examined with trans-esophageal ultrasound probes using Other-Sonic Generic Ultrasound Transmission Gel.
  • Upon investigation, the ultrasound gel was found to be contaminated with the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca.

Purpose:

  • As the contamination was found out in the lot numbers 060111,090111 and 120111, FDA’s main goal is to alert health care professionals and facilities to stop using Other-Sonic Generic Ultrasound Transmission Gel containing these lot numbers which were manufactured  June through December 2011 because of bacterial contamination
  • The FDA is issuing this update to notify the public about Pharmaceutical Innovations, Inc’s recall of its Other-Sonic Generic Ultrasound Transmission Gel.
  • To advise health care providers stop using products from lot 120111 because FDA testing revealed that this lot also was contaminated with Pseudomonas aeruginosa and Klebsiella oxytoca bacteria although Pharmaceutical Innovations, Inc reported to the FDA that lot 120111 was never distributed to United States customers, and therefore, is not part of the voluntary recall.
  • To provide recommendations for healthcare professionals and facilities regarding other – sonic generic ultrasound transmission gel as also regarding all ultrasound transmission gels.

Summary:

It can be summarized that the FDA wants to alert the healthcare industry about other- sonic generic ultrasound transmission gel due to contamination found in some of its lots with the target audience being hospital and clinic administrators, risk managers, infection control practitioners, purchasing departments, surgical centers, medical offices, health care professionals using or referring patients for ultrasound procedures for e.g., radiologists, urologists, gastroenterologists etc. and also provide recommendations to them about its usage.

If you want to discuss about this update or more info on recommendations for usage of ultrasound transmission gel  please contact mdi at info@mdiconsultants.com and reference “Ultrasound Gel”.