Hundreds of ineffective face masks are withdrawn from sale in Australia - here's how to find out if your protective gear is up to the job

  • More than 200 face masks have been degistered across Australia
  • The items were identified as not being surgical grade under national regulations  
  • They can still be sold in retailers if they are labelled appropriately

More than 200 face mask products have been withdrawn because they are not deemed suitable for surgical use. 

The masks de-registered by the Australian Therapeutic Goods Administration (TGA) are typically made from cloth and don't protect the wearer from coronavirus

A rush to secure personal protective equipment when the pandemic struck meant many were mistakenly classified as registered medical goods before having their status corrected in a post market review by the TGA.

But while the non-surgical-grade masks may no longer be sold to hospitals, they are still available from stores - as long as they are not advertised as being for medical use or providing protection from COVID-19.

Hundreds of face masks were able to be classified as medical grade despite offering the wrong protections (pictured: Melbourne residents wear masks on the streets during lockdown)

Hundreds of face masks were able to be classified as medical grade despite offering the wrong protections (pictured: Melbourne residents wear masks on the streets during lockdown)

Medical Authorities are racing to find out if any incorrectly registered face masks ended up with frontline healthcare workers (pictured: a staff member sanitises her hands outside the Menarook aged care facility in Melbourne on Tuesday)

Medical Authorities are racing to find out if any incorrectly registered face masks ended up with frontline healthcare workers (pictured: a staff member sanitises her hands outside the Menarook aged care facility in Melbourne on Tuesday)

The TGA said: 'concerns have been raised about the quality and effectiveness of some products.' 

This was the result of the federal government granting an emergency exemption on March 22 to import large quantities of medical supplies for the National Medical Stockpile.

Three months later the TGA conducted a post-market review, and informed face masks suppliers they would face significant fines if their goods weren't up to medical standards.

This resulted in more than 200 suppliers withdrawing their products from inclusion as medical goods across Australia.

The Victorian state government has encourage residents to don cloth masks if they will be in public spaces where they can't practice social distancing

The Victorian state government has encourage residents to don cloth masks if they will be in public spaces where they can't practice social distancing 

University of Queensland Occupational Health and Safety Expert Professor Keith Adam said he was witnessed an incredibly low standard of face masks.

TGA APPROVED MEDICAL FACE MASKS

N95 respirators 

A single use item designed to form a very close seal around the nose and mouth, to protect the wearer from exposure to 95 per cent of airborne particles, including pathogenic biological airborne particulates such as viruses and bacteria. 

Surgical N95 respirators 

A similar structure and design to standard N95 respirators and therefore meet the same testing requirements to achieve a minimum 95% filtration against airborne particulates, but have also been tested for fluid resistance against penetration by synthetic blood under different pressures, such as may occur during certain high risk medical procedures.

Surgical masks  

Single use, fluid-resistant, disposable, and loose-fitting protection devices that create a physical barrier between the mouth and nose of the wearer and the immediate environment but do not achieve a close seal to the wearer's face.  

Surgical masks have different grades of filtration and are useful for blocking splashes and large particle droplets or sprays which may occur. They do not provide complete protection from germs and other small particle contaminants.

Source: Therapeutic Goods Administration

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'The quality had to be dodgy … I've seen lots of dodgy masks walking down the street,' he told the Herald Sun.  

He said it was 'like the wild west' in the first few months of the pandemic due to the sheer number of fraudulent operators selling their wares.  

The TGA told News Corp it will be notifying hospitals and health facilities about the affected masks and it is still investigating where the equipment may have ended up. 

While the face masks can no longer be supplied to medical professionals they are still allowed to remain up for sale in hardware stores and other retailers.

But the items must not be marketed as medical devices or a way of preventing the transmission of diseases like coronavirus.  

Surgical grade masks need to be at least three layers thick and fabricated out of a material which acts like a filter.

They achieve a physical barrier between the mouth and nose but do not form a tight seal around the face.

While masks which offer the wearer greater protection from the risk of infection are typically labelled as P2 or N95 and filter out 95 per cent of fine aerosol particles.

But not all masks with these ratings are necessarily regulated as medical supplies and should be double-checked by buyers. 

Residents are being urged to check face masks comply with the Australian/New Zealand protective standard for respiratory equipment: AS/NZS1716.

This includes brands like 3M and Drager, Uvex, iQuip or ProChoice. 

The TGA is urging Australians to take extra caution when it comes to purchasing masks as a result of complaints around dodgy medical equipment.

'Be aware of potentially counterfeit devices. Look at product markings, such as the name of the manufacturer, to determine whether anything is amiss (incorrect spelling, faded packaging, incorrect filters/materials, etc.)' the TGA website says.

A man walks down Collins Street in Melbourne wearing a surgical face mask

A man walks down Collins Street in Melbourne wearing a surgical face mask

The Drager P2 mask is one of the recommended masks which complies with Australian standards for respiratory equipment

The Drager P2 mask is one of the recommended masks which complies with Australian standards for respiratory equipment 

The warning comes as health authorities urge residents to wear face masks out in public as cases surge in Victoria and New South Wales.

The Victorian state government has encourage residents to don cloth masks if they will be in public spaces where they can't practice social distancing.

Cloth masks do not need to be surgical grade, meaning they will protect the wearer from spreading any possible infections but won't protect people around them.  

TGA ADVICE ON FACE MASKS FOR MEDICAL PROFESSIONALS

If you are a user of medical grade face masks, you should familiarise yourself with the differences in available face masks and be aware of the manner in which these products are used in order to maximise the protection they can offer. In particular:

· While other languages can also be used, medical devices must be supplied with the labels, packaging and Instructions for Use in English.

· The name and address of the supplier, and the name of the manufacturer, should be provided on the packaging or label.

· You can check if a face mask is included in the ARTG by searching the ARTG using the name of the person or company legally responsible for the product (ie: the sponsor). Product names are not available in the ARTG.

· Face masks are supplied as both medical devices and as personal protection for use in industrial settings. Ratings such as N95 and P2 relate to standards that may not be associated with a therapeutic use. You should familiarise yourself with the specific claims and ratings associated with the product you are using to ensure it is appropriate for the manner in which you intend to use it. 

· Ensure you always use your medical device in the manner intended by the manufacturer by following the Instructions for Use.

· Be aware of potentially counterfeit devices. Look at product markings, such as the name of the manufacturer, to determine whether anything is amiss (incorrect spelling, faded packaging, incorrect filters/materials, etc.).

Source: Therapeutic Goods Administration 

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Hundreds of dodgy face masks withdrawn in Australia because they do not protect against coronavirus

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