Statements From FHD, DHHS And AMA
Statements From Federal Health Department, DHHS and AMA regarding PPE shortages:
Federal Health Department
While not routinely being made available, as they have been traditionally a core area held by states and territories for their needs, gowns and gloves have been recently purchased by the Commonwealth and dispatched where required for outbreaks. Further supply has been contracted for future needs, beyond the existing provisions.
The Australian Government, through the Department of Industry, Science, Energy and Resources, has established a register to capture expressions of interest from Australian based manufacturers and individuals looking to assist with supply of goods, services or knowledge in tackling the current COVID-19 outbreak in Australia. Offers of assistance can be registered online at: www.amgc.org.au/covid-19-manufacturer-response
For PPE intended for therapeutic/medical use where the manufacturer indicates it can be reused, information is required to be provided with the gown about the appropriate processes to take that will allow it to be reused safely. This includes information about cleaning, disinfecting, packaging and if appropriate, re-sterilising, as well as an indication of the number of times a reusable gown can be safely cleaned, disinfected and reused.
For single-use face masks and gowns, if it should become necessary to reprocess single use PPE in order to address critical shortages, and when there is no alternative option available, please refer to the following information on the TGA website:
for an overview of PPE regulation, and
for information on the reuse of PPE, including gowns.
As ‘Gowns for Doctors’ is a Victorian initiative, it is likely that the conduct of persons making the gowns in Victoria is subject to the Commonwealth Therapeutic Goods Act 1989 (administered by the TGA). The Therapeutic Goods (Victoria) Act 2020 adopts the Commonwealth Therapeutic Goods Act 1989 as a law of the state of Victoria.
By way of background, initiatives similar to the ‘Gowns for Doctors’ initiative are regulated by the States and Territories. Some States adopt the Commonwealth Therapeutic Goods Act 1989 as a law of the states, while other states and territories do not. Accordingly, whether such initiatives are regulated varies from jurisdiction to jurisdiction.
Under the Commonwealth Therapeutic Goods Act 1989, gowns which are presented or claimed to be for therapeutic/medical 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. As such, those making the gowns will be considered a “manufacturer”, and will therefore need to meet all the responsibilities of a manufacturer under the therapeutic goods legislation and regulations, and are also assuming responsibility and liability should the device fail to perform as intended.
The TGA expedites all applications related to Covid-19 and actively supports companies seeking regulatory guidance. For non-sterile PPE, the process for registration can occur within 24 hours on the TGA website via a self declaration process by the sponsor of the medical device that all relevant documentation and quality certificates relating to the manufacturer are current.
The Commonwealth government is responsible for the supply of PPE to GP clinics, but we stand ready to receive stock from Canberra and distribute to GPs if they need.
We have ordered billions of items of PPE to keep our hospital frontline workers safe with millions of gloves, N95 masks, surgical masks, gowns and face shields expected to arrive in the next two weeks.
COVID-19 has put extraordinary pressures on health systems around the world. One pressure has been a still continuing shortage of clinical grade personal protective equipment (PPE).
Shortages have meant doctors have needed to be practical and inventive, but above all, operate within clinical safety guidelines. PPE shortages are continuing, and current shortages appear to impact regional and rural areas particularly. Efforts of governments to source clinical grade PPE continue, and these efforts need to be supported.
Australia has a rigorous safety approval process through the Therapeutic Goods Administration for health consumables such as PPE. The approvals process is tough for a reason; to assure safety of doctors and patients alike. When PPE sourced globally or sewed at home locally meets TGA approval, doctors, patients and the AMA alike can have confidence that care will be delivered in compliance with clinical safety guidelines.