URGENT NOTIFICATION: Recall Meditech ultrasound gel.

-filed under: Anaesthetic Equipment
High Priority
 
Bacterial blood steam infection following US guided central line insertion using Meditech ultrasound gel has led to an urgent recall.

Advice from the TGA is as follows:
  • TGA has received reports of patients being infected by contaminated Meditech ultrasound gel being used in intensive care and radiology units. The sponsor is undertaking a recall of all lots of the gel (recall number: RC-2017-RN-00631-1).
  • The affected gel is provided as part of a kit which includes a sterile ultrasound probe cover and has been used in some States and Territories for specialist catheter insertion.
  • The ultrasound gel sachets pictured below may also be supplied in other kits or on their own. Health professionals and other users of this gel should cease use of this gel and source another product..
  • Burkholderia cenocepacia bacteria have been isolated from the blood cultures of a small number of patients in Queensland and ACT since the end of March 2017..
  • All of these patients had recently had central lines placed under ultrasound guidance using an ultrasound probe cover and gel manufactured by Linmed.
  • All patients are recovering from the infection, although many have other serious health issues..
  • Testing by the microbiology laboratories at affected hospitals found that several samples of the gel in the Meditech kits, which should be sterile, were heavily contaminated with Burkholderia cenocepacia..
  • In addition, Burkholderia cenocepacia has been isolated from fluid in the abdominal cavity of a patient at another Queensland hospital where the same Meditech covers and gel are used.
Approximately 2500 ultrasound probe cover kits have been supplied by Meditech that were manufactured by Linmed, to 13 hospitals and distributors in Queensland, ACT, NSW and WA.

Health facilities are advised to immediately cease using Meditech ultrasound gel products and to quarantine unused stock and when notified of the recall follow the instructions regarding the disposal or return of the gel.

Facilities should be alert to patients who may have been exposed and follow advice from their infection control teams and state or territory health departments.

Further advice from the TGA regarding this issue and associated recall will be provided as more information becomes available.
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