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Originator: National Patient Safety Alert - MHRA

Issue date: 11-Mar-2021 16:46:06

This alert has been issued to:
  • Care Trusts
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  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
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  • GP Practices
  • Primary Care Networks
  • GP Practices 1

Action category: Action

Title: Supply disruptions of sterile infusion sets and connectors manufactured by Becton Dickinson (BD)

Broadcast content:
Becton Dickinson (BD) have notified MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider. BD is recalling all affected stock of the following products:

·        Infusion sets for specific Alaris pumps

·        Gravity infusion sets and connectors

Although the devices are likely to be sterile this cannot be guaranteed so there is a very small risk of infection from treatment with these devices. There will be supply disruption whilst BD transfer products to a new sterilisation provider.

Affected product codes are listed in the Field Safety Notice (FSN).

The quality issue was recently identified but ongoing for a number of years. No infection issues have been identified relating to these products.

Supply disruption is to be expected for 4 weeks. Mutual aid of alternative infusion devices and associated consumables is advised to ensure that clinical risk is minimised.

The risks of rapidly changing clinical practice or using unfamiliar devices must be balanced against the risk of continuing to use these products while they remain available.

Unusual or low-virulence organisms isolated from blood culture, which are commonly considered contaminants, should be considered potentially pathogenic in discussion with the local infection specialist.

Based on current evidence, there is no need for a review of patients previously treated with these devices.


Additional information: This alert is relevant to GP Practices, but not Community Pharmacy, Dental or Optometry

Alert reference: NatPSA/2021/001/MHRA

Action underway deadline: 16-Mar-2021

Action complete deadline: 31-Mar-2021

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency