Phillips Respironics Field Safety Notice (ICN 1296)

Important Customer Notice Update

Ref: 2021/1296 ICN Number: 1296
  • NHS Supply Chain has set up a new NPC to provide FAG6391 via our stocked route.
  • To ensure fair allocation these products will be demand managed.
  • NHS England and NHS Improvement have requested for FAG6391 to be suspended from our online catalogue.
  • If you have a clinical requirement to order any of these products, please escalate this to the Consumables Group lead via the Suspended Code Submission webform. Please see our Useful Links section.
  • The completed webform is then submitted to NHS England and NHS Improvement who review all requests for suspended products.
  • This is to protect stockholding and allocate volumes as determined by NHS England and NHS Improvement consumption model. It aims to ensure that trusts continue to have access to the products they need to provide patient care and to avoid unnecessary risks of stock shortages.
  • An alternative product code has now been added for FAG6214.
  • The alternative product code is an indirect alternative:
    FAG6326 – Sleep therapy device prismaSMART max including modem.
  • The alternative product is being reviewed by NHS England and NHS Improvement therefore, If you have a clinical requirement to order this new product, please escalate this to the Consumables Group lead via the Suspended Code Submission webform (please see our Useful Links section.)
  • The completed webform is then submitted to NHS England and NHS Improvement who review all requests for suspended products.
  • NHS Supply Chain Customers Services will contact you with details of your order once received by NHS England and NHS Improvement.
  • Please see our Downloads ▼ section to view the updated product listing and affected product code.
  • NHS Supply Chain has set up a new NPC to provide FAG6262 – Masks NIV and Sleep Therapy LUMIS 150 VPAP ST-A via our stocked route.
  • FAG6262 is now available to order from our online catalogue from Monday 19 July 2021.
  • To ensure fair allocation this product will be demand managed. NHS England and NHS Improvement (NHSEI) set daily order limits at a trust level based on the national stock position.
  • If you have been unable to get the quantities, you clinically require please escalate to your NHS Supply Chain Customer Services Advisor.
  • Allocations for FAG1365 and FAG1366 are now being reviewed by NHS England and NHS Improvement with an aim to start processing orders by the end of the week.
  • If you have a clinical requirement to order any of these products, please escalate this to the Consumables Group lead via the Suspended Code Submission webform (please see our Useful Links section.)
  • The completed webform is then submitted to NHS England and NHS Improvement who review all requests for suspended products.
  • NHS Supply Chain Customers Services will contact you with details of your order once received by NHS England and NHS Improvement.
  • The alternatives FAG1365 and FAG1366 are moving from being supplied via our eDirect route into stock.
  • We are expecting stock to arrive shortly at which time our online catalogue will update to reflect the change of route.
  • To ensure fair allocation these products will be demand managed.
  • NHSE/I have requested for FAG1365 and FAG1366 to be suspended from our online catalogue.
  • If you have a clinical requirement to order any of these products, please escalate this to the Consumables Group lead via the Suspended Code Submission webform (please see our Useful Links section.)
  • The completed webform is then submitted to NHS England and NHS Improvement who review all requests for suspended products.
  • This is to protect stockholding and allocate volumes as determined by NHS England and NHS Improvement consumption model. It aims to ensure that trusts continue to have access to the products they need to provide patient care and to avoid unnecessary risks of stock shortages.
  • MHRA have now issued their National Patient Safety Alert, please see our Useful Links section.</strong
  • The alert states that the risk of discontinuing therapy for the vast majority of patients far outweighs continuing therapy until a replacement device can be sourced. For most patients this means they should continue to use their device as normal.
  • It also states that one exception to this guidance is patients with certain very rare forms of occupational asthma related to isocyanates who should be contacted to arrange an alternative device. This is a measure being undertaken out of an abundance of caution.
  • Unfortunately, the affected Philips Respironics product codes are now suspended.
  • Please see our Downloads ▼ section to refer to the product listing for potential alternative product codes.
  • Customer are advised to read and follow the full instructions in the National Patient Safety Alert.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.

Alert: 

  • The supplier Phillips Respironics has issued a Field Safety Notification due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators:
    1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user.
    2) The PE-PUR foam may emit certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners). Emission of chemicals may occur during operation.

Products Affected:  

  • There are 28 NHS Supply Chain product codes affected:
  • Please see our Downloads ▼ section to refer to the product listing for further information on the affected product codes.
  • Please see our Useful Links section. to refer to the Field Safety Notice.

Next Steps:

  • Please seek to source alternative devices through your normal supply route in the first instance.  Where normal supply routes are unable to meet requirements, please contact NHS Supply Chain customer services.
  • It should be noted that supply is likely to be constrained and demand management may be applied to support cases of greatest clinical need.
  • Further alternatives may be added as they are identified.
  • Please note that due to the clinical nature of these alternative products we do advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.

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

Downloads ▼

  • 1296 Phillips Product Listing with Alternatives

    An Excel file detailing the affected product codes for ICN 1296.

    Please to view this content.