A third of N95 masks fail government tests, putting medics at risk

One-third of supposedly highly protective N95 masks used by hospital and hotel quarantine staff exposed to COVID-positive patients have failed government testing, putting the frontline workers at risk of coronavirus infection.

Healthcare workers have spent much of the pandemic fighting to get N95 masks – meant to filter out 95 per cent of airborne particles – for dealing with people who have tested positive to coronavirus.

One-third of N95 masks – highly protective masks used in hospitals and hotel quarantine – failed government testing, placing doctors and nurses at risk of COVID-19 infection.Credit:Justin Sullivan/Getty Images

But government testing results leaked to The Age and The Sydney Morning Herald and confirmed by three separate sources indicate the N95 masks frontline workers are supplied with are often flawed.

Of 263 respirators and surgical respirators – including N95 and P2 masks – reviewed by Australia’s Therapeutic Goods Administration, about a third failed the particle filtration efficiency test.

About half of 78 surgical respirators tested failed to meet fluid-resistance tests to ensure the masks block any bodily fluid – like blood – from a patient.

On Thursday, the TGA was unable to say how many of those masks had been used by healthcare workers.

It’s like wearing a raincoat, going out in the rain, and it lets 50 per cent of the droplets through.

A flood of faulty masks has entered Australia since the start of the pandemic, many of which have been cheap masks sold to the public, not high-quality N95s supplied to doctors and nurses on COVID-19 wards.

The N95 testing showed the problems were worse than expected, said Jane Whitelaw, director of the occupational health and safety program at the University of Wollongong.

“It’s like wearing a raincoat, going out in the rain, and it lets 50 per cent of the droplets through,” she said.

In the 12 months since concerns about faulty masks were first revealed, the government has been forced to issue a defect warning about masks on its own national stockpile, hundreds of thousands of dollars in fines have been handed out, 48 product defect alerts have been issued and 1022 masks have had their registration cancelled.

Australian Society of Anaesthetists president Dr Suzi Nou holds an N95 mask.Credit:Jason South

That covers about half of all masks registered in Australia since the pandemic began, said certified occupational hygienist Kate Cole, who first blew the whistle on the scandal.

“It calls into question the quality of these products that were provided to our frontline healthcare workers,” she said.

Before the TGA changed mask regulations in October, registering a mask for sale to hospitals was as simple as “submission, payment, approval”, according to Graham Powe from mask retailer Safety Equipment Australia. “You did not have to have the mask tested. It is a trust-based system.”

A spokeswoman for the TGA said it was not its role to test medical products before they were registered for sale. “This is also the case for other major regulators,” she said.

When testing identified problems with masks, the masks’ sponsor was asked to quarantine all affected stock, the TGA spokeswoman said.

If the TGA had tested every mask before it arrived, there would not have been enough masks in Australian hospitals and aged care homes in the early months of the outbreak, the spokeswoman said.

“The lack of protection could have led to much higher COVID-19 case and death rates in Australia.”

Credit:Matt Golding

The Victorian government long denied healthcare workers were getting infected with COVID-19 at work during the state’s second major outbreak in 2020 but has now admitted that 2599 doctors and nurses did catch the deadly disease in their workplace.

Healthcare workers campaigned extensively for N95 masks to be rolled out, first in high-risk areas, then across hospitals as more workers fell sick. Late last year, the state government agreed to roll them out in hospitals and then in February to hotel quarantine workers after some who were wearing surgical masks fell sick.

But the TGA’s audit raises questions about how protective N95 masks truly are.

“Absolutely, it is a concern,” said Australian Medical Association president Omar Khorshid.

“Australia is in a very lucky position that we haven’t had to deal with much COVID. I think healthcare workers would still be feeling very safe.

“But we are seeing brands of masks on our shelves in our hospitals we have not seen before. There is concern about what the quality of those devices is.”

Science and health explained and analysed with a rigorous focus on the evidence. Examine is a free weekly newsletter by science reporter Liam Mannix. Sign up to The Age’s here and the Sydney Morning Herald’s here.

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