Field Safety Notice Becton Dickinson Bodyguard™ MicroSets (ICN 2031)
Important Customer Notice Update
- In February 2023, Becton Dickinson (BD) released an advisory Field Safety Notice (MMS-23-4678) limiting the BD BodyGuard™ MicroSets for use with adults, as evidence to support compliance with Ethylene Oxide residual level requirements (per ISO 10993-7:2008/AMD. 1:2019) did not exist for use in special populations, specifically children, infants, neonates and pre-mature neonates.
- This limitation is now removed as BD can confirm that this evidence has been gathered for all patient populations. The evidence has been reviewed by the Notified Body. Therefore, these devices in Appendix 1 can be returned to normal use for all patient populations, in line with the provided Instructions for Use.
- BD has determined there is no different clinical risk associated with Ethylene Oxide residual levels as the compliance evidence has now been confirmed for all patient populations.
- No additional follow-up activities are required.
- Please refer to the latest Field Safety Notice for full details MMS-23-4678-B
- The MHRA has issued further guidance relating to the Field Safety Notice issued by BD as the result of an amendment to the international standard which sets outs the applicability of allowable limits of ethylene oxide (EO) for neonates and infants on medical devices.
- As a precautionary measure, following MHRA assessment of currently available data on EO levels, alternative devices to the BD BodyGuard™ Microsets should be sought in users of 5kg bodyweight and below.
- Please refer to BD BodyGuard MicroSets and residual ethylene oxide: devices may continue to be used to treat paediatric patients 5kg and above, DSI/2023/004 – GOV.UK (www.gov.uk) for more information.
- BD has issued an advisory Field Safety Notice having identified internally through a product review that the BD BodyGuard™ MicroSets do not currently have the evidence to support compliance with Ethylene Oxide residual level requirements as per ISO 10993-7:2008/AMD. 1:2019) for use in special populations, specifically children, infants, neonates and pre-mature neonates.
- Therefore, these devices are currently being limited for use with adults until the compliance evidence is gathered.
- BD does not have any data to suggest that the lack of compliance evidence has resulted in any clinical harm but, in the worst case, if the EO residual levels are too high for these intended special patient populations (children, infants, neonates and pre-mature neonates), there may be an elevated risk of health consequences.
- If the devices have already been safely used no additional follow-up activities are required.
- To date there has been no adverse events worldwide related to this issue.
- Some of the products affected are available from NHS Supply Chain, please refer to the attached product listing.
- Read and follow the full instructions in the Field Corrective Notice and share with all users of the affected products.
- There is no requirement for customers to return any BD BodyGuard™ MicroSets to BD.
- These products can continue to be used in accordance with the guidance in the Field Safety Notice.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.