1. Explanation of identified safety issue
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. 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 (up to 4 weeks) while BD transfers products to a new sterilisation provider.
Affected product codes are listed in the Field Safety Notice (FSN).
2. Actions required
Identify if your organisation uses any of the listed Alaris model pumps (full list here).
If so please identify alternative devices and once staff are trained and determined to be competent, remove unused Alaris pump giving sets, gravity infusion sets and connectors from shelves and storage areas.
If no alternatives are available the advice is that your organisation should:
- Undertake and document a risk assessment
- Follow established local protocols for resource shortage escalation or contingency
- Set up systems to ensure that any infections that may be linked to these infusion sets are reported, as appropriate, in your region.
Full document available here:
National Patient Safety Alert: Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (NatPSA/2021/001/MHRA)