Medical device supply disruptions

Medical device supply disruptions or shortages can occur because:

• 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
• there is an unexpected surge in demand of a particular material or product
• manufacturers or sponsors have discontinued a device.

We survey national supply disruptions of critical devices impacting multiple jurisdictions and work with affected stakeholders to minimise the impact.

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.

Serious supply disruptions

We will follow up on reports of serious supply disruptions.

We do this using a risk-based approach. To help minimise 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
• 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 to us. We encourage sponsors to let us know about potential supply disruptions.

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 keep on top of things. This centralised approach helps avoid multiple calls from hospitals.

There are times when we can help gather stock and order information. This helps sponsors and jurisdictions make decisions on where there are urgent needs.

Consumers

If there is a supply disruption 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.

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 serious supply disruption.

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 can limit treatment options or make some devices unavailable to patients.

Health professionals are crucial in helping patients find alternative devices or treatments.

When certain devices are in short supply, health professionals should exercise clinical judgement when deciding on treatment options.

Contact us

You can email us about potential supply disruptions.