The Age, 22 January 2021:
Some of the masks distributed to hospitals and aged care homes at the height of the pandemic as part of the federal government's national medical stockpile have been judged defective by the Therapeutic Goods Administration.
Laboratory testing by Australia’s medical regulator identified a range of issues with some disposable surgical masks branded Softmed and imported by M House.
The issues include quality control, lack of proper labelling, and inconsistent fluid resistance between batches. Fluid resistance is vital for medical masks, as fluid droplets generated by coughing and sneezing have been found to spread COVID-19.
A Kirby Institute study, published in November, estimated Australian healthcare workers were nearly three times more likely to become infected with coronavirus than other Australians. More than 3560 healthcare workers have been infected with COVID-19 in Victoria. Nearly three-quarters of them caught the virus at work.
At the peak of the state's second wave of infections in early August, so many staff were off sick or isolating from the Royal Melbourne Hospital that the facility was forced to temporarily close four of its wards…...
"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…..[my yellow highlighting]
