Supply Issues Smiths Medical Bivona Tracheostomy Multiple Products (ICN 1423)

Important Customer Notice Update

Ref: 2021/1423 ICN Number: 1423
  • The supplier Smiths Medical has informed us that the temporary supply issue with its Bivona Tracheostomy Products is still ongoing with an anticipated resolution going into December – February 2022.
  • The materials shortage supply from their manufacturing facilities is now being resolved but the supplier is working through a backlog of global orders.
  • We have reached out to suppliers awarded to the framework that provide Tracheostomy Tubes.  These suppliers have provided us with information that will assist in a clinical review of the products on framework.  This information is provided in Tracheostomy Tubes – Information Requirement for all awarded suppliers.
  • Note that these are for clinical review to determine clinical viability prior to ordering. Some product codes will be demand managed, given the current climate of the market and shortage of supply as a result of increased demand.
  • Smiths Medical have provided additional documentation to support the Instruction For Use (IFU) for cleaning and reprocessing guidance (please see our Downloads section).
  • Please also see our Downloads section to view the updated product listing for further information on the affected product codes.
  • The product listing is demonstrating a number of options based on stock availability and will need the trust clinical review before use.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.
  • The supplier Smiths Medical has informed us that the temporary supply issue with its Bivona Tracheostomy Products is ongoing.
  • A further 65 product codes are now affected by the issue and have been added to the ICN.
  • In total there are 111 product codes affected.
  • Smiths Medical are experiencing global supply chain issues on raw materials which are used in manufacturing and packaging of many Neonat and Paedeatric Tracheostomy products.
  • Smiths Medical recognise the significant impact and role the products have in patient care, Smiths are undertaking mitigation measures to try and resolve this by communicating with our government agencies to try and minimise any disruptions. Please note all Tracheostomy tubes (Paediatric) can be re-used up to five times.
  • Please see our Downloads section to to view the Instructions for re-use. (IFU) and updated product listing for further information on the affected product codes.
  • The Temporary Supply Issue is anticipated to be resolved on 1 February 2022.
  • Alternative products are currently being identified and validated for clinical suitability. When/if the alternative has been identified the ICN will be updated accordingly.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

Change:

  • The supplier Smiths Medical has informed us of a temporary supply issue with its Bivona Tracheostomy Products.
  • There are 46 product codes affected.
  • The supplier is experiencing global supply chain issues on raw materials which are used in manufacturing and packaging of many Bivona products.
  • Smiths Medical recognise the significant impact and role Bivona products have in patient care. and, are undertaking mitigation measures to try and resolve this by communicating with the government agencies to try and minimize any disruptions.

Impact:

  • The affected product codes are currently unavailable to order.
  • Unfortunately, there are no suitable alternatives products available.
  • See our Downloads Section to for further information on the affected product codes in the product listing.
  • The supply issue is anticipated to be resolved by 1 February 2022.

Next Steps:

  • Please note all Bivona Tracheostomy tubes (Paediatric) can be re-used up to 5 times. See our Downloads Section for Instructions for re-use (IFU).
  • If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

Downloads ▼

  • 1423 Smiths Medical Product Listing

    An Excel file detailing the affected product codes for ICN 1423.

    Please to view this content.

  • 1423 Smiths Medical Bivona IFU

    A PDF of the Instructions For Use for ICN 1423.

    Please to view this content.

  • 1423 Smiths Medical Bivona Customer Update

    A PDF of the Customer Update for ICN 1423.

    Please to view this content.

  • 1423 Bivona Reprocessing Instructions

    A PDF providing Bivona Reprocessing Instructions for ICN 1423.
  • 1423 Bivona Supply Raw Materials

    A PDF providing additional information for ICN 1423.
  • 1423 CIN Bivona General Cleaning Cycles

    A PDF providing additional information for ICN 1423.