The FDA released a proposed rule on its long-awaiting "unique device identifier" system for tracking and monitoring medical technology.
The rule would require most medical devices to carry labels with unique codes and scannable barcodes that will allow healthcare providers, regulators and the public at large to track the devices and monitor safety.
"The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," according to the proposal.
The UDI program will assign unique codes to most medical devices and would gather data to be stored in a public database.
While not required for patients’ medical records, the FDA also hopes the codes will be useful for physicians by allowing them to electronically capture information such as a device’s history and use, or even helping identify device shortages or counterfeit products.
The system has been a long time coming. Congress initially approved the UDI program in 2006 to enable tracking of medical implants and to add medical devices to the Sentinel post-market surveillance program that currently monitors prescription drug safety.
"FDA consulted extensively with the medical device industry, the broader healthcare community, and other stakeholders in the development of this proposed rule and invites comment on whether the proposed approach achieves these goals while minimizing burdens to the maximum extent possible," according to the proposal. "A final rule would become effective in stages, over a period of 7 years, to ensure a smooth implementation and to spread the costs and burdens of implementation over time, rather than having to be absorbed all at once."
The FDA’s latest user fee agreement, which breezed through Congress and is now awaiting a final sign-off from President Barack Obama, contained updated timelines for the UDI program.
The federal watchdog agency will grant a 120-day comment period to gather suggestions on the UDI proposal and must then issue a final rule within 6 months, meaning the FDA has until April 2013 to define the program.
Implantable medical devices must begin carrying UDI labels within 1 year, according to the proposal, although the user fee law provided 2 years for initial launch.
Lower-risk Class II medical devices will likely roll out UDI programs in phases in the years thereafter. Devices exempt from labeling requirements include those sold directly to consumers at retail stores; those delivered directly to hospitals and other care facilities; and Class I devices.
The FDA also took pains to work with healthcare regulators around the world to establish global protocols for device makers outside of the U.S.
"They worked very hard to globally harmonize the regulations," Global Healthcare Exchange industry relations executive director Karen Conway told MassDevice today. "They’ve worked with a group called the Global Harmonization Task Force, which includes areas like the U.S., the European Union, Canada, Australia, Japan and China to create a framework document, that they published last year, that’s designed to be a kind of guideline for regulators around the world."
The guidelines aim to foster consistency among regulations in various countries, Conway added, as global manufacturers will need to comply with the new UDI guidelines when selling devices into the U.S.
The UDI system represents a big shift in medical device surveillance, but the FDA worked extensively with device makers and other healthcare providers to ensure that the program would represent a reasonable burden with respect to the most benefit gained.
The biggest challenges will be for device manufacturers, Conway told us, especially those with multiple production lines.
"You should really look at this in 3 parts," she said. "It’s about assigning the codes, it’s about labeling the products and it’s about providing the associated attributes that are tied to the identifiers to the FDA."
"They need to make changes to their production lines that enable them to label their products appropriately," Conway told us. "They need to figure out what products are covered by regulation, they need to figure out when a product changes is it an enhancement or a new product that would require a different identifier. They need to look at things like the paper and ink they use to make sure the identifiers on the labels can be read by machines."
"It’s something that people need to be preparing for now," she said.