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Important Safety Information on Ultrasound and Medical Gels

Oct 20, 2004 |

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Diagnostic Imaging, Obstetrics & Gynaecology, Urology, Cardiology, Surgery, Blood Flow Laboratory, Intensive Care, Emergency and other involved professional staff and post this NOTICE in your institution.

Subject: Risk of serious infection from ultrasound and medical gels

Heath Canada is aware of several cases of bacteremia and septicaemia whose source was traced to ultrasound and medical gels used during various procedures. The cause of the problem was a contamination of the gel at the manufacturing facility and appropriate corrective measures were taken with the manufacturers to rectify the problem.

This situation led Health Canada to examine current practices regarding the use of ultrasound and medical gels in clinical settings and revealed significant deficiencies: for example, gel containers are placed in a warming device, without a cap and for extended periods of time, refillable squeeze bottles are not cleaned between refills, non-sterile gels labelled for external use only are used on mucous membranes or during invasive procedures like biopsies.

In order to minimize the health risks associated with the use of ultrasound gels, Health Canada is making the following recommendations.


Sterile Gels

Sterile gels must be used for all invasive procedures that pass a device through a tissue, e.g., needle aspiration, needle localization, and tissue biopsy, for all procedures involving sterile environment or non-intact skin, and on neonates.

Sterile gels should be used for procedures performed on intact mucous membranes (e.g., oesophageal, gastric, rectal or vaginal) and in patients with immundodeficiencies or on immunosuppressive therapy.

Aseptic technique should be followed when using sterile gels.

Non-Sterile Gels

Single use containers are recommended for non-sterile gels.

If reusable containers are used, they must be emptied, washed in hot soapy water or hospital-grade disinfectant, rinsed thoroughly and dried prior to refilling. Bottles should not be “topped upâ€. Cracked reusable bottles should be discarded.

When filling a reusable container, ensure that the large bulk container has not passed the expiration date.

Bottles should be filled using a dispensing device on the large bulk container, not by inserting the tip of the refillable bottle into the bulk container to aspirate the contents.

Bottles should be refilled as close as possible to the time of use.

When opening a new gel bottle or a newly refilled bottle, date the bottle and discard unused gel after one month.

Tips of containers or dispensing nozzles must not come in direct contact with a patient, staff, instrumentation or the environment. Gel should be dispensed into a medicine cup or on a clean disposable cloth and then to the patient’s skin.

If a medicine cup or a disposable cloth is not used, wipe the dispensing nozzle clean with an alcohol swab and wipe the outside of the container with a disinfectant between patients.

If a gel is being used on a patient who is in droplet or contact isolation, use a single-use gel container, or leave the reusable container in the room if repeat procedures are necessary and discard the gel when isolation of the patient is discontinued.

For infrequent procedures, use small or single-use containers.

Warming of Gel

Warmed gel should only be used when required.

Bottles should be removed from the warmer as soon as possible and dried immediately.

Gel warmers must be cleaned weekly with low level hospital-approved disinfectant, and immediately if the warmer becomes soiled.

Storage of Ultrasound and Medical Gels

Products must be stored in areas that are dry and protected from potential sources of contamination such as dust, moisture, insects, rodents, etc.

If evidence of contamination is present or package integrity has been breached, the product must be discarded.

Products should be rotated when restocking takes place.

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