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Archived – Serious Risk of Infection From Ultrasound and Medical Gels – Revision

Starting date:
December 14, 2004
Posting date:
December 16, 2004
Type of communication:
Notice to Hospitals
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Hospitals
Identification number:
RA-17000855

Notice to hospitals - Important Safety Information on Ultrasound and Medical Gels

December 14, 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

This is a revision of the information in the Health Canada Notice to Hospitals dated October 20, 2004.

Heath Canada is aware of several cases of bacteremia and septicaemia whose source was traced to ultrasound and medical gels used during various invasive 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.

Recommended practices

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 babies in neonatal intensive care units.
  • Sterile gels or bacteriostatic gels should be considered for procedures performed on intact mucous membranes (e.g., oesophageal, gastric, rectal or vaginal).
  • once a sterile gel package has been used once it can no longer be considered sterile.

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 up". 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.

Health Canada's program for the risk management of adverse events related to medical devices depends on the active participation of health care professionals. You are asked to report any problems or complaints pertaining to medical devices to Health Canada at the address below, or through the toll-free number at 1-800-267-9675.

Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline at 1-800-267-9675

For other inquiries: please refer to contact information.

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.

References:

  1. Hutchinson J. et al. Burkholderia cepacia Infections Associated with Intrinsically Contaminated Ultrasound Gel: The Role of Microbial Degradation of Parabens. Infection Control and Hospital Epidemiology; 2004, vol. 25 No. 4
  2. Weist K. et al. An Outbreak of Pyodermas Among Neonates Caused by Ultrasound Gel Contaminated with Methicillin-Susceptible Staphylococcus aureus. Infection Control and Hospital Epidemiology; 2000, vol. 21 No. 12
  3. Calgary Health Region Infection Prevention and Control, Ultrasound Gel: Infection Prevention and Control (IPC) Review and Practice Recommendations, Addendum Report, May 14, 2002
  4. Community and Hospital Infection Control Association of Canada (CHICA Canada) Position Statement, November, 2003
  5. Calgary Health Region Public Health Update, June, 2002

This Notice to Hospitals is one in a series prepared by the Health Products and Food Branch (HPFB) of Health Canada as a service to health professionals.