In July 2018 I published a blog about being ready for unique surgical instrument identification (UDI) and its implications for Australia and New Zealand.
Since then, the therapeutic goods administration (TGA) in Australia has released a consultation paper relating to the implementation of UDI.
The purpose of this blog is to look at the document and provide an update on what’s happening with the implementation of UDI in Australia.
In September 2013 the US Food & Drug Administration (FDA) implemented regulations establishing a system to identify surgical devices through distribution and use. Under this rule, each medical device must be labelled with a Unique Device Identifier (UDI).
The UDI needs to be directly marked on the device itself if the device is intended to be used more than once and to be reprocessed before each use.
