For some GPOs, however, this is too slow. "The proposed seven-year staged implementation timeline is too long," the GPO Premier Inc. said in a press release this week. The GPO said all devices should be labeled within two years, and those products that need direct marking in three years.

Novation, the second largest GPO by purchasing volume, according to a Healthcare Purchasing News database, also wants to speed things up. "Given the clear and substantial benefits that will be found through the adoption of a unique identification system, Novation encourages the FDA to move forward with implementation as expediently as possible," the group said.


Too fast

Medical device manufacturers, perhaps unsurprisingly, disagree, and they stress the expense and cost of switching over to the new system: they will have to buy and install new labeling machines in factories, implement and validate production software and train staff.

In its comments submitted to the FDA, AdvaMed urged the agency to delay Class III requirements by one year, for a two-year post-final rule effective date. "There is no direct device safety and effectiveness issue that is compromised by extending the effective date for Class III devices by one year, and doing so will assist regulated persons and those in the health care community to integrate the UDI into their daily practices effectively," the group wrote.

The lobby also wants to clarify what they say could be one of the biggest troublemakers with implementing the system: what to do about devices that were created before the regulations take effect. That's why AdvaMed is asking that the rules be prospective, and only apply to devices produced after the effective date.

"The cost of applying UDI requirements to existing inventory once an effective date is reached is huge," AdvaMed said in its comments. "For example, sterilized devices cannot, in all cases, be safely and economically re-labeled, re-packaged and re-sterilized, and therefore, must be destroyed. Other devices that arguably could be reprocessed would present such large expense that doing so would be impractical. More importantly, such massive reprocessing would interfere with other device production, thus threatening potential shortages and an endangerment to public health."

Financial impact

AdvaMed has tried to come up with some figures to show how costly implementing UDIs would be to the industry, specifically focusing on the impact of direct marking.

According to an Accenture survey of 18 companies commissioned by the lobby and released Thursday, three-quarters expect significant costs for switching production lines to direct marking. The total associated costs per packaging line averaged around $125,000, according to the survey. All told, about 44 percent of respondents said they'd have to spend upwards of $1 million to purchase new manufacturing equipment, and the complete one-time cost of putting the system in place for all respondents was nearly $80 million.

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