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Important message: Alaris giving set alert

March 26, 2021

Problem:

Becton Dickinson (BD) have notified the Medicines and Healthcare products Regulatory Agency (MHRA) that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider. The following stock is affected:

Alaris GP volumatic pump (with safety clamp)

Alaris Infusion Set (gravity)

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 Becton Dickinson transfer products to a new sterilisation provider.

This is a global issue and all Becton Dickinson infusion lines will be recalled when:

  • Alternative products are available or
  • When Becton Dickinson advise that the disruption to the supply chain has been resolved.

Please see MHRA safety notice in regards to supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson.

Immediate actions:

Using an alternative volumatic pump – should be considered. However colleagues MUST be trained and competent in their use and able to verify their competency, by ensuring their training records are updated.

If administering fluids and drug infusions via gravity line always seek to use an alternative line other the Becton Dickinson infusion set.

If no alternative device or clinical approach is available you should before administration through the Alaris giving set:

  1. Undertake the Risk Assessment Checklist for Use of Alaris (BD) giving sets (please see volumatic pump checklist)
  2. Follow the alternative advice outlined below
  3. Following completion the checklist must be scanned into the patient’s UNITY notes
  4. Ensure any incidence of infection that may be linked to these infusion sets are reported through Safeguard.

Monidrop devices are available for wards, prior to use colleagues MUST be trained and competent in their use.

Over the coming weeks the Trust will be providing stock from other manufacturers and we will keep you updated as to when Becton Dickinson stocks can be removed from use.

Administration set supplies:

Becton Dickinson stocks within the Trust will be rationalised and centrally stored from the following bases:

  • Sandwell – Room 369, Bryan Knight
  • City – Ward D30 (sister’s office).

Prior to collection please ensure you complete the volumatic pump checklist, which MUST be left in the tray. This is very important so that we can monitor use.

Areas that routinely use the critical medicines will be allowed to keep reserve stocks of administration sets. All other areas will need to collect administration sets when required from the central bases, provided that the drug to administer is on the critical medicines list. This will be confirmed by colleagues who are manning the central distribution points.

Gravity IV Sets have not been removed, however all wards and departments should manage their stocks on a daily basis.

Advice/alternative:

Prior to administering any fluids or drug infusions, the NHS Medusa Injectable Medicines Guide MUST be checked. Many drugs are appropriate to be given as a bolus injection and this should be the first choice where clinically appropriate. To access Medusa please click here.

The following general information may be of use.

Gravity infusion calculations and drip rates:

When administering an infusion by a gravity giving set, nursing colleagues will be required to calculate the drip rate. Guidance on how to do this can be found by clicking here.

Fluid replacement:

Alternative gravity giving sets have been procured by the Trust. It is clinically appropriate to give most routine fluid infusions via a gravity infusion. Exceptions to this include strong potassium solutions and some electrolyte containing infusions, so the NHS Medusa injectable medicines guide must always be checked before starting to administer any fluids.

The list of critical medicines, medicines suitable for gravity infusion, Alaris IV volumatic pump sets affected and further detailed information can be found by clicking here. Please also see IV infusion administration alternate methods by clicking here.

Actions:

  1. All clinical colleagues are to conserve stocks of administration sets when administering fluids and infusions by following the advice.
  2. All clinical colleagues are to use the NHS Medusa Injectable Medicines Guide to confirm whether a drug is suitable for bolus or gravity infusion prior to administration.
  3. The procurement team will identify excess BD administration sets from non-critical areas and will be returned, to be redistributed centrally.

When collecting administration sets from the central base, ward colleagues must provide details of the drug required to be administered, which must be on the critical medicines list.