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Earlier this week, HSCA formally submitted comments offering recommendations to the Food and Drug Administration on its proposed rule to establish a Unique Device Identification System (UDI) for medical devices. HSCA applauded the FDA for highlighting the potential for improved reporting of adverse medical device events and efficiency in removing recalled devices, as well as reduced device-related medical errors.
“A UDI system properly aligned with the GS1 standards so widely recognized worldwide, will not only achieve the numerous health benefits identified by the FDA in its proposal and its preliminary regulatory impact analysis, but will also yield huge savings to the healthcare system that will far outweigh any costs incurred by manufacturers, suppliers or providers,” said HSCA President Curtis Rooney in the letter.
The GS1 system employs a series of Identification Numbers to identify physical things like trade items, assets, logistic units and locations; as well as service relationships between provider and patient. It is one of the most widely used supply chain standards in the world.
“Without standards, various actors along the supply chain often develop their own system for identifying products and recording data, resulting in numerous proprietary standards that healthcare suppliers and providers must manage. Numerous standards lead to inefficiencies and inaccurate data, which lead to unnecessary costs. Global standards promote simplicity, consistency, and accuracy in supply chain communications,” added Rooney.
A 1996 study, Efficient Healthcare Consumer Response, estimated that $11 billion is wasted in the healthcare supply chain each year as a result of inefficiencies and errors attributable to the absence or under-utilization of data standards.
“The ability to track and recall faulty medical devices is critical to protecting the health of American patients, many of whom depend on medical devices in their day-to-day lives. Unique device identifiers will help ensure that patients can be quickly located and alerted in the event of a recall, and that patients do not continue to use devices that may be harmful to their health,” added Rooney.