Orthopedic companies should be allowed to continue distributing devices that don’t bear unique device identifiers even after the FDA’s compliance deadline, Globus Medical says in a recent citizen’s petition to the agency.
The final rule gives devicemakers three years to use or relabel preexisting stock after UDIs are required for new devices. For Class III devices, that deadline falls in 2018; for Class II devices, it’s a year later. After that, the agency may take enforcement action against companies whose products don’t carry UDIs.
That’s unrealistic for orthopedic implants because of their distribution model, Globus Senior Group Manager Kelly Quick writes in the petition. Because patients have such varying implant needs, devicemakers commonly provide many choices for each surgery. Implants that aren’t used are put back into storage, she says, adding that implants are paid for only when they are used.
The upshot of this model is that many implants could remain in commercial distribution, unsold, for years past the UDI compliance date. The process of recalling devices already shipped to healthcare facilities to apply UDI markings would be expensive, technically difficult and offer few benefits in terms of product traceability, Quick says. The FDA offered a similar pass to drugmakers when introducing universal product codes in 2004, she notes.
The issue isn’t a new one, says former FDA officer and UDI architect Jay Crowley, now vice president and UDI practice lead at USDM Life Sciences. When the FDA considered the question of consignment stocks during development of the UDI final rule, it concluded that two years to UDI implementation plus three years to comply was ample time to use up or relabel supplies.
“For FDA to consider this petition, it will need to consider more broadly the issues of consignment and existing inventory,” he tells IDDM. “It is not clear to me if they really want to do that.”