How we manage your medical device adverse event report

We receive adverse event reports from consumers, healthcare professionals, and companies through our online web form and sponsor portal. Reports can also be submitted via e-mail.  See Report an adverse event or safety problem.

Online adverse event reports automatically go into our Incident Reporting and Investigation Scheme (IRIS) database. We manually enter reports in this database when we receive them via e-mail. We check all reports for completeness and accuracy.

Information we ask for includes the details of the adverse event, the product involved and other information, such as medical history, laboratory results and how the adverse event was treated. 

After 3 months, we transfer the reports data from our internal IRIS database to the public-access searchable database: Database of Adverse Event Notifications (DAEN) - Medical devices.

Healthcare facilities can also report on medical devices using our medical device Adverse Signal Detection and Event Reporting (ASDER) system. See Reporting of medical device adverse events by healthcare facilities.

Reports from healthcare facilities through the ASDER system are not added to the DAEN, as this data is only used for safety signal detection.

Healthcare facilities only need to report via IRIS or ASDER – they do not need to report through both.

All reports are risk-assessed to determine if further actions are required:

• A panel of scientific, engineering, and clinical experts review reports of concern after risk assessment to recommend appropriate actions.
• We prioritise serious adverse events that are assessed as high risk.
• We examine details and trends of incidents that led to injury or may lead to injury or with unusually high levels of occurrence.

Isolated incidents or incidents not likely to lead to injury or a detrimental effect to patients or operators are not routinely investigated. These are assessed as part of a trend analysis of the adverse event reports we receive.

If an incident is investigated, the investigator will:

• contact the sponsor/supplier of the medical device
• work with the sponsor/supplier and the reporter of the incident to resolve issues
• inform the reporter and sponsor/supplier of the investigation outcomes, and
• keep all reports confidential.

Medical device adverse event reports can lead to a variety of actions. When we identify a safety concern, we can:

• inform health professionals and consumers through alerts and articles in publications such as the Medical Devices Safety Update
• require changes to product labelling, or add warnings, precautions and adverse event information to the Product Information
• take market action to resolve a problem with therapeutic goods supplied in the Australian market (see Database of Recalls, Product Alerts and Product Corrections)
• cancel or suspend inclusion of the product in the ARTG, or limit the population in which it can be used, see the cancellations and suspensions database
• require the sponsor to provide additional user training material or user training activities
• require the sponsor to undertake post-market studies to continue to monitor the device  
• require no further action at this stage but continue to monitor for trends.

We also exchange information on significant incident investigations with overseas regulatory authorities.