Some supply-chain experts are questioning why a coalition of healthcare organizations sent a letter to the Food and Drug Administration urging the agency to publish a universal device identification, or UDI, system rule that specifically supports the use of standards created by GS1—a not-for-profit organization that develops supply-chain tracking systems.
Suppliers question push for lone device ID system
The letter, sent July 7 by the Advancing Patient Safety Coalition—a group of provider, healthcare-quality and patient-advocacy organizations—took the FDA to task for taking “an unreasonable amount of time to publish a proposed rule” for a UDI system. Congress mandated development of a system in 2007 with the passage of that year's FDA amendment act. The system would use universal codes assigned to manufacturers and their specific products to track movement of medical devices.
Supply-chain officials said they are waiting on the FDA to stipulate what type of tracking and product-specification information should be gleanable from the code. An FDA spokesman said the UDI rule is under development and that the agency hopes to publish it this year.
UDI system advocates say it would promote a broad range of improvements, including patient safety, comparative effectiveness and cost reduction. But while nearly all supply-chain experts agree that creation of a UDI system is crucial, some take issue with the coalition's request that the FDA endorse a single set of standards. They argue that the supply chain could incorporate GS1 and Health Industry Business Communications Council standards.
“I have items in my warehouse that are labeled with GS1 and HIBCC codes and my scanners are capable of reading both,” said Ted Almon, president and CEO of the medical product distributor Claflin Co. Almon said he is suspicious of the effort by some to push the industry toward the adoption of a single set of standards, and that it would be costly for companies that are already using the HIBCC system to switch to GS1. “It's the antithesis to the healthcare reform” law's focus on cost savings, he said.
But Nancy Foster, vice president of quality and patient-safety policy for the American Hospital Association, one of the more than 25 groups signing the letter, said there is significant value in a single standard. She noted that standards organizations can have different methods of identifying what constitutes a product unit, and that can make it impossible for hospitals to cross-reference products.
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