Introduction
Over the last few years, the U.S. healthcare industry has rallied around establishing a unique device identification (UDI) system that will provide a platform for communicating accurate, reliable information about medical devices to stakeholders who need information about the device. A UDI system will enable many benefits, including faster and easier recalls, improved traceability, more effective counterfeit detection and abatement, increased accuracy in electronic transactions and information sharing, reduced costs and, most importantly in the healthcare industry, improved patient safety. For patient safety reasons, the U.S. Food and Drug Administration (FDA) is not only interested in developing a UDI system in the U.S., but would like to see the adoption of such a system globally for the healthcare industry.

Challenges in medical device identification            
The U.S. medical device industry is diverse, and devices vary dramatically in size, complexity, packaging and use. Medical devices cover a wide range of products – everything from complex imaging systems, implants, hospital equipment and supplies, clinical lab products, dental care, home care and over the counter devices. Some items are packaged individually, others in boxes, and some are not “packaged” at all. They may be implanted in patients, used once and thrown away, used and reprocessed, or used for many years until next generation models are launched.

Sharing information about a device is inherently complex. From the time a device is manufactured to the time it is used in patient care, information about the device is passed up and down the healthcare supply chain many times with all of the distributors, group purchasing organizations, hospitals and users in between. The lack of data standardization adds further complexities to these interactions, as the information shared is oftentimes inaccurate, duplicative, out of date or confusing.

Today, hospitals and their suppliers use thousands of different numbers to electronically track devices. The U.S. Healthcare information systems are filled with inaccurate and manually created item and company names, and self-created numbering systems that differ from user-to-user and vendor-to-vendor, creating an environment for data exchange that is fraught with errors and inconsistencies which creates both inefficiencies throughout the supply chain and potential impact on patient safety.

Lack of consistent device identifiers in healthcare has been a long-standing problem, yet is one that can be solved with the industry-wide adoption of consistent global identification standards across the industry and the implementation of systems to provide accurate data throughout the healthcare system. After many years of research and industry input, hospitals, distributors, manufacturers and other key stakeholders are now coming together to collaborate on the use of data standards to improve patient safety.

The solution: Critical visibility through UDI
The FDA’s Sentinel Initiative is intended to strengthen FDA’s ability to query data systems for relevant device information after a device is on the market. In today’s environment, with no UDI system in place, there are many challenges in doing so. UDI will vastly improve our understanding of medical device use, post-market surveillance, and adverse event reporting. UDI will facilitate the ability to identify and locate medical devices, whether physically in route to a hospital or recorded in a patient’s EHR, or in hospital information systems.

Inaccurate and inconsistent data about medical devices plague the healthcare system today, with potential serious consequences. For example, in 2007, the FDA received more than 100,000 reports of adverse events associated with medical/surgical devices: 15% of the reports lacked model or catalog numbers, 50% of the reports lacked lot numbers or other production identifiers, and more than 10% lacked needed information in both categories. Because there is no consistent, systematic way to gather information about these devices, the FDA receives information that varies widely from one reporter to the next. With a UDI system in place, the reporting of adverse events would be more seamless, with more complete information, so that the FDA can strengthen its ability to monitor the safety and effectiveness of device use and adverse events and take action when needed.

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