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This information is available to help anyone who would like to report a medical device disruption or shortage to us. It could be helpful if you are:
We monitor medical device supply disruptions and shortages at a national level across Australia. Reports provide us important information about what disruptions and shortages are occurring, where, and how critical these are.
Your report provides us important information that helps our awareness, monitoring and to assist in managing medical device supply disruptions or shortages. Your report may:
Reports are reviewed based on risk, such as where the medical devices have limited or no alternatives. We may need to contact you for more information about what you have reported, so providing contact details and consent is important.
Reporting via this form is to support information sharing related to potential shortages. If you require access to a device, you should talk to your healthcare provider or a medical device supplier.
Report potential medical device supply disruptions or shortages using the TGA's online form.
Anyone who is aware of a potential or actual medical device supply disruption or shortage can report these to us using the online form.
Advice about how to contact us if you are deaf, have a speech or hearing impediment, or need help with English are available on our website.
When discussing medical devices, two terms are used:
A supply disruption occurs when there is a delay in availability of a particular medical device or may be restricted to a region or be very limited in time.
A shortage occurs when the demand of a medical device has, or may, exceed supply. Alternative brands of the kind of medical device are also not available to meet the demand. A shortage can be prolonged and affects all patients in Australia who use it or who may need to use it.
When discussing medical device disruptions and shortages, there are a few terms used to describe the timing.
An anticipated disruption or shortage is when it is foreseeable or expected that availability becomes limited or reduced, for example, if something halts production or there are expected transport delays.
A current disruption or shortage is when there is no or insufficient availability to meet demand at that point in time.
A discontinuation is when the medical device is no longer manufactured or supplied.
Disruptions and shortages can occur for several reasons, some examples include:
Disruptions/shortages to one product can have flow on effects. Unexpected demand for a product that is being used as an alternative device may not be able to be met, therefore creating another disruption/shortage for that product.
When you submit a report, we need to work out what medical device you are submitting a report about. To help us, the following information can be provided:
If you are unsure how to identify the device, you can contact the person/company who sold you the device to ask for more information. If purchased in-person, you can ask for or provide us with any consumer information or promotional material. If purchased online, you could also provide us with the URL.
Please submit one (1) report per medical device. If you believe there are more devices affected, such as accessories or other sizes, there are spaces in the form for you to tell us about this.
All medical devices supplied in Australia have a legal entity responsible for them, the Australian sponsor. Their details should be provided to you on the products packaging or labelling.
If you are unsure who the Australian sponsor is but you know who manufactured or supplied the device to you, you can provide these details.
When you submit a report, we need to understand why there is a disruption or shortage. You will be asked questions about the reason, you can use the What is a disruption or a shortage section to help you with this.
Some additional context can be extremely helpful for us to triage your report.
If there is any additional information that you are aware of that may assist the team in reviewing your report to provide context or clarity, it would be welcomed.
Find more information about privacy here.
Find more information about how we treat your information here.
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