Medical device supply disruptions or shortages can occur for several reasons, some examples include:
- there is a shortage of a raw material or a component needed to manufacture the device
- a natural disaster or other incident prevents the manufacturer from operating normally
- a manufacturing site issue (e.g. quality control or certification)
- a transportation/shipping issue or delay
- there is an unexpected surge in demand
- manufacturers or sponsors have discontinued supplying a device.
We monitor national supply disruptions and shortages of critical medical devices and work with those affected to minimise the impact.
A supply disruption happens when there is a delay in availability of a particular medical device or the impact may be restricted to a region. The impact is often time limited. Sometimes there are temporary disruptions in supply of devices in certain localised areas. In these cases, suppliers address the disruption and state or territory health departments may monitor the situation
A supply shortage happens when the demand of a medical device has, or may, exceed supply. Alternative brands of the kind of medical device may also not meet the demand. Shortages can be prolonged and affect all patients in Australia who use the medical device or may need to use it.
Critical supply disruptions or shortages
We receive reports from various sources about disruptions and shortages.
We use a risk-based approach to follow up and reduce the impact of a medical device supply disruption on patient care.
We may:
- undertake an assessment of the priority and urgency of a supply disruption signal
- contact the sponsor of the device to confirm that there is a supply disruption
- find similar alternative devices in the Australian Register of Therapeutic Goods (ARTG)
- check stock levels/availability of similar devices
- provide information to state and territory health departments
- seek alternate products for supply into Australia.
Sponsors
There is no legislated requirement for reporting potential medical device supply disruptions or shortages to us. However, we encourage sponsors to let us know by reporting potential supply disruptions through our online form.
Early notification helps health care facilities mitigate the effects of supply disruptions on patient care. Sponsors should work closely with manufacturers to receive regular updates and be notified of potential disruptions.
Due to the urgency of some supply disruptions, we may request information with very short timelines. Getting interim updates means we can help jurisdictions and healthcare providers keep on top of things. This centralised approach helps avoid multiple calls from hospitals.
For critical or lifesaving devices, sponsors may also consider supplying unapproved devices from overseas. This can be done through the Special Access Category A or Authorised Prescriber Schemes or the section 41HD pathway.
Consumers
If there is a supply disruption or shortage for a device you use, there are often other similar devices (or brands) available in the Australian market. You should talk to your doctor, pharmacist, or other healthcare professional about alternatives.
You can also access a three-month supply (per order) of certain devices from overseas via the Personal Importation Scheme. Be aware of risks with importing a medical device not approved for supply in Australia.
Serious supply disruptions may affect hospitals’ ability to provide treatment or surgery to patients. We work together with state and territory health departments and suppliers to manage them.
You can use our online reporting form if you would like to let us know about a supply disruption or shortage you are experiencing with your medical device.
Hospital procurement/healthcare facilities
State and territory health departments and private health facilities should:
- contact suppliers, including notification of clinical need
- put in place a system for alerting and collating medical device supply disruptions from health providers
- manage localised supply issues
- notify us if a situation escalates or is likely to escalate to a critical disruption or shortage.
When there are serious device shortages, health professionals play a key role in reviewing internal policies and clinical guidelines to ensure devices are allocated according to clinical need. A delay in elective health care may be necessary, or a substitute device may be available.
For critical or lifesaving devices, healthcare professionals may apply to access unapproved devices from overseas. This is through the Special Access Category A or Authorised Prescriber Schemes.
Health professionals
Supply disruptions or shortages can limit treatment options or make some devices unavailable to patients.
Health professionals are crucial in helping patients find alternative devices or treatments. You may also report disruptions or shortages to us using our online form.
When certain devices are in short supply, health professionals should exercise clinical judgement when deciding on treatment options.
Contact us
You can complete our online form to notify us of a medical device disruption or shortage. You can email us if you have questions.