Edwards Lifesciences Field Safety Notice - recall of atrioseptostomy balloon catheters
On behalf of the MHRA, the BCCA are disseminating this important Field Safety Notice (FSN). The interventional community are already aware of this issue but it could have major implications for how we manage babies with TGA.
The MHRA is supporting Edwards Lifesciences in the dissemination of their ongoing field safety corrective action, which is to recall their portfolio of atrioseptostomy balloon catheters following an increase in device failures. Details can be found in the attached FSN
. Download list of customers affected by FCA 131
UK NSC consultation open: pulse oximetry as an additional test for the NIPE
As you may already be aware, the UK National Screening Committee (NSC) has opened a national consultation: pulse oximetry
on their evidence review and preliminary decision not to recommend pulse oximetry screening. Prof Andrew Ewer, Birmingham Women’s Hospital, attended the recent BCCA Council meeting to discuss his group's efforts to reverse the NSC's decision. BCCA Council have given their support to Prof Ewer's group.
If you have a view on pulse oximetry screening then now is the last opportunity to make it heard. Network leads are encouraged to respond. Please do forward this message to colleagues across the country.