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.

For more information on the program please contact: iris@tga.gov.au