In this edition: National guidelines for head injuries in children, Life Biotech Pty Ltd fined by the Therapeutic Goods Administration, Virtual support centre for healthcare workers, Repurposing Medicines – TGA Consultation, Outcome of Bacchus Marsh / Djerriwarrh Health Service Inquiry
The latest insights from our Health Law team:
The Paediatric Research in Emergency Departments International Collaborative (PREDICT) publish national guidelines for head injuries in children
Life Biotech Pty Ltd fined by the Therapeutic Goods Administration
Victorian Government set up virtual support centre for healthcare workers
Repurposing Medicines – TGA Consultation
Outcome of Bacchus Marsh / Djerriwarrh Health Service Inquiry
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The Paediatric Research in Emergency Departments International Collaborative (PREDICT) publish national guidelines for head injuries in children
On 3 February 2021 the first ever national guidelines for the management of head injuries in children were published in Emergency Medicine Australia.
Head injuries such as those resulting from a baby rolling off a change table or a child falling off school play equipment, are an ongoing issue for emergency departments, with 4% of children being presented for this reason.
The new guidelines offer directions for ambulance services, general medical practitioners, parents and schools. Examples of new recommendations include:
- Children with ‘trivial’ head injuries do not need to attend hospital for assessment and can be safely managed at home; and
- On all children presenting with mild to moderate head injury, the possibility of abusive head trauma should be considered.
The main purpose of the guidelines is to ensure a balance between conducting enough CT scans in order not to overlook any significant injuries and, on the other hand, avoiding unnecessary CT scans that would increase the radiation burden of children.
The guidelines will have a significant impact on aiding health professionals managing mild to moderate head injuries including issues such as when to resume contact sport post-concussion. The guidelines should help alleviate some of the anxiety around head injuries, regarding concerns about long term concussion, for medical practitioners, parents and school staff.
You can read the guidelines here.
Life Biotech Pty Ltd fined by the Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) has fined Sydney-based Life Biotech Pty Ltd (Life Biotech) $106,560 for allegedly failing to provide information and face mask samples to the TGA when required to do so and for providing false and misleading information.
Eight infringements were issued after Life Biotech allegedly failed to comply with providing the information and samples as part of a post-market review of face masks which were included in the Australian Register of Therapeutic Goods (ARTG).
Importers and manufacturers of therapeutic goods have ongoing responsibilities with respect to medical devices included in the ARTG. Under the Therapeutic Goods Act 1989, importers and manufacturers are required to facilitate access to technical documentation to demonstrate compliance with essential principles and to prove conformity assessment procedures have been applied.
The TGA uses a range of compliance and enforcement tools to ensure that integrity of the regulatory scheme. Persons suspecting non compliance may report illegal or questionable practices online to the TGA.
To read more on the fines imposed on Life Biotech, click here for a link to the TGA website.
Victorian Government set up virtual support centre for healthcare workers
On 8 February 2020, the Minister for Health Martin Foley announced the opening of the healthcare worker wellbeing centre (the centre) as part of a $9.8 million investment by the State Government. The centre has been established by the Victorian Government to support the mental health and wellbeing of healthcare workers.
The centre will be operated through Safer Care Victoria, and will provide support to all who work in clinical and non-clinical roles in health services, community health and aged and primary care settings. The centre will operate as a central resource for staff by directing them to existing tailored support programs. In the coming months, the centre is set to expand as it takes on feedback from healthcare workers on the care they need.
Organisational leaders and managers will have access to shared tools, resources and training to assist them to better support staff. The centre will also look at ways to create system level changes and embed worker wellbeing as a priority across the broader health system.
To subscribe to updates from the healthcare worker wellbeing centre and to get advance invites and notification on new resources, click here.
To read more about the State Government’s announcement, click here for a link an announcement from Premier Daniel Andrews.
Repurposing Medicines – TGA Consultation
The Therapeutic Goods Administration (TGA) has opened a consultation to understand the obstacles and benefits of repurposing existing approved medicines for new uses on the Australian Register of Therapeutic Goods (ARTG).
This consultation has been opened generally response to COVID-19, where research regarding existing medicines has been a key tool in developing treatments and vaccines. Currently, medicines listed on the ARTG can only be used for the therapeutic use that they are registered for which results in sponsors needing to make new applications to the TGA for a new use.
The benefit of repurposing medicines lies in the established record of safety for the medicines. As such, this consultation will not consider medicines not currently registered on the ARTG.
You can read an overview of the consultation, and provide a response, here. The consultation closes on 23 March 2021.
Outcome of Bacchus Marsh / Djerriwarrh Health Service Inquiry
The review of maternity deaths at the Bacchus Marsh / Djerrwarrh Health Service identifies many failings in management and clinical governance. It prompted a major reform of clinical governance for health services in Victoria and led to the creation of Safer Care Victoria.
Several health professionals were investigated by the Australian Health Practitioner Regulation Agency, and a number of senior practitioners have been subject to regulatory action.
This recent VCAT case relates to the then Director of Nursing.
Read the full Alert for more background information on the case, the outcome of the inquiry, and its practical implications for medical practitioners.
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