Industry behind 'vast majority' of adverse event reports

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The TGA has issued updated statistics on adverse event reports in relation to medical devices.

According to the regulator, it received 3,841 adverse event reports in 2016 relating to medical devices, compared to 3,359 in 2015.

The "vast majority" of all reports - 3,122 or 81 per cent - were made by sponsors.

"There was a spike in reports from sponsors in 2014 and the number of reports returned to the longer-term growth trend in 2015," said the regulator.

The number of reports made by doctors increased from 54 in 2015 to 88 in 2016 - 2.3 per cent of all reports. "There was a spike in reports from doctors in 2012-13 due to issues with PIP breast implants."

In contrast, the number of reports from nurses increased from 134 in 2015 to 157 in 2016, whole allied health professionals provided 347 reports, up from 266 reports in 2015.

Consumers were responsible for just 2.5 per cent of reports - 97 - only a minor increase on the previous year.

The Consumers Health Forum recently said, while welcoming reform aimed at strengthening adverse event reporting, more needed to be done to encourage healthcare professionals to report medical device adverse events.