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National stockpile masks deemed ‘defective’ by medical watchdog

Health Minister Greg Hunt and Therapeutic Goods Administration head Professor John Skerrit at Parliament House last month.

Health Minister Greg Hunt and Therapeutic Goods Administration head Professor John Skerrit at Parliament House last month.Credit:Alex Ellinghausen

The TGA’s product defect alert does not cover all Softmed-branded masks supplied to the stockpile, or masks from other suppliers.

In a statement, M House accused Australia’s medical watchdog of incompetence or bad faith and said it had serious concerns about the regulator’s lab testing.

“Based on the results of internal and external accredited laboratory testing, M House is very confident that its products supplied during the height of the pandemic do not pose a risk to frontline workers but in fact protect them,” the spokeswoman said.

“M House genuinely believes that, at best, the TGA has conducted itself incompetently in relation to the testing of the device and, at worst, has acted and continues to act in bad faith towards M House, in respect of which M House has reserved its rights and, if necessary, will prosecute them to the full extent necessary, including to obtain the removal of the alert notice which it genuinely believes is unjustified.”

The TGA issued a product defect alert for the disposable surgical masks in November and the Health Department has since written to aged care homes, healthcare networks, the National Disability Insurance Scheme and state and territory health authorities, warning about the defective batches.

The TGA has been running its own lab tests on masks, with priority given to the millions of masks on Australia’s national medical stockpile. Of the first 25 results released, seven had problems identified.

A spokeswoman for the TGA said: “A strong precautionary approach was taken by issuing a Product Defect Alert notice on 14 November 2020 for the relevant Softmed branded surgical masks, sponsored by M House, to ensure customers who purchase or are supplied with these masks safeguard healthcare workers if the masks are being used in high-risk settings,”

Andrew Hewat, Victorian Allied Health Professionals Association assistant secretary, said: “Any concerns in terms of the level of safety, the standards that are being applied, raises concerns for our members.

“[Masks are] the baseline protection for the wearer and anyone they interact with.”

Safety experts have called for an overhaul of Australia’s “trust-based” mask regulations.

Australia’s summer of bushfires, the COVID-19 pandemic and government-mandated mask rules led to a flood of masks entering the country in 2020. In May The Age revealed serious concerns that many of these masks were counterfeit or did not meet the standards claimed – and that some of these products ended up in hospitals.

At the time, the Health Department told The Age it was satisfied with the quality of all masks it had purchased.

A post-market review by the TGA has now led to the watchdog cancelling the registration of 90 different face masks, with sponsors voluntarily cancelling another 647.

Several masks were cancelled for making “false or misleading” statements in their application or because “the safety and performance of the kind of device is unacceptable”.

Kate Cole, president-elect of the Australian Institute of Occupational Hygienists, said: “It’s really demonstrated the lack of mask regulation in Australia.

“The harm that can happen is: a healthcare worker, in good faith, uses an N95 respirator and that respirator does not actually provide N95 protection, and exposes them to COVID.”

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The TGA also issued four product defect alerts, including three for masks that had “insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance”.

Two of those three were apparently sponsored by a home nursing service.

“What it shows is there needs to be that front-end quality check and assurance process built into our importing market,” said Naomi Kemp, chairwoman of the Australian Institute of Health and Safety.

Australia’s medical regulations allow companies to register “low-risk” items, such as masks, on the Australian Register of Therapeutic Goods – allowing them to be used in healthcare – by simply stating they have evidence to back up claims about meeting certain standards.

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That evidence is often not checked before the mask is registered, a regime Monash University associate professor Ken Harvey has labelled “trust-based”.

The TGA defended its mask regulation system and decision to treat masks as low risk.

“The impact of COVID-19 has highlighted that while risks are low if all regulatory requirements are met, some manufacturers and sponsors were not aware or were not meeting regulatory requirements,” a spokeswoman said.

The Australian Institute of Occupational Hygienists, along with the Australian Institute of Health and Safety, the Indoor Air Quality Association Australia and the Australian Council of Trade Unions, has called for the federal government to set up a national register of approved respirators.

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