Australia’s Therapeutic Goods Administration (TGA) has published an article this week on the introduction of the IRIS InSite program which encourages Health Facilities to submit problems that have caused, or could cause harm through quality issues, user difficulty or malfunction.
The regulator has successfully trialed the program in Australia’s Capital (close to the TGA offices), however no information has been shared with regard to increases in IRIS reports submitted.
Part of the program implementation will be training of health facility staff in the definition of a medical device, and more importantly, what and how to react to a potential adverse event. TGA says that they will be analyzing the submitted reports to identify trends and emerging issues.
What is unknown at this stage is the potential impact to local Sponsors and the manufacturer. We would anticipate an increase in requests from TGA to Sponsors on investigation results.
As per the normal TGA IRIS process, the TGA does expect that the manufacturer and sponsor will work together to ensure the complaint is managed and investigated as per TGA requirements and provide feedback to the regulator on request. Furthermore, it is unknown whether the TGA is recommending health facilities report the issue to their supplier (Sponsor).
All of this reinforces the need for Sponsors to ensure management of customer complaints as required. This should include a process to capture complaints and feedback to the Manufacturer.
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