Exclusive The Government has issued an alert telling GPs to throw away batches of out-of-date face masks distributed to practices after finding they posed a ‘risk to staff’, Pulse has learned.
The Type IIR face masks from supplier Cardinal Health are potentially harmful to staff wearing the mask if the foam strip on the mask flakes and enters the mouth or airways, the DHSC said after an MHRA assessment of the products.
Practices, which have been using the masks, have now been asked to dispose of them locally.
A spokesperson for Cardinal Health told Pulse that it stopped distributing the masks in Europe in 2010 when it divested to Medline Industries, which undertook shelf life testing ‘at the request’ of the Government.
The DHSC safety alert said the face mask boxes were re-labelled with new dates of expiry – as revealed by Pulse – after the manufacturer tested them in 2013/14 and found their shelf life could be extended.
The Government had said that they were ‘safe to use’.
However, a sample of seven batches of masks was put through ‘additional testing’ by the manufacturer this month after ‘potential issues’ were raised with NHS Supply Chain in May.
Six out of the seven batches tested did not pass an inspection of the foam strip.
The alert, sent out by the NHS’s PPE Dedicated Supply Channel, said: ‘Although these masks meet the breathability, filtration and splash resistance requirements of BS EN 14683, in light of ongoing monitoring, further complaints reported and testing from the manufacturer on the masks, the MHRA recommends that all lots of this product are disposed of locally.
‘There is a risk to staff wearing the mask if the foam strip on the mask flakes and enters their airway or mouth.’
There have also been ‘complaints’ of the ties and stitching coming away from the mask, the alert added.
Buckinghamshire GP Dr Daniel Djemal told Pulse that his practice would have to throw away ‘up to 600’ masks.
He said the practice had already been using ‘around 300’ of the items for both staff and patients.
He said: ‘We’ve been using these masks ourselves as well as giving them to our patients, as we were reassured that they were safe to use. To find out after three months they are unsafe is incredibly disappointing but unfortunately not surprising.
‘This just further highlights the failings in the Government to adequately address the issue of PPE which has been going on since the beginning of the pandemic.’
Pulse previously reported that practices across the country had been supplied with expired face masks that had concealed ‘best before’ stickers.
Dr Matt Mayer, chief executive of Berkshire, Buckinghamshire and Oxfordshire LMCs, told Pulse that today’s alert ‘seems to suggest the affected masks are the same ones that were re-dated with new expiry dates and delivered to practices in March’.
He said: ‘This further calls into question the Government’s shambolic approach to PPE for frontline staff.
‘We all know colleagues who have been infected during this pandemic in the course of their duties and sadly some who have not survived. If NHS staff have come to harm as a result of being supplied with defective equipment then that is indefensible and those responsible should be held to account.’
In March, 20 regions were found to have received batches of face masks with a 2016 expiry date hidden by a ‘2021’ sticker.
However, the Government defended the move to supply the masks to practices, saying that they had been tested.
A spokesperson for Cardinal Health said: ‘Cardinal Health has not distributed type IIR facemasks in Europe since 2010. At that time, the business divested to Medline Industries. At this point, Medline took all responsibility for the safety and efficacy of the masks.
‘Medline Industries communicated to Cardinal Health that, in 2013, they undertook a shelf life extension project on these types of masks at the request of the UK Department of Health. Cardinal Health was not involved in any way in these decisions on the expired products with the UK Department of Health.’
Please note, this article was amended at 12.52 on 1/7/20 to clarify that the safety alert was issued by the DHSC rather than the MHRA as previously stated.
Action recommended for GP practices
- Identify, stop using and immediately quarantine all lots relating to BWM028 of the Cardinal Type IIR masks.
- All stock should be disposed of locally.
- If you have a shortage of Type IIR masks, please notify NSDR on 0800 915 9964 who will arrange an emergency delivery if required.
- For all general enquiries for the PPE Dedicated Channel, call Customer Services on 0800 876 6802.
Source: PPE Dedicated Supply Channel alert