Advantages of Unique Device Identification (UDI)

There are still medical device companies that view Unique Device Identification regulations as a federal tax.  It’s true, UDI regulations will cost organizations money.  But, there are plenty of advantages worth noting.

• A device identification system provides the ability to connect the manufacturers, suppliers and the healthcare community with a shared electronic infrastructure to create clarity of each device’s specification for support and maintenance.

• UDI has the ability to create better visibility of demand so manufacturers don’t overproduce.  Healthcare facilities can share inventory information with distributors who could also share the information with manufacturers.  A clear picture of demand for medical devices can prevent over production.

Here are more benefits listed in the FDA’s Unique Identification System; Final Rule report.

• UDI regulations are expected to improve medical device event reporting by providing a standardized, reliable and unique identifier with which to report a problem device.  With more reliable identification of devices associated with an adverse medical event, FDA would be able to improve post-market surveillance of medical devices and detect problem devices more rapidly.

• FDA expects that more accurate and prompt identification of problems would lead to a reduced incidence of adverse events.  Public health safety alerts, for example, could be more accurate and timely.

• FDA expects that recall actions could more effectively target a problem device.

• FDA expects the increased accuracy of adverse medical device reporting and improved recalls would reduce the total number of adverse medical device events, although we are unable to quantify that reduction.