Purpose
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:
- unsure what sort of information is important to report
- unfamiliar with medical device terminology
- unsure where to look to find the information you need.
Why reporting is important
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.
How the reports will be used
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:
- provide us with a signal to investigate, or
- provide additional information/context on a known shortage, or
- help us manage disruptions and shortages occurring at a national level.
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.
Where to report
Report potential medical device supply disruptions or shortages using the TGA's online form.
Who can report medical device supply disruptions or shortages
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.
What is a disruption or a shortage
When discussing medical devices, two terms are used:
- disruption, or
- shortage.
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.
Timing
Timing
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.
Why do they happen
Disruptions and shortages can occur for several reasons, some examples include:
- a shortage of a raw material
- a shortage of a component
- a natural disaster/incident interrupts production
- a manufacturing site issue (e.g. quality control or certification)
- a transportation/shipping issue or delay
- an unexpected surge in demand
- a product is discontinued
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.
What information should you prepare
Device information
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:
- Device name
- Australian Register of Therapeutic Goods (ARTG) number
- Other identifying information, such as
- Unique device identifier (UDI)
- Product code
- Stock-keeping unit code (SKU)
- Catalogue number
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.
Device supplier information
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.
The disruption/shortage
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.
Helpful context
Some additional context can be extremely helpful for us to triage your report.
- How did you find out about the potential disruption/shortage?
- Do you have access to an alternative device or safe workaround?
- Is it a disruption or a shortage?
- The timing of the disruption or shortage.
- What is the known or potential extent or scale of the disruption/shortage?
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.
Privacy
Find more information about privacy here.
Find more information about how we treat your information here.
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