The IRIS inSite program works closely with health facilities to improve awareness amongst health professionals about medical device adverse event reporting. Health professionals play an important role in reporting problems that have caused, or could cause harm through quality issues, user difficulty or malfunction.
The program has a focus on three key actions:
Recognise - what is a medical device, what is a medical device event, how to report
Retain - keep the device and its packaging until you find out whether the TGA needs to examine it
Report - you don't have to be certain, just suspicious.
Reports received through IRIS inSite are analysed to identify potential emerging problems for detailed investigation. The program has had a positive impact on the frequency, rate and quality of reports received and consequently TGA's ability to safeguard the use of therapeutic goods in Australia.
A number of hospitals have agreed to join the inSite program, with TGA staff running training and education sessions across key clinical units to raise awareness of what and how to report.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.