The Advancing Patient Safety Coalition, a group of provider, healthcare-quality and patient-advocacy organizations, has sent a letter to Food and Drug Administration Commissioner Margaret Hamburg urging the agency to publish a rule establishing a unique device identification, or UDI, system.
In the letter, the group said the agency was taking "an unreasonable amount of time to publish a proposed rule" for a UDI system, which Congress mandated be developed in 2007 with the passage of that year's FDA Amendments Act. The system would be used to track movement of medical devices from the point of manufacture to their use in patients. Advocates for a UDI system say it would promote a broad range of healthcare system improvements, including patient safety, comparative effectiveness of medical devices and cost reduction through supply-chain efficiencies.
“The UDI is critical to patient-safety improvement initiatives as well as implementing electronic health records and the delivery system reforms included in the recently enacted health reform bill,” the coalition wrote in its letter. The group said the continued lack of a universal tracking system puts patients at risk for receiving defective or counterfeit medical devices and makes recalls on products difficult.
The 25-organization coalition, which includes groups such as the American Hospital Association, the North American Spine Society and the Association for Healthcare Resources and Materials Management, also specifically asked the FDA to establish a UDI system that supports use of GS1 standards. Although GS1 is not the only organization to have developed tracking and identification standards, the not-for-profit organization's standards are broadly used in international markets to track healthcare products. Several U.S.-based group purchasing organizations, large providers and manufacturers have said they plan to adopt and implement the use of GS1 standards by 2012.