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However, a CSIRO spokesman said the organisation is not a body that can certify a mask meeting Australian standards. The CSIRO said it never tested the specific masks themselves.
Chemist Warehouse provided testing by multiple labs showing the mask passed all performance checks. It said the mask was not claiming to be American-certified, only that it meets the standard set by the American government.
The federal government has denied reports a loophole created by the Therapeutic Goods Administration to allow masks to be quickly approved for use by the federal Health Department has led to a flood of fake masks entering the country.
However, since March 22, 774 new masks have been registered with the TGA. Days after The Age and The Sydney Morning Herald revealed concerns fake masks were being used in some Australian hospitals, 58 companies selling masks in Australia abruptly cancelled their TGA registration.
The Chemist Warehouse mask had an authentic TGA registration.
“The TGA are fast-tracking and allowing masks to be sold in Australia, but they are not doing the checks,” said president of the Australian Institute of Occupational Hygienists Andrew Orfanos.
“So a lot of companies that are trying to sell respirators in Australia are trying to use the line ‘it’s TGA approved’ – and that does not mean anything.”
Chemist Warehouse supplied certificates claiming to show their masks had been certified by the US FDA, the TGA and had a European Union “CE” mark.
Neither the TGA nor the FDA certify N95 masks. The EU certificate comes from a lab that is not able to issue CE certification, and certifies the mask to a different standard.
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Chemist Warehouse said that standard was equivalent to N95.
The Age and the Herald alerted Officeworks to KN95 masks – a Chinese standard equivalent to N95 – it was selling that several mask experts identified as fake.
A company spokeswoman initially said Officeworks was “satisfied that these masks meet the appropriate Chinese KN95 standard”. However, the masks were removed from sale. The company said they would go back on sale, but as of Friday that had not happened.
After occupational hygienist Kate Cole pointed out that Bunnings appeared to be selling fake KN95 masks, the company said they had been tested and shown to be authentic by independent laboratories.
The Age and the Herald had them reviewed by the representatives from the Australian Institute of Health and Safety, the Australian Institute of Occupational Hygienists, and Richard Donarski, national compliance director for CertMark and one of Australia’s most-respected mask experts.
All said they were most likely fake. Bunnings later said it was working on the issue with NSW Fair Trading.
On March 22, the TGA changed regulations allowing mask manufacturers to skip some regulatory requirements so long as the products were being sold to the federal government’s national stockpile.
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“What happened with the expedited processing was that some basic checks were being rushed to get things listed,” said Melbourne-based surgeon Associate Professor Jason Chuen.
“Many of the people who applied for ARTG (Australian Register of Therapeutic Goods) listing had no experience with medical devices and didn’t really understand their responsibilities and the standards and documentation that was involved.
“ARTG listing is not a guarantee that TGA has checked and verified the claims of manufacturers or suppliers. People were saying ‘if it’s listed it must be OK’ — and that’s not right.”
The government has denied this loophole allowed fake masks to be sold in Australia.
“There has been no change to the regulations or the process for including masks that meet the definition of a medical device in the ARTG,” a TGA spokeswoman said.
When The Age and the Herald questioned the veracity of Chemist Warehouse’s masks, the company sent a form it said showed the masks were “certified” by the TGA.
A TGA spokeswoman said publicly claiming a product was certified by the TGA was illegal.
Liam is The Age and Sydney Morning Herald’s science reporter
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