Millions of people young and old are walking around with a variety of implanted medical devices—from artificial hips and knees to heart valves and pacemakers, spinal screws and rods, breast implants and ear tubes—that are improving their health and well-being. That is, as long as the devices are safe and effective.
In September, the U.S. Food and Drug Administration (FDA) took steps to improve patient safety. The FDA issued a final rule on the Unique Device Identification System, which requires that most medical devices distributed in the United States carry a unique device identifier (UDI). The system is designed to facilitate quick and efficient identification of recalled devices, improve accuracy and specificity of reports about adverse events, and provide a foundation for a global, secure distribution chain to thwart counterfeiting and diversion.
In addition to implantable and single-use medical devices, the ruling applies to devices that may be used multiple times, such as surgical instruments and some life-supporting and life-sustaining devices. According to the FDA, a UDI will be required on the device itself if the device is intended to be used more than once and to be reprocessed before each use. In all cases, device manufacturers must submit data to the FDA-administered Global Unique Device Identification Database (GUDID), which will serve as a reference catalog.
"The UDI system will provide all stakeholders—health-care professionals, patients, industry, researchers, health-care community and other government agencies—with a consistent and standardized way to identify devices throughout their distribution and use," says Jennifer Rodriguez, press officer in the FDA's Office of Media Affairs. "The data in the GUDID will be foundational to realizing benefit from the UDI system. As UDIs become part of electronic health records, clinical information systems, claims data and registries, the FDA and other stakeholders can use the device identification information in the GUDID to make reliable, meaningful links across these data sources and the clinical information contained in them, within the constraints of patient privacy protection."
Medical device manufacturers that adopt RFID to meet UDI requirements should expect the effort to involve a large capital expenditure, including buying tags and building the infrastructure, says Faisal Ghaus, VP of TechNavio, a global technology research firm. But, he adds, there will be a return on that investment. From an operational standpoint, Ghaus says, the implementation of the UDI ruling will help eradicate counterfeit products that account for revenue losses for major companies. It also will allow companies to employ better inventory management across the product's value chain, since expiration dates, manufacturing dates, batches and so on will be identified almost instantaneously.
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