Hundreds of different types of face masks have been withdrawn from Australia’s register of therapeutic goods and the regulator has started a mass audit of the equipment amid concerns that some may not adequately prevent infection.
Surgical or examination masks intended to reduce or prevent the transmission of disease are considered medical devices, are regulated by the Therapeutic Goods Administration and must be included in the register of therapeutic goods before they can be supplied.
As of Thursday, 286 types of mask had been removed from the register as part of a post-market review triggered by concerns that many masks do not meet regulatory standards and, if used in medical environments, may increase disease spread.
The TGA said of one supplier that the “single use surgical masks have not provided sufficient evidence to show compliance … Continued use of these particular surgical masks may increase the risk of spreading infections (including Covid-19) between individuals.”
A face mask may be cancelled from the register in two ways: the sponsor (the supplier within Australia) may voluntarily cancel the entry or the TGA may cancel it.
Those products voluntarily cancelled by the supplier are not necessarily subject to a recall action because they failed to meet appropriate manufacturing standards or that they failed to perform as intended. Most products were cancelled by the supplier.
The news comes after Guardian Australia was sent images from nurses working in Victorian and New South Wales hospitals of masks and surgical gowns they were supplied with carrying labels in Chinese characters that stated “Single-use protective masks (not for medical use)” and “Disposable not for medical use isolation gown”.
While other languages can also be used on masks on the register, they must also contain labels, packaging and instructions for use in English.
Guardian Australia has contacted the federal Department of Health and the TGA for comment.
The president of the Australian Medical Association’s New South Wales branch, Dr Danielle McMullens, said all personal protective equipment provided to healthcare workers should, at a minimum, meet regulatory standards and be made for medical use.
“AMA New South Wales has called on both the state and federal governments to ensure that there are zero healthcare worker deaths from Covid-19,” she said. “Providing them with sufficient PPE [personal protective equipment] that is of sufficient quality is vital to pursuit of this goal.”
A spokeswoman for the NSW department of health told Guardian Australia that in July, the department discovered “a small set” of personal protective equipment gowns were labelled as “not for medical use”. Each local health district was contacted and asked to remove the gowns while their suitability was checked.
An expert infection control team “subsequently found these specific gowns were suitable for clinical use in a medical setting,” the spokeswoman said. “NSW Health has a sufficient supply of PPE and health facilities are provided with clinically appropriate replacements to ensure they can retain adequate supply for their ongoing requirements.”
On Tuesday Guardian Australia reported that nurses had written to the Victorian premier, Daniel Andrews, asking to “urgently know what’s being done to protect and care for Victorian nurses” as more than 800 health workers in the state remain sick with active infections of Covid-19. The letter to the premier, seen by Guardian Australia, states “the situation is still inadequate months after the outbreak started”. At least three Victorian health workers are in intensive care.
Jill Tayler is the founder of Global Health Workz, which supplies and imports PPE such as masks and gowns. She said she had been in contact with a number of nurses working in hospital wards with Covid-19 patients.
“They tell me they are not being given the correct PPE,” she said. “The masks are not even hospital grade or fluid resistant, and neither are the gowns.
“The nurses are scared to speak out and are concerned about the ramifications of being a whistleblower. They are not allowed to provide their own PPE.
“A friend who works at a major hospital in reception at radiology tells me she is not allowed to wear a mask or face shield and yet patients lean across the counter to speak to her. There are no perspex screens in place.”
A senior nurse who has been in the profession for 25 years and is part of a chat group of more than 200 nurses treating Covid patients said that in the past fortnight, large deliveries of masks had been made to hospitals but many of those had unclear labelling and were not appropriate for use in hospitals. She said there were also differences in standards between hospitals. Some major tertiary hospitals were providing nurses with similar standards of protection to doctors and surgeons, while other hospitals were telling some nurses they were “low risk” even if they were swabbing potentially positive Covid-19 patients.
“We are not saying the governments aren’t doing anything,” she said. “The supplies are getting better. But where are they procuring these masks from? Why aren’t they meeting standards?”
More than 1,100 Victorian healthcare workers have contracted Covid overall, including active and non-active cases. The Australian Health Protection Principal Committee is reviewing its advice on PPE use by health professionals.
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