Medical devices: identity tracking changes on the way (Global)

The FDA in the States has recently mandated that all healthcare equipment sold in the US will have to carry a unique device identifier (UDI), which is specific to a particular item and includes an identifying number and other information such as use-by date.Europe will follow suit as soon as the US requirements are confirmed. It is not a question of ‘if’, but ‘when’ and ‘how’. Roger Lamb, healthcare sector manager at GS1 UK is quoted in this article that “[when] you can attach specific device codes to individual patient records. In the case of the PiP implants, or where there might be a problem with a device affecting only one batch, you would quickly be able to identify both the devices and the patients affected…This is really great news for healthcare in the UK and for the supply chain as a whole.” Heads up thanks to Peter Range.