The FDA has proposed a risk-based approach that would require manufacturers to implement UDI standards over a seven-year period, beginning with the packaging of certain high-risk devices one year after the final rule is published.
Several organizations are calling for a shorter implementation period, according to comment letters submitted to the agency. They include the American Hospital Association, BayCare Health System, GNYHA Ventures, the Healthcare Supply Chain Association, Novation, Premier and the Strategic Marketplace Initiative.
Although legislation was passed five years ago that required the development of the UDI system, the rule was delayed until this year when the user-fee legislation mandated that the FDA issue the proposed rule this year.
“Safety advocates and patients have waited a long time for the UDI—we see no compelling reason to wait an additional seven years,” the AHA said in its letter.
The AHA recommended a phased implementation that would require the packaging and direct marking of a high-risk device take place one year after the final rule is issued. The FDA's current proposal requires a device's packaging to be marked with a unique identifier two years before the direct marking of the device itself.
However, manufacturers say the proposed implementation period doesn't give them enough time.
The Advanced Medical Technology Association is proposing that the manufacturers of high-risk devices have two years to comply with the final UDI rule, rather than one year, while the Medical Imaging and Technology Alliance said the one-year deadline for high-risk devices is “insufficient.”
AdvaMed also said it “questions the logic and usefulness of directly marking implantable medical devices” and noted that the FDA has “failed to make the case in this proposed rule that directly marking implants with UDI will provide more benefit than risk to the public.”
Janet Trunzo, AdvaMed's senior executive vice president of technology and regulatory affairs, said during a call with reporters that the proposed rule on UDIs was one of the most extensive and complex regulations to be issued by the FDA in recent years.
Comments submitted by more than 100 organizations addressed a number of topics, including the format of the dates on the labels, whether kits assembled for hospitals should be subject to UDI requirements and the role of the agency that issues the identifier. The proposed rule would allow for multiple issuing agencies, including the FDA and other standards organizations, which most providers and GPOs oppose.
Another concern for some stakeholders is how successful the UDI system can be if providers, which are not regulated by the FDA, are not required to participate.
BayCare Health System in Tampa, Fla., and Children's Medical Center in Dallas both cited financial concerns tied to participation.
The proposed rule doesn't recognize the technology and labor costs that are needed to incorporate the UDI into a hospital's electronic health record, said Judy Lipscomb, vice president of materials management for BayCare. “There's still a lot of unknowns,” she said.
Strategic Marketplace Initiative, a not-for-profit organization that counts integrated delivery networks, academic medical centers and manufacturers as its members, said it is working in Washington to encourage the adoption of the UDI system with providers.
SMI has proposed that adoption of the UDI system become a required component of meaningful-use requirements. It also recommended that the government offer financial incentives to providers to encourage adoption or make UDI adoption a requirement of Medicare participation.
The organization met with staffers at the CMS, the Senate Finance Committee and the House Ways and Means Committee last year and will continue to advocate for incentives to encourage UDI adoption, said Thomas Hughes, SMI's executive director.
“I'd hate to see a hospital wait 20 years to do something,” Hughes said.
