Date Issued: June 8, 2012
- 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 (e.g., radiologists, urologists, gastroenterologists, obstetricians/gynecologists, internists, chiropractors, nurses, physical therapists, and sonographers).
Other-Sonic Generic Ultrasound Transmission Gel, manufactured by Pharmaceutical Innovations Inc. is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
To alert health care professionals and facilities to STOP using Other-Sonic Generic Ultrasound Transmission Gel manufactured June through December 2011 because of bacterial contamination. The contamination was found in lot numbers:
These lots are sold in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers.
The FDA is issuing this update to notify the public about Pharmaceutical Innovations, Inc’s recall of its Other-Sonic Generic Ultrasound Transmission Gel.
The recall is for lot numbers:
The FDA continues 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. However, 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.
Summary of Problem and 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 transesophageal 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.
Although Other-Sonic Generic Ultrasound Transmission Gel is not labeled as either sterile or non-sterile, it is NOT sterile.
At this time, the FDA is concerned about contamination of Other-Sonic Generic Ultrasound Transmission Gel lot numbers 060111 through 120111. These lots contain both 250 milliliter (mL) bottles and 5 liter (L) dispensing containers of gel. The lot number is printed on each bottle of gel. You cannot identify contaminated products by looking at the gel. The lots were manufactured June through December 2011 by Pharmaceutical Innovations.
Not every patient exposed to Pseudomonas aeruginosa and Klebsiella oxytoca bacteria in Other-Sonic Generic Ultrasound Transmission Gel will develop colonization (the presence of bacteria at a site without any signs of infection) or infection, but the risk remains present.
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.
Invasive biopsy procedures can carry bacteria into tissues, and could cause an abscess or sepsis. The bacteria can also move from one site to another. For example, if Pseudomonas aeruginosa is introduced into the upper airway through a transesophageal echocardiography (TEE) procedure and begins to grow, it may cause no symptoms. However, if it is accidentally aspirated into the lower airway, it could cause tracheobronchitis or pneumonia.
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.
Recommendations for Health Care Professionals and Facilities Regarding Other-Sonic Generic Ultrasound Transmission Gel:
- Do NOT use Other-Sonic Generic Ultrasound Transmission Gel from lot numbers 060111 through 120111.
- Identify patients who have been exposed to these lots of Other-Sonic Generic Ultrasound Transmission Gel. Review the procedures they underwent and the outcomes of those procedures. Then, determine if further evaluation is needed.
- Contact Pharmaceutical Innovations Inc. at 973-242-2900 (897 Frelinghuysen Avenue, Newark, NJ 07114) if you have questions and to report adverse events associated with use of the contaminated gel.
- Refer to your facility’s infection control or other risk control procedures for appropriate disposal of Other-Sonic Generic Ultrasound Transmission Gel. Opened and unopened containers of the contaminated gel should be handled as bio-hazardous materials and disposed of following the proper procedures.
Recommendations for Health Care Professionals Regarding All Ultrasound Transmission Gels:
- Be aware that the only ultrasound gel that is sterile is unopened ultrasound gel containers/packets labeled as sterile. Ultrasound gel products that are labeled as non-sterile or that are not labeled at all with respect to sterility are NOT sterile.
- Review your policies and clinical practice standards to ensure you are always using sterile ultrasound gel for those procedures that require it.
- Check the instructions for use as well as hospital/facility policies, to determine if sterile ultrasound gel is needed for a particular procedure or if non-sterile ultrasound gel is recommended for procedures using ultrasound transducers.
- Use sterile ultrasound gel as recommended in clinical practice standards for all sterile body site procedures and any invasive procedures using ultrasound-guided biopsy.
- Use sterile ultrasound gel for procedures with mucosal contact where biopsy is not planned but any possible added bioburden would be undesirable or mucosal trauma is likely (e.g., transesophageal echocardiography (TEE) procedures, transvaginal ultrasound procedures without biopsy, transrectal ultrasound procedures without biopsy).
- Be aware that once a container of sterile or non-sterile ultrasound gel is opened, it is no longer sterile and contamination during ongoing use is possible.
- Use open containers of ultrasound gel promptly for low risk procedures on intact skin and for low risk patients.
- Never refill or "top off" containers of ultrasound gel during use. The original container should be used and then discarded.
- Review clinical policies for the handling of ultrasound gel products, and take these recommendations into account when choosing the ultrasound gel product, size and type.
The FDA collected and tested unopened bottles of Other-Sonic Generic Ultrasound Transmission Gel at the reporting hospital and at Pharmaceutical Innovations Inc.’s facility. The FDA’s testing revealed that the finished product contained significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca. This result suggests that the source of this contamination occurred during the manufacturing process.
On April 18, 2012, the Food and Drug Administration issued a news release notifying the public about the seizure of Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations, Inc. Newark, N.J.
Pharmaceutical Innovations, Inc sent an Urgent Message Notice letter dated March 2, 2012 with a follow-up letter dated March 9, 2012 and an Inventory Withdrawal letter dated March 23, 2012 by email and fax to all affected customers. The notice instructed customers to examine their inventory, stop distributing this product, and return all remaining inventory for a replacement. Customers with questions can contact Pharmaceutical Innovations, Inc at 973-242-2900.
Class 1 Recall: Other-Sonic Generic Ultrasound Transmission Gel (Posted May 30, 2012)
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with Other-Sonic Generic Ultrasound Transmission Gel, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.
To help us learn as much as possible about the adverse events associated with Other-Sonic Generic Ultrasound Transmission Gel, please include the following information in your reports, if available:
- Lot number
- Bottle size
- Date of adverse event
- Type of ultrasound procedure
- Details of the adverse event and medical intervention (if required)
If you have questions about this communication, please contact the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.