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Unlocking the power of barcoding

In healthcare, barcodes have been used primarily for asset tracking. But unique device identification (UDI) is about to change that.

By Phil Colpas

hen you go grocery shopping, all your pur- chases are scanned, itemized and listed on your receipt. But if you have to go to a hospital, there isn’t a universal system in place to scan and catalog all devices used on you or implanted within you. According to researcher Lee Ann Jarousse: “Lack of data standards in the healthcare supply chain make it difficult to track and trace products, creating inefficiencies that raise cost and impact patient safety” (“Data Standards in the Supply Chain”).

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That’s all about to change with the implementation of unique device identification (UDI). On Sept. 27, 2007, President George W. Bush signed into

law FDAAA (Public Law 110-85). Section 226 of FDAAA amended the Federal Food, Drug and Cosmetic Act by re- quiring the Food & Drug Administration (FDA) to develop regulations establishing a unique device identification (UDI) system for medical devices. After years of work, the FDA has finalized its proposed rule, comments on which are due by Nov. 7, 2012. According to the rule summary: The system established by this rule would require the label

6 November 2012

PHOTO COURTESY HONEYWELL For demanding healthcare applications such as bedside point of care, specimen collection and inventory management, Honeywell’s Dolphin 7800hc rugged enterprise digital assistant (EDA) delivers multi-purpose computing, communication and data collection at desktop-like speed. The unit reads linear and 2D barcodes.

of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device, such as devices sold over the counter and low-risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be suf- ficient; for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database (UDID) that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribu- tion and use.

For more information on UDI, check out www.fda.gov/udi.

The Global Harmonization Task Force (a voluntary in- ternational group of representatives from medical device regulatory authorities and trade associations from Europe, the United States, Canada, Japan and Australia) says a glob- ally harmonized and consistent approach to UDI is expected

HEALTH MANAGEMENT TECHNOLOGY www.healthmgttech.com

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