Skip to main content

Supply Issue Rocket Medical and Fannin (Stroud) Foetal Scalp Electrodes (ICN 1953)

Important Customer Notice Update

Ref: 2023/1953 ICN Number: 1953
  • FDK85021, FDK097 and FDK314 have now moved to Protect Demand Management, away from Control Demand Management.
  • The product codes are available to order through NHS Supply Chain. However, trusts are allocated a maximum daily quantity aka “threshold” to ensure fair supply of available stock across the NHS.
  • See our Downloads section for a full list of product codes subject to Protect Demand Management.

NHS Supply Chain is aware that:

  • Suppliers Philips and Fannin have advised us that they will be delisting their full product range of Foetal Scalp Electrodes (FSE).
    • Delisting ICN 1639 (Fannin) was updated on 11 January 2023.
    • Delisting ICN 1963 (Philips) was updated on 9 January 2023.
  • The supplier Rocket Medical is currently in the process of recertifying their FSE products.
    • Supply Issues ICN 1953 (Rocket Medical) was issued on 11 January 2023
    • We continue to work closely with Rocket Medical to keep updated on the status of supply.
    • As soon as Rocket Medical FSE products are available to order, we will update this ICN.

NHS Supply Chain activity:

  • We have worked closely with the market to source alternative supply of FSE products.
  • We have identified suitable alternatives from suppliers Neoventa, Vyaire and Huntleigh.
  • We have produced a FSE Clinical Product Matrix to support product switching. The Matrix indicates the compatibility of CTG devices with alternative consumables and accessories.
  • The FSE Clinical Product Matrix has had oversight and review from NHS England (NHSE) National Clinical Advisor for National Maternity and the NHSE National Clinical Advisor for the Maternity and Neonatal Safety Improvement Programme.
  • The FSE Clinical Product Matrix is to be used to inform and support discussions and clinical decision making at a local level.
  • To inform on alternative product compatibility, customers will need to review this matrix and the alternative products listed that relate to their device(s).
  • We are currently adding Vyaire product codes to our online catalogue and we will update this ICN as they become available.

Status of supply:

  • We are working closely with the suppliers to build stock levels to meet customer requirements and demand. This will take a minimum of 15 working days and we will update customers if this time line changes.
  • The supply position will continue to improve at which point usual ordering patterns can resume.
  • In this interim period, four products will remain on Control Demand Management until adequate stock levels are achieved.
    • FDK097 – Foetal Scalp Electrode Rocket Medical
    • FDK557 – Foetal Scalp Electrode Rocket Medical
    • FDK314 – Foetal Scalp Electrode Fannin (AWSL)
    • FDK85021 – Foetal Scalp Electrode Neoventa.
  • In addition, FDK896 – Foetal Scalp Electrode Fannin (AWSL) remains available to order via the online catalogue.

Stock queries:

  • We are building good stock levels and aim to support customers to fulfil their demand.
  • Should you have any queries regarding stock availability or escalations, please contact your local NHS Supply Chain Customer Service Advisor only.
  • Please refrain from contacting suppliers direct.

Next Steps

  • NHS Supply Chain appreciate the clinical procedure complexity surrounding the use of Foetal Scalp Electrodes. The FSE Clinical Product Matrix is to be used as a tool to support local clinical decision making aligned to local clinical skills and local expertise.
  • See our Downloads ▼ section to access the FSE Clinical Product Matrix for further information on the affected product codes and potential alternatives.
  • See our Useful Links section for associated ICNs 1639 and 1963.
  • If you have an urgent clinical need for any of the suspended codes, you need to complete and submit the Control Suspended Consumables Product Submission Webform. See our Useful Links section to access this web form.
  • We will update this ICN as soon as we have further information.

Change:

  • The supplier Rocket Mail and Fannin has informed us of a supply issue with its Foetal Scalp Electrode products.
  • There are four product codes affected.
  • Three product codes affected are subject to intermittent supply
    • FDK097 – Foetal Scalp Electrode
    • FDK557 – Foetal Scalp Electrode
    • FDK314 – Foetal Scalp Electrode.
  • One code is available while stock lasts and will be delisted once stock has been depleted
    • FDK896.
  • The supply issue is due to CE certification/ MDR issues which is leading to supply constraints across their range of Foetal Scalp Electrodes.
  • Due to the ongoing supply issue this product is now subject to Control Demand Management.
  • If you have an urgent clinical need for any of the suspended codes, you need to complete and submit the Control Suspended Consumables Product Submission Webform. See our Useful Links section to access this web form.

Impact:          

  • See our Downloads ▼ section to access the product matrix for further information on the affected product codes and the potential alternatives.
  • Please note, the alternative codes are subject Control Demand Management and will need to be ordered via the ICU Suspended Products Submission Webform.
  • Although we do not currently have a resolution date for the supply issue, we will update the ICN as soon as we have further information.

Next Steps:              

  • Customers are advised to log into our website to view the product codes currently subject to Control Demand Management and the potential alternatives.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.

Downloads ▼

  • 1953 Rocket and Fannin Product Listing with Alternatives 24 January 2023

    An Excel file showing the product listing with alternatives for ICN 1953.
    Login to view the downloads
  • Control and Protect Demand Managed Product Matrix

    An Excel file detailing the products currently subject to Control and Protect Demand Management. This is updated weekly.
    Login to view the downloads
  • Foetal Scalp Electrodes Clinical Product Matrix 24 January 2023

    An Excel file detailing CTG device, FSE consumables and accessory compatibility.