TGA safety monitoring of medical devices
Database of Adverse Event Notifications
The TGA, like other regulatory agencies around the world, monitors the safety of medical devices to contribute to a better understanding of their possible adverse effects when they are used in the market place and outside of any pre-market assessment. This is a part of the ongoing monitoring and compliance activities undertaken by the TGA.
Adverse event reports provide important information for the medical device safety monitoring program.
The TGA monitors the safety of medical devices marketed in Australia using:
- reports of adverse events
- post market reviews of medical devices
- annual reports submitted for class IIb implantable, class III and Active implantable medical devices (AIMD)
- audits of the manufacturer's facility, records and quality systems
- testing of the medical device (onsite or taking samples off site) to confirm compliance with essential principles
- reviews of literature
- sharing of information with other regulatory agencies
- sharing of information with Australian state and territory health authorities.
For further information on TGA's approach to safety monitoring of therapeutic products (including medical devices), see Therapeutic product vigilance.
Adverse event reports
Anyone can report an adverse event:
- reports by consumers and health professionals are voluntary
- sponsors are obliged to report any adverse events associated with a medical device of which they are aware.
All medical device adverse event reports made to the TGA are risk assessed. Reports selected for investigation are investigated by scientific, engineering and clinical experts within TGA.
Where appropriate, the TGA shares medical device adverse event reports with overseas regulatory bodies and uses reports from those regulatory bodies in its investigation of safety signals associated with medical devices supplied in Australia.
Signal detection involves identifying patterns of adverse events associated with a particular device that warrant further investigation.
A medical device safety signal may arise from:
- a previously unrecognised safety issue
- a change in the frequency or severity of a known safety issue
- identification of a new at-risk group
- use of the device different to that intended by the manufacturer.
Steps following the identification of a potential safety concern
Once a safety signal has been detected it is assessed to determine the nature, magnitude and significance of the concern, and the impact on the overall benefit risk profile of the device.
The information in adverse event reports is insufficient to determine the exact level of risk associated with that medical device. Other information is necessary to assess the impact of reported adverse events on the benefit-risk profile of the device.
The TGA has to consider the balance between the benefits offered by any medical device and the potential risks associated with its use for the Australian population as a whole (or individual patient groups where the risks may be higher) before it makes a decision on the response to the signal. There are a range of actions that can follow when a potential safety issue is identified. These include:
- informing health professionals and consumers through alerts and articles on the TGA's website and other publications
- requiring changes to product labelling, such as adding warnings, precautions and adverse event information to the Product Information or device label
- withdrawing the market approval of the product
- compliance testing of device
- referral to the Office of Manufacturing Quality (TGA) for follow up audits
- recalling the device or particular batches of the device
- requiring no further action at this stage, but continuing to monitor the signal.
The Advisory Committee on the Safety of Medical Devices (ACSMD)
The TGA may seek advice on medical device safety from the Advisory Committee on the Safety of Medical Devices (ACSMD).
ACSMD provides advice to the TGA on:
- the safety of medical devices
- risk assessment and risk management of medical devices
- performance of medical devices supplied in Australia.
Consultations with health professionals
The TGA cannot give medical advice to individuals and strongly encourages consumers to talk with a health professional if they think they might be experiencing an adverse event related to a medical device.
The benefits and the risks of a medical device to an individual need to be considered, along with the risks involved if the device is not used. The decision to use or undergo an intervention involving a particular device should be made between the patient and the patient's health professional, and should entail informed consent.