Urgent – reports of patient infection from contaminated ultrasound gel [SEC=UNCLASSIFIED]

[Professor Ramon Shaban, ACIPC President]

Colleagues

Please note advice from the HAI Committee of the Australian Commission on
Safety and Quality in Healthcare for noting please.

Kind regards,
Ramon

[image: ACIPC_Logo_Colour_RGB_Hi_Res.jpg]

*Professor Ramon Z ShabanPRESIDENT*

*Australasian College for Infection Prevention and Control*

228 Liverpool Street, Hobart TAS 7000, Australia

———- Forwarded message ———-
gel [SECUNCLASSIFIED]
To:

Dear HAI Committee members

Please see the email below from Kathy Meleady regarding recent notification
of patient infections associated with an ultrasound gel.

Kind regards

Marilyn

Professor Marilyn Cruickshank RN PhD FACN CICP

Director National Healthcare Associated Infection Program

Professor School of Nursing and Midwifery, Griffith University

The Commission has received advice from the TGA regarding reports from QLD
on 11 May 2017 regarding patient infections associated with an ultrasound
gel. The TGA have risk assessed this report as life threatening.

This gel is supplied in a kit with a sheath for ultrasound use (see
attached photo). The clinicians appear to be using the gel from this kit
when inserting central venous catheters (CVC) or Peripherally inserted
central catheters (PICC). The gel product is labelled as sterile. The gel
is supplied by Meditech Systems limited and labelled Medical Ultrasound
Gel. The manufacturer appears to be Linmed Medical Co. Ltd in China.

Patients understood to be affected with infections are in QLD (6) and ACT
(2). It appears that most patients have been ICU patients where the CVC or
PICC was inserted. There is also a possible ninth case. The gel has been
tested by the hospitals and confirmed as the same organism, Burkholderia
cenocepacia. The laboratory reports have been supplied by the reporter.

The Sponsor has been notified and requested to:

Provide samples for testing

Cease supply

Clarify the ARTG entry

This morning the sponsor will be requested to recall , and the TGA are
preparing a web statement for later today.

There appears from the reports that there is also a matter of off-label
use.

Burkholderia cenocepacia is a species of Gram-negative bacteria that is
common in the environment, can form a biofilm with itself, is resistant to
many antibiotics. It is common in patients with cystic fibrosis and can be
fatal in this particular group.

The TGA contact at this point is:

Pamela Carter

Director, Device Vigilance and Monitoring Section

Thank you

Kathy

*Adj Prof Kathy Meleady PSM*

*Director, Commonwealth Programs*

Australian Commission on Safety and Quality in Health Care

GPO Box 5480 Sydney NSW 2001 | Level 5, 255 Elizabeth Street, Sydney NSW
2000

T (02) 9126 3640 | M 0419 220 816| F (02) 9126 3613 |
http://www.safetyandquality.gov.au

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