Logistics

What does the new identifier entail?


The FDA said because 35 to 50 percent of devices are already coded with existing systems, such as GS1's Global Trade Identification Number (GTIN) or the Health Industry Bar Code (HIBC) put out by the Health Industry Business Communications Council (HIBCC), it would be "inefficient and counterproductive" to develop its own system. Instead, the existing systems could be used, provided the administering organizations apply for accreditation.

As mentioned earlier, on the device, the UDI appears in two formats: plain text and machine-readable. For the machine-readable part, the FDA said it would be agnostic as to what automatic identification and data capture, or AIDC, technology is used: bar codes, RFID, near field communication and others are all acceptable.

Timeline

The rule hasn't been published by the Federal Register yet. Once that happens, likely within a week, stakeholders will have a 120-day period to comment on the regulation. After that wraps up, the FDA plans to phase in different aspects of the rule over the next seven years.

"Phasing in UDI labeling requirements over several years allows all parties -- FDA, device labelers, hospitals and other device user facilities, and health care professionals -- to prepare for, and implement, the requirements in an orderly, efficient manner," the FDA said. "It also provides FDA the opportunity to clarify any confusion in implementation within the scope and authority of this rule, after it is finalized."

A year after the finale rules are published, device makers would have to include a UDI on the packaging or label of a Class 3 device, which includes the riskiest products, such as pacemakers. Two years later, all devices in Class 2, a category that includes most imaging equipment, would require the UDI. And two years after that it would apply to Class 1, the least-risky items.

Certain devices, such as implantables, software and reusable products that have to be sterilized between each use, would require the UDI as a permanent marking, the FDA said. This would be instituted from three to seven years after the final rule is published, with the riskier devices getting UDIs first.

Reactions

Patient advocates welcomed the publication of the proposed UDI rules, with Consumers Union senior policy analyst Lisa Swirsky calling them "long overdue."

“Effective post-market surveillance of medical devices depends on having UDI in place," she said in a statement.

Premier healthcare alliance, a group purchasing organization, also cheered the UDI rules, with Blair Childs, senior vice president of public affairs for the GPO, saying the rules bring us "one step closer to a UDI system that will enhance adverse event reporting, a safety gap that the Institute of Medicine said made it impossible to draw conclusions about the safety of medical devices."

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