Update, new Field Safety Notice to recall additional products
Summary:
This is an update to Briefing notes 2024/045 (issued 17 October 2024) and 2024/048
(issued 22 October 2024) following update to Field Safety Notice (FSN) recalling
additional products.
Key Updates:
- There has been no change in total number of Burkholderia (B.) stabilis ST1565
cases (6 confirmed and 2 probable). - Targeted product testing and whole genome sequencing of isolates obtained
from cases and gel supports the hypothesis of non-sterile ultrasound gel as the
source linked to this outbreak. - The manufacturer previously issued a FSN to recall a specific product lot of
ultrasound gel. However, following investigation by the manufacturer and further
evidence of contamination, this recall has now been expanded and the FSN
updated to include an additional product lot. - 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 the product. - MHRA continue to engage the manufacturer to obtain assurance on safety of
other batches of products.
UKHSA Key Recommendations:
- The FSN advises to immediately stop distribution and use of listed products, and
to quarantine and dispose of products.
UKHSA Briefing Note 2024/050 Issued 11/11/2024 - Laboratories are reminded to refer all new Burkholderia cepacia complex (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.
Background and Interpretation:
UKHSA is investigating a cluster of B. stabilis ST 1565, described previously in Briefing Notes 2024/045 and 2024/048. As of 11/11/2024, there are 6 confirmed and 2 probable cases in the UK, all in England. Since the previous Briefing Note 2024/048, one previously reported probable case has now been excluded from the cluster, and one further probable case has since been identified.
Targeted product sampling of opened and unopened bottles of Ebrington AquaUltra Clear 260g ultrasound gel (lot 2024.04) recovered Burkholderia species (provisionally identified as B. cepacia group or B. stabilis). Further testing has now confirmed the same sequence type as case isolates (B. stabilis ST1565). Whole genome sequencing has also indicated close relatedness between case and gel isolates.
Investigation by the manufacturer has found evidence of contamination during the manufacturing process. Additionally, product sampling of unopened bottles of another product lot (lot 2024.06) has also revealed evidence of contamination with Burkholderia species.
As a result, the manufacturer has published an updated FSN on 8 November 2024 to recall this additional product lot. UKHSA is working with partners to implement control measures and prepare communications, and ensure alternate products are available.
Implications & Recommendations for UKHSA Regions
UKHSA regional teams are asked to be aware of this incident and to use their DIPC, microbiology and laboratory networks to share information in this briefing note for further cascade. New cases potentially linked to this outbreak should be notified to
HCAIAMR.IOIG@ukhsa.gov.uk
Implications & Recommendations for UKHSA sites and services
UKHSA microbiologists are asked to support cascade to NHS and other non-UKHSA labs, as well as NHS Trust infection control leads. Clinical laboratories are requested to refer all new isolates of Burkholderia cepacia complex (Bcc) to the Antimicrobial Resistance and Healthcare Associated Infection Reference Unit (AMRHAI) for identification and sequencing.
Implications & Recommendations for NHS
NHS and independent laboratories
NHS and Independent laboratories are requested to submit any new isolates of Bcc to the AMRHAI reference laboratory.
IPC teams
IPC teams are asked to share the FSN with service providers and managers of facilities providing ultrasound services and ultrasound guided procedures. Providers and managers are asked to follow information in the FSN to quarantine and return or dispose of products. If you have concerns about incidents in relation to use of this product, please report via the MHRA Yellow Card Scheme.
IPC teams are asked to share guidance for safe use of ultrasound gel with the same providers and managers to ensure adherence to the previous issued National Patient Safety Alert.
Front-line clinicians and practitioners
Healthcare providers, clinicians and practitioners using ultrasound gel should stop using the product listed in the FSN. Clinicians are reminded to follow recommendations in the UKHSA guidance for safe use of ultrasound which outlines measures to reduce risk to patients associated with the use of non-sterile ultrasound. UKHSA previously issued a National Patient Safety Alert to ensure alignment to this guidance and contents of the alert remain valid.
Implications and recommendations for Local Authorities
None
References/ Sources of information
- References/ Sources of information
- Field Safety Notice AquaUltra Clear ultrasound transmission gel (lot 2024.06 and
lot 2024.04) - Good infection prevention practice: using ultrasound gel – GOV.UK (www.gov.uk)
- National Patient Safety Alert: The safe use of ultrasound gel to reduce infection
risk - NHS England » National infection prevention and control manual (NIPCM) for
England - Health and Social Care Act 2008: code of practice on the prevention and control
of infections – GOV.UK (www.gov.uk) - NHS Supply Chain: Important Customer Notice