Coronavirus: recall of defective masks in nursing homes and general practitioners | UK News


Batches of surgical masks delivered to nursing homes and general practitioners during the coronavirus pandemic have been recalled because they are defective, Sky News learned.

The masks, which are out of date for up to seven years but have been found to be safe to use, were removed after defects were reported with the straps and the nose guard that hold them in place.

In a recall notice issued by the Department of Health and Social Services on June 26, nursing homes were told that they should immediately stop using Cardinal Healthcare IIR masks and destroy them due to ” risk to personnel ”in the event of degradation of the masks.

Over 80 different lots of the mask have now been recalled.

They are expected to be part of a stockpile created in 2009 in the event of an influenza pandemic and their shelf life extended after testing by the manufacturer.

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He left some nursing home bosses and doctors concerned that staff and patients could have contracted the virus despite the use of personal protective equipment due to the fault, which was first identified in May.

In the notice sent to staff this week, the Ministry of Health and Social Affairs warned: “Although these masks meet the breathability, filtration and splash resistance requirements of BS EN 14683, to light of continuous monitoring, new complaints have been reported and manufacturer’s tests on masks, the MHRA [Medicines and Healthcare Products Regulatory Agency] recommends that all lots of this product be disposed of locally.

“There is a risk for personnel wearing the mask if the foam strip on the mask flakes off and enters the airways or mouth. Links and / or seams have come off the mask. ”

It follows a warning issued in May after complaints were made about the masks due to defects preventing them from staying properly. It also happens after the masks have passed their expiration date – some as much as seven years.

In the recall notice, the department said, “You will see that the boxes have been labeled with a new expiration date. Indeed, they were subjected to life extension tests by the manufacturer in 2013/2014 and passed a number of relevant tests to support a new expiration date.

“When potential problems were identified in May, a sample of seven batches was subjected to additional testing by the manufacturer in June 2020. Six batches failed to pass a physical inspection of the foam strip. ”

On May 22, a full month before the masks were removed from use, a notice was issued regarding a small number of PPE lots which stated: “The first defect was identified by the seams that broke away from the links. The second defect was identified on the foam nose strip which breaks down with the application of a small amount of pressure and friction causing the particles to dislodge. ”

Staff were told not to use the masks, but they were not removed completely.

Sky News also understands that the same masks have been issued to general surgeons and have also been removed, raising concerns that thousands of medical and healthcare staff may have been affected.

Speaking about the impact on general practitioners, Dr. Richard Vautrey, chairman of the general medical committee of the British Medical Association, said: “Practitioners rightly questioned him when they received expired masks earlier this year, but were reassured that they were safe.

“Therefore, it is extremely disturbing to hear that, after further testing, some have been found to be unusable. Staff have been able to use these masks for some time assuming they are safe and will naturally be very concerned.

“We now need urgent clarification on the number of practices and other suppliers that are affected, and how the defective masks will be replaced. protection will continue.

“Above all, questions must be asked about how the dangerous equipment was approved for use on the front line, and if anyone has been harmed as a result, those responsible must be held accountable. ”

PPE was issued for nursing homes and others during the early stages of the crisis when supplies were insufficient. The masks were manufactured by Cardinal Health.

The company was forced to remove thousands of medical-grade gowns earlier this year, fearing it might be contaminated.

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A spokesperson for the Ministry of Health and Social Affairs said: “The safety of health, care and all front line staff is our top priority.

“We have been informed of a defect in certain Cardinal Health Type IIR surgical masks. Last week, we advised healthcare providers to check and dispose of these masks.

“The problem is now resolved. ”

Cardinal Health has been contacted for comment.


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