How TGA manages medical device adverse event reports

We receive adverse event reports from consumers, health professionals, and companies through the online web form and sponsor portal. The reports can also be submitted via e-mail or post in case of difficulty submitting online forms.  These reports are received and managed under the Incident Reporting and Investigation Scheme (IRIS).

Reports received by the online web form automatically go into the database. Reports received via e-mail or post are entered manually in the IRIS database. We check all reports for completeness and accuracy.

Data analysis

All reports are risk-assessed to determine further actions:

• a panel of scientific, engineering, and clinical experts review reports of concern after risk assessment to recommend appropriate actions.
• serious adverse events that are assessed as high risk are investigated immediately.
• incidents that led to injury or may lead to injury or with unusually high levels of occurrence are routinely investigated.
• reports that require investigations are assigned to the appropriately qualified investigator.
• 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 received by the TGA.
• we have expert knowledge, experience, and testing facilities that we use during these investigations.

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.

Steps following data analysis

Medical device adverse event reports can lead to a variety of actions. These include:

• informing health professionals and consumers through alerts and other publications
• requiring changes to the product, the instructions or labelling
• recalling the product from the market
• withdrawing market approval of the product, or narrowing the product’s use
• requiring the sponsor to undertake additional education
• referrals to the internal stakeholders of the TGA for follow up investigations, and
• requiring no further action at this stage but continuing to monitor for trends.

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

Reporting problems

Reporting adverse events (side effects to medicines and problems with medical devices) helps make medicines and medical devices safer for everyone.

More information