URGENT UPDATE: The Australian Commission on Safety and Quality in Health Care 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:
Director, Device Vigilance and Monitoring Section
Ph: +61 2 6232 8713