Unique Device Identifier (UDI)
A standardized code that identifies a specific medical device throughout its distribution and use, comprising a device identifier and production information. UDIs support recall tracking, adverse-event reporting, and accurate documentation of implants used in surgical cases.
What is a Unique Device Identifier (UDI)?
A Unique Device Identifier (UDI) is a standardized code that identifies a specific medical device as it moves through distribution and use. It has two parts: a device identifier, which names the make and model, and a production identifier, which captures details such as lot number, serial number, expiration date, and manufacturing date.
UDIs appear on device labels in both human-readable and machine-readable formats, and they are registered in a public database so that any given device can be looked up and traced.
How is a UDI used in an ambulatory surgery center?
Because the UDI ties a physical device to its full identity and production history, it underpins recall management and adverse-event reporting. When a manufacturer issues a recall, facilities can use UDIs to pinpoint exactly which lots they have on hand or have already implanted.
For surgery centers that place implants and use single-use devices, capturing the UDI in the procedure record creates an accurate accounting of what was used in each case. That documentation supports patient safety, supply chain accuracy, and clean charge capture for implantable items.
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