to increase patient safety and help optimize patient care by facilitating: • Traceability of devices, especially for recalls and other field-service corrective actions;
• Adequate identification of the device through its dis- tribution and use;
• Identification of devices in adverse events; • Reduction of medical errors; and • Documentation and longitudinal capture of data on medical devices.
HMT attended the recent UDI Conference, which was held in Orlando Sept. 18-19. For a relatively small event still in its infancy, it was well attended by approximately 400 people and 21 vendors, including: • VeriTeQ, the manufacturer of the world’s first implant- able RFID microchip cleared for use by the FDA as a UDI to identify medical devices and patients. (VeriTeQ also likely made the chip in your dog.)
• GS1 Healthcare US, one of 24 GS1 Healthcare user groups around the world that supports the adoption and implementation of global standards developed by GS1, the most widely used supply chain standards worldwide.
• PTC, specializing in solutions that aggregate, analyze and manage product information to drive strategy and achieve compliance.
• Ramtron, which pioneered the integration of ferro- electric materials into semiconductor products, called ferroelectric random access memory (F-RAM) and used in portable medical devices and radio frequency identification (RFID) systems.
• Label Vision Systems Inc. and Webscan, both manu- facturers of barcode verifiers that check conformance to standards.
• Manufacturers of UDI labeling and printing equipment, such as ID Integration Inc., Monode Marking Products Inc., Primera Technology Inc., RMI Laser LLC and Roland DGA.
• And several software companies specializing in solutions related to UDI, including A2B Tracking Solutions, Acsis Inc., Evanhoe & Associates Inc., Global Healthcare Exchange (GHX), PRISYM ID, Seagull Scientific and TEKLYNX International.
The highlights of the event were the conference sessions led by FDA reps and pioneers in the medical device indus- try, who explained how UDI will advance patient safety by improving the ability to keep track of devices, monitor adverse events and maximize the value of electronic health records (EHRs). Jay Crowley, senior advisor for patient safety, Center for Devices and Radiological Health, FDA, says medical devices include a wide range of medical products, such as traditional hospital-based devices (beds, ventilators, monitors, infusion pumps, etc.), implants, patient/home-use devices (glucom-
Example of what a universal device identifier (UDI) would look like on a medical device label. The label contains information about the product name, its expiration date, reference and lot numbers, manufacturer information, barcode, details about the item and an illustration.
eters), disposables, accessories (test strips, catheters), in vitro diagnostic devices (IVDs) – both clinical labs and point of care, health information technology (HIT), convenience kits, combination products and products used at alternative sites, such as a home or dentist’s office. According to Ken Koldan, chair of the Association for
Automatic Identification and Mobility (AIM) North America UDI Committee, UDI transactions comprise three parts: 1. Reformat existing data using approved issuing agency; 2. Encode into auto ID and data capture (AIDC) format; and 3. Update database (UDID).
“The unique device identification database (UDID) is a repository of UDI information for all marketed medical devices,” says Indira Konduri, UDID program manager. “The database serves two main functions: It captures the device identifier (DI), and it unlocks and integrates device informa- tion from multiple sources.” According to Crowley, the UDID will include the device identifier type/code, make/model, brand/trade name, clini- cally relevant size, device version number and GMDN (global medical device nomenclature) classification. Crowley says organizations should start implementing UDI
now: Develop a UDI code, created and maintained by the product manufacturer, according to ISO 15459 (the inter- national standard for naming medical devices), and including a device identifier (DI) and production identifier (PI). The label or mark needs to have a human-readable identification (HRI) component and be encoded in a form of AIDC (the GS1 standard is most widely used; others include HIBCC, ICCBBA and DUNS). HMT will continue to cover UDI as it progresses from proposed rule to final rule, from implementation to how it will interface with EHRs.
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