Medical device adverse event monitoring update - June 2025

Medical device incidents: why reporting matters

Sometimes, problems can happen when people use medical devices, including devices used for testing. These problems are called adverse events. They can hurt patients, caregivers, or health workers, or could have caused harm if they had not been caught in time- these are called near misses. Even if no one was harmed, it’s still important to report these events, especially if they were near misses.

The Therapeutic Goods Administration depends on reports from people who use or work with medical devices. This includes sponsors, health professionals, patients and carers. These reports help us to monitor safety and spot and respond to any new risks earlier.

More reports, better safety

We’re now receiving more reports about medical device issues. This is because of several recent changes that are helping improve how information is shared with us.

• Medical device companies are updating how they report problems and are sharing more information such as near misses and feedback from users and healthcare workers. They’re also making reporting more consistent with practices elsewhere in the world.
• Hospitals have started reporting adverse events under a new mandatory reporting scheme, which is now in the transition phase.
• The launch of the Australian Unique Device Identifier Database (AusUDID) is helping everyone- users, manufacturers, and the TGA- to identify specific device models more easily when something goes wrong.

These changes mean we’re getting more information, faster. It helps us to detect safety issues and respond earlier and more appropriately.

We will continue to work closely with any medical device company interested in making improvements in their reporting processes.

Why you may see more reports

You might notice that more reports are being made about certain devices. This doesn’t mean the devices are not safe. It just means more people are reporting issues, which helps to improve safety for everyone.

We will continue to review all reports and investigate any serious concerns. We thank sponsors, hospitals, health professionals and the wider community for helping us by sharing this important information.