FW: Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection

[Glenys Harrington]

Dear All,

You may have read the recent CDC and FDA notification of the outbreak in the
USA relating to contaminated ultrasound transmission gel used for
TransEsophageal Echo (TEE) procedures which were performed during
cardiothoracic surgery.
Information at links below:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6115a3.htm

Upon investigation, the ultrasound gel was also found to be contaminated
with Klebsiella oxytoca.

I have checked with the TGA and the ultrasound gel mentioned in these
articles is included in the Australian Register of Therapeutic Goods Devices
(ARTG). The TGA is aware of this issue and is working with suppliers to
recall identified batches.

However you need to be aware that this product called “Other-Sonic Generic
Ultrasound Transmission Gel” manufactured by Pharmaceutical Innovations Inc
(see FDA alert and Warning Letter – links below) is not labelled as either
sterile or non-sterile, it is NOT sterile and the FDA have recommended the
following in their alert:

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.

o 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.

o Use sterile ultrasound gel as recommended in clinical practice
standards for all sterile body site procedures and any invasive procedures
using ultrasound-guided biopsy.

o 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.

o Use open containers of ultrasound gel promptly for low risk procedures
on intact skin and for low risk patients.

o Never refill or “top off” containers of ultrasound gel during use. The
original container should be used and then discarded.

o 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.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm299409.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm270263.htm

You may want to follow up on the use of ultrasonic gels at your facility.

In addition ultrasound gel whether it is supplied sterile or unsterile meets
the definition of a medical device, therefore the must be included on the
ARTG prior to supply.

regards

Glenys

Glenys Harrington

Consultant

Infection Control Consultancy (ICC)

PO Box 5202

Middle Park

Victoria, 3206

Australia

H: +61 3 96902216

M: +61 404 816 434

infexion@ozemail.com.au

ABN 47533508426

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