TGA on shortages of surgical masks and gowns

The demand for surgical masks, surgical and isolation gowns, and surgical suits may overtake the supply available to healthcare organisations during the COVID-19 pandemic.

Masks had already been in short supply after months of Australian bushfires. The COVID-19 crisis and shortage of masks has led some pharmacies and online businesses charging exorbitant prices for these.

In response to this increased demand, the Department of Health, Office of Health Protection (OHP) and the Therapeutic Goods Administration (TGA) has prepared the following information to assist healthcare organisations as they update their operating procedures during the outbreak.

The presentation and claims made regarding face masks and gowns will determine how these products are regulated by the TGA.

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Face masks or gowns which are presented or claimed to be for therapeutic use, such as being labelled for surgical use, or to reduce or prevent the transmission of disease or micro-organisms such as bacteria or viruses, meet the definition of a medical device and are regulated by the TGA under the Act.

If these masks or gowns are supplied as non-sterile, they are likely to be regulated as low risk, class I medical devices.

The TGA and Office of Health Protection (OHP) are collaborating with manufacturers of surgical masks and gowns to better understand the current supply chain issues related to the COVID-19 outbreak, and to avoid longer term shortages of these products.

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