Multi-region cluster of Burkholderia stabilis ST1565 suspected to be associated with non-sterile ultrasound gel

The UK Health Security Agency (UKHSA) is investigating a cluster of Burkholderia (B.) stabilis sequence type (ST) 1565 suspected to be associated with a non-sterile ultrasound gel product used in clinical settings in England. UKHSA report that isolates have been recovered from sterile sites for all cases and the agency is collaborating with system partners to investigate and implement control measures.

Whilst investigation is being undertaken, supply of a specific non-sterile ultrasound products has been suspended by NHS Supply Chain. Burkholderia cepacia complex (Bcc) has frequently been implicated in the contamination of numerous medicinal and hygiene products. Laboratories are reminded to refer all new Bcc isolates to the Antimicrobial Resistance and Healthcare Associated Infection Reference Unit for identification and sequencing.

Healthcare providers, clinicians and practitioners using ultrasound gel are reminded that there are published recommendations from UKHSA on guidance for safe use of ultrasound gel which outlines measures to reduce risk to patients associated with the use of non-sterile ultrasound gel and when to use sterile gel. UKHSA previously issued a National Patient Safety Alert to ensure alignment to this guidance and contents of this alert remain valid.

Read the full briefing note from UKHSA.

Updated UKHSA briefing note issued 22 October 2024

• There have been no new cases of B. stabilis ST 1565 since the previous Briefing Note 2024/045.
• Ultragel Medical Kft has issued an urgent Field Safety Notice (FSN) to recall lot 2024.04 of Ebrington Medical AquaUltra Clear ultrasound gel 260g.
• NHS Supply Chain have updated the Important Customer Notice (ICN) to suspend distribution of specific products (published on 17 October 2024) to include the FSN.
• Distributors, healthcare professionals and other customers are advised to immediately stop using and selling products listed in the FSN, and to quarantine and dispose of this product lot.
• MHRA continue to engage the manufacturer to obtain assurance on safety of other batches of products.

Read the full updated briefing note from UKHSA.