Overview of how TGA manages medical device adverse event reports
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Database of Adverse Event Notifications
The TGA receives adverse event reports of medical devices from consumers, health professionals and the medical device industry.
The medical device incident reporting and investigation scheme (IRIS) manages all reports of adverse events or problems associated with medical devices.
The reports can be received from manual sources such as faxes, letters and e-mails or via the online web form available on the internet. Reports received by the online web form are entered automatically into the database. Reports received from manual sources are entered into the database by the TGA. All received reports are checked by the TGA for correctness and completeness.
All reports are risk assessed and entered into a database for future reference:
- serious adverse events are investigated immediately and given priority
- a panel of scientific, engineering and clinical experts will assess reports and recommend the appropriate type of investigation to undertake
- unusual incidents, incidents that led to injury or with unusually high levels of occurrence are routinely investigated
- 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
- reports that are to be investigated are assigned to the most appropriately qualified investigator
- reports, regardless of investigation, are notified to the suppliers for trending purposes
- the TGA has extensive expert knowledge, experience and testing facilities that may be used during 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
- treat all reports confidentially.
Steps following data analysis
There are a range of actions that can follow the analysis of medical device adverse event reports. These include:
- informing health professionals and consumers through alerts and articles on the TGA’s website and other publications
- requiring improvements to the product or changes to the instructions for use or product labelling, such as adding warnings and precautions
- recalling the product from the market
- withdrawing the market approval of the product, or narrowing the population in which it can be used
- requiring the sponsor to undertake additional user education
- referrals to the Office of Manufacturing Quality (TGA) for follow up inspections
- requiring no further action at this stage, but continuing to monitor for trends.
The TGA also exchanges information on significant incident investigations with overseas regulatory authorities.