Public Health England Good Infection Prevention Using Ultrasound Gel Practice Guidance Multiple Products (ICN 1187)

Update:

• UKHSA (formerly Public Health England) has identified that a long-standing outbreak of Burkholderia cepacia is linked to a non-sterile ultrasound gel product used in hospitals in the UK and Ireland.
• The affected products remain suspended pending investigation.

Next Steps:

• Customers are advised to follow the latest guidance published on Gov.UK. (please  see our Useful Links section).
• For alternative products please log onto the catalogue on NHS Supply Chain’s website.
• If you have any questions, contact your NHS Supply Chain Customer Relationship Manager.

• Unfortunately, due to the ongoing issues there are now nine product codes affected and unavailable to order.
• Please see our Downloads ▼ section to refer to the product listing for further information on the affected codes.
• Potential indirect alternative products are available to order through our online catalogue.
• Three product codes are now available to order:
  FTM338 – Ultrasound Gel Sterile 20ml sachet in sterile packaging and double wrapped
  FDK1439 – Ultrasound Gel 250ml clear non-sterile
  FDK1442 – Ultrasound Gel 20g Sachet (sterile).
• Investigations are still ongoing and the ICN will be updated once more information becomes available.
• If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

The below two products have since become temporarily unavailable:

• FTM338, Ultrasound Gel Sterile 20ml sachet is now out of stock with no current estimated date of availability
• FDK1433, Ultrasound Gel Brand: Parker non-sterile 20ml sachet, out of stock with supplier until 6 April 2021.

Suitable alternatives are:

• FDK1429, Ultrasound Gel Brand: AquaUltra Clear 260g bottle
• FDK1431, Ultrasound Gel Brand: Transonic 250ml bottle
• FTM306, Sterile lubricant 5g sachet.

Please note FTM306 is a temporary alternative from Sexual Health framework so is not reflected in the catalogue as an alternative.

• Please see our Downloads ▼ section to refer to the product listing for further information on the affected codes.

• The below two products have since become temporarily unavailable.
  FDK1430 – Ultrasound Gel Brand: Henleys Clear 260g – This product is expected to be available to order through our online catalogue w/c 15 March 2021.
  FDK1432 -Ultrasound Gel Brand: Parker Clear 250ml bottle – This product is expected to be back in stock mid-April 2021.
• Potential indirect alternative products are available to order through our online catalogue.
• Please see our Downloads ▼ section to refer to the product listing for further information on the affected codes.

 Available to order now:

• The following product codes are available to order now:
  FDK1429 – Ultrasound Gel Brand: AquaUltra Clear 260g bottle
  FDK1431 – Ultrasound Gel Brand: Transonic 250ml bottle
  FDK1433 – Ultrasound Gel Brand: Parker non-sterile 20ml sachet
  FTM338 – Ultrasound Gel Sterile 20ml sachet.
• If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

• Two product codes are now unavailable to order through our online catalogue:
  FTM338 – Ultrasound Gel Sterile 20ml sachet.
  FDK1431 – Ultrasound Gel Brand: Transonic 250ml bottle.
  FDK1431 it is expected to be available to order through our online catalogue on from w/c Monday 22 February 2021.
  FTM338 is expected to be available to order through our online catalogue on from w/c Monday 22 February 2021.
• The following product codes that are available to order now are the following:
  FDK1429 – Ultrasound Gel Brand: AquaUltra Clear 260g bottle
  FDK1430 – Ultrasound Gel Brand: Henleys Clear 260g bottle
  FDK1432 – Ultrasound Gel Brand: Parker Clear 250ml bottle.
  FDK1433 – Ultrasound Gel Brand: Parker non-sterile 20ml sachet.
• Please see our Downloads ▼ section to view the product listing for further information on the affected product codes.
• If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

• Two product codes are now unavailable to order through our online catalogue:
  FDK1429 – Ultrasound Gel Brand: AquaUltra Clear 260g bottle
  FDK1431 – Ultrasound Gel Brand: Transonic 250ml bottle.
• The anticipated resolution date for product code FDK1429 is w/c 15 February 2021.
• Due to delays in shipping FDK1431 is expected to be available to order through our online catalogue on from w/c Monday 8 February 2021. Please note FDK1431 will not appear as an active code until stocks have been goods receipted and orders cannot be placed before as a result.
• The product codes that are available to order now are the following:
  FDK1430 – Ultrasound Gel Brand: Henleys Clear 260g bottle
  FDK1432 – Ultrasound Gel Brand: Parker Clear 250ml bottle.
  FDK1433 – Ultrasound Gel Brand: Parker non-sterile 20ml sachet
  FTM338 – Ultrasound Gel Sterile 20ml sachet.
• Please see our Downloads ▼ section to view the product listing for further information on the affected product codes.
• If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

