FDA urges clinicians to stop using certain ultrasound gel
FDA: Clinicians Urged to Stop Using Certain Ultrasound Gel
HealthDay News -- Hospitals, clinics and health-care professionals should immediately stop using Other-Sonic Generic Ultrasound Transmission Gel due to risk of bacterial contamination in certain batches, the FDA urged in a safety communication.
The contaminated ultrasound gel includes lot numbers 060111, 090111, and 120111, manufactured by Pharmaceutical Innovations between June and December 2011. These lots are are sold in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers and can only be identified using the lot numbers listed on their containers.
An FDA investigation revealed the ultrasound gel is contaminated with Pseudomonas aeruginosa, a bacteria that can cause inflammatory dermatitis, and Klebsiella oxytoca, which can cause penumonia and other serious infections.
So far the agency has identified 16 patients that have been colonized or infected with P. aeruginosa. All patients had transesophageal ultrasound procedures using Other-Sonic Generic Ultrasound Transmission Gel while undergoing heart valve replacement.
The FDA is advising health-providers to remember that only unopened ultrasound gel labeled as sterile is safe to use for procedures that require sterile products. Those products that are not labeled with respect to sterility are not sterile, the agency emphasized.
They issued the following guidance for healthcare providers:
- 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 in which biopsy is not planned, but any possible added bioburden would be undesirable, or in which mucosal trauma is likely, such as transesophageal echocardiography (TEE) procedures, transvaginal ultrasound procedures without biopsy, and transrectal ultrasound procedures without biopsy.