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

Important Customer Notice Supply Issues,Update

Ref: 2021/1423 ICN Number: 1423
  • Whilst supply disruption continues, Smiths Medical have started to increase production and manufacturing of the Bivona range of products.
  • The stock position of the Smiths Medical Bivona range of Tracheostomy tubes is therefore starting to improve.
  • Five products have since been delisted and are no longer available to order.
  • Please see our Downloads section to view the updated product listing. Whilst some codes will still be suspended and only available via the ICU webform, suspension has been lifted on a number of codes which can now be ordered through the catalogue. Please note the colour rating at the top of the Product Listing, outlining which products are available.
  • Demand will continue to be monitored to ensure continuity of supply for all customers.
  • The supply disruption on the Smiths Medical Bivona range of Tracheostomy tubes continues.
  • We continue to update the availability status of these products in the product listing available in the Downloads section.
  • Please see our Downloads section to view the communications released from NHS England and NHS Improvement.
  • This letter contains a Bivona Tracheostomy clinical risk stratification tool.
  • Smiths Medical Bivona Tracheostomy Tubes – supply disruption is ongoing.
  • Please see our Downloads section to view the updated product listing.
  • Customers are advised to check this list as it will detail which codes have been bought into stock and are demand managed as well as any changes to suspended codes.
  • The listing itself details a RAG status reflecting current stock positions.
  • For further detail on next steps, please refer to ICN updates below.
  • The supplier Smiths Medical are still experiencing disruption in regards to raw materials, this is still affecting all codes in scope of the ICN along with the addition of the adult range of Bivona Tracheostomy tubes.
  • NHS Supply Chain is working closely with Smiths Medical senior team in order to identify a number of codes that require to be bought into the NHS Supply Chain network to allow for national demand management.
  • The product listing (see our Downloads section) shows all codes impacted by this supply chain disruption.
  • Products where the disruption has now been resolved are highlighted in green.
  • Products available via the ICU webform due to being demand managed are highlighted in yellow.
  • Products that are not available through NHS Supply Chain or directly from the supplier are highlighted in red.
  • Should customers need to order the products that are demand managed, please see our Useful Links section and follow the link to access the ICU suspended products submission webform.
  • Please see our Downloads section to view a product matrix detailing alternatives for the affected product codes. Customers must undertake clinical review before use.
  • This ICN and the product list will be updated regularly to reflect the current supply position.
  • The supply issue is anticipated to be resolved by the end of May 2022.

Supporting documents below includes – (also in our Downloads Section )

  • Product listing
  • Product matrix with alternative products
  • Smiths Medical customer communications
  • Smiths Instruction For Use (IFU) for cleaning and reprocessing guidance
  • Bivona Communication.

If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor

  • The supplier Smiths Medical are still experiencing disruption in regard to raw materials, this is still affecting all codes in scope of the ICN along with the addition of the adult range of Bivona Tracheostomy tubes.
  • In total there are 167 product codes now affected.
  • 159 codes are unavailable to order via NHS Supply Chain, the supplier, or any other route.
  • Eight codes are available to order but are being demand managed
  • Should customers need to order these eight codes that are demand managed, please see our Useful Links section and follow the link to access the ICU products suspended products submission webform.
  • Customers are advised the number of demand managed codes and the number of suspended codes will change regularly. This ICN will be updated to reflect changes.
  • The supply issue is anticipated to be resolved on 5 May 2022.
  • Please see our Downloads section to view the updated product listing and product matrix for further information on the affected product codes.
  • The product listing is demonstrating a number of potential alternative options based on stock availability and will need the trust clinical review before use.
  • Smiths Medical has provided additional documentation to support the Instruction For Use (IFU) for cleaning and reprocessing guidance (please see our Downloads section).

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 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 21 June 2022

    An Excel file detailing the affected product codes for ICN 1423.
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  • 1423 Smiths Medical Bivona IFU

    A PDF of the Instructions For Use for ICN 1423.
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  • 1423 Bivona Reprocessing Instructions

    A PDF providing Bivona Reprocessing Instructions for ICN 1423.
  • 1423 Bivona Tracheostomy Clinical Risk Stratification Tool

    A PDF providing the Clinical Risk Stratification Tool for ICN 1423.
  • 1423 Tracheostomy Tubes Product Matrix

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

    A PDF of Bivona's Communication for ICN 1423.