Karen Conway, executive director of industry relations for GHX, a company that automates supply chain management, told InformationWeek Healthcare that the FDA has had discussions with the Office of the National Coordinator of Health IT (ONC) about including UDI in stage 3 of the Meaningful Use program.
She said that in the meantime, device suppliers want health IT vendors to incorporate communication protocols that will allow UDIs to flow into EHRs after the FDA announces its UDI regulations.
There is no mention of the UDI in the Meaningful Use Stage 2 proposed rule. The only allusion to medical devices in the proposed final rule on EHR certification and standards requires the use of the Agency for Healthcare Research and Quality's Common Format to capture information on patient safety incidents. Both rules were published in the Federal Register on March 7, kicking off a 60-day public comment period.
[ Most of the largest healthcare data security and privacy breaches have involved lost or stolen mobile computing devices. For possible solutions, see 7 Tools To Tighten Healthcare Data Security. ]
Conway said that safety is a prime reason for establishing UDIs. Among other things, a UDI would help investigators track data on particular medical devices that had failed or that had been recalled. A UDI number in an EHR also could tell surgeons in advance which kinds of devices a patient had implanted in him before the doctor performed follow-up surgery.
Additionally, she said, UDIs could help hospitals make sure they are accurately charging for devices, and they could also capture data for inventory and supply chain purposes. "Right now, there are significant costs to healthcare because of products that sit on the shelf and inventory that gets lost, has expired, or is recalled."
In 2007, Congress required the FDA to formulate a regulation on UDIs. The agency did a proof-of-concept test in 2009 to figure out what data suppliers would have to provide to make UDIs useful and feasible. When the FDA issues its final regulation on UDIs, suppliers will have to include them on all packaging and publish the identification numbers to an FDA database.
The FDA has been working closely with U.S. supplier groups to let them know what's coming so they can prepare for the UDI, said Conway. "It's going to be a significant expense [for suppliers], but I think people recognize the value."
Meanwhile, a group of leading providers known as the Healthcare Transformation Group has asked the FDA to adopt the GS1 product identification standard as the official UDI. The members of the group--which includes Geisinger Health System, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic, and the St. Louis-based Mercy system--have also demanded that their top five suppliers apply GS1 identification codes to all of the products they distribute as soon as possible.
Conway said that the FDA plans to allow device suppliers to use either the GS1 or the competing HBCC standard if they comply with its UDI requirements, because some devices bear the HBCC imprint. However, she added, the market seems to be moving decisively toward the GS1 standard.
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