• Product code FDK1431, Ultrasound Gel Brand: Transonic 250ml bottle, will be available to order through our online catalogue on Thursday 4 February 2021.
• Please note this product will not appear as an active line until Thursday 4 February 2021 and orders cannot be placed before that date as a result.
• Product codes that are now available to order:
  FDK1429 – Ultrasound Gel Brand: AquaUltra Clear 260g bottle
  FDK1430 – Ultrasound Gel Brand: Henleys Clear 260g bottle
  FDK1432 – Ultrasound Gel Brand: Parker Clear 250ml bottle.
  FDK1433 – Ultrasound Gel Brand: Parker non-sterile 20ml sachet
  FTM338 – Ultrasound Gel Sterile 20ml sachet.
• If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

• The list of Frequently Asked Questions is now available to view to support this process. (Please see our Downloads ▼ section)

• We continue to engage with NHSEI and the MHRA on this matter.

• We are aware that a communication has now been issued to Chief Nursing Officers in England to further support alignment to the Public Health England guidance we shared in our previous communication in relation to the use of remaining stock of the affected gels.

• This guidance can be found at the following link and updates will be made directly by Public Health England as the guidance changes: https://www.gov.uk/government/publications/ultrasound-gel-good-infection-prevention-practice

• We have engaged with the British Medical Ultrasound Society who may also issue communications directly to their stakeholders in due course.

• In respect of alternative products due shortly to be available for purchase:
  • FDK1429, AquaUltra Clear 260g bottle, will be available to order through our online catalogue week commencing Monday 25 January 2021.
  • Please note this product will not be visible in our online catalogue until week commencing Monday 25 January 2021 and orders cannot be placed before that date as a result.

• FTM338, Ultrasound Gel Sterile 20ml sachet, is also available to order now.

• Additional indirect alternative products are being sourced and this ICN will be updated as they become available in the short to medium term.

• If you have any further questions relating to supply or clinical use please refer these to patient.safety@supplychain.nhs.uk in the first instance.

• Using this email address will enable us to ensure prioritisation of responses from NHS Supply Chain, including by our Customer Services Team and Clinical and Product Assurance function.

• We are also now preparing a list of Frequently Asked Questions which will be available on our website from Monday 25 January 2021 to support this process.

• Public Health England (PHE) has issued Good Infection Prevention Practice Guidance – ‘Using Ultrasound Gel’ accessible on the Gov.UK website at https://www.gov.uk/government/publications/ultrasound-gel-good-infection-prevention-practice

• This guidance has been generated because contaminated ultrasound gel has been associated with outbreaks of infection in various settings, and / or identified as a potential vector for infection.

• Standard ultrasound gel is not produced as a sterile product. Ultrasound and ultrasound guided procedures are conducted routinely both in radiology and clinical areas, including use in high dependency care and among patients with immunosuppression.

• There is currently little available guidance on good practice in use of ultrasound gel for the UK setting. The PHE document provides interim guidance on the safe use of ultrasound gel to reduce risk of transmission of infection. It has been in part adapted from guidance produced elsewhere and should be considered in the wider context of standard infection prevention and control precautions.

• NHS Supply Chain has taken the precautionary measure of suspending with immediate effect supplies of three products – pending the outcome of further investigation.

• We will provide further advice on this suspension following further engagement with our key stakeholders, including Public Health England and the Medicines and Healthcare Products Regulatory Agency (MHRA).

• We have communicated our decision to NHSEI to enable further dissemination of this guidance to those purchasing the product directly outside of the NHS Supply Chain.

Products Affected:
There are three NHS Supply Chain products affected:

• NHS Supply Chain has taken the precautionary measure of suspending with immediate effect, supplies of these three products pending the outcome of further investigation.

• A further update will be provided next week with details of alternatives.

Next Steps:

• Read and follow the full instructions in Public Health England’s Good Infection Guide. If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